{"id":"mercaptopurine","rwe":[{"pmid":"41851112","year":"2026","title":"Solvation-mediated isomerization of surface motifs tunes emissions and electron transfer dynamics in gold nanoclusters.","finding":"","journal":"Nature communications","studyType":"Clinical Study"},{"pmid":"41834326","year":"2026","title":"Prospective Collaborative Study for Pulse Dexamethasone and Lenalidomide in Relapsed/Refractory Langerhans Cell Histiocytosis (LENDEX-LCH Study): INPHOG-HIST-19-03 (CTRI/2020/07/026937).","finding":"","journal":"Pediatric blood & cancer","studyType":"Clinical Study"},{"pmid":"41826961","year":"2026","title":"6-mercaptopurine and tofacitinib alter microbial protein expression but not composition in fecal microbiota incubations from Crohn's disease patients.","finding":"","journal":"BMC biology","studyType":"Clinical Study"},{"pmid":"41819030","year":"2026","title":"Optimizing mercaptopurine therapy in indian pediatric ALL: The role of TPMT and NUDT15 genetic polymorphisms.","finding":"","journal":"Cancer treatment and research communications","studyType":"Clinical Study"},{"pmid":"41788072","year":"2026","title":"PHARMACOGENETIC MARKERS IN PEDIATRIC ACUTE LYMPHOBLASTIC LEUKEMIA THERAPY.","finding":"","journal":"Experimental oncology","studyType":"Clinical Study"}],"_fda":{"id":"b78ac663-f9b6-4359-a353-7b7243b11da5","set_id":"0a366cf3-91f0-4aa4-8f34-a7a27cad8f15","openfda":{"unii":["E7WED276I5"],"route":["ORAL"],"rxcui":["1536484"],"spl_id":["b78ac663-f9b6-4359-a353-7b7243b11da5"],"brand_name":["MERCAPTOPURINE"],"spl_set_id":["0a366cf3-91f0-4aa4-8f34-a7a27cad8f15"],"package_ndc":["0054-0879-49"],"product_ndc":["0054-0879"],"generic_name":["MERCAPTOPURINE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["MERCAPTOPURINE"],"manufacturer_name":["Hikma Pharmaceuticals USA Inc."],"application_number":["ANDA216418"],"is_original_packager":[true]},"version":"2","pregnancy":["8.1 Pregnancy Risk Summary Mercaptopurine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Pregnant women who receive mercaptopurine have an increased incidence of miscarriage and stillbirth (see Data ) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Women receiving mercaptopurine in the first trimester of pregnancy have an increased incidence of miscarriage; the risk of malformation in offspring surviving first trimester exposure is not known. In a series of 28 women receiving mercaptopurine after the first trimester of pregnancy, 3 mothers died prior to delivery, 1 delivered a stillborn child, and 1 aborted; there were no cases of macroscopically abnormal fetuses. Animal Data Mercaptopurine was embryo-lethal and teratogenic in several animal species (rat, mouse, rabbit, and hamster) at doses less than the recommended human dose."],"overdosage":["10 OVERDOSAGE Signs and symptoms of mercaptopurine overdosage may be immediate (anorexia, nausea, vomiting, and diarrhea) or delayed (myelosuppression, liver dysfunction, and gastroenteritis). Dialysis cannot be expected to clear mercaptopurine. Hemodialysis is thought to be of marginal use due to the rapid intracellular incorporation of mercaptopurine into active metabolites with long persistence. Withhold mercaptopurine immediately if severe or life-threatening adverse reactions occur during treatment. If a patient is seen immediately following an accidental overdosage, it may be useful to induce emesis."],"references":["15 REFERENCES 1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html"],"description":["11 DESCRIPTION Mercaptopurine is a nucleoside metabolic inhibitor. The chemical name is 6 H -purine-6-thione, 1,7-dihydro-, monohydrate. The molecular formula is C 5 H 4 N 4 S•H 2 O and the molecular weight is 170.20. The structural formula is: Mercaptopurine, USP is a yellow, crystalline powder; odorless. It is practically insoluble in water and in ether; slightly soluble in ethanol (96%). It dissolves in solutions of alkali hydroxides; pKa 7.8, 11.2. Mercaptopurine oral suspension contains 2,000 mg/100 mL (20 mg/mL) of mercaptopurine, USP. The suspension also contains the following inactive ingredients: aspartame, ethylparaben sodium, hydrochloric acid, methylparaben sodium, potassium sorbate, raspberry juice powder (raspberry juice, rice syrup solids, silicon dioxide), sodium hydroxide, sucrose, water (purified), xanthan gum. Mercaptopurine oral suspension is a pink to brown viscous suspension. Chemical Structure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Mercaptopurine Oral Suspension is supplied as 2,000 mg/100 mL (20 mg/mL) pink to brown viscous liquid in amber glass multiple-dose bottles. In addition, a press-in bottle adapter and two oral dispensing syringes (one 1 mL and one 5 mL) are provided. Each carton NDC 0054-0879-49 contains 1 bottle of Mercaptopurine Oral Suspension NDC 0054-0879-49. • Store Mercaptopurine Oral Suspension at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Store in a dry place. Mercaptopurine is a hazardous drug. Follow special handling and disposal procedures. 1"],"geriatric_use":["8.5 Geriatric Use Clinical studies of mercaptopurine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or another drug therapy."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness of mercaptopurine has been established in pediatric patients. Use of mercaptopurine in pediatrics is supported by evidence from the published literature and clinical experience. Symptomatic hypoglycemia has been reported in pediatric patients with ALL receiving mercaptopurine. Reported cases were in pediatrics less than 6 years or with a low body mass index."],"effective_time":"20250404","pharmacodynamics":["12.2 Pharmacodynamics Exposure-Response Relationships Mercaptopurine exposure-response relationships and the time course of pharmacodynamics response are unknown."],"pharmacogenomics":["12.5 Pharmacogenomics Several published studies indicate that patients with reduced TPMT or NUDT15 activity receiving usual doses of mercaptopurine, accumulate excessive cellular concentrations of active 6-TGNs, and are at higher risk for severe myelosuppression [see Warnings and Precautions ( 5.1 )] . In a study of 1028 children with ALL, the approximate tolerated mercaptopurine dosage for patients with TPMT and/or NUDT15 deficiency on mercaptopurine maintenance therapy (as a percentage of the planned dosage) was as follows: heterozygous for either TPMT or NUDT15, 50-90%; heterozygous for both TPMT and NUDT15, 30-50%; homozygous for either TPMT or NUDT15, 5-10%. Approximately 0.3% (1:300) of patients of European or African ancestry have two loss-of-function alleles of the TPMT gene and have little or no TPMT activity (homozygous deficient or poor metabolizers), and approximately 10% of patients have one loss-of-function TPMT allele leading to intermediate TPMT activity (heterozygous deficient or intermediate metabolizers). The TPMT*2, TPMT*3A, and TPMT*3C alleles account for about 95% of individuals with reduced levels of TPMT activity. NUDT15 deficiency is detected in <1% of patients of European or African ancestry. Among patients of East Asian ancestry (i.e., Chinese, Japanese, Vietnamese), 2% have two loss-of-function alleles of the NUDT15 gene, and approximately 21% have one loss-of-function allele. The p.R139C variant of NUDT15 (present on the *2 and *3 alleles) is the most commonly observed, but other less common loss-of-function NUDT15 alleles have been observed. Consider all clinical information when interpreting results from phenotypic testing used to determine the level of thiopurine nucleotides or TPMT activity in erythrocytes, since some coadministered drugs can influence measurement of TPMT activity in blood, and blood from recent transfusions will misrepresent a patient’s actual TPMT activity [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] ."],"pharmacokinetics":["12.3 Pharmacokinetics Following a single oral dose of mercaptopurine 50 mg under fasted conditions to adult healthy subjects, the median (min – max) AUC 0-INF was 137 h∙ng/mL (77 – 268 h∙ng/mL) and C max was 93 ng/mL (40 – 204 ng/mL). Absorption Mercaptopurine is absorbed after oral administration with a median (min – max) T max of 0.75 (0.33 – 2.5) hours. Effect of Food Food has been shown to decrease the exposure of mercaptopurine. Distribution The volume of distribution exceeds total body water with a mean volume of distribution of approximately 0.9 L/kg. There is negligible entry of mercaptopurine into cerebrospinal fluid. Plasma protein binding averages 19% over the concentration range 10 to 50 mcg/L. Elimination The median (min – max) elimination half-life (t 1/2 ) was 1.3 (0.9 – 5.4) hours. Metabolism Mercaptopurine is inactivated via two major pathways. One is thiol methylation, which is catalyzed by the polymorphic enzyme thiopurine S-methyltransferase (TPMT), to form the inactive metabolite methyl-mercaptopurine. The second inactivation pathway is oxidation, which is catalyzed by xanthine oxidase. The product of oxidation is the inactive metabolite 6-thiouric acid. Elimination After oral administration of mercaptopurine, urine contains intact mercaptopurine, thiouric acid (formed by direct oxidation by xanthine oxidase, probably via 6-mercapto-8-hydroxypurine), and a number of 6-methylated thiopurines. In one subject, a total of 46% of the dose could be accounted for in the urine (as parent drug and metabolites) in the first 24 hours. Specific Populations Pediatric Patients Wide inter individual variations in systemic exposure is observed. Following oral administration of 50 mg/m 2 mercaptopurine in 10 children, median plasma concentrations 1 hour post dose was 0.35 (range 0.03 to 1.03) μM and median AUC 1–5hours was 56 (range 23 to 65) μM·min. T max ranged from 1 to 3 hours. Drug Interactions Studies Methotrexate: Mercaptopurine AUC increased by approximately 31% when coadministered with oral methotrexate 20 mg/m 2 . Mercaptopurine AUC increased by 69% when coadministered with IV methotrexate 2 g/m 2 , and by 93% when coadministered with IV methotrexate 5 g/m 2 ."],"adverse_reactions":["6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Myelosuppression [see Warnings and Precautions ( 5.1 )] • Hepatotoxicity [see Warnings and Precautions ( 5.2 )] • Immunosuppression [see Warnings and Precautions ( 5.3 )] • Treatment Related Malignancies [see Warnings and Precautions ( 5.4 )] • Macrophage Activation Syndrome [see Warnings and Precautions ( 5.5 )] The most common adverse reaction (>20%) is myelosuppression, including anemia, neutropenia, lymphopenia and thrombocytopenia. Adverse reactions occurring in 5% to 20% of patients include anorexia, nausea, vomiting, diarrhea, malaise and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Based on multicenter cooperative group ALL trials, the most common adverse reaction occurring in > 20% of patients was myelosuppression, including anemia, neutropenia, lymphopenia and thrombocytopenia. Adverse reactions occurring in 5% to 20% of patients included anorexia, nausea, vomiting, diarrhea, malaise, and rash. Adverse reactions occurring in < 5% of patients included urticaria, hyperuricemia, oral lesions, elevated transaminases, hyperbilirubinemia, hyperpigmentation, infections, and pancreatitis. Oral lesions resemble thrush rather than antifolic ulcerations. Delayed or late toxicities include hepatic fibrosis, hyperbilirubinemia, alopecia, pulmonary fibrosis, oligospermia and secondary malignancies [see Warnings and Precautions ( 5.1 , 5.2 )] . Drug fever has been reported with mercaptopurine. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of mercaptopurine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: photosensitivity, hypoglycemia, portal hypertension, intrahepatic cholestasis of pregnancy (ICP), pellagra, and erythema nodosum."],"contraindications":["4 CONTRAINDICATIONS None. • None"],"drug_interactions":["7 DRUG INTERACTIONS • Allopurinol : Reduce the dose of mercaptopurine when coadministered with allopurinol. ( 2.4 , 7.1 ) • Warfarin : Mercaptopurine may decrease the anticoagulant effect. ( 7.2 ) 7.1 Allopurinol Allopurinol can inhibit the first-pass oxidative metabolism of mercaptopurine by xanthine oxidase, which can lead to an increased risk of mercaptopurine adverse reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )] . Reduce the dose of mercaptopurine when coadministered with allopurinol [see Dosage and Administration ( 2.4 )] . 7.2 Warfarin The coadministration of mercaptopurine with warfarin may decrease the anticoagulant effectiveness of warfarin. Monitor the international normalized ratio (INR) in patients receiving warfarin and adjust the warfarin dosage as appropriate. 7.3 Myelosuppressive Products Mercaptopurine can cause myelosuppression. Myelosuppression may be increased when mercaptopurine is coadministered with other drugs that cause myelosuppression. Enhanced myelosuppression has been noted in some patients receiving trimethoprim-sulfamethoxazole. Monitor the CBC and adjust the dose of mercaptopurine for excessive myelosuppression [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.1 )] . 7.4 Aminosalicylates Aminosalicylates (e.g., mesalamine, olsalazine or sulfasalazine) may inhibit the TPMT enzyme, which may increase the risk of myelosuppression when coadministered with mercaptopurine. When aminosalicylates and mercaptopurine are coadministered, use the lowest possible doses for each drug and monitor more frequently for myelosuppression [see Warnings and Precautions ( 5.1 )] . 7.5 Hepatotoxic Products Mercaptopurine can cause hepatotoxicity. Hepatotoxicity may be increased when mercaptopurine is coadministered with other products that cause hepatotoxicity. Monitor liver tests more frequently in patients who are receiving mercaptopurine with other hepatotoxic products [see Warnings and Precautions ( 5.2 )] . 7.6 Methotrexate Mercaptopurine dosage may need adjustment when administered concomitantly with high dose methotrexate [see Warnings and Precautions ( 5.1 )] . Mercaptopurine exposure increases with concomitant methotrexate use [see Clinical Pharmacology ( 12.3 )] which may increase the risk of mercaptopurine adverse reactions. The mechanism of this interaction has not been fully characterized [see Clinical Pharmacology ( 12.3 )] ."],"mechanism_of_action":["12.1 Mechanism of Action Mercaptopurine is a purine analog that undergoes intracellular transport and activation to form metabolites including thioguanine nucleotides (TGNs). Incorporation of TGNs into DNA or RNA results in cell-cycle arrest and cell death. TGNs and other mercaptopurine metabolites are also inhibitors of de novo purine synthesis and purine nucleotide interconversions. Mercaptopurine was cytotoxic to proliferating cancer cells in vitro and had antitumor activity in mouse tumor models. It is not known which of the biochemical effects of mercaptopurine and its metabolites are directly or predominantly responsible for cell death."],"instructions_for_use":["INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE Mercaptopurine (mer kapʺ toe pureʹ een) Oral Suspension 20 mg/mL Read these Instructions for Use before you start taking Mercaptopurine Oral Suspension, and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Important information about measuring Mercaptopurine Oral Suspension • Always use the oral dispensing syringe provided with your Mercaptopurine Oral Suspension to make sure you measure the right amount. • You will be provided: • 1 bottle of Mercaptopurine Oral Suspension • 1 bottle adapter • 2 oral dispensing syringes (one 1 mL and one 5 mL) If you did not receive an oral dispensing syringe with your Mercaptopurine Oral Suspension, ask your pharmacist to give you one. You will also need disposable gloves. Important Information You Need to Know Before Administering Mercaptopurine Oral Suspension: 1. Wash your hands well with soap and water before and after administering a dose. 2. Put on disposable gloves before handling Mercaptopurine Oral Suspension. 3. Shake the bottle vigorously for at least 30 seconds to make sure that the medicine is well mixed (See Figure A ) . Figure A 4. Remove the child-resistant bottle cap (See Figure B ). Figure B 5. Push the smaller end of the bottle adapter into the neck of the bottle until it is firmly in place. The bottom edge of the adapter should fully contact the top rim of the bottle (See Figure C ). Do not remove the adapter from the bottle after it is inserted. Figure C Preparing a dose of Mercaptopurine Oral Suspension: 6. Hold the bottle upright. Remove the bottle cap by turning in the direction of the arrow (See Figure B ). 7. Push the tip of the oral dispensing syringe into the hole in the bottle adapter (See Figure D and Figure E ). Figure D Figure E 8. Turn the bottle upside down (See Figure F ). Figure F 9. Pull back slowly on the plunger of the oral dispensing syringe to withdraw the prescribed dose of Mercaptopurine Oral Suspension. Pull the plunger back to the mL mark on the syringe that corresponds to the dose prescribed ( Figure F ). If you are not sure about how much medicine to draw into the oral dispensing syringe, always ask your doctor, pharmacist or nurse for advice. 10. Leave the oral dispensing syringe in the bottle adapter and turn the bottle right-side up. Place the bottle onto a flat surface. Hold the oral dispensing syringe by the barrel and carefully remove it from the adapter. Do not hold the oral dispensing syringe by the plunger, because the plunger may come out. 11. Place the tip of the oral dispensing syringe in your mouth and aim the tip toward the inside of your cheek. 12. Gently squirt the Mercaptopurine Oral Suspension into your mouth by pushing on the plunger until the oral dispensing syringe is empty. Swallow the medicine. • Do not forcefully push on the plunger. • Do not squirt the medicine to the back of your mouth or throat. This may cause you to choke. 13. Remove the oral dispensing syringe from your mouth. 14. Swallow the dose of oral suspension then drink some water, making sure no medicine is left in your mouth. 15. Put the cap back on the bottle with the adapter left in place. Close the cap tightly. 16. Wash the oral dispensing syringe with warm soapy water and rinse well. Hold the oral dispensing syringe under water and move the plunger up and down several times to make sure the inside of the oral dispensing syringe is clean. Let the oral dispensing syringe dry completely before you use it again for dosing. Do not throw away the oral dispensing syringe after use. Ingredients in Mercaptopurine Oral Suspension Active ingredient: mercaptopurine, USP Inactive ingredients: aspartame, ethylparaben sodium, hydrochloric acid, methylparaben sodium, potassium sorbate, raspberry juice powder (raspberry juice, rice syrup solids, silicon dioxide), sodium hydroxide, sucrose, water (purified), xanthan gum. Storing Mercaptopurine Oral Suspension • Store Mercaptopurine Oral Suspension at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Store in a dry place. Do not store above 25°C. • Store the oral dispensing syringe in a clean place, with the medicine. • Mercaptopurine Oral Suspension should be used within 8 weeks after opening the bottle. Dispose of (throw away) any unused medicine after 8 weeks. • Do not use after the expiry date which is stated on the carton and the bottle after ‘EXP’. • Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage. • Keep Mercaptopurine Oral Suspension and all medicines out of the reach of children, preferably in a locked cupboard. If a child accidentally takes Mercaptopurine Oral Suspension, it could cause death. Ask your pharmacist how to dispose of (throw away) Mercaptopurine Oral Suspension that is no longer needed. Disposing of Mercaptopurine Oral Suspension • Ask your pharmacist how to dispose of Mercaptopurine Oral Suspension that is expired or no longer required. Medicines should not be disposed of via wastewater or household waste. Clean Up Spillage of Mercaptopurine Oral Suspension Use appropriate personal protective equipment (disposable gloves and eye protection). Mop up and contain spill material in a compatible container. Wash your hands thoroughly afterwards. Mercaptopurine Oral Suspension Contact with Skin, Eyes, or Clothes • Remove and launder contaminated clothing. • Wash skin or eyes immediately with water. Contact with skin or eyes can cause hypersensitive reactions resulting in rash, redness, itching and inflammation. If symptoms appear, seek medical attention. This “Instructions for Use” has been approved by the U.S. Food and Drug Administration. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50001544/01 Revised April 2025 Figure A Figure B Figure C Figure D Figure E Figure F"],"recent_major_changes":["Warnings and Precautions, Hepatotoxicity ( 5.2 ) 7/2024"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Mercaptopurine is a purine analog that undergoes intracellular transport and activation to form metabolites including thioguanine nucleotides (TGNs). Incorporation of TGNs into DNA or RNA results in cell-cycle arrest and cell death. TGNs and other mercaptopurine metabolites are also inhibitors of de novo purine synthesis and purine nucleotide interconversions. Mercaptopurine was cytotoxic to proliferating cancer cells in vitro and had antitumor activity in mouse tumor models. It is not known which of the biochemical effects of mercaptopurine and its metabolites are directly or predominantly responsible for cell death. 12.2 Pharmacodynamics Exposure-Response Relationships Mercaptopurine exposure-response relationships and the time course of pharmacodynamics response are unknown. 12.3 Pharmacokinetics Following a single oral dose of mercaptopurine 50 mg under fasted conditions to adult healthy subjects, the median (min – max) AUC 0-INF was 137 h∙ng/mL (77 – 268 h∙ng/mL) and C max was 93 ng/mL (40 – 204 ng/mL). Absorption Mercaptopurine is absorbed after oral administration with a median (min – max) T max of 0.75 (0.33 – 2.5) hours. Effect of Food Food has been shown to decrease the exposure of mercaptopurine. Distribution The volume of distribution exceeds total body water with a mean volume of distribution of approximately 0.9 L/kg. There is negligible entry of mercaptopurine into cerebrospinal fluid. Plasma protein binding averages 19% over the concentration range 10 to 50 mcg/L. Elimination The median (min – max) elimination half-life (t 1/2 ) was 1.3 (0.9 – 5.4) hours. Metabolism Mercaptopurine is inactivated via two major pathways. One is thiol methylation, which is catalyzed by the polymorphic enzyme thiopurine S-methyltransferase (TPMT), to form the inactive metabolite methyl-mercaptopurine. The second inactivation pathway is oxidation, which is catalyzed by xanthine oxidase. The product of oxidation is the inactive metabolite 6-thiouric acid. Elimination After oral administration of mercaptopurine, urine contains intact mercaptopurine, thiouric acid (formed by direct oxidation by xanthine oxidase, probably via 6-mercapto-8-hydroxypurine), and a number of 6-methylated thiopurines. In one subject, a total of 46% of the dose could be accounted for in the urine (as parent drug and metabolites) in the first 24 hours. Specific Populations Pediatric Patients Wide inter individual variations in systemic exposure is observed. Following oral administration of 50 mg/m 2 mercaptopurine in 10 children, median plasma concentrations 1 hour post dose was 0.35 (range 0.03 to 1.03) μM and median AUC 1–5hours was 56 (range 23 to 65) μM·min. T max ranged from 1 to 3 hours. Drug Interactions Studies Methotrexate: Mercaptopurine AUC increased by approximately 31% when coadministered with oral methotrexate 20 mg/m 2 . Mercaptopurine AUC increased by 69% when coadministered with IV methotrexate 2 g/m 2 , and by 93% when coadministered with IV methotrexate 5 g/m 2 . 12.5 Pharmacogenomics Several published studies indicate that patients with reduced TPMT or NUDT15 activity receiving usual doses of mercaptopurine, accumulate excessive cellular concentrations of active 6-TGNs, and are at higher risk for severe myelosuppression [see Warnings and Precautions ( 5.1 )] . In a study of 1028 children with ALL, the approximate tolerated mercaptopurine dosage for patients with TPMT and/or NUDT15 deficiency on mercaptopurine maintenance therapy (as a percentage of the planned dosage) was as follows: heterozygous for either TPMT or NUDT15, 50-90%; heterozygous for both TPMT and NUDT15, 30-50%; homozygous for either TPMT or NUDT15, 5-10%. Approximately 0.3% (1:300) of patients of European or African ancestry have two loss-of-function alleles of the TPMT gene and have little or no TPMT activity (homozygous deficient or poor metabolizers), and approximately 10% of patients have one loss-of-function TPMT allele leading to intermediate TPMT activity (heterozygous deficient or intermediate metabolizers). The TPMT*2, TPMT*3A, and TPMT*3C alleles account for about 95% of individuals with reduced levels of TPMT activity. NUDT15 deficiency is detected in <1% of patients of European or African ancestry. Among patients of East Asian ancestry (i.e., Chinese, Japanese, Vietnamese), 2% have two loss-of-function alleles of the NUDT15 gene, and approximately 21% have one loss-of-function allele. The p.R139C variant of NUDT15 (present on the *2 and *3 alleles) is the most commonly observed, but other less common loss-of-function NUDT15 alleles have been observed. Consider all clinical information when interpreting results from phenotypic testing used to determine the level of thiopurine nucleotides or TPMT activity in erythrocytes, since some coadministered drugs can influence measurement of TPMT activity in blood, and blood from recent transfusions will misrepresent a patient’s actual TPMT activity [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] ."],"indications_and_usage":["1 INDICATIONS AND USAGE Mercaptopurine is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia Mercaptopurine is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS • Myelosuppression : Monitor complete blood count (CBC) and adjust the dose of mercaptopurine for excessive myelosuppression. Consider testing in patients with severe myelosuppression or repeated episodes of myelosuppression for thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) deficiency. Patients with homozygous-TPMT or homozygous-NUDT15 deficiency may require a dose reduction. ( 2.2 , 5.1 ) • Hepatotoxicity : Monitor transaminases, alkaline phosphatase and bilirubin. Withhold mercaptopurine at onset of hepatotoxicity. ( 5.2 ) • Immunosuppression : Response to all vaccines may be diminished and there is a risk of infection with live virus vaccines. Consult immunization guidelines for immunocompromised pediatrics. ( 5.3 ) • Treatment Related Malignancies : Aggressive and fatal cases of hepatosplenic T-cell lymphoma have occurred. ( 5.4 ) • Macrophage Activation Syndrome : Monitor for and treat promptly; discontinue mercaptopurine. ( 5.5 ) • Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 ) • Phenylketonuria : Patients should be informed that mercaptopurine oral suspension contains phenylalanine, a component of aspartame. Each mL of the 20 mg/mL oral suspension contains 0.015 mg of phenylalanine. ( 5.7 ) 5.1 Myelosuppression The most consistent, dose-related adverse reaction of mercaptopurine is myelosuppression, manifested by anemia, leukopenia, thrombocytopenia, or any combination of these. Monitor CBC and adjust the dosage of mercaptopurine for excessive myelosuppression [see Dosage and Administration ( 2.1 )] . Consider testing for thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) deficiency in patients with severe myelosuppression or repeated episodes of myelosuppression. TPMT genotyping or phenotyping (red blood cell TPMT activity) and NUDT15 genotyping can identify patients who have reduced activity of these enzymes. Patients with homozygous TPMT or NUDT15 deficiency may require a dose reduction [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.5 )] . Myelosuppression can be exacerbated by coadministration with allopurinol, aminosalicylates or other products that cause myelosuppression [see Drug Interactions ( 7.1 , 7.3 , 7.4 )] . Reduce the dosage of mercaptopurine when coadministered with allopurinol [see Dosage and Administration ( 2.4 )] . 5.2 Hepatotoxicity Mercaptopurine is hepatotoxic. There are reports of deaths attributed to hepatic necrosis associated with the administration of mercaptopurine. Hepatic injury can occur with any dosage but seems to occur with greater frequency when the recommended dosage is exceeded. In some patients, jaundice has cleared following withdrawal of mercaptopurine and reappeared with rechallenge. Usually, clinically detectable jaundice appears early in the course of treatment (1 to 2 months); however, jaundice has been reported as early as 1 week and as late as 8 years after starting mercaptopurine. The hepatotoxicity has been associated in some cases with anorexia, diarrhea, jaundice, ascites, and pruritus. Hepatic encephalopathy has occurred. Monitor serum transaminase levels, alkaline phosphatase, and bilirubin levels at weekly intervals when first beginning therapy and at monthly intervals thereafter. Monitor liver tests more frequently in patients who are receiving mercaptopurine with other hepatotoxic drugs [see Drug Interactions ( 7.5 )] or with known pre-existing liver disease. Withhold mercaptopurine at onset of hepatotoxicity. Intrahepatic Cholestasis of Pregnancy Postmarketing cases of intrahepatic cholestasis of pregnancy (ICP) have been reported in patients with inflammatory bowel disease who received mercaptopurine during pregnancy. Mercaptopurine is not indicated for use in inflammatory bowel disease [see Indications and Usage ( 1.1 )] . Discontinue mercaptopurine if ICP develops in a pregnant woman . 5.3 Immunosuppression Mercaptopurine is immunosuppressive and may impair the immune response to infectious agents or vaccines. Due to the immunosuppression associated with maintenance chemotherapy for ALL, response to all vaccines may be diminished and there is a risk of infection with live virus vaccines. Consult immunization guidelines for immunocompromised patients. 5.4 Treatment Related Malignancies Hepatosplenic T-cell lymphoma has been reported in patients treated with mercaptopurine for inflammatory bowel disease (IBD), an unapproved use. Mercaptopurine is mutagenic in animals and humans, carcinogenic in animals, and may increase the risk of secondary malignancies. Patients receiving immunosuppressive therapy, including mercaptopurine, are at an increased risk of developing lymphoproliferative disorders and other malignancies, notably skin cancers (melanoma and non-melanoma), sarcomas (Kaposi’s and non-Kaposi’s) and uterine cervical cancer in situ. The increased risk appears to be related to the degree and duration of immunosuppression. It has been reported that discontinuation of immunosuppression may provide partial regression of the lymphoproliferative disorder. A treatment regimen containing multiple immunosuppressants (including thiopurines) should therefore be used with caution as this could lead to lymphoproliferative disorders, some with reported fatalities. A combination of multiple immunosuppressants, given concomitantly increases the risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders. 5.5 Macrophage Activation Syndrome Macrophage activation syndrome (MAS) (hemophagocytic lymphohistiocytosis) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD), and there could potentially be an increased susceptibility for developing the condition with the use of mercaptopurine (an unapproved use). If MAS occurs, or is suspected, discontinue mercaptopurine. Monitor for and promptly treat infections such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS. 5.6 Embryo-Fetal Toxicity Mercaptopurine can cause fetal harm when administered to a pregnant woman. An increased incidence of miscarriage has been reported in women who received mercaptopurine in the first trimester of pregnancy. Adverse embryo-fetal findings, including miscarriage and stillbirth, have been reported in women who received mercaptopurine after the first trimester of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with mercaptopurine and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with mercaptopurine and for 3 months after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] . 5.7 Risks in Patients with Phenylketonuria Phenylalanine can be harmful to patients with phenylketonuria (PKU). Phenylketonuric patients should be informed that mercaptopurine oral suspension contains phenylalanine, a component of aspartame. Each mL of the mercaptopurine oral suspension, 20 mg/mL contains 0.015 mg of phenylalanine."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Mercaptopurine is carcinogenic in animals. Mercaptopurine causes chromosomal aberrations in cells derived from animals and humans and induces dominant-lethal mutations in the germ cells of male mice. Mercaptopurine can impair fertility. In mice, surviving female offspring of mothers who received chronic low doses of mercaptopurine during pregnancy were found sterile, or if they became pregnant, had smaller litters and more dead fetuses as compared to control animals."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patients and caregivers to read the FDA-approved patient labelling (Patient Information and Instructions for Use). Major Adverse Reactions Advise patients and caregivers that mercaptopurine can cause myelosuppression, hepatotoxicity, and gastrointestinal toxicity. Advise patients to contact their healthcare provider if they experience fever, sore throat, jaundice, nausea, vomiting, signs of local infection, bleeding from any site, or symptoms suggestive of anemia [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Proper Preparation and Administration Advise patients or caregivers on proper handling, storage, preparation, administration, and disposal and clean-up of accidental spillage of the medication prior to initiation and on each visit to the clinic [see Dosage and Administration ( 2.5 )] . Embryo-Fetal Toxicity • Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.2 , 5.6 ), Use in Specific Populations ( 8.1 )] . • Advise females of reproductive potential to use effective contraception during treatment with mercaptopurine and for 6 months after the last dose [see Use in Specific Populations ( 8.3 )] . • Advise males with female partners of reproductive potential to use effective contraception during treatment with mercaptopurine and for 3 months after the last dose [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )] . Lactation Advise women not to breastfeed during treatment with mercaptopurine and for 1 week after the last dose [see Use in Specific Populations ( 8.2 )] . Infertility Advise males and females of reproductive potential that mercaptopurine can impair fertility [see Use in Specific Populations ( 8.3 )] . Other Adverse Reactions Instruct patients to minimize sun exposure due to risk of photosensitivity [see Adverse Reactions ( 6.2 )] . Patients with Phenylketonuria Inform patients with phenylketonuria that each mL of mercaptopurine oral suspension contains 0.015 mg of phenylalanine [see Warnings and Precautions ( 5.7 )] . Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50001544/01 Revised April 2025"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION • The recommended starting dosage of mercaptopurine oral suspension is 1.5 mg/kg to 2.5 mg/kg (50 mg/m 2 to 75 mg/m 2 ) orally once daily as part of a combination chemotherapy maintenance regimen. Adjust dose to maintain desirable absolute neutrophil count and for excessive myelosuppression. ( 2.1 ) • Renal Impairment : Use the lowest recommended starting dose or increase the dosing interval. ( 2.3 , 8.6 ) • Hepatic Impairment : Use the lowest recommended starting dose. ( 2.3 , 8.7 ) 2.1 Recommended Dosage The recommended starting dose of mercaptopurine oral suspension is 1.5 mg/kg to 2.5 mg/kg (50 mg/m 2 to 75 mg/m 2 ) orally once daily as part of combination chemotherapy maintenance regimen. Take mercaptopurine oral suspension either consistently with or without food. After initiating mercaptopurine, monitor complete blood counts (CBC) and adjust the dose to maintain absolute neutrophil count (ANC) at a desirable level and for excessive myelosuppression. Evaluate the bone marrow in patients with prolonged myelosuppression or repeated episodes of myelosuppression to assess leukemia status and marrow cellularity. Evaluate thiopurine S-methyltransferase (TPMT) and nucleotide diphosphatase (NUDT15) status in patients with severe myelosuppression or repeated episodes of myelosuppression [see Dosage and Administration ( 2.2 )] . If a patient misses a dose, instruct the patient to continue with the next scheduled dose. 2.2 Dosage Modifications in Patients with TPMT and NUDT15 Deficiency Consider testing for TPMT and NUDT15 deficiency in patients who experience severe myelosuppression or repeated episodes of myelosuppression [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.5 )] . Homozygous Deficiency in either TPMT or NUDT15 Patients with homozygous deficiency of either enzyme typically require 10% or less of the recommended dosage. Reduce the recommended starting dosage of mercaptopurine in patients who are known to have homozygous TPMT or NUDT15 deficiency. Heterozygous Deficiency in TPMT and/or NUDT15 Reduce the mercaptopurine dosage based on tolerability. Most patients with heterozygous TPMT or NUDT15 deficiency tolerate recommended dosage, but some require dose reduction based on adverse reactions. Patients who are heterozygous for both TPMT and NUDT15 may require more substantial dose reductions. 2.3 Dosage Modifications in Renal and Hepatic Impairment Renal Impairment Use the lowest recommended starting dosage for mercaptopurine in patients with renal impairment (CLcr less than 50 mL/min). Adjust the dosage to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see Uses in Specific Populations ( 8.6 )] . Hepatic Impairment Use the lowest recommended starting dosage for mercaptopurine in patients with hepatic impairment. Adjust the dosage to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see Uses in Specific Populations ( 8.7 )] . 2.4 Dosage Modification with Concomitant Use of Allopurinol Reduce the dose of mercaptopurine to one-third to one-quarter of the current dosage when coadministered with allopurinol [see Drug Interactions ( 7.1 )] . 2.5 Administration Shake the bottle vigorously for at least 30 seconds to ensure the oral suspension is well mixed. Mercaptopurine oral suspension is a pink to brown viscous oral suspension. Provide a press-in bottle adapter and two oral dispensing syringes (one 1 mL and one 5 mL). Train patients or caregivers on proper handling, storage, administration, disposal and clean-up of accidental spillage prior to initiation of mercaptopurine oral suspension and during each visit to the clinic. Advise patients and caregivers to use mercaptopurine oral suspension within 8 weeks and properly discard remaining mercaptopurine oral suspension after 8 weeks. Provide instructions regarding which syringe to use and how to administer the specified dose, since mercaptopurine oral suspension is supplied with 1 mL and 5 mL oral dispensing syringes. Advise patients that the oral dispensing syringe is intended for multiple uses and provide the following instructions: • Wash the oral dispensing syringe with warm ‘soapy’ water and rinse well; • Hold the oral dispensing syringe under water and move the plunger up and down several times to make sure the inside of the oral dispensing syringe is clean; • Ensure the oral dispensing syringe is completely dry before use of the oral dispensing syringe again; and • Store the oral dispensing syringe in a hygienic place with mercaptopurine oral suspension. Mercaptopurine is a hazardous drug. Follow special handling and disposal procedures. 1"],"spl_product_data_elements":["MERCAPTOPURINE MERCAPTOPURINE MERCAPTOPURINE MERCAPTOPURINE ANHYDROUS ASPARTAME ETHYLPARABEN SODIUM HYDROCHLORIC ACID METHYLPARABEN SODIUM POTASSIUM SORBATE RASPBERRY JUICE CORN SYRUP SILICON DIOXIDE SODIUM HYDROXIDE SUCROSE WATER XANTHAN GUM Pink to Brown"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Oral Suspension: 2,000 mg/100 mL (20 mg/mL) pink to brown in color. Oral suspension: 2,000 mg/100 mL (20 mg/mL) ( 3 )"],"instructions_for_use_table":["<table width=\"100%\"><col width=\"5%\"/><col width=\"59%\"/><col width=\"37%\"/><tbody><tr><td colspan=\"3\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Important Information You Need to Know Before Administering Mercaptopurine Oral Suspension:</content></paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>1.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Wash your hands well with soap and water before and after administering a dose.</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>2.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Put on disposable gloves before handling Mercaptopurine Oral Suspension.</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>3.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Shake the bottle vigorously for at least 30 seconds to make sure that the medicine is well mixed (See <linkHtml href=\"#FIG_A\">Figure A</linkHtml><content styleCode=\"underline\">)</content>.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph ID=\"FIG_A\"><renderMultiMedia ID=\"id1393385062\" referencedObject=\"C2672F8E-FEDB-4F0B-B52A-24A9CEEC0AF3\"/><content styleCode=\"bold\"> Figure A</content></paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>4.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Remove the child-resistant bottle cap (See <linkHtml href=\"#FIG_B\">Figure B</linkHtml>).</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph ID=\"FIG_B\"><renderMultiMedia ID=\"id-1948303362\" referencedObject=\"ID_6bfa1e70-b113-4e1b-8961-f9dd949fac02\"/><content styleCode=\"bold\"> Figure B</content></paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>5.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Push the smaller end of the bottle adapter into the neck of the bottle until it is firmly in place. The bottom edge of the adapter should fully contact the top rim of the bottle (See <linkHtml href=\"#FIG_C\">Figure C</linkHtml>). Do not remove the adapter from the bottle after it is inserted.</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph ID=\"FIG_C\"><renderMultiMedia ID=\"id-2137708845\" referencedObject=\"ID_2656282f-1ab9-4737-81d0-36c5c371b4a4\"/><content styleCode=\"bold\"> Figure C</content></paragraph></td></tr><tr><td colspan=\"3\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Preparing a dose of Mercaptopurine Oral Suspension:</content></paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>6.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Hold the bottle upright. Remove the bottle cap by turning in the direction of the arrow (See <linkHtml href=\"#FIG_B\">Figure B</linkHtml>). </paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>7.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Push the tip of the oral dispensing syringe into the hole in the bottle adapter (See <linkHtml href=\"#FIG_D\">Figure D</linkHtml> and <linkHtml href=\"#FIG_E\">Figure E</linkHtml>).</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph ID=\"FIG_D\"><renderMultiMedia ID=\"id1094134720\" referencedObject=\"ID_165a1ae0-bee4-45cc-8d18-b35f088ec23d\"/><content styleCode=\"bold\"> Figure D </content></paragraph><paragraph ID=\"FIG_E\"><renderMultiMedia ID=\"id-1594463122\" referencedObject=\"ID_4963e9f4-5728-413f-8a8a-7ebe396fbdcd\"/><content styleCode=\"bold\"> Figure E</content></paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>8.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Turn the bottle upside down (See <linkHtml href=\"#FIG_F\">Figure F</linkHtml>).</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph ID=\"FIG_F\"><renderMultiMedia ID=\"id-1360734942\" referencedObject=\"ID_2c52dc69-b28d-4245-9773-38e2595cafc2\"/><content styleCode=\"bold\"> Figure F</content></paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>9.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Pull back slowly on the plunger of the oral dispensing syringe to withdraw the prescribed dose of Mercaptopurine Oral Suspension. Pull the plunger back to the mL mark on the syringe that corresponds to the dose prescribed (<linkHtml href=\"#FIG_F\">Figure F</linkHtml>). If you are not sure about how much medicine to draw into the oral dispensing syringe, always ask your doctor, pharmacist or nurse for advice.  </paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>10.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Leave the oral dispensing syringe in the bottle adapter and turn the bottle right-side up. Place the bottle onto a flat surface. Hold the oral dispensing syringe by the barrel and carefully remove it from the adapter. <content styleCode=\"bold\">Do not</content> hold the oral dispensing syringe by the plunger, because the plunger may come out. </paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>11.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Place the tip of the oral dispensing syringe in your mouth and aim the tip toward the inside of your cheek. </paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>12.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Gently squirt the Mercaptopurine Oral Suspension into your mouth by pushing on the plunger until the oral dispensing syringe is empty. Swallow the medicine. </paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not </content>forcefully push on the plunger.</item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Do not </content>squirt the medicine to the back of your mouth or throat. This may cause you to choke. </item></list></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>13.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Remove the oral dispensing syringe from your mouth.</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>14.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Swallow the dose of oral suspension then drink some water, making sure no medicine is left in your mouth. </paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>15.</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>Put the cap back on the bottle with the adapter left in place. Close the cap tightly. </paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"/></tr><tr><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>16.</paragraph></td><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>Wash the oral dispensing syringe with warm soapy water and rinse well. Hold the oral dispensing syringe under water and move the plunger up and down several times to make sure the inside of the oral dispensing syringe is clean. Let the oral dispensing syringe dry completely before you use it again for dosing. <content styleCode=\"bold\">Do not throw away the oral dispensing syringe after use. </content></paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"/></tr></tbody></table>"],"spl_patient_package_insert":["PATIENT INFORMATION PATIENT INFORMATION Mercaptopurine (mer kapʺ toe pureʹ een) Oral Suspension What is Mercaptopurine Oral Suspension? Mercaptopurine Oral Suspension is a prescription medicine used along with other medicines to treat people with acute lymphoblastic leukemia (ALL). What should I tell my healthcare provider before taking Mercaptopurine Oral Suspension? Before you take Mercaptopurine Oral Suspension, tell your healthcare provider about all of your medical conditions , including if you: • have kidney or liver problems. • have a condition where your body produces too little of the enzyme thiopurine methyltransferase (TPMT) or the enzyme nucleotide diphosphatase (NUDT15). • have phenylketonuria (PKU). Mercaptopurine contains phenylalanine which is a part of aspartame. • have recently received or plan to receive a vaccine. • are pregnant or plan to become pregnant. Mercaptopurine Oral Suspension can harm your unborn baby. If you are a female who is able to become pregnant: o Your healthcare provider will do a pregnancy test before you start treatment with Mercaptopurine Oral Suspension. o Use an effective method of birth control (contraception) during treatment with Mercaptopurine Oral Suspension and for 6 months after your last dose. Talk with your healthcare provider about birth control methods you can use during this time. o Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Mercaptopurine Oral Suspension. If you are a male with a female partner who is able to become pregnant: o Use effective birth control (contraception) during treatment with Mercaptopurine Oral Suspension and for 3 months after your last dose. o Tell your healthcare provider right away if your female partner becomes pregnant or thinks she is pregnant during your treatment with Mercaptopurine Oral Suspension. • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with Mercaptopurine Oral Suspension and for at least 1 week after your last dose. • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take Mercaptopurine Oral Suspension? • See the detailed “Instructions for Use” that comes with Mercaptopurine Oral Suspension for information about the right way to measure and take a dose of Mercaptopurine Oral Suspension. • Take Mercaptopurine Oral Suspension exactly as your healthcare provider tells you. Do not stop taking Mercaptopurine Oral Suspension or change your dose without talking to your healthcare provider. • Take Mercaptopurine Oral Suspension by mouth 1 time each day. • If Mercaptopurine Oral Suspension comes into contact with skin, eyes, or clothes? • Remove contaminated clothing. • Wash skin or eyes immediately with water. • Contact with skin or eyes can cause hypersensitive reactions resulting in rash, redness, itching and inflammation. If symptoms appear seek medical attention. • During treatment with Mercaptopurine Oral Suspension, your healthcare provider will do blood tests regularly to check your blood cell counts and liver function. Your healthcare provider may change your dose if you have side effects. • If you miss a dose of Mercaptopurine Oral Suspension, call your healthcare provider for advice. • If you take too much Mercaptopurine Oral Suspension, call your healthcare provider or go to the nearest emergency room right away. What should I avoid while taking Mercaptopurine Oral Suspension? Mercaptopurine Oral Suspension can make your skin more sensitive to sunlight. Protect yourself from sunlight during treatment with Mercaptopurine Oral Suspension. What are the possible side effects of Mercaptopurine Oral Suspension? Mercaptopurine Oral Suspension can cause serious side effects, including: • Decreased blood cell counts are common with Mercaptopurine Oral Suspension but can also be severe. Mercaptopurine Oral Suspension affects your bone marrow and can cause decreased white blood cells, red blood cells, and platelets. Decreased blood cell counts can make you more likely to develop infections, bleeding, or anemia. If you take certain medicines during treatment with Mercaptopurine Oral Suspension, it could make the effects on your bone marrow worse. Tell your healthcare provider if you develop any of the following symptoms during treatment with Mercaptopurine Oral Suspension: • fever • sore throat • cuts or wounds that are red, or swollen, or are draining • any bleeding • tiredness or weakness • shortness of breath • Liver problems. Increases in liver function test results are common with Mercaptopurine Oral Suspension, but you can also develop severe liver problems with Mercaptopurine Oral Suspension that can lead to death. Your healthcare provider may tell you to stop taking Mercaptopurine Oral Suspension if you develop liver problems. Tell your healthcare provider right away if you develop any of the following symptoms of a liver problem during treatment with Mercaptopurine Oral Suspension: • decreased appetite • diarrhea • nausea or vomiting • yellowing of your skin or the whites of your eyes • a build-up of fluid in your stomach-area (ascites) • Possible increased risk of other cancers. Talk with your healthcare provider about your risk of other cancers if you take Mercaptopurine Oral Suspension. Less common side effects of Mercaptopurine Oral Suspension include: loss of appetite, nausea, vomiting, diarrhea, generally do not feel well, and rash. Low blood sugar (hypoglycemia) can happen, especially in children under six years of age. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Mercaptopurine Oral Suspension. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Mercaptopurine Oral Suspension? • Mercaptopurine Oral Suspension comes in a bottle with a child-resistant cap. • Store Mercaptopurine Oral Suspension at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Store in a dry place. Do not store above 25°C. • Store the oral dispensing syringe in a clean place, with the medicine. • Mercaptopurine Oral Suspension should be used within 8 weeks after opening the bottle. Dispose of (throw away) any unused medicine after 8 weeks. • Do not use after the expiry date which is stated on the carton and the bottle after ‘EXP’. • Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage. • Keep Mercaptopurine Oral Suspension out of the reach of children, preferably in a locked cupboard. If a child accidentally takes Mercaptopurine Oral Suspension, it could cause death. How should I dispose of Mercaptopurine Oral Suspension? • This medicine should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of (throw away) Mercaptopurine Oral Suspension that is no longer needed. General information about the safe and effective use of Mercaptopurine Oral Suspension. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Mercaptopurine Oral Suspension for a condition for which it was not prescribed. Do not give Mercaptopurine Oral Suspension to other people, even if they have the same symptoms you have. It could harm them. You can ask your healthcare provider or pharmacist for information about Mercaptopurine Oral Suspension that is written for health professionals. What are the ingredients in Mercaptopurine Oral Suspension? Active ingredient: mercaptopurine, USP Inactive ingredients: aspartame, ethylparaben sodium, hydrochloric acid, methylparaben sodium, potassium sorbate, raspberry juice powder (raspberry juice, rice syrup solids, silicon dioxide), sodium hydroxide, sucrose, water (purified), xanthan gum. This Patient Information has been approved by the U.S. Food and Drug Administration. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50001544/01 Revised April 2025"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS • Lactation : Advise not to breastfeed. ( 8.2 ) • Infertility : Can impair fertility. ( 8.3 ) 8.1 Pregnancy Risk Summary Mercaptopurine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Pregnant women who receive mercaptopurine have an increased incidence of miscarriage and stillbirth (see Data ) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Women receiving mercaptopurine in the first trimester of pregnancy have an increased incidence of miscarriage; the risk of malformation in offspring surviving first trimester exposure is not known. In a series of 28 women receiving mercaptopurine after the first trimester of pregnancy, 3 mothers died prior to delivery, 1 delivered a stillborn child, and 1 aborted; there were no cases of macroscopically abnormal fetuses. Animal Data Mercaptopurine was embryo-lethal and teratogenic in several animal species (rat, mouse, rabbit, and hamster) at doses less than the recommended human dose. 8.2 Lactation Risk Summary There are no data on the presence of mercaptopurine or its metabolites in human milk, the effects on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with mercaptopurine and for 1 week after the last dose. 8.3 Females and Males of Reproductive Potential Mercaptopurine can cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Verify the pregnancy status in females of reproductive potential prior to initiating mercaptopurine [see Use in Specific Populations ( 8.1 )] . Contraception Females Advise females of reproductive potential to use effective contraception during treatment with mercaptopurine and for 6 months after the last dose. Males Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with mercaptopurine and for 3 months after the last dose [see Nonclinical Toxicology ( 13.1 )] . Infertility Females and Males Based on findings from animal studies, mercaptopurine can impair female and male fertility [see Nonclinical Toxicology ( 13.1 )] . The long-term effects of mercaptopurine on female and male fertility, including the reversibility have not been studied. 8.4 Pediatric Use Safety and effectiveness of mercaptopurine has been established in pediatric patients. Use of mercaptopurine in pediatrics is supported by evidence from the published literature and clinical experience. Symptomatic hypoglycemia has been reported in pediatric patients with ALL receiving mercaptopurine. Reported cases were in pediatrics less than 6 years or with a low body mass index. 8.5 Geriatric Use Clinical studies of mercaptopurine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or another drug therapy. 8.6 Renal Impairment Use the lowest recommended starting dosage for mercaptopurine or increase the dosing interval to every 36 to 48 hours in patients with renal impairment (CLcr less than 50 mL/min). Adjust the dose to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see Dosage and Administration ( 2.3 )] . 8.7 Hepatic Impairment Use the lowest recommended starting dosage for mercaptopurine in patients with hepatic impairment. Adjust the dose to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see Dosage and Administration ( 2.3 )] ."],"spl_patient_package_insert_table":["<table width=\"100%\"><col width=\"100%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">PATIENT INFORMATION</content> <content styleCode=\"bold\">Mercaptopurine  (mer kap&#x2BA; toe pure&#x2B9; een)  Oral Suspension</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What is Mercaptopurine Oral Suspension?</content> Mercaptopurine Oral Suspension is a prescription medicine used along with other medicines to treat people with acute lymphoblastic leukemia (ALL).</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What should I tell my healthcare provider before taking Mercaptopurine Oral Suspension?</content></paragraph><paragraph><content styleCode=\"bold\">Before you take Mercaptopurine Oral Suspension, tell your healthcare provider about all of your medical conditions</content>, including if you: </paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>have kidney or liver problems. </item><item><caption>&#x2022;</caption>have a condition where your body produces too little of the enzyme thiopurine methyltransferase (TPMT) or the enzyme nucleotide diphosphatase (NUDT15). </item><item><caption>&#x2022;</caption>have phenylketonuria (PKU). Mercaptopurine contains phenylalanine which is a part of aspartame.</item><item><caption>&#x2022;</caption>have recently received or plan to receive a vaccine. </item><item><caption>&#x2022;</caption>are pregnant or plan to become pregnant. Mercaptopurine Oral Suspension can harm your unborn baby.  <content styleCode=\"bold\">If you are a female who is able to become pregnant:</content></item><item><caption>o</caption>Your healthcare provider will do a pregnancy test before you start treatment with Mercaptopurine Oral Suspension. </item><item><caption>o</caption>Use an effective method of birth control (contraception) during treatment with Mercaptopurine Oral Suspension and for 6 months after your last dose. Talk with your healthcare provider about birth control methods you can use during this time. </item><item><caption>o</caption>Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Mercaptopurine Oral Suspension. </item><item><caption> </caption><content styleCode=\"bold\">If you are a male with a female partner who is able to become pregnant: </content></item><item><caption>o</caption>Use effective birth control (contraception) during treatment with Mercaptopurine Oral Suspension and for 3 months after your last dose. </item><item><caption>o</caption>Tell your healthcare provider right away if your female partner becomes pregnant or thinks she is pregnant during your treatment with Mercaptopurine Oral Suspension. </item><item><caption>&#x2022;</caption>are breastfeeding or plan to breastfeed. <content styleCode=\"bold\">Do not</content> breastfeed during treatment with Mercaptopurine Oral Suspension and for at least 1 week after your last dose. </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Tell your healthcare provider about all the medicines you take,</content> including prescription and over-the-counter medicines, vitamins, and herbal supplements. </item></list></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I take Mercaptopurine Oral Suspension? </content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">See the detailed &#x201C;Instructions for Use&#x201D; that comes with Mercaptopurine Oral Suspension for information about the right way to measure and take a dose of Mercaptopurine Oral Suspension. </content></item><item><caption>&#x2022;</caption>Take Mercaptopurine Oral Suspension exactly as your healthcare provider tells you. Do not stop taking Mercaptopurine Oral Suspension or change your dose without talking to your healthcare provider. </item><item><caption>&#x2022;</caption>Take Mercaptopurine Oral Suspension by mouth 1 time each day. </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">If Mercaptopurine Oral Suspension comes into contact with skin, eyes, or clothes? </content></item><item><caption>&#x2022;</caption>Remove contaminated clothing. </item><item><caption>&#x2022;</caption>Wash skin or eyes immediately with water. </item><item><caption>&#x2022;</caption>Contact with skin or eyes can cause hypersensitive reactions resulting in rash, redness, itching and inflammation. If symptoms appear seek medical attention.</item><item><caption>&#x2022;</caption>During treatment with Mercaptopurine Oral Suspension, your healthcare provider will do blood tests regularly to check your blood cell counts and liver function. Your healthcare provider may change your dose if you have side effects. </item><item><caption>&#x2022;</caption>If you miss a dose of Mercaptopurine Oral Suspension, call your healthcare provider for advice. </item><item><caption>&#x2022;</caption>If you take too much Mercaptopurine Oral Suspension, call your healthcare provider or go to the nearest emergency room right away. </item></list></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What should I avoid while taking Mercaptopurine Oral Suspension? </content> Mercaptopurine Oral Suspension can make your skin more sensitive to sunlight. Protect yourself from sunlight during treatment with Mercaptopurine Oral Suspension. </paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What are the possible side effects of Mercaptopurine Oral Suspension?</content></paragraph><paragraph><content styleCode=\"bold\">Mercaptopurine Oral Suspension can cause serious side effects, including: </content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption><content styleCode=\"bold\">Decreased blood cell counts</content> are common with Mercaptopurine Oral Suspension but can also be severe. Mercaptopurine Oral Suspension affects your bone marrow and can cause decreased white blood cells, red blood cells, and platelets. Decreased blood cell counts can make you more likely to develop infections, bleeding, or anemia. If you take certain medicines during treatment with Mercaptopurine Oral Suspension, it could make the effects on your bone marrow worse. Tell your healthcare provider if you develop any of the following symptoms during treatment with Mercaptopurine Oral Suspension: </item><item><caption>&#x2022;</caption>fever </item><item><caption>&#x2022;</caption>sore throat </item><item><caption>&#x2022;</caption>cuts or wounds that are red, or swollen, or are draining </item><item><caption>&#x2022;</caption>any bleeding </item><item><caption>&#x2022;</caption>tiredness or weakness </item><item><caption>&#x2022;</caption>shortness of breath </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Liver problems.</content> Increases in liver function test results are common with Mercaptopurine Oral Suspension, but you can also develop severe liver problems with Mercaptopurine Oral Suspension that can lead to death. Your healthcare provider may tell you to stop taking Mercaptopurine Oral Suspension if you develop liver problems. Tell your healthcare provider right away if you develop any of the following symptoms of a liver problem during treatment with Mercaptopurine Oral Suspension: </item><item><caption>&#x2022;</caption>decreased appetite </item><item><caption>&#x2022;</caption>diarrhea </item><item><caption>&#x2022;</caption>nausea or vomiting </item><item><caption>&#x2022;</caption>yellowing of your skin or the whites of your eyes </item><item><caption>&#x2022;</caption>a build-up of fluid in your stomach-area (ascites) </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Possible increased risk of other cancers.</content> Talk with your healthcare provider about your risk of other cancers if you take Mercaptopurine Oral Suspension. </item><item><caption> </caption><content styleCode=\"bold\">Less common side effects of Mercaptopurine Oral Suspension include: </content>loss of appetite, nausea, vomiting, diarrhea, generally do not feel well, and rash. </item></list><paragraph>Low blood sugar (hypoglycemia) can happen, especially in children under six years of age. </paragraph><paragraph>Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Mercaptopurine Oral Suspension.  Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">How should I store Mercaptopurine Oral Suspension? </content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Mercaptopurine Oral Suspension comes in a bottle with a child-resistant cap. </item><item><caption>&#x2022;</caption>Store Mercaptopurine Oral Suspension at 20&#xBA; to 25&#xBA;C (68&#xBA; to 77&#xBA;F) [see USP Controlled Room Temperature]. Store in a dry place. Do not store above 25&#xB0;C. </item><item><caption>&#x2022;</caption>Store the oral dispensing syringe in a clean place, with the medicine. </item><item><caption>&#x2022;</caption>Mercaptopurine Oral Suspension should be used within 8 weeks after opening the bottle. Dispose of (throw away) any unused medicine after 8 weeks. </item><item><caption>&#x2022;</caption>Do not use after the expiry date which is stated on the carton and the bottle after &#x2018;EXP&#x2019;.</item><item><caption>&#x2022;</caption>Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage. </item><item><caption>&#x2022;</caption><content styleCode=\"bold\">Keep Mercaptopurine Oral Suspension out of the reach of children, preferably in a locked cupboard. If a child accidentally takes Mercaptopurine Oral Suspension, it could cause death. </content></item></list><paragraph><content styleCode=\"bold\">How should I dispose of Mercaptopurine Oral Suspension? </content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>This medicine should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of (throw away) Mercaptopurine Oral Suspension that is no longer needed. </item></list></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">General information about the safe and effective use of Mercaptopurine Oral Suspension.</content> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Mercaptopurine Oral Suspension for a condition for which it was not prescribed. Do not give Mercaptopurine Oral Suspension to other people, even if they have the same symptoms you have. It could harm them. You can ask your healthcare provider or pharmacist for information about Mercaptopurine Oral Suspension that is written for health professionals.</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">What are the ingredients in Mercaptopurine Oral Suspension?</content> Active ingredient: mercaptopurine, USP</paragraph><paragraph>Inactive ingredients: aspartame, ethylparaben sodium, hydrochloric acid, methylparaben sodium, potassium sorbate, raspberry juice powder (raspberry juice, rice syrup solids, silicon dioxide), sodium hydroxide, sucrose, water (purified), xanthan gum.</paragraph></td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL – Bottle Carton NDC 0054- 0879 -49 100 mL per bottle Mercaptopurine Oral Suspension 2000 mg/100 mL (20 mg/mL) Shake vigorously before use for at least 30 seconds. Rx only Bottle Carton - 100 mL per bottle","PRINCIPAL DISPLAY PANEL – Bottle Label NDC 0054- 0879 -49 100 mL per bottle Mercaptopurine Oral Suspension 2000 mg/100 mL (20 mg/mL) Rx only Shake vigorously before use for at least 30 seconds. Bottle Label - 100 mL per bottle"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Mercaptopurine is carcinogenic in animals. Mercaptopurine causes chromosomal aberrations in cells derived from animals and humans and induces dominant-lethal mutations in the germ cells of male mice. Mercaptopurine can impair fertility. In mice, surviving female offspring of mothers who received chronic low doses of mercaptopurine during pregnancy were found sterile, or if they became pregnant, had smaller litters and more dead fetuses as compared to control animals."]},"tags":[{"label":"mercaptopurine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Prostaglandin G/H synthase 1","category":"target"},{"label":"PTGS1","category":"gene"},{"label":"PPAT","category":"gene"},{"label":"ABCC4","category":"gene"},{"label":"L01BB02","category":"atc"},{"label":"Oral","category":"route"},{"label":"Suspension","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Acute lymphoid leukemia","category":"indication"},{"label":"Acute promyelocytic leukemia, FAB M3","category":"indication"},{"label":"Stason Pharms","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Antimetabolites","category":"pharmacology"},{"label":"Antimetabolites, Antineoplastic","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Immunologic Factors","category":"pharmacology"},{"label":"Immunosuppressive Agents","category":"pharmacology"},{"label":"Noxae","category":"pharmacology"},{"label":"Nucleic Acid Synthesis Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FEBRILE NEUTROPENIA","source":"FDA FAERS","actionTaken":"1857 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"1177 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1102 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1082 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"779 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"739 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"685 reports"},{"date":"","signal":"ABDOMINAL PAIN","source":"FDA FAERS","actionTaken":"678 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"588 reports"},{"date":"","signal":"NEUTROPENIA","source":"FDA FAERS","actionTaken":"584 reports"}],"drugInteractions":[{"url":"/drug/mesalazine","drug":"mesalazine","action":"Monitor closely","effect":"May interact with Mesalamine","source":"DrugCentral","drugSlug":"mesalazine"},{"url":"/drug/olsalazine","drug":"olsalazine","action":"Monitor closely","effect":"May interact with Olsalazine","source":"DrugCentral","drugSlug":"olsalazine"},{"url":"/drug/sulfasalazine","drug":"sulfasalazine","action":"Monitor closely","effect":"May interact with Sulfasalazine","source":"DrugCentral","drugSlug":"sulfasalazine"},{"url":"/drug/warfarin","drug":"warfarin","action":"Monitor closely","effect":"May interact with Warfarin","source":"DrugCentral","drugSlug":"warfarin"}],"commonSideEffects":[{"effect":"Myelosuppression","drugRate":"reported","severity":"serious"},{"effect":"Anemia","drugRate":"reported","severity":"serious"},{"effect":"Leukopenia","drugRate":"reported","severity":"serious"},{"effect":"Thrombocytopenia","drugRate":"reported","severity":"serious"},{"effect":"Hyperuricemia","drugRate":"reported","severity":"serious"},{"effect":"Hyperuricosuria","drugRate":"reported","severity":"serious"},{"effect":"Intestinal ulceration","drugRate":"reported","severity":"serious"},{"effect":"Nausea","drugRate":"reported","severity":"mild"},{"effect":"Vomiting","drugRate":"reported","severity":"mild"},{"effect":"Anorexia","drugRate":"reported","severity":"mild"},{"effect":"Diarrhea","drugRate":"reported","severity":"mild"},{"effect":"Sprue-like symptoms","drugRate":"reported","severity":"mild"},{"effect":"Oral lesions","drugRate":"reported","severity":"mild"},{"effect":"Skin rashes","drugRate":"reported","severity":"mild"},{"effect":"Hyperpigmentation","drugRate":"reported","severity":"mild"},{"effect":"Alopecia","drugRate":"reported","severity":"mild"},{"effect":"Drug fever","drugRate":"reported","severity":"unknown"},{"effect":"Oligospermia","drugRate":"reported","severity":"unknown"}],"contraindications":["Acute pancreatitis","Anemia","Ascites","Bone marrow depression","Breastfeeding (mother)","Chemotherapy-Induced Hyperuricemia","Dehydration","Disease of liver","Gastrointestinal ulcer","Hepatosplenic T-cell lymphoma","Hyperbilirubinemia","Kidney disease","Leukopenia","Liver function tests abnormal","Neutropenic disorder","Obstruction of bile duct","Pregnancy, function","Thiopurine S-Methyltransferase Deficiency","Thrombocytopenic disorder"],"specialPopulations":{"Lactation":"Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with Mercaptopurine Tablets and for week after the last dose.","Pregnancy":"Teratogenic Effects: Pregnancy Category D. See WARNINGS section.","Infertility":"Can impair fertility.","Geriatric use":"Clinical studies of mercaptopurine therapy did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or","Paediatric use":"See DOSAGE AND ADMINISTRATION section."}},"trials":[],"aliases":[],"company":"Stason Pharms","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.8574/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$313","description":"MERCAPTOPURINE 50 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=MERCAPTOPURINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:14:21.491272+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Mercaptopurine","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:14:31.395498+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:14:29.533705+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MERCAPTOPURINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:14:30.158268+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:14:20.328716+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:14:20.328740+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:14:31.837536+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1425/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:14:31.048386+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA216418","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:14:20.328747+00:00"}},"allNames":"purixan","offLabel":[],"synonyms":["mercaptopurine monohydrate","6-mercaptopurine monohydrate","6-mercaptopurine","xaluprine","mercaptopurine","mercapurin","purimethol","purinethiol","purinethol","thiohypoxanthine","mercaptopurine hydrate"],"timeline":[{"date":"1953-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from STASON PHARMS to Stason Pharms"},{"date":"1953-09-11","type":"positive","source":"DrugCentral","milestone":"FDA approval (Stason Pharms)"},{"date":"2004-02-11","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 2 manufacturers approved"},{"date":"2014-04-28","type":"positive","source":"FDA Orange Book","milestone":"Purixan approved — 20MG/ML"}],"aiSummary":"Purixan (Mercaptopurine) is a small molecule drug developed by Stason Pharms, targeting Prostaglandin G/H synthase 1. It is a member of the mercaptopurine class and was first approved by the FDA in 1953 for the treatment of Acute lymphoid leukemia, Acute promyelocytic leukemia, and FAB M3. Purixan is off-patent and has multiple generic manufacturers. Key safety considerations include its short half-life of 1.0 hours and low bioavailability of 12%. As an off-patent medication, its commercial status is primarily generic.","approvals":[{"date":"1953-09-11","orphan":false,"company":"STASON PHARMS","regulator":"FDA"}],"brandName":"Purixan","ecosystem":[{"indication":"Acute lymphoid leukemia","otherDrugs":[{"name":"asparaginase","slug":"asparaginase","company":"Merck"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"clofarabine","slug":"clofarabine","company":"Genzyme"}],"globalPrevalence":null},{"indication":"Acute promyelocytic leukemia, FAB M3","otherDrugs":[{"name":"arsenic trioxide","slug":"arsenic-trioxide","company":"Cephalon"},{"name":"cytarabine","slug":"cytarabine","company":""},{"name":"daunorubicin","slug":"daunorubicin","company":""},{"name":"idarubicin","slug":"idarubicin","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Prostaglandin G/H synthase 1","novelty":"Follow-on","targets":[{"gene":"PTGS1","source":"DrugCentral","target":"Prostaglandin G/H synthase 1","protein":"Prostaglandin G/H synthase 1"},{"gene":"PPAT","source":"DrugCentral","target":"Amidophosphoribosyltransferase","protein":"Amidophosphoribosyltransferase"},{"gene":"ABCC4","source":"DrugCentral","target":"Multidrug resistance-associated protein 4","protein":"Multidrug resistance-associated protein 4"},{"gene":"ABCC5","source":"DrugCentral","target":"Multidrug resistance-associated protein 5","protein":"Multidrug resistance-associated protein 5"},{"gene":"PNP","source":"DrugCentral","target":"Purine nucleoside phosphorylase","protein":"Purine nucleoside phosphorylase"},{"gene":"TPMT","source":"DrugCentral","target":"Thiopurine S-methyltransferase","protein":"Thiopurine S-methyltransferase"}],"modality":"Small Molecule","drugClass":"mercaptopurine","explanation":"Mechanism of Action: Mercaptopurine (6-MP) competes with hypoxanthine and guanine for the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRTase) and is itself converted to thioinosinic acid (TIMP). This intracellular nucleotide inhibits several reactions involving inosinic acid (IMP), including the conversion of IMP to xanthylic acid (XMP) and the conversion of IMP to adenylic acid (AMP) via adenylosuccinate (SAMP). In addition, 6-methylthioinosinate (MTIMP) is formed by the methylation of TIMP. Both TIMP and MTIMP have been reported to inhibit glutamine-5-phosphoribosylpyrophosphate amidotransferase, the first enzyme unique to the de novo pathway for purine ribonucleotide synthesis. Experiments indicate that radiolabeled mercaptopurine may be recovered from the DNA in the form of deoxythioguanosine. Some mercaptopurine is converted to nucleotide derivatives of 6-thioguanine (6-TG) by the sequential action of inosinate (IMP) dehydrogenase and xanthylate (XMP) aminase, convert","oneSentence":"Purixan works by inhibiting the enzyme responsible for producing prostaglandins, which are involved in inflammation and immune response.","technicalDetail":"Purixan exerts its therapeutic effect by competitively inhibiting the enzyme xanthine oxidase, which is involved in the metabolism of mercaptopurine, thereby increasing its intracellular concentration and activity as a purine antagonist.","_target_confidence":0.5},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Mercaptopurine","title":"Mercaptopurine","extract":"Mercaptopurine (6-MP), sold under the brand name Purinethol among others, is a medication used for cancer and autoimmune diseases. Specifically it is used to treat acute lymphocytic leukemia (ALL), acute promyelocytic leukemia (APL), Crohn's disease, and ulcerative colitis. For acute lymphocytic leukemia it is generally used with methotrexate. It is taken orally.","wiki_history":"==History==\n6-MP was discovered by Nobel Prize–winning scientists Gertrude B. Elion and George H. Hitchings at Burroughs Wellcome in Tuckahoe, New York, and was clinically developed in collaboration with investigators at Memorial Hospital (now Memorial Sloan Kettering Cancer Center in New York City).  The collaboration was initiated by Cornelius P. Rhoads, who had run chemical weapons programs for the US Army and had been involved in the work that led to the discovery that nitrogen mustards could potentially be used as cancer drugs, and had become the director of Memorial in 1948."},"commercial":{"launchDate":"1953","_launchSource":"DrugCentral (FDA 1953-09-11, STASON PHARMS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1708","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=MERCAPTOPURINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MERCAPTOPURINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Mercaptopurine","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T14:20:01.415602","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:14:35.950991+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"thioguanine","drugSlug":"thioguanine","fdaApproval":"1966-01-18","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"cladribine","drugSlug":"cladribine","fdaApproval":"1993-02-26","patentExpiry":"Sep 10, 2041","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fludarabine phosphate","drugSlug":"fludarabine-phosphate","fdaApproval":"1991-04-18","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"clofarabine","drugSlug":"clofarabine","fdaApproval":"2004-12-28","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"nelarabine","drugSlug":"nelarabine","fdaApproval":"2005-10-28","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"mercaptopurine","indications":{"approved":[{"name":"Acute lymphoid leukemia","source":"DrugCentral","snomedId":91857003,"regulator":"FDA"},{"name":"Acute promyelocytic leukemia, FAB M3","source":"DrugCentral","snomedId":110004001,"regulator":"FDA"}],"offLabel":[{"name":"Acute myeloid leukemia, disease","source":"DrugCentral","drugName":"MERCAPTOPURINE","evidenceCount":753,"evidenceLevel":"strong"},{"name":"Crohn's disease","source":"DrugCentral","drugName":"MERCAPTOPURINE","evidenceCount":2219,"evidenceLevel":"strong"},{"name":"Polycythemia vera","source":"DrugCentral","drugName":"MERCAPTOPURINE","evidenceCount":14,"evidenceLevel":"moderate"},{"name":"Psoriasis with arthropathy","source":"DrugCentral","drugName":"MERCAPTOPURINE","evidenceCount":27,"evidenceLevel":"moderate"},{"name":"Ulcerative colitis","source":"DrugCentral","drugName":"MERCAPTOPURINE"}],"pipeline":[]},"currentOwner":"Stason Pharms","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"thioguanine","brandName":"thioguanine","genericName":"thioguanine","approvalYear":"1966","relationship":"same-class"},{"drugId":"cladribine","brandName":"cladribine","genericName":"cladribine","approvalYear":"1993","relationship":"same-class"},{"drugId":"fludarabine-phosphate","brandName":"fludarabine phosphate","genericName":"fludarabine phosphate","approvalYear":"1991","relationship":"same-class"},{"drugId":"clofarabine","brandName":"clofarabine","genericName":"clofarabine","approvalYear":"2004","relationship":"same-class"},{"drugId":"nelarabine","brandName":"nelarabine","genericName":"nelarabine","approvalYear":"2005","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06317662","phase":"PHASE2","title":"Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2025-06-05","conditions":["Acute Leukemia of Ambiguous Lineage","B Acute Lymphoblastic Leukemia"],"enrollment":153,"completionDate":"2028-12-31"},{"nctId":"NCT03914625","phase":"PHASE3","title":"A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-07-03","conditions":["B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Down Syndrome"],"enrollment":6720,"completionDate":"2027-09-30"},{"nctId":"NCT07495631","phase":"NA","title":"Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia","status":"NOT_YET_RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2026-03-01","conditions":["Acute Lymphoblastic Leukemia, Adult"],"enrollment":80,"completionDate":"2030-03-01"},{"nctId":"NCT02143414","phase":"PHASE2","title":"Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2015-06-30","conditions":["Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Recurrent Acute Lymphoblastic Leukemia","Refractory Acute Lymphoblastic Leukemia"],"enrollment":53,"completionDate":"2027-01-26"},{"nctId":"NCT05681260","phase":"PHASE3","title":"Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)","status":"RECRUITING","sponsor":"Children's Cancer Group, China","startDate":"2023-02-06","conditions":["T-cell Lymphoblastic Lymphoma"],"enrollment":200,"completionDate":"2029-12-31"},{"nctId":"NCT02845882","phase":"PHASE3","title":"LBL-2016 for Children or Adolescents in China","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Cancer Group, China","startDate":"2016-01","conditions":["Lymphoblastic Lymphoma"],"enrollment":150,"completionDate":"2031-12"},{"nctId":"NCT06918431","phase":"PHASE2","title":"Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2025-10-10","conditions":["B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","Lymphoblastic Lymphoma"],"enrollment":53,"completionDate":"2029-03-30"},{"nctId":"NCT07271069","phase":"","title":"Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2026-01-29","conditions":["Ulcerative Colitis (UC)"],"enrollment":150,"completionDate":"2027-12-31"},{"nctId":"NCT06124157","phase":"PHASE3","title":"A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2025-05-30","conditions":["B Acute Lymphoblastic Leukemia"],"enrollment":222,"completionDate":"2030-12-01"},{"nctId":"NCT02723994","phase":"PHASE2","title":"A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia","status":"COMPLETED","sponsor":"Incyte Corporation","startDate":"2016-09-30","conditions":["Leukemia"],"enrollment":171,"completionDate":"2026-03-03"},{"nctId":"NCT07462299","phase":"NA","title":"NUDT15/TPMT Multi-gene Guided 6-MP Dosing in Childhood ALL Maintenance Therapy","status":"NOT_YET_RECRUITING","sponsor":"The Children's Hospital of Zhejiang University School of Medicine","startDate":"2026-02-20","conditions":["Childhood Acute Lymphoblastic Leukemia"],"enrollment":110,"completionDate":"2028-12-31"},{"nctId":"NCT03959085","phase":"PHASE3","title":"Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2019-10-31","conditions":["B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Central Nervous System Leukemia","Mixed Phenotype Acute Leukemia","Testicular Leukemia"],"enrollment":5951,"completionDate":"2032-03-31"},{"nctId":"NCT07454226","phase":"NA","title":"ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL","status":"NOT_YET_RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2026-03-01","conditions":["Ph-Like","Acute Lymphoblastic Leukemia"],"enrollment":30,"completionDate":"2030-03-01"},{"nctId":"NCT05157971","phase":"PHASE1","title":"Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2022-03-17","conditions":["B Acute Lymphoblastic Leukemia","Ph-Like Acute Lymphoblastic Leukemia"],"enrollment":24,"completionDate":"2026-05-12"},{"nctId":"NCT04216524","phase":"PHASE2","title":"Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2020-05-29","conditions":["Blastic Plasmacytoid Dendritic Cell Neoplasm"],"enrollment":40,"completionDate":"2026-12-31"},{"nctId":"NCT07443592","phase":"NA","title":"Treatment for Ph-negative ALL for Adults up to 65 Years","status":"NOT_YET_RECRUITING","sponsor":"PETHEMA Foundation","startDate":"2026-03-06","conditions":["Acute Lymphoblastic Leukemia"],"enrollment":330,"completionDate":"2033-06-01"},{"nctId":"NCT03150693","phase":"PHASE3","title":"Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia","status":"SUSPENDED","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2017-09-20","conditions":["B Acute Lymphoblastic Leukemia"],"enrollment":310,"completionDate":"2027-08"},{"nctId":"NCT06390319","phase":"PHASE2","title":"Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)","status":"RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2024-12-27","conditions":["T-cell Acute Lymphoblastic Leukemia","T-cell Lymphoma","Mixed Phenotype Acute Leukemia"],"enrollment":100,"completionDate":"2033-12"},{"nctId":"NCT07431060","phase":"NA","title":"Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis","status":"RECRUITING","sponsor":"West China Second University Hospital","startDate":"2026-02-13","conditions":["Langerhans Cell Histiocytosis (LCH)"],"enrollment":120,"completionDate":"2030-12-31"},{"nctId":"NCT03007147","phase":"PHASE3","title":"Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2017-08-08","conditions":["Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia","Mixed Phenotype Acute Leukemia","T Acute Lymphoblastic Leukemia"],"enrollment":475,"completionDate":"2027-09-30"},{"nctId":"NCT00400946","phase":"PHASE3","title":"05-001: Treatment of Acute Lymphoblastic Leukemia in Children","status":"COMPLETED","sponsor":"Dana-Farber Cancer Institute","startDate":"2005-04","conditions":["Drug/Agent Toxicity by Tissue/Organ","Leukemia"],"enrollment":800,"completionDate":"2019-06"},{"nctId":"NCT06533748","phase":"PHASE2","title":"Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma","status":"RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2025-01-23","conditions":["Acute Lymphoblastic Leukemia","Lymphoblastic Lymphoma"],"enrollment":128,"completionDate":"2034-05"},{"nctId":"NCT02523976","phase":"PHASE2","title":"Dasatinib Combined With Chemotherapy in Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia","status":"COMPLETED","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2015-08-01","conditions":["Acute,Leukemia, Lymphoid"],"enrollment":30,"completionDate":"2021-12-31"},{"nctId":"NCT06941376","phase":"PHASE2","title":"An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis","status":"RECRUITING","sponsor":"University of Pennsylvania","startDate":"2025-08-01","conditions":["Relapsing Polychondritis"],"enrollment":20,"completionDate":"2027-12"},{"nctId":"NCT04182984","phase":"","title":"TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study","status":"RECRUITING","sponsor":"Tang-Du Hospital","startDate":"2019-11-04","conditions":["Ocular Myasthenia Gravis"],"enrollment":200,"completionDate":"2026-06-30"},{"nctId":"NCT04259138","phase":"PHASE4","title":"Determination of the Optimal Treatment Target in Ulcerative Colitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alimentiv Inc.","startDate":"2020-02-18","conditions":["Colitis, Ulcerative"],"enrollment":672,"completionDate":"2026-03-31"},{"nctId":"NCT02081755","phase":"PHASE4","title":"Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer","status":"ENROLLING_BY_INVITATION","sponsor":"Baylor Research Institute","startDate":"2014-03","conditions":["Carcinoma, Hepatocellular"],"enrollment":336,"completionDate":"2027-03"},{"nctId":"NCT02939573","phase":"PHASE2","title":"A Randomized Multicenter Study for Isolated Skin Vasculitis","status":"RECRUITING","sponsor":"University of Pennsylvania","startDate":"2017-01-01","conditions":["Primary Cutaneous Vasculitis","Cutaneous Polyarteritis Nodosa","IgA Vasculitis","Henoch-Schönlein Purpura"],"enrollment":90,"completionDate":"2028-12-31"},{"nctId":"NCT03020030","phase":"PHASE3","title":"Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents","status":"ACTIVE_NOT_RECRUITING","sponsor":"Dana-Farber Cancer Institute","startDate":"2017-03-03","conditions":["Acute Lymphoblastic Leukemia, Pediatric"],"enrollment":560,"completionDate":"2034-11"},{"nctId":"NCT07352566","phase":"PHASE4","title":"Utilization of a Microdevice for Psoriasis and Atopic Dermatitis","status":"NOT_YET_RECRUITING","sponsor":"University of California, San Francisco","startDate":"2026-01-01","conditions":["Psoriasis","Atopic Dermatitis"],"enrollment":10,"completionDate":"2030-06-01"},{"nctId":"NCT05276284","phase":"PHASE1,PHASE2","title":"Thiopurine Enhanced Mutations for PD-1/Ligand-1 Efficacy","status":"COMPLETED","sponsor":"Kristoffer Rohrberg","startDate":"2022-09-01","conditions":["Solid Tumor, Adult","Metastatic Cancer"],"enrollment":18,"completionDate":"2025-09-01"},{"nctId":"NCT05848687","phase":"PHASE1,PHASE2","title":"TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II","status":"RECRUITING","sponsor":"Tanja Andrea Gruber","startDate":"2023-11-03","conditions":["Lymphoblastic Leukemia"],"enrollment":90,"completionDate":"2033-12"},{"nctId":"NCT03571321","phase":"PHASE1","title":"Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"University of Chicago","startDate":"2019-05-28","conditions":["Acute Lymphoblastic Leukemia","ALL, Childhood","ALL"],"enrollment":15,"completionDate":"2027-09-05"},{"nctId":"NCT00501826","phase":"PHASE2","title":"Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2007-07-11","conditions":["T Acute Lymphoblastic Leukemia","T Lymphoblastic Lymphoma"],"enrollment":160,"completionDate":"2026-10-31"},{"nctId":"NCT07072585","phase":"PHASE2,PHASE3","title":"Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)","status":"NOT_YET_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2026-06-28","conditions":["Stage II T Lymphoblastic Leukemia/Lymphoma","Stage III T Lymphoblastic Leukemia/Lymphoma","Stage IV T Lymphoblastic Leukemia/Lymphoma","T Acute Lymphoblastic Leukemia","T Lymphoblastic Lymphoma"],"enrollment":1708,"completionDate":"2035-09-01"},{"nctId":"NCT01371630","phase":"PHASE1,PHASE2","title":"Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2011-08-26","conditions":["B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","Burkitt-Like Lymphoma With 11q Aberration","High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Recurrent B Acute Lymphoblastic Leukemia","Recurrent Burkitt Lymphoma","Refractory B Acute Lymphoblastic Leukemia","Refractory Burkitt Lymphoma"],"enrollment":276,"completionDate":"2027-12-25"},{"nctId":"NCT06387121","phase":"PHASE2","title":"Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2024-04-02","conditions":["Precursor Cell Lymphoblastic Leukemia-Lymphoma"],"enrollment":53,"completionDate":"2028-12-31"},{"nctId":"NCT07235904","phase":"PHASE4","title":"Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis","status":"RECRUITING","sponsor":"University Hospital Schleswig-Holstein","startDate":"2025-12-05","conditions":["Ulcerative Colitis (UC)"],"enrollment":300,"completionDate":"2028-10"},{"nctId":"NCT02881086","phase":"PHASE3","title":"Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment","status":"COMPLETED","sponsor":"Goethe University","startDate":"2016-08","conditions":["Acute Lymphoblastic Leukemia","Lymphoblastic Lymphoma"],"enrollment":1023,"completionDate":"2024-12"},{"nctId":"NCT05969730","phase":"NA","title":"Baricitinib Versus Azathioprine in Patients With Moderate-to-Severe Atopic Dermatitis","status":"COMPLETED","sponsor":"Mazandaran University of Medical Sciences","startDate":"2023-08-15","conditions":["Atopic Dermatitis"],"enrollment":40,"completionDate":"2025-11-14"},{"nctId":"NCT02553460","phase":"PHASE1,PHASE2","title":"Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2016-01-29","conditions":["Acute Lymphoblastic Leukemia"],"enrollment":50,"completionDate":"2031-10"},{"nctId":"NCT03117751","phase":"PHASE2,PHASE3","title":"Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2017-03-29","conditions":["Acute Lymphoblastic Leukemia","Acute Lymphoblastic Lymphoma"],"enrollment":790,"completionDate":"2028-09-30"},{"nctId":"NCT07258043","phase":"","title":"Efficacy of Dose-Adjusted Regimen on Survival in Frail Adults With Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"Hospital General de Mexico","startDate":"2025-07-23","conditions":["Acute Lymphobkastic Leukemia","Leukemia","Overall Survival"],"enrollment":45,"completionDate":"2026-07-26"},{"nctId":"NCT02101853","phase":"PHASE3","title":"Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2014-12-17","conditions":["Recurrent B Acute Lymphoblastic Leukemia"],"enrollment":669,"completionDate":"2026-09-16"},{"nctId":"NCT02112916","phase":"PHASE3","title":"Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2014-10-04","conditions":["Adult T Acute Lymphoblastic Leukemia","Ann Arbor Stage II Adult Lymphoblastic Lymphoma","Ann Arbor Stage II Childhood Lymphoblastic Lymphoma","Ann Arbor Stage III Adult Lymphoblastic Lymphoma","Ann Arbor Stage III Childhood Lymphoblastic Lymphoma","Ann Arbor Stage IV Adult Lymphoblastic Lymphoma","Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma","Childhood T Acute Lymphoblastic Leukemia"],"enrollment":847,"completionDate":"2026-09-16"},{"nctId":"NCT02003222","phase":"PHASE3","title":"Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2014-05-19","conditions":["Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative"],"enrollment":488,"completionDate":"2026-03-25"},{"nctId":"NCT03760003","phase":"PHASE2","title":"Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis","status":"COMPLETED","sponsor":"Abivax S.A.","startDate":"2019-08-13","conditions":["Ulcerative Colitis"],"enrollment":355,"completionDate":"2021-04-16"},{"nctId":"NCT02883049","phase":"PHASE3","title":"Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2012-02-29","conditions":["B Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia, BCR-ABL1-Like","Central Nervous System Leukemia","Testicular Leukemia"],"enrollment":5949,"completionDate":"2026-10-03"},{"nctId":"NCT07168161","phase":"PHASE3","title":"BDB-001 Phase III Trial in ANCA-Associated Vasculitis","status":"RECRUITING","sponsor":"Staidson (Beijing) Biopharmaceuticals Co., Ltd","startDate":"2025-11-10","conditions":["ANCA Associated Vasculitis (AAV)"],"enrollment":300,"completionDate":"2028-02-29"},{"nctId":"NCT00748644","phase":"PHASE3","title":"Efficacy Study of Two Treatments in the Remission of Vasculitis","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2008-10","conditions":["Wegener Granulomatosis","Microscopic Polyangiitis"],"enrollment":117,"completionDate":"2013-06"},{"nctId":"NCT03164473","phase":"PHASE3","title":"Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis.","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2018-03-07","conditions":["Eosinophilic Granulomatosis With Polyangiitis"],"enrollment":98,"completionDate":"2024-09-23"},{"nctId":"NCT05030155","phase":"PHASE3","title":"Study of Mepolizumab-based Regimen Compared to Conventional Therapeutic Strategy in Patients With Eosinophilic Granulomatosis With Polyangiitis (E-merge)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-05-30","conditions":["Eosinophilic Granulomatosis With Polyangiitis"],"enrollment":100,"completionDate":"2025-11"},{"nctId":"NCT07227584","phase":"PHASE2","title":"ALL Backbone in AYAs","status":"NOT_YET_RECRUITING","sponsor":"Dana-Farber Cancer Institute","startDate":"2026-04","conditions":["Acute Lymphoblastic Leukemia","Philadelphia Chromosome-Negative Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia (ALL)","Leukemia"],"enrollment":67,"completionDate":"2035-07-31"},{"nctId":"NCT04773392","phase":"PHASE4","title":"Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR","status":"TERMINATED","sponsor":"University of Southern California","startDate":"2021-11-23","conditions":["Kidney Transplantation","Kidney Transplant Rejection"],"enrollment":20,"completionDate":"2024-02-23"},{"nctId":"NCT02877303","phase":"PHASE2","title":"Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2016-11-01","conditions":["B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma"],"enrollment":80,"completionDate":"2026-11-01"},{"nctId":"NCT02879643","phase":"PHASE1","title":"Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy","status":"COMPLETED","sponsor":"Therapeutic Advances in Childhood Leukemia Consortium","startDate":"2017-01-31","conditions":["ALL, Childhood","Lymphoblastic Leukemia, Acute, Childhood","Lymphoblastic Leukemia, Acute"],"enrollment":29,"completionDate":"2024-12-31"},{"nctId":"NCT00136435","phase":"PHASE2","title":"A Study in Adults With Untreated Acute Lymphoblastic Leukemia","status":"COMPLETED","sponsor":"Dana-Farber Cancer Institute","startDate":"2002-06","conditions":["Acute Lymphoblastic Leukemia"],"enrollment":100,"completionDate":"2011-05"},{"nctId":"NCT05645718","phase":"PHASE2","title":"Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2023-07-14","conditions":["Leukemia"],"enrollment":27,"completionDate":"2029-12-31"},{"nctId":"NCT05192889","phase":"PHASE1,PHASE2","title":"Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2022-08-25","conditions":["Refractory Acute Lymphoblastic Leukemia","Relapsed Acute Lymphoblastic Leukemia"],"enrollment":35,"completionDate":"2027-02"},{"nctId":"NCT01503632","phase":"PHASE3","title":"Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2012-02-21","conditions":["Acute Lymphoblastic Leukemia"],"enrollment":570,"completionDate":"2029-12-31"},{"nctId":"NCT01284725","phase":"PHASE3","title":"Weaning of Immunosuppression in Nephritis of Lupus","status":"COMPLETED","sponsor":"Assistance Publique Hopitaux De Marseille","startDate":"2011-02-16","conditions":["Nephritis of Lupus"],"enrollment":100,"completionDate":"2018-12-31"},{"nctId":"NCT01920737","phase":"PHASE2","title":"A Novel \"Pediatric-Inspired\" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2013-08-07","conditions":["Leukemia"],"enrollment":39,"completionDate":"2026-08"},{"nctId":"NCT00647166","phase":"PHASE3","title":"Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome)","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2008-05","conditions":["MPA","PAN or EGPA With FFS=0","At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids"],"enrollment":114,"completionDate":"2015-04"},{"nctId":"NCT02670707","phase":"PHASE3","title":"Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)","status":"RECRUITING","sponsor":"Baylor College of Medicine","startDate":"2016-03-07","conditions":["Langerhans Cell Histiocytosis"],"enrollment":124,"completionDate":"2029-01"},{"nctId":"NCT04546399","phase":"PHASE2","title":"A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2020-12-17","conditions":["Down Syndrome","Recurrent B Acute Lymphoblastic Leukemia"],"enrollment":461,"completionDate":"2028-06-30"},{"nctId":"NCT07152041","phase":"PHASE3","title":"Newly-diagnosed Pediatric Ph-positive B-ALL Protocol","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2025-03-28","conditions":["Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)","Childhood Leukemia, Acute Lymphoblastic"],"enrollment":150,"completionDate":"2030-06"},{"nctId":"NCT06639958","phase":"NA","title":"A Study of Different Programs to Help ALL Patients With Taking Maintenance Medicine at Home","status":"SUSPENDED","sponsor":"Children's Oncology Group","startDate":"2024-12-04","conditions":["Acute Lymphoblastic Leukemia","Childhood Acute Lymphoblastic Leukemia"],"enrollment":64,"completionDate":"2027-03-03"},{"nctId":"NCT06882057","phase":"PHASE2,PHASE3","title":"Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2025-03-03","conditions":["Acute Lymphoblastic Leukemia ALL","Childhood Leukemia, Acute Lymphoblastic","B Cell Acute Lymphoblastic Leukemia (B-ALL)"],"enrollment":3000,"completionDate":"2033-06"},{"nctId":"NCT06855810","phase":"PHASE2,PHASE3","title":"Newly-diagnosed Pediatric T-cell ALL Protocol","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2025-03-11","conditions":["Acute Lymphoblastic Leukemia","Childhood Leukemia, Acute Lymphoblastic","T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma"],"enrollment":610,"completionDate":"2031-06"},{"nctId":"NCT07138898","phase":"PHASE2","title":"Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty","status":"NOT_YET_RECRUITING","sponsor":"NYU Langone Health","startDate":"2025-09","conditions":["Rheumatic Disease"],"enrollment":80,"completionDate":"2027-09"},{"nctId":"NCT06476366","phase":"EARLY_PHASE1","title":"Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial","status":"COMPLETED","sponsor":"Pak Emirates Military Hospital","startDate":"2024-07-14","conditions":["Chronic Actinic Dermatitis"],"enrollment":20,"completionDate":"2025-07-02"},{"nctId":"NCT05646992","phase":"PHASE2,PHASE3","title":"Uterus Transplantation to Treat Infertility","status":"RECRUITING","sponsor":"Johns Hopkins University","startDate":"2023-03-01","conditions":["Uterine Factor Infertility"],"enrollment":40,"completionDate":"2043-02-28"},{"nctId":"NCT04362293","phase":"PHASE2","title":"Reduced Intensity Transplantation for Severe Sickle Cell Disease","status":"SUSPENDED","sponsor":"St. Jude Children's Research Hospital","startDate":"2020-04-30","conditions":["Sickle Cell Disease"],"enrollment":40,"completionDate":"2029-08-01"},{"nctId":"NCT05032183","phase":"PHASE1,PHASE2","title":"Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","startDate":"2022-02-17","conditions":["Recurrent Adult Lymphoblastic Lymphoma","Recurrent B Acute Lymphoblastic Leukemia","Recurrent T Acute Lymphoblastic Leukemia","Refractory B Acute Lymphoblastic Leukemia","Refractory Lymphoblastic Lymphoma","Refractory T Acute Lymphoblastic Leukemia"],"enrollment":4,"completionDate":"2024-07-31"},{"nctId":"NCT03414502","phase":"PHASE3","title":"Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response","status":"RECRUITING","sponsor":"University of Nebraska","startDate":"2007-12-10","conditions":["Rheumatoid Arthritis"],"enrollment":400,"completionDate":"2029-03"},{"nctId":"NCT04440267","phase":"PHASE2","title":"Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2020-07-08","conditions":["Acute Leukemia of Ambiguous Lineage"],"enrollment":50,"completionDate":"2027-12-20"},{"nctId":"NCT02521493","phase":"PHASE3","title":"Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2015-12-23","conditions":["Acute Myeloid Leukemia","Down Syndrome","Myelodysplastic Syndrome","Myeloid Leukemia Associated With Down Syndrome","Myeloproliferative Neoplasm"],"enrollment":280,"completionDate":"2026-06-30"},{"nctId":"NCT05660473","phase":"PHASE2","title":"Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2022-08-01","conditions":["Precursor Cell Lymphoblastic Leukemia-Lymphoma"],"enrollment":100,"completionDate":"2027-12-30"},{"nctId":"NCT07059156","phase":"PHASE2,PHASE3","title":"Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL","status":"RECRUITING","sponsor":"Shanxi Bethune Hospital","startDate":"2025-06-01","conditions":["Acute Lymphoblastic Leukemia, Adult"],"enrollment":50,"completionDate":"2027-07"},{"nctId":"NCT06516679","phase":"PHASE2","title":"Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia","status":"RECRUITING","sponsor":"Yonsei University","startDate":"2024-12-11","conditions":["Leukemia, Lymphoid"],"enrollment":40,"completionDate":"2032-12-31"},{"nctId":"NCT06199557","phase":"PHASE1,PHASE2","title":"A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients","status":"RECRUITING","sponsor":"Haukeland University Hospital","startDate":"2024-05-23","conditions":["Acute Myeloid Leukemia, Adult","Myelodysplastic Syndromes, Adult"],"enrollment":48,"completionDate":"2029-09-30"},{"nctId":"NCT07044141","phase":"PHASE1","title":"Efficacy of Oral Tofacitinib in Combination of Narrow Band UVB in Treatment of Vitiligo","status":"ACTIVE_NOT_RECRUITING","sponsor":"Lahore General Hospital","startDate":"2025-03-01","conditions":["Vitiligo"],"enrollment":20,"completionDate":"2025-09-30"},{"nctId":"NCT00476190","phase":"PHASE2","title":"ALL Adult Consortium Trial: Adult ALL Trial","status":"COMPLETED","sponsor":"Dana-Farber Cancer Institute","startDate":"2007-04","conditions":["Acute Lymphoblastic Leukemia"],"enrollment":112,"completionDate":"2020-03"},{"nctId":"NCT07012239","phase":"","title":"The Frequency of Thiopurine Methyltransferase Polymorphism in Systemic Lupus Erythematosus SLE","status":"COMPLETED","sponsor":"Bangladesh Medical University","startDate":"2016-01-01","conditions":["Genetic Polymorphism"],"enrollment":348,"completionDate":"2018-01-01"},{"nctId":"NCT02420717","phase":"PHASE2","title":"Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","startDate":"2015-07-15","conditions":["Recurrent B Acute Lymphoblastic Leukemia","Recurrent Ph-Like Acute Lymphoblastic Leukemia","Refractory B Acute Lymphoblastic Leukemia","Refractory Ph-Like Acute Lymphoblastic Leukemia"],"enrollment":11,"completionDate":"2021-01-20"},{"nctId":"NCT06099366","phase":"PHASE2","title":"Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children","status":"RECRUITING","sponsor":"Hee Young Ju","startDate":"2024-03-05","conditions":["Lymphoblastic Leukemia in Children"],"enrollment":116,"completionDate":"2033-12-31"},{"nctId":"NCT05827549","phase":"PHASE2","title":"Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"Ho Joon Im","startDate":"2024-04-04","conditions":["Acute Lymphoid Leukemia"],"enrollment":90,"completionDate":"2032-12-31"},{"nctId":"NCT02303821","phase":"PHASE1","title":"Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia","status":"COMPLETED","sponsor":"Amgen","startDate":"2015-02-16","conditions":["Acute Lymphoblastic Leukemia (ALL)"],"enrollment":141,"completionDate":"2024-06-28"},{"nctId":"NCT03384654","phase":"PHASE2","title":"A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2018-05-14","conditions":["Precursor Cell Lymphoblastic Leukemia-Lymphoma"],"enrollment":47,"completionDate":"2022-09-27"},{"nctId":"NCT02205762","phase":"PHASE2,PHASE3","title":"LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis","status":"RECRUITING","sponsor":"North American Consortium for Histiocytosis","startDate":"2016-11-02","conditions":["Langerhans Cell Histiocytosis"],"enrollment":1400,"completionDate":"2026-07"},{"nctId":"NCT03828019","phase":"PHASE3","title":"Adalimumab vs. Conventional Immunosuppression for Uveitis Trial","status":"COMPLETED","sponsor":"JHSPH Center for Clinical Trials","startDate":"2019-09-16","conditions":["Uveitis"],"enrollment":227,"completionDate":"2024-09-09"},{"nctId":"NCT03681652","phase":"","title":"Post-Operative Crohn's Disease Outcome in Children","status":"RECRUITING","sponsor":"Schneider Children's Medical Center, Israel","startDate":"2019-02-11","conditions":["Crohn Disease"],"enrollment":100,"completionDate":"2027-03-01"},{"nctId":"NCT05959720","phase":"","title":"Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil","status":"RECRUITING","sponsor":"Instituto do Cancer do Estado de São Paulo","startDate":"2023-09-05","conditions":["Acute Lymphoid Leukemia","Minimal Residual Disease","Gene Abnormality","Chemotherapeutic Toxicity"],"enrollment":180,"completionDate":"2030-06"},{"nctId":"NCT00408005","phase":"PHASE3","title":"Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2007-01-30","conditions":["T Acute Lymphoblastic Leukemia","T Lymphoblastic Lymphoma"],"enrollment":1895,"completionDate":"2025-03-31"},{"nctId":"NCT03643276","phase":"PHASE3","title":"Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017","status":"RECRUITING","sponsor":"Martin Schrappe","startDate":"2018-07-15","conditions":["Acute Lymphoblastic Leukemia, Pediatric"],"enrollment":5000,"completionDate":"2028-07-14"},{"nctId":"NCT05303792","phase":"PHASE2","title":"Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2023-06-09","conditions":["B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma"],"enrollment":68,"completionDate":"2028-05"},{"nctId":"NCT01190930","phase":"PHASE3","title":"Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2010-08-09","conditions":["Acute Lymphoblastic Leukemia","Adult B Lymphoblastic Lymphoma","Ann Arbor Stage I B Lymphoblastic Lymphoma","Ann Arbor Stage II B Lymphoblastic Lymphoma","Childhood B Acute Lymphoblastic Leukemia","Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Childhood B Lymphoblastic Lymphoma","Down Syndrome","Hypodiploid B Acute Lymphoblastic Leukemia","Philadelphia Chromosome Positive"],"enrollment":9350,"completionDate":"2028-03-31"},{"nctId":"NCT01085617","phase":"","title":"Standard Chemotherapy with or Without Nelarabine or Rituximab in Treating Patients with Newly Diagnosed Acute Lymphoblastic Leukemia","status":"COMPLETED","sponsor":"University College, London","startDate":"2010-12","conditions":["Leukemia","Mucositis","Oral Complications"],"enrollment":0,"completionDate":"2025-02-24"},{"nctId":"NCT02994927","phase":"PHASE3","title":"A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis","status":"COMPLETED","sponsor":"Amgen","startDate":"2017-03-15","conditions":["ANCA-Associated Vasculitis"],"enrollment":331,"completionDate":"2019-11-01"},{"nctId":"NCT04043494","phase":"PHASE3","title":"International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma","status":"RECRUITING","sponsor":"University Hospital Muenster","startDate":"2019-08-23","conditions":["Lymphoblastic Lymphoma, Childhood"],"enrollment":683,"completionDate":"2027-11-22"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Suspension, Tablet","formulations":[{"form":"SUSPENSION","route":"ORAL","productName":"PURIXAN"},{"form":"TABLET","route":"ORAL","productName":"Mercaptopurine"},{"form":"TABLET","route":"ORAL","productName":"mercaptopurine"},{"form":"TABLET","route":"ORAL","productName":"PURINETHOL"},{"form":"TABLET","route":"ORAL","productName":"Mercaptopurine"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000147079","MMSL":"3886","NDDF":"002647","UNII":"E7WED276I5","VUID":"4018776","CHEBI":"CHEBI:50667","VANDF":"4018776","RXNORM":"103","UMLSCUI":"C0000618","chemblId":"CHEMBL1425","ChEMBL_ID":"CHEMBL1425","KEGG_DRUG":"D00161","DRUGBANK_ID":"DB01033","PDB_CHEM_ID":" PM6","PUBCHEM_CID":"667490","SNOMEDCT_US":"1039008","IUPHAR_LIGAND_ID":"7226","SECONDARY_CAS_RN":"6112-76-1","MESH_DESCRIPTOR_UI":"D015122"},"formularyStatus":[],"originalProduct":{"form":"TABLET","route":"ORAL","company":"Stason Pharmaceuticals, Inc.","brandName":"PURINETHOL","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1953-","companyName":"Stason Pharms","relationship":"Original Developer"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"1.0 hours","clearance":"15.0 mL/min/kg","bioavailability":"12%","fractionUnbound":"0.85%","volumeOfDistribution":"1.0 L/kg"},"publicationCount":5534,"therapeuticAreas":["Oncology"],"atcClassification":{"source":"DrugCentral","atcCode":"L01BB02","allCodes":["L01BB02"]},"biosimilarFilings":[],"originalDeveloper":"Stason Pharms","recentPublications":[{"date":"2026 Mar 18","pmid":"41851112","title":"Solvation-mediated isomerization of surface motifs tunes emissions and electron transfer dynamics in gold nanoclusters.","journal":"Nature communications"},{"date":"2026 Mar 15","pmid":"41834326","title":"Prospective Collaborative Study for Pulse Dexamethasone and Lenalidomide in Relapsed/Refractory Langerhans Cell Histiocytosis (LENDEX-LCH Study): INPHOG-HIST-19-03 (CTRI/2020/07/026937).","journal":"Pediatric blood & cancer"},{"date":"2026 Mar 14","pmid":"41826961","title":"6-mercaptopurine and tofacitinib alter microbial protein expression but not composition in fecal microbiota incubations from Crohn's disease patients.","journal":"BMC biology"},{"date":"2026 Mar 10","pmid":"41819030","title":"Optimizing mercaptopurine therapy in indian pediatric ALL: The role of TPMT and NUDT15 genetic polymorphisms.","journal":"Cancer treatment and research communications"},{"date":"2026 Mar 5","pmid":"41788072","title":"PHARMACOGENETIC MARKERS IN PEDIATRIC ACUTE LYMPHOBLASTIC LEUKEMIA THERAPY.","journal":"Experimental oncology"}],"companionDiagnostics":[],"genericManufacturers":3,"_genericFilersChecked":true,"genericManufacturerList":["Dr Reddys Labs Sa","Hikma","Mylan"],"status":"approved","companyName":"Stason Pharms","companyId":"stason-pharms","modality":"Small molecule","firstApprovalDate":"1953","enrichmentLevel":4,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1953-09-11T00:00:00.000Z","mah":"STASON PHARMS","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"AU","regulator":"TGA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"CH","regulator":"Swissmedic","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"NO","regulator":"NoMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"IS","regulator":"IMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"NZ","regulator":"Medsafe","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"BG","regulator":"BDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"AT","regulator":"AGES","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"BE","regulator":"FAMHP","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":"EMEA/H/C/002022"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"HR","regulator":"HALMED","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"CY","regulator":"PHS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"CZ","regulator":"SUKL","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"DK","regulator":"DKMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"EE","regulator":"SAM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"FI","regulator":"Fimea","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"FR","regulator":"ANSM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"DE","regulator":"BfArM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"GR","regulator":"EOF","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"HU","regulator":"OGYEI","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"IE","regulator":"HPRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"IT","regulator":"AIFA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"LV","regulator":"ZVA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"LT","regulator":"VVKT","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"LU","regulator":"MS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"MT","regulator":"MMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"NL","regulator":"MEB","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"PL","regulator":"URPL","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"PT","regulator":"Infarmed","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"RO","regulator":"ANMDMR","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"SK","regulator":"SIDC","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"SI","regulator":"JAZMP","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"ES","regulator":"AEMPS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"SE","regulator":"MPA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Xaluprine (previously Mercaptopurine Nova Laboratories)","application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":27,"withResults":6},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:14:35.950991+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}