{"id":"cromolyn","_fda":{"id":"15aec235-80e7-4d95-b48c-bbca69b4b04d","set_id":"00623958-a8fe-47d1-a0d2-0aa4e2f7966e","openfda":{"unii":["Q2WXR1I0PK"],"route":["ORAL"],"rxcui":["831261","831269"],"spl_id":["15aec235-80e7-4d95-b48c-bbca69b4b04d"],"brand_name":["Gastrocrom"],"spl_set_id":["00623958-a8fe-47d1-a0d2-0aa4e2f7966e"],"package_ndc":["0037-0678-08","0037-0678-96"],"product_ndc":["0037-0678"],"generic_name":["CROMOLYN SODIUM"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CROMOLYN SODIUM"],"manufacturer_name":["Viatris Specialty LLC"],"application_number":["NDA020479"],"is_original_packager":[true]},"version":"6","warnings":["WARNINGS The recommended dosage should be decreased in patients with decreased renal or hepatic function. Severe anaphylactic reactions may occur rarely in association with cromolyn sodium administration."],"pregnancy":["Pregnancy In reproductive studies in pregnant mice, rats, and rabbits, cromolyn sodium produced no evidence of fetal malformations at subcutaneous doses up to 540 mg/kg in mice (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis) and 164 mg/kg in rats (less than the maximum recommended daily oral dose in adults on a mg/m 2 basis) or at intravenous doses up to 485 mg/kg in rabbits (approximately 4 times the maximum recommended daily oral dose in adults on a mg/m 2 basis). There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed."],"description":["DESCRIPTION Each 5 mL ampule of GASTROCROM contains 100 mg cromolyn sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. GASTROCROM (cromolyn sodium, USP) Oral Concentrate is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The empirical formula is C 23 H 14 Na 2 O 11 ; the molecular weight is 512.34. Its chemical structure is: Pharmacologic Category: Mast cell stabilizer Therapeutic Category: Antiallergic Cromolyn Sodium Structural Formula"],"precautions":["PRECAUTIONS In view of the biliary and renal routes of excretion of GASTROCROM, consideration should be given to decreasing the dosage of the drug in patients with impaired renal or hepatic function. Carcinogenesis, Mutagenesis, and Impairment of Fertility In carcinogenicity studies in mice, hamsters, and rats, cromolyn sodium had no neoplastic effects at intraperitoneal doses up to 150 mg/kg three days per week for 12 months in mice, at intraperitoneal doses up to 53 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks in hamsters, and at subcutaneous doses up to 75 mg/kg six days per week for 18 months in rats. These doses in mice, hamsters, and rats are less than the maximum recommended daily oral dose in adults and children on a mg/m 2 basis. Cromolyn sodium showed no mutagenic potential in Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes. In rats, cromolyn sodium showed no evidence of impaired fertility at subcutaneous doses up to 175 mg/kg in males (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis) and 100 mg/kg in females (less than the maximum recommended daily oral dose in adults on a mg/m 2 basis). Pregnancy In reproductive studies in pregnant mice, rats, and rabbits, cromolyn sodium produced no evidence of fetal malformations at subcutaneous doses up to 540 mg/kg in mice (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis) and 164 mg/kg in rats (less than the maximum recommended daily oral dose in adults on a mg/m 2 basis) or at intravenous doses up to 485 mg/kg in rabbits (approximately 4 times the maximum recommended daily oral dose in adults on a mg/m 2 basis). There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Drug Interaction During Pregnancy In pregnant mice, cromolyn sodium alone did not cause significant increases in resorptions or major malformations at subcutaneous doses up to 540 mg/kg (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis). Isoproterenol alone increased both resorptions and major malformations (primarily cleft palate) at a subcutaneous dose of 2.7 mg/kg (approximately 7 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis). The incidence of major malformations increased further when cromolyn sodium at a subcutaneous dose of 540 mg/kg was added to isoproterenol at a subcutaneous dose of 2.7 mg/kg. No such interaction was observed in rats or rabbits. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GASTROCROM is administered to a nursing woman. Pediatric Use In adult rats no adverse effects of cromolyn sodium were observed at oral doses up to 6144 mg/kg (approximately 25 times the maximum recommended daily oral dose in adults on a mg/m 2 basis). In neonatal rats, cromolyn sodium increased mortality at oral doses of 1000 mg/kg or greater (approximately 9 times the maximum recommended daily oral dose in infants on a mg/m 2 basis) but not at doses of 300 mg/kg or less (approximately 3 times the maximum recommended daily oral dose in infants on a mg/m 2 basis). Plasma and kidney concentrations of cromolyn after oral administration to neonatal rats were up to 20 times greater than those in older rats. In term infants up to six months of age, available clinical data suggest that the dose should not exceed 20 mg/kg/day. The use of this product in pediatric patients less than two years of age should be reserved for patients with severe disease in which the potential benefits clearly outweigh the risks. Geriatric Use Clinical studies of GASTROCROM 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 other drug therapy."],"how_supplied":["HOW SUPPLIED GASTROCROM Oral Concentrate is an unpreserved, colorless solution supplied in a low density polyethylene plastic unit dose ampule with 8 ampules per foil pouch. Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water. NDC 0037-0678-08 8 ampules x 5 mL NDC 0037-0678-96 96 ampules x 5 mL GASTROCROM Oral Concentrate should be stored between 15°-30°C (59°-86°F) and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children. Store ampules in foil pouch until ready for use. Distributed by: Meda Pharmaceuticals ® 1000 Mylan Blvd Canonsburg, PA 15317 U.S.A. GASTROCROM is a registered trademark of Meda Pharma S.A.R.L., a Viatris Company. © 2024 Viatris Inc. Rev. 06/2024 STW-ME7096-642R02 IN-0678-03"],"geriatric_use":["Geriatric Use Clinical studies of GASTROCROM 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 other drug therapy."],"pediatric_use":["Pediatric Use In adult rats no adverse effects of cromolyn sodium were observed at oral doses up to 6144 mg/kg (approximately 25 times the maximum recommended daily oral dose in adults on a mg/m 2 basis). In neonatal rats, cromolyn sodium increased mortality at oral doses of 1000 mg/kg or greater (approximately 9 times the maximum recommended daily oral dose in infants on a mg/m 2 basis) but not at doses of 300 mg/kg or less (approximately 3 times the maximum recommended daily oral dose in infants on a mg/m 2 basis). Plasma and kidney concentrations of cromolyn after oral administration to neonatal rats were up to 20 times greater than those in older rats. In term infants up to six months of age, available clinical data suggest that the dose should not exceed 20 mg/kg/day. The use of this product in pediatric patients less than two years of age should be reserved for patients with severe disease in which the potential benefits clearly outweigh the risks."],"effective_time":"20240626","nursing_mothers":["Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GASTROCROM is administered to a nursing woman."],"clinical_studies":["CLINICAL STUDIES Four randomized, controlled clinical trials were conducted with GASTROCROM in patients with either cutaneous or systemic mastocytosis; two of which utilized a placebo-controlled crossover design, one utilized an active-controlled (chlorpheniramine plus cimetidine) crossover design, and one utilized a placebo-controlled parallel group design. Due to the rare nature of this disease, only 36 patients qualified for study entry, of whom 32 were considered evaluable. Consequently, formal statistical analyses were not performed. Clinically significant improvement in gastrointestinal symptoms (diarrhea, abdominal pain) were seen in the majority of patients with some improvement also seen for cutaneous manifestations (urticaria, pruritus, flushing) and cognitive function. The benefit seen with GASTROCROM 200 mg QID was similar to chlorpheniramine (4 mg QID) plus cimetidine (300 mg QID) for both cutaneous and systemic symptoms of mastocytosis. Clinical improvement occurred within 2-6 weeks of treatment initiation and persisted for 2-3 weeks after treatment withdrawal. GASTROCROM did not affect urinary histamine levels or peripheral eosinophilia, although neither of these variables appeared to correlate with disease severity. Positive clinical benefits were also reported for 37 of 51 patients who received GASTROCROM in United States and foreign humanitarian programs."],"adverse_reactions":["ADVERSE REACTIONS Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received GASTROCROM during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each. One report of malaise was also recorded. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8406 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Other Adverse Events: Additional adverse events have been reported during studies in other clinical conditions and from worldwide postmarketing experience. In most cases the available information is incomplete and attribution to the drug cannot be determined. The majority of these reports involve the gastrointestinal system and include: diarrhea, nausea, abdominal pain, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, esophagospasm. Other less commonly reported events (the majority representing only a single report) include the following: Skin: pruritus, rash, urticaria/angioedema, erythema/ burning, photosensitivity Musculoskeletal: arthralgia, myalgia, stiffness/weakness of legs Neurologic: headache, dizziness, hypoesthesia, paresthesia, migraine, convulsions, flushing Psychiatric: psychosis, anxiety, depression, hallucinations, behavior change, insomnia, nervousness Heart Rate: tachycardia, premature ventricular contractions (PVCs), palpitations Respiratory: pharyngitis, dyspnea Miscellaneous: fatigue, edema, unpleasant taste, chest pain, postprandial lightheadedness and lethargy, dysuria, urinary frequency, purpura, hepatic function test abnormal, polycythemia, neutropenia, pancytopenia, tinnitus, lupus erythematosus (LE) syndrome"],"contraindications":["CONTRAINDICATIONS GASTROCROM is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium."],"drug_interactions":["Drug Interaction During Pregnancy In pregnant mice, cromolyn sodium alone did not cause significant increases in resorptions or major malformations at subcutaneous doses up to 540 mg/kg (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis). Isoproterenol alone increased both resorptions and major malformations (primarily cleft palate) at a subcutaneous dose of 2.7 mg/kg (approximately 7 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis). The incidence of major malformations increased further when cromolyn sodium at a subcutaneous dose of 540 mg/kg was added to isoproterenol at a subcutaneous dose of 2.7 mg/kg. No such interaction was observed in rats or rabbits."],"instructions_for_use":["PATIENT INSTRUCTIONS Gastrocrom ® (cromolyn sodium, USP) Oral Concentrate For Oral Use Only – Not for Inhalation or Injection. How to Use GASTROCROM: As with all prescription drugs, follow the directions for dosage that your physician recommends. The effect of GASTROCROM therapy is dependent upon its administration at REGULAR intervals, for as long as recommended by your physician. Usual Starting Dose: Adults and Adolescents (13 Years and Older): Two ampules four times daily, taken one-half hour before meals and at bedtime. Children 2-12 Years: One ampule four times daily, taken one-half hour before meals and at bedtime. Note: Your physician may decide to increase OR decrease your dosage to achieve optimum results with GASTROCROM. However, do not change your dose or stop taking GASTROCROM without first consulting your physician. Care & Storage: GASTROCROM Oral Concentrate should be stored between 15°-30°C (59°-86°F) and protected from light. Do not use if it contains a precipitate (particles or cloudiness) or becomes discolored. Keep out of the reach of children. Store ampules in foil pouch until ready for use. Recycling Information: GASTROCROM Oral Concentrate ampules are made with a low density polyethylene plastic (recycling material code: LDPE). Directions for Use: 1.Open foil pouch by tearing at serrated edge as shown. 2.Remove ampule(s) from the strip. 3.Open the ampule by twisting off the tabbed top section. 4.Squeeze liquid contents into a glass of water. Stir solution. Drink all of the liquid. Discard the empty ampule. Distributed by: Meda Pharmaceuticals ® 1000 Mylan Blvd Canonsburg, PA 15317 U.S.A. GASTROCROM is a registerd trademark of Meda Pharma S.A.R.L., a Viatris Company. © 2024 Viatris Inc. Rev. 06/2024 STW-ME7096-642R02 IN-0678-03 Recycling Material Code Image Directions for Use Image 01 Directions for Use Image 02 Directions for Use Image 03 Directions for Use Image 04"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the release of mediators from sensitized mast cells. Cromolyn sodium acts by inhibiting the release of histamine and leukotrienes (SRS-A) from the mast cell. Cromolyn sodium has no intrinsic vasoconstrictor, antihistamine, or glucocorticoid activity. Cromolyn sodium is poorly absorbed from the gastrointestinal tract. No more than 1% of an administered dose is absorbed by humans after oral administration, the remainder being excreted in the feces. Very little absorption of cromolyn sodium was seen after oral administration of 500 mg by mouth to each of 12 volunteers. From 0.28 to 0.50% of the administered dose was recovered in the first 24 hours of urinary excretion in 3 subjects. The mean urinary excretion of an administered dose over 24 hours in the remaining 9 subjects was 0.45%."],"indications_and_usage":["INDICATIONS AND USAGE GASTROCROM is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION NOT FOR INHALATION OR INJECTION. SEE DIRECTIONS FOR USE. The usual starting dose is as follows: Adults and Adolescents (13 Years and Older) Two ampules four times daily, taken one-half hour before meals and at bedtime. Children 2-12 Years One ampule four times daily, taken one-half hour before meals and at bedtime. Pediatric Patients Under 2 Years Not recommended. If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day. Patients should be advised that the effect of GASTROCROM therapy is dependent upon its administration at regular intervals, as directed. Maintenance Dose Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained. Administration GASTROCROM should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions: 1. Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water. 2. Stir solution. 3. Drink all of the liquid."],"spl_product_data_elements":["Gastrocrom cromolyn sodium CROMOLYN SODIUM CROMOLYN WATER"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL – 100 mg/5 mL NDC 0037-0678-96 Gastrocrom ® (cromolyn sodium, USP) Oral Concentrate FOR ORAL USE ONLY – NOT FOR INHALATION OR INJECTION. Rx Only 100 mg/5 mL 96 Plastic Ampules DESCRIPTION: Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water. NOTE: See package circular for full prescribing information including contraindications, warnings and precautions. GASTROCROM Oral Concentrate should be stored between 15º-30ºC (59º-86ºF) and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children. Store ampules in foil pouch until ready to use Rev. 06/2024 STW-ME7096-442R02 UC-0678-04 Distributed by: MEDA PHARMACEUTICALS ® 1000 Mylan Blvd, Canonsburg, PA 15317 U.S.A. GASTROCROM is a registered trademark of Meda Pharma S.A.R.L., a Viatris Company. © 2024 Viatris Inc. Gastrocrom Oral Concentrate Carton Label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, and Impairment of Fertility In carcinogenicity studies in mice, hamsters, and rats, cromolyn sodium had no neoplastic effects at intraperitoneal doses up to 150 mg/kg three days per week for 12 months in mice, at intraperitoneal doses up to 53 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks in hamsters, and at subcutaneous doses up to 75 mg/kg six days per week for 18 months in rats. These doses in mice, hamsters, and rats are less than the maximum recommended daily oral dose in adults and children on a mg/m 2 basis. Cromolyn sodium showed no mutagenic potential in Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes. In rats, cromolyn sodium showed no evidence of impaired fertility at subcutaneous doses up to 175 mg/kg in males (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis) and 100 mg/kg in females (less than the maximum recommended daily oral dose in adults on a mg/m 2 basis)."]},"safety":{"boxedWarnings":[],"commonSideEffects":[{"effect":"Transient ocular stinging or burning upon instillation","drugRate":"","severity":"common","organSystem":""},{"effect":"Conjunctival injection","drugRate":"","severity":"infrequent","organSystem":""},{"effect":"Watery eyes","drugRate":"","severity":"infrequent","organSystem":""},{"effect":"Itchy eyes","drugRate":"","severity":"infrequent","organSystem":""},{"effect":"Dryness around the eye","drugRate":"","severity":"infrequent","organSystem":""},{"effect":"Puffy eyes","drugRate":"","severity":"infrequent","organSystem":""},{"effect":"Eye irritation","drugRate":"","severity":"infrequent","organSystem":""},{"effect":"Styes","drugRate":"","severity":"infrequent","organSystem":""}],"seriousAdverseEvents":[{"effect":"Dyspnea","drugRate":"","severity":"serious"},{"effect":"Edema","drugRate":"","severity":"serious"},{"effect":"Rash","drugRate":"","severity":"serious"}]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CROMOLYN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T06:09:13.164161+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T06:09:50.448714+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CROMOLYN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T06:09:29.410560+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:09:11.082307+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:09:43.488444+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:09:11.082337+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL428880/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T06:09:29.887330+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA020479","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:09:11.082344+00:00"}},"_dailymed":{"setId":"a742664b-265e-49f9-9744-d04e1fb620ae","title":"CROMOLYN SODIUM SOLUTION, CONCENTRATE [OMNIVIUM PHARMACEUTICALS LLC]"},"aiSummary":"Cromolyn is a marketed drug primarily indicated for the management of mastocytosis, with a key composition patent expiring in 2028. Its primary strength lies in its established market presence and specific indication for mastocytosis, a niche but significant therapeutic area. The primary risk is the potential increase in competition post-patent expiry in 2028.","_scrapedAt":"2026-03-27T23:32:16.652Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T06:09:50.449137+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"id":"cromolyn-management-of-mastocytosis","name":"Management of mastocytosis","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with mastocytosis","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with mastocytosis","diagnosticRequired":null,"brandNameForIndication":""}]},"trialDetails":[{"nctId":"NCT03794076","phase":"PHASE1, PHASE2","title":"Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia","status":"RECRUITING","sponsor":"Vishwajit Nimgaonkar, MD PhD","startDate":"2019-04-01","conditions":"Schizophrenia, Schizo Affective Disorder","enrollment":160},{"nctId":"NCT07419880","phase":"PHASE2","title":"Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Fudan University","startDate":"2026-01-30","conditions":"Triple -Negative Breast Cancer","enrollment":46},{"nctId":"NCT07142291","phase":"PHASE2","title":"PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS","status":"RECRUITING","sponsor":"PhenoNet, Inc.","startDate":"2025-11-25","conditions":"Amyotrophic Lateral Sclerosis (ALS)","enrollment":105},{"nctId":"NCT02131038","phase":"","title":"Application of Ectoine Nasal Spray in Comparison With Cromolyn Sodium Containing Nasal Spray in Patients With Allergic Rhinitis","status":"COMPLETED","sponsor":"Bitop AG","startDate":"2009-05","conditions":"Allergic Rhinitis","enrollment":50},{"nctId":"NCT05076682","phase":"PHASE2","title":"Reverse Triple Negative Immune Resistant Breast Cancer","status":"RECRUITING","sponsor":"Fudan University","startDate":"2022-06-30","conditions":"Triple-negative Breast Cancer","enrollment":80},{"nctId":"NCT06801626","phase":"PHASE3","title":"Novel Strategies for Reducing Burn Scar Itch","status":"RECRUITING","sponsor":"The University of Texas Medical Branch, Galveston","startDate":"2025-03-01","conditions":"Burn Scar, Itch Scarring, Wound","enrollment":44},{"nctId":"NCT01722812","phase":"PHASE2","title":"Cromoglicate in Psoriasis","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2012-11","conditions":"Psoriasis","enrollment":30},{"nctId":"NCT01701843","phase":"PHASE2","title":"Cromoglicate in Mastocytosis","status":"TERMINATED","sponsor":"LEO Pharma","startDate":"2012-10","conditions":"Mastocytosis","enrollment":7},{"nctId":"NCT03167216","phase":"EARLY_PHASE1","title":"Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2017-08-01","conditions":"Chronic Prostatitis With Chronic Pelvic Pain Syndrome","enrollment":20},{"nctId":"NCT05077917","phase":"PHASE3","title":"Cromolyn Sodium for Treatment of COVID-19 Pneumonia","status":"TERMINATED","sponsor":"Texas Tech University Health Sciences Center, El Paso","startDate":"2021-11-15","conditions":"COVID-19 Pneumonia, COVID-19 Respiratory Infection, Pneumonia, Viral","enrollment":22},{"nctId":"NCT06535087","phase":"","title":"The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life","status":"RECRUITING","sponsor":"Wenjing Zhou","startDate":"2024-07-20","conditions":"Pediatric Asthma, Rhinitis, Allergic, Quality of Life","enrollment":600},{"nctId":"NCT02664051","phase":"PHASE4","title":"Mast Cells in Acid-induced Intestinal Permeability","status":"TERMINATED","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2013-08","conditions":"Dyspepsia","enrollment":20},{"nctId":"NCT04846348","phase":"PHASE2","title":"Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis","status":"TERMINATED","sponsor":"Joseph Butterfield","startDate":"2021-07-26","conditions":"Cutaneous Mastocytoses","enrollment":1},{"nctId":"NCT02371941","phase":"PHASE4","title":"Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis","status":"COMPLETED","sponsor":"University of Tennessee","startDate":"2014-12","conditions":"Eosinophilic Esophagitis","enrollment":16},{"nctId":"NCT04408664","phase":"PHASE3","title":"Influence of Cromones on Eucapnic Hyperventilation (EVH)-Test in Young (Elite) Athletes Who Tested Positive for EIB.","status":"TERMINATED","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2021-04-06","conditions":"Exercise-Induced Bronchoconstriction","enrollment":8},{"nctId":"NCT04333108","phase":"PHASE3","title":"Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis Unresponsive to Optimal Symptomatic Treatment","status":"UNKNOWN","sponsor":"AB Science","startDate":"2020-07-01","conditions":"Indolent Systemic Mastocytosis","enrollment":140},{"nctId":"NCT05449444","phase":"PHASE2","title":"Masitinib for the Treatment of Severe Mast Cell Activation Syndrome","status":"UNKNOWN","sponsor":"AB Science","startDate":"2022-07-01","conditions":"Mast Cell Activation Syndrome","enrollment":72},{"nctId":"NCT04570644","phase":"PHASE1","title":"Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers","status":"COMPLETED","sponsor":"AZTherapies, Inc.","startDate":"2020-08-28","conditions":"Healthy Volunteers, Alzheimer Disease","enrollment":56},{"nctId":"NCT03202147","phase":"PHASE2","title":"Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)","status":"WITHDRAWN","sponsor":"AZTherapies, Inc.","startDate":"2023-12","conditions":"Ischemic Stroke, Post-stroke Cognitive Impairment","enrollment":""},{"nctId":"NCT00777348","phase":"PHASE2","title":"To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol","status":"COMPLETED","sponsor":"MEDA Pharma GmbH & Co. KG","startDate":"2007-11","conditions":"Asthma, Exercise-Induced","enrollment":62},{"nctId":"NCT00943397","phase":"PHASE3","title":"Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-04","conditions":"Asthma","enrollment":190},{"nctId":"NCT02547818","phase":"PHASE3","title":"Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease","status":"COMPLETED","sponsor":"AZTherapies, Inc.","startDate":"2015-09-15","conditions":"Alzheimer's Disease","enrollment":620},{"nctId":"NCT04428775","phase":"PHASE2","title":"A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease","status":"TERMINATED","sponsor":"AZTherapies, Inc.","startDate":"2020-09-08","conditions":"Amyotrophic Lateral Sclerosis","enrollment":12},{"nctId":"NCT00814073","phase":"PHASE3","title":"Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis","status":"COMPLETED","sponsor":"AB Science","startDate":"2008-12","conditions":"Indolent Systemic Mastocytosis","enrollment":135},{"nctId":"NCT01933464","phase":"PHASE1, PHASE2","title":"An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema","status":"COMPLETED","sponsor":"University of California, San Diego","startDate":"2013-08","conditions":"Papulopustular Rosacea","enrollment":10},{"nctId":"NCT01841307","phase":"PHASE1","title":"Cromolyn Detection of Silent Aspiration","status":"TERMINATED","sponsor":"University of California, San Francisco","startDate":"2015-07","conditions":"Gastroesophageal Reflux, Respiratory Aspiration, Idiopathic Pulmonary Fibrosis","enrollment":16},{"nctId":"NCT02566252","phase":"PHASE1","title":"Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)","status":"COMPLETED","sponsor":"Pulmotect, Inc.","startDate":"2015-07","conditions":"Healthy","enrollment":16},{"nctId":"NCT01346852","phase":"","title":"Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-07","conditions":"Asthma","enrollment":101437},{"nctId":"NCT02478957","phase":"PHASE2","title":"Treatment of Indolent Systemic Mastocytosis With PA101","status":"COMPLETED","sponsor":"Patara Pharma","startDate":"2015-06","conditions":"Mastocytosis, Systemic Mastocytosis, Indolent Systemic Mastocytosis","enrollment":41},{"nctId":"NCT02482324","phase":"PHASE1","title":"Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers","status":"COMPLETED","sponsor":"AZTherapies, Inc.","startDate":"2015-06","conditions":"Healthy Volunteers","enrollment":26},{"nctId":"NCT01175525","phase":"PHASE3","title":"Treatment of Acute Stroke With Cromolyn(Single Dose)","status":"UNKNOWN","sponsor":"Wolfson Medical Center","startDate":"","conditions":"Acute Stroke","enrollment":""},{"nctId":"NCT00745199","phase":"PHASE2","title":"Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus","status":"COMPLETED","sponsor":"Shiraz University of Medical Sciences","startDate":"2008-05","conditions":"End Stage Renal Disease, Pruritus","enrollment":62}],"_emaApprovals":[],"_faersSignals":[{"count":1041,"reaction":"TREATMENT FAILURE"},{"count":396,"reaction":"DRUG INEFFECTIVE"},{"count":250,"reaction":"FATIGUE"},{"count":228,"reaction":"NAUSEA"},{"count":201,"reaction":"HEADACHE"},{"count":192,"reaction":"OFF LABEL USE"},{"count":182,"reaction":"DIARRHOEA"},{"count":174,"reaction":"URTICARIA"},{"count":164,"reaction":"DYSPNOEA"},{"count":160,"reaction":"DIZZINESS"}],"administration":{"route":"Oral"},"crossReferences":{"chemblId":"CHEMBL428880"},"_approvalHistory":[{"date":"20130404","type":"ORIG","sponsor":"MICRO LABS LTD INDIA","applicationNumber":"ANDA202745"},{"date":"20231205","type":"SUPPL","sponsor":"MICRO LABS LTD INDIA","applicationNumber":"ANDA202745"},{"date":"20231114","type":"SUPPL","sponsor":"MICRO LABS LTD INDIA","applicationNumber":"ANDA202745"},{"date":"20171016","type":"ORIG","sponsor":"AILEX PHARMS LLC","applicationNumber":"ANDA209264"},{"date":"20251002","type":"SUPPL","sponsor":"TEVA PHARMS","applicationNumber":"ANDA075271"},{"date":"20000118","type":"ORIG","sponsor":"TEVA PHARMS","applicationNumber":"ANDA075271"},{"date":"20010815","type":"SUPPL","sponsor":"TEVA PHARMS","applicationNumber":"ANDA075271"},{"date":"20080903","type":"SUPPL","sponsor":"TEVA PHARMS","applicationNumber":"ANDA075271"},{"date":"20010815","type":"SUPPL","sponsor":"TEVA PHARMS","applicationNumber":"ANDA075271"},{"date":"20021223","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"ANDA075282"},{"date":"20020328","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"ANDA075282"},{"date":"19991007","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"ANDA075282"},{"date":"19990616","type":"ORIG","sponsor":"SANDOZ","applicationNumber":"ANDA075282"},{"date":"20021001","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"ANDA075282"},{"date":"20000407","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"ANDA075282"},{"date":"20030213","type":"SUPPL","sponsor":"VIATRIS SPECIALTY","applicationNumber":"NDA020479"},{"date":"19991216","type":"SUPPL","sponsor":"VIATRIS SPECIALTY","applicationNumber":"NDA020479"},{"date":"19990310","type":"SUPPL","sponsor":"VIATRIS SPECIALTY","applicationNumber":"NDA020479"},{"date":"19960229","type":"ORIG","sponsor":"VIATRIS SPECIALTY","applicationNumber":"NDA020479"},{"date":"20000208","type":"SUPPL","sponsor":"VIATRIS SPECIALTY","applicationNumber":"NDA020479"}],"publicationCount":1479,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"approved","brandName":"CROMOLYN","genericName":"CROMOLYN","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"1982","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T06:09:50.449137+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}