{"id":"crofelemer","rwe":[{"pmid":"38265977","year":"2024","title":"Effects of orally administered crofelemer on the incidence and severity of neratinib-induced diarrhea in female dogs.","finding":"","journal":"PloS one","studyType":"Clinical Study"},{"pmid":"38058249","year":"2024","title":"Clinical course and therapeutic trial for a case of congenital secretory diarrhea due to novel GUCY2C variant.","finding":"","journal":"American journal of medical genetics. Part A","studyType":"Clinical Study"},{"pmid":"37643022","year":"2023","title":"Patient-derived enteroids provide a platform for the development of therapeutic approaches in microvillus inclusion disease.","finding":"","journal":"The Journal of clinical investigation","studyType":"Clinical Study"},{"pmid":"37474374","year":"2023","title":"Crofelemer for the Management of Neratinib-Associated Diarrhea in Patients With HER2+ Early-Stage Breast Cancer.","finding":"","journal":"Clinical breast cancer","studyType":"Clinical Study"},{"pmid":"36747680","year":"2023","title":"Therapy Development for Microvillus Inclusion Disease using Patient-derived Enteroids.","finding":"","journal":"bioRxiv : the preprint server for biology","studyType":"Clinical Study"}],"_fda":{"id":"8640ba06-76d4-4855-a1d3-c25220b7366e","set_id":"45584fba-8081-4cd1-a21e-3ea8237f62ff","openfda":{"nui":["N0000178374"],"upc":["0370564802601"],"unii":["PY79D6C8RX"],"route":["ORAL"],"rxcui":["1364454","1806878"],"spl_id":["8640ba06-76d4-4855-a1d3-c25220b7366e"],"brand_name":["MYTESI"],"spl_set_id":["45584fba-8081-4cd1-a21e-3ea8237f62ff"],"package_ndc":["70564-802-60"],"product_ndc":["70564-802"],"generic_name":["CROFELEMER"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CROFELEMER"],"pharm_class_epc":["Antidiarrheal [EPC]"],"manufacturer_name":["Napo Pharmaceuticals, Inc."],"application_number":["NDA202292"],"is_original_packager":[true]},"version":"7","pregnancy":["8.1 Pregnancy Risk Summary Crofelemer is minimally absorbed systemically by the oral route of administration and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] . In pregnant rats, no adverse fetal effects were observed with oral administration of crofelemer at doses up to 177 times the recommended clinical dose during the period of organogenesis. In pregnant rabbits, an increase in fetal resorptions and abortions compared to controls were observed with crofelemer at a dose of 96 times the recommended clinical dose. However, it is not clear whether these effects in rabbits are related to the maternal toxicity (decreased body weight and decreased food consumption) observed at this dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population 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 Animal Data Crofelemer was not teratogenic and did not produce embryofetal toxicity in pregnant rats following oral administration at doses up to 738 mg/kg/day during the period of organogenesis. The 738 mg/kg/day dose is 177 times the recommended daily human dose of 4.2 mg/kg/day. Crofelemer was not teratogenic in pregnant rabbits following oral administration at doses up to 400 mg/kg/day during the period of organogenesis. At a dose level of 400 mg/kg/day, which is 96 times the recommended daily human dose of 4.2 mg/kg/day, crofelemer produced an increase in fetal resorptions and abortions compared to controls. However, it is not clear whether these effects are related to the maternal toxicity (decreased body weight and decreased food consumption) observed."],"description":["11 DESCRIPTION MYTESI (crofelemer) delayed-release tablets is an anti-diarrheal, enteric-coated drug product for oral administration. It contains 125 mg of crofelemer, a botanical drug substance that is derived from the red latex of Croton lechleri Müll. Arg. Crofelemer is an oligomeric proanthocyanidin mixture primarily composed of (+)–catechin, (–)–epicatechin, (+)–gallocatechin, and (–)–epigallocatechin monomer units linked in random sequence, as represented below. The average degree of polymerization for the oligomers ranges between 5 and 7.5, as determined by phloroglucinol degradation. R = H or OH range n = 3 to 5.5 Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Coating ingredients: ethylacrylate and methylacrylate copolymer dispersion, talc, triethyl citrate, and white dispersion which contains xanthan gum, titanium dioxide, propyl paraben, and methyl paraben. The following chemical structure for MYTESI (crofelemer) is delayed-release tablets is an anti-diarrheal, enteric-coated drug product for oral administration. It contains 125 mg of crofelemer, a botanical drug substance that is derived from the red latex of Croton lechleri Müll. Arg. Crofelemer is an oligomeric proanthocyanidin mixture primarily composed of (+)–catechin, (–)–epicatechin, (+)–gallocatechin, and (–)–epigallocatechin monomer units linked in random sequence, as represented below. The average degree of polymerization for the oligomers ranges between 5 and 7.5, as determined by phloroglucinol degradation."],"how_supplied":["16 HOW SUPPLIED /STORAGE AND HANDLING MYTESI (crofelemer) 125 mg delayed-release tablets are white, oval tablets printed on one side with 125SLXP. They are available in the following package size: Bottles of 60: NDC 70564-802-60 Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F). See USP Controlled Room Temperature."],"geriatric_use":["8.5 Geriatric Use Clinical studies with MYTESI did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of MYTESI have not been established in pediatric patients."],"effective_time":"20251222","clinical_studies":["14 CLINICAL STUDIES The efficacy of MYTESI was evaluated in a randomized, double-blind, placebo-controlled (one month) and placebo-free (five month), multi-center study. The study enrolled 374 HIV-positive patients on stable anti-retroviral therapy with a history of diarrhea for one month or more. Diarrhea was defined as either persistently loose stools despite regular use of anti-diarrheal medication (e.g., loperamide, diphenoxylate, and bismuth subsalicylate) or one or more watery bowel movements per day without regular anti-diarrheal medicine use. Patients were excluded if they had a positive gastrointestinal biopsy, gastrointestinal culture, or stool test for multiple bacteria (Salmonella, Shigella, Campylobacter, Yersinia, Mycobacterium), bacterial toxin ( Clostridium difficile ), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus). Patients were also excluded if they had a history of ulcerative colitis, Crohn’s disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea. The study had a two-stage adaptive design. In both stages, patients received placebo for 10 days (screening period) followed by randomization to crofelemer or placebo for 31 days of treatment (double-blind period). Only patients with 1 or more watery bowel movements per day on at least 5 of the last 7 days in the screening period were randomized to the double-blind period. Each stage enrolled patients separately; the dose for the second stage was selected based on an interim analysis of data from the first stage. In the first stage, patients were randomized 1:1:1:1 to one of three crofelemer dosage regimens (125 mg twice daily, or one of two higher dosage regimens) or placebo. In the second stage, patients were randomized 1:1 to MYTESI 125 mg twice daily or placebo. The efficacy analysis was based on results from the double-blind portion of both stages. Each study stage also had a five month period (placebo-free period) that followed the double-blind period. Patients treated with MYTESI continued the same dose in the placebo-free period. In the first stage, patients that received placebo were re-randomized 1:1:1 to one of the three crofelemer dosage regimens (125 mg twice daily, or one of the two higher dosage regimens) in the placebo-free period. In the second stage, patients that received placebo were treated with MYTESI 125 mg twice daily in the placebo-free period. The median time since diagnosis of HIV was 12 years. The percentage of patients with a CD4 cell count of less than 404 was 39%. The percentage of patients with a HIV viral load greater than or equal to 1000, 400 to 999, and less than 400 HIV copies/mL was 7%, 3%, and 9%, respectively; the remainder had a viral load that was not detectable. The median time since diarrhea started was 4 years. The median number of daily watery bowel movements was 2.5 per day. Most patients were male (85%). The percentage of patients that were Caucasian was 46%; the percentage of patients that were African-American was 32%. The median age was 45 years with a range of 21 to 68 years. In the double-blind period of the study, 136 patients received MYTESI 125 mg twice daily, 101 patients received one of the two higher dosage regimens and 138 patients received placebo. The percentages of patients that completed the double-blind period were 92% in the MYTESI 125 mg group and 94% in the placebo arm. Most patients received concomitant protease inhibitors during the double-blind period ( Table 2 ). The most frequently used anti-retroviral therapies in the MYTESI 125 mg and placebo groups were tenofovir/emtricitabine, ritonavir, and lopinavir/ritonavir. Table 2: Concomitant Anti-Retroviral Therapy Used in the Double-Blind Period in Patients with HIV MYTESI 125 mg twice daily (N = 136)n (%) Placebo N = 138 n (%) Any antiretroviral therapy 135 (99) 134 (97) Any protease inhibitor 87 (64) 97 (70) Tenofovir/Emtricitabine 45 (33) 52 (38) Ritonavir 46 (34) 49 (36) Lopinavir/Ritonavir 30 (22) 40 (29) Efavirenz/Tenofovir/Emtricitabine 30 (22) 21 (15) Tenofovir disoproxil fumarate 18 (13) 14 (10) Atazanavir sulfate 19 (14) 22 (16) Abacavir w/ lamivudine 17 (13) 18 (13) Darunavir 19 (14) 14 (10) Raltegravir 16 (12) 11 (8) Valaciclovir hydrochloride 12 (9) 16 (12) Fosamprenavir 12 (9) 13 (9) Zidovudine w/lamivudine 12 (9) 15 (11) Lamivudine 7 (5) 6 (4) Nevirapine 8 (6) 9 (7) Atazanavir 5 (4) 2 (1) The primary efficacy endpoint was the proportion of patients with a clinical response, defined as less than or equal to 2 watery bowel movements per week during at least 2 of the 4 weeks of the placebo-controlled phase. Patients who received concomitant anti-diarrheal medications or opiates were counted as clinical non-responders. A significantly larger proportion of patients in the MYTESI 125 mg twice daily group experienced clinical response compared with patients in the placebo group (18% vs. 8%, 1–sided p < 0.01). In the randomized clinical study, examination of duration of diarrhea, baseline number of daily watery bowel movements, use of protease inhibitors, CD4 cell count and age subgroups did not identify differences in the consistency of the crofelemer treatment effect among these subgroups. There were too few female patients and patients with an HIV viral load > 400 copies/mL to adequately assess differences in effects in these populations. Among race subgroups, there were no differences in the consistency of the crofelemer treatment effect except for the subgroup of African-Americans; crofelemer was less effective in African-Americans than non-African-Americans. Although the CD4 cell count and HIV viral load did not appear to change over the one month placebo-controlled period, the clinical significance of this finding is unknown because of the short duration of the placebo-controlled period. Of the 24 clinical responders to MYTESI 125 mg twice daily, 22 entered the placebo-free period; 16 were responding at the end of month 3, and 14 were responding at the end of month 5."],"pharmacodynamics":["12.2 Pharmacodynamics Consistent with the mechanism of action of crofelemer (i.e., inhibition of CFTR and CaCC in the gastrointestinal lumen), data suggest stool chloride concentrations decreased in patients treated with crofelemer 500 mg four times daily (8-times the recommended daily dosage) (n=25) for four days relative to placebo (n=24); stool chloride concentrations decreased in both African American patients treated with crofelemer (n=3) relative to placebo (n=5) and non-African American patients treated with Mytesi (n=22) relative to placebo (n=19). Cardiac Electrophysiology At a dose 10 times the maximum recommended dose, crofelemer does not prolong the QTc interval to any clinically relevant extent."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption The absorption of crofelemer is minimal following oral dosing in healthy adults and HIV–positive patients and concentrations of crofelemer in plasma are below the level of quantitation (50 ng/mL). Therefore, standard pharmacokinetic parameters such as area under the curve, maximum concentration, and half-life cannot be estimated. Effect of Food Administration of crofelemer with a high-fat meal was not associated with an increase in systemic exposure of crofelemer in healthy subjects. In the clinical trial, a single 500 mg dose of crofelemer (4-times the recommended dose) was administered one-half hour before the morning and evening meals [see Dosage and Administration ( 2 )] . Drug Interaction Studies In vitro studies have shown that crofelemer has the potential to inhibit transporters MRP2 and OATP1A2 but not P-gp and BCRP at concentrations expected in the gut. Due to the minimal absorption of crofelemer, crofelemer is unlikely to inhibit cytochrome P450 isoenzymes 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, and 2E1 systemically. Nelfinavir, Zidovudine, Lamivudine Results of a crossover study in healthy subjects showed crofelemer 500 mg administered four times daily (8- times the recommended daily dosage) for five days had no effect on the exposure of zidovudine and nelfinavir when administered as a single dose. A 20% decrease in lamivudine exposure was also observed in the same study but was not considered to be clinically important. Midazolam In vitro studies have shown that crofelemer has the potential to inhibit CYP3A4 enzymes at concentrations expected in the gut. The effects of crofelemer on the pharmacokinetics of a single oral dose of 2 mg midazolam, a sensitive CYP3A4 substrate, was evaluated in healthy subjects following crofelemer dosed orally at 500 mg twice daily (4-times the recommended dosage) for six consecutive days. No significant changes in the mean C max and AUC were observed for midazolam and its active metabolite, hydroxymidazolam after co- administration with crofelemer compared to that after administration of midazolam alone."],"adverse_reactions":["6 ADVERSE REACTIONS Most common adverse reactions (≥ 3%) are upper respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Napo Pharmaceuticals at 1-844-722-8256 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. A total of 696 HIV-positive patients in three placebo-controlled trials received MYTESI for a mean duration of 78 days. Of the total population across the three trials, 229 patients received a dosage of 125 mg twice a day for a mean duration of 141 days, and 171 patients received one of four higher than recommended dosages for a mean duration of 139 days (N=69) 14 days (N=102), 146 days (N=54), and 14 days (N=242), respectively. Adverse reactions in patients treated with MYTESI 125 mg twice daily that occurred in at least 2% of patients and at a higher incidence than placebo are provided in Table 1 . Table 1: Common Adverse Reactions occurring in at least 2% of patients and at a higher incidence than placebo in HIV-Positive Patients in Three Placebo-Controlled Trials Adverse Reaction MYTESI 125 mg Twice Daily N = 229 n (%) Placebo N = 274 n (%) Upper respiratory tract infection 13 (6) 4 (2) Bronchitis 9 (4) 0 Cough 8 (4) 3 (1) Flatulence 7 (3) 3 (1) Increased bilirubin 7 (3) 3 (1) Nausea 6 (3) 4 (2) Back pain 6 (3) 4 (2) Arthralgia 6 (3) 0 Urinary tract infection 5 (2) 2 (1) Nasopharyngitis 5 (2) 2 (1) Musculoskeletal pain 5 (2) 1 (<1) Hemorrhoids 5 (2) 0 Giardiasis 5 (2) 0 Anxiety 5 (2) 1 (<1) Increased alanine aminotransferase 5 (2) 3 (1) Abdominal distension 5 (2) 1 (<) Less common adverse reactions that occurred in between 1% and 2% of patients taking 125 mg twice daily of MYTESI were abdominal pain, acne, increased aspartate aminotransferase, increased conjugated bilirubin, increased unconjugated blood bilirubin, constipation, depression, dermatitis, dizziness, dry mouth, dyspepsia, gastroenteritis, herpes zoster, nephrolithiasis, pain in extremity, pollakiuria, sinusitis and decreased white blood cell count."],"contraindications":["4 CONTRAINDICATIONS None. None ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS 7.1 Nelfinavir, Zidovudine, and Lamivudine MYTESI administration did not have a clinically relevant interaction with nelfinavir, zidovudine, or lamivudine in a drug-drug interaction trial [see Clinical Pharmacology ( 12.3 )] ."],"mechanism_of_action":["12.1 Mechanism of Action Crofelemer is an inhibitor of both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl¯) channel, and the calcium-activated Cl¯ channels (CaCC) at the luminal membrane of enterocytes. The CFTR Cl¯ channel and CaCC regulate Cl¯ and fluid secretion by intestinal epithelial cells. Crofelemer acts by blocking Cl¯ secretion and accompanying high volume water loss in diarrhea, normalizing the flow of Cl¯ and water in the gastrointestinal tract."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Crofelemer is an inhibitor of both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl¯) channel, and the calcium-activated Cl¯ channels (CaCC) at the luminal membrane of enterocytes. The CFTR Cl¯ channel and CaCC regulate Cl¯ and fluid secretion by intestinal epithelial cells. Crofelemer acts by blocking Cl¯ secretion and accompanying high volume water loss in diarrhea, normalizing the flow of Cl¯ and water in the gastrointestinal tract. 12.2 Pharmacodynamics Consistent with the mechanism of action of crofelemer (i.e., inhibition of CFTR and CaCC in the gastrointestinal lumen), data suggest stool chloride concentrations decreased in patients treated with crofelemer 500 mg four times daily (8-times the recommended daily dosage) (n=25) for four days relative to placebo (n=24); stool chloride concentrations decreased in both African American patients treated with crofelemer (n=3) relative to placebo (n=5) and non-African American patients treated with Mytesi (n=22) relative to placebo (n=19). Cardiac Electrophysiology At a dose 10 times the maximum recommended dose, crofelemer does not prolong the QTc interval to any clinically relevant extent. 12.3 Pharmacokinetics Absorption The absorption of crofelemer is minimal following oral dosing in healthy adults and HIV–positive patients and concentrations of crofelemer in plasma are below the level of quantitation (50 ng/mL). Therefore, standard pharmacokinetic parameters such as area under the curve, maximum concentration, and half-life cannot be estimated. Effect of Food Administration of crofelemer with a high-fat meal was not associated with an increase in systemic exposure of crofelemer in healthy subjects. In the clinical trial, a single 500 mg dose of crofelemer (4-times the recommended dose) was administered one-half hour before the morning and evening meals [see Dosage and Administration ( 2 )] . Drug Interaction Studies In vitro studies have shown that crofelemer has the potential to inhibit transporters MRP2 and OATP1A2 but not P-gp and BCRP at concentrations expected in the gut. Due to the minimal absorption of crofelemer, crofelemer is unlikely to inhibit cytochrome P450 isoenzymes 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, and 2E1 systemically. Nelfinavir, Zidovudine, Lamivudine Results of a crossover study in healthy subjects showed crofelemer 500 mg administered four times daily (8- times the recommended daily dosage) for five days had no effect on the exposure of zidovudine and nelfinavir when administered as a single dose. A 20% decrease in lamivudine exposure was also observed in the same study but was not considered to be clinically important. Midazolam In vitro studies have shown that crofelemer has the potential to inhibit CYP3A4 enzymes at concentrations expected in the gut. The effects of crofelemer on the pharmacokinetics of a single oral dose of 2 mg midazolam, a sensitive CYP3A4 substrate, was evaluated in healthy subjects following crofelemer dosed orally at 500 mg twice daily (4-times the recommended dosage) for six consecutive days. No significant changes in the mean C max and AUC were observed for midazolam and its active metabolite, hydroxymidazolam after co- administration with crofelemer compared to that after administration of midazolam alone."],"indications_and_usage":["1 INDICATIONS AND USAGE MYTESI is indicated for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. MYTESI is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Risks of Treatment in Patients with Infectious Diarrhea : Consider infectious etiologies of diarrhea before starting treatment to reduce the risk of inappropriate therapy and worsening disease. ( 2 , 5.1 ) 5. 1 Risks of Treatment in Patients with Infectious Diarrhea Before starting MYTESI, rule out infectious etiologies of diarrhea. If infectious etiologies are not considered, and MYTESI is initiated based on a presumptive diagnosis of non-infectious diarrhea, then there is a risk that patients with infectious etiologies will not receive the appropriate treatments, and their disease may worsen. MYTESI is not indicated for the treatment of infectious diarrhea."],"clinical_studies_table":["
Table 2: Concomitant Anti-Retroviral Therapy Used in the Double-Blind Period in Patients with HIV
MYTESI 125 mg twice daily (N = 136)n (%)Placebo N = 138 n (%)
Any antiretroviral therapy135 (99)134 (97)
Any protease inhibitor87 (64)97 (70)
Tenofovir/Emtricitabine45 (33)52 (38)
Ritonavir46 (34)49 (36)
Lopinavir/Ritonavir30 (22)40 (29)
Efavirenz/Tenofovir/Emtricitabine30 (22)21 (15)
Tenofovir disoproxil fumarate18 (13)14 (10)
Atazanavir sulfate19 (14)22 (16)
Abacavir w/ lamivudine 17 (13)18 (13)
Darunavir19 (14)14 (10)
Raltegravir16 (12)11 (8)
Valaciclovir hydrochloride12 (9)16 (12)
Fosamprenavir12 (9)13 (9)
Zidovudine w/lamivudine12 (9)15 (11)
Lamivudine7 (5)6 (4)
Nevirapine8 (6)9 (7)
Atazanavir5 (4)2 (1)
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 6-month carcinogenicity study in Tg.rasH2 transgenic mice, crofelemer at oral doses up to 125 mg/kg twice a day (250 mg/kg/day) did not produce any drug-related neoplasms in male and female animals. The 250 mg/kg/day dose is about 60 times the recommended clinical dose of 4.2 mg/kg/day (125 mg twice daily). In a 2-year oral carcinogenicity study in rats, crofelemer at doses up to 100/50 mg/kg twice a day (200/100 mg/kg/day), which is 47.6/23.8 times the recommended clinical dose, did not produce any drug-related neoplastic findings in male and female rats (due to drug-related decreased survival in male rats, 37.5 mg/kg twice daily and 100 mg/kg twice daily doses were reduced to 25 mg/kg twice daily and 50 mg/kg twice daily, respectively, at week 67). Mutagenesis Crofelemer was negative in the bacterial reverse mutation assay, chromosomal aberration assay, and rat bone marrow micronucleus assay. Impairment of Fertility Crofelemer, at oral doses of up to 738 mg/kg/day (177 times the recommended human daily dose of 125 mg twice daily), had no effects on fertility or reproductive performance of male and female rats."],"adverse_reactions_table":["
Table 1: Common Adverse Reactionsoccurring in at least 2% of patients and at a higher incidence than placebo in HIV-Positive Patients in Three Placebo-Controlled Trials
Adverse ReactionMYTESI 125 mg Twice Daily N = 229 n (%)Placebo N = 274 n (%)
Upper respiratory tract infection13 (6)4 (2)
Bronchitis9 (4)0
Cough8 (4)3 (1)
Flatulence7 (3)3 (1)
Increased bilirubin7 (3)3 (1)
Nausea6 (3)4 (2)
Back pain6 (3)4 (2)
Arthralgia6 (3)0
Urinary tract infection5 (2)2 (1)
Nasopharyngitis5 (2)2 (1)
Musculoskeletal pain5 (2)1 (<1)
Hemorrhoids5 (2)0
Giardiasis5 (2)0
Anxiety5 (2)1 (<1)
Increased alanine aminotransferase5 (2)3 (1)
Abdominal distension5 (2)1 (<)
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Instruct patients that MYTESI tablets may be taken with or without food. Instruct patients to swallow MYTESI tablets whole and not to crush or chew the tablets. Manufactured by Patheon, Inc. for Napo Pharmaceuticals, Inc., San Francisco, CA 94105 Copyright © Napo Pharmaceuticals, Inc. US Patent Nos. 7,341,744 and 7,323,195. NP-367-1 11/2020 70033046 The botanical drug substance of MYTESI is extracted from Croton lechleri (the botanical raw material) that is harvested from the wild in South America."],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Before starting MYTESI, rule out infectious etiologies of diarrhea [see Warnings and Precautions ( 5.1 )] . The recommended adult dosage of MYTESI is 125 mg taken orally two times a day, with or without food. Do not crush or chew MYTESI tablets. Swallow whole. Before starting MYTESI, rule out infectious etiologies of diarrhea. ( 2 , 5.1 ) The recommended adult dosage is 125 mg taken orally twice a day, with or without food. ( 2 ) Do not crush or chew the tablets. Swallow whole. ( 2 )"],"spl_product_data_elements":["MYTESI Crofelemer CROFELEMER CROFELEMER CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE ETHYL ACRYLATE TALC TRIETHYL CITRATE XANTHAN GUM TITANIUM DIOXIDE PROPYLPARABEN METHYLPARABEN 125SLXP"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Delayed-Release Tablets: 125 mg of crofelemer as a white, oval, delayed-release tablet printed on one side with 125SLXP. Delayed-Release Tablets: 125 mg ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Lactation : Women infected with HIV-1 should be instructed not to breastfeed due to the potential for HIV transmission. ( 8.2 ) 8.1 Pregnancy Risk Summary Crofelemer is minimally absorbed systemically by the oral route of administration and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] . In pregnant rats, no adverse fetal effects were observed with oral administration of crofelemer at doses up to 177 times the recommended clinical dose during the period of organogenesis. In pregnant rabbits, an increase in fetal resorptions and abortions compared to controls were observed with crofelemer at a dose of 96 times the recommended clinical dose. However, it is not clear whether these effects in rabbits are related to the maternal toxicity (decreased body weight and decreased food consumption) observed at this dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population 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 Animal Data Crofelemer was not teratogenic and did not produce embryofetal toxicity in pregnant rats following oral administration at doses up to 738 mg/kg/day during the period of organogenesis. The 738 mg/kg/day dose is 177 times the recommended daily human dose of 4.2 mg/kg/day. Crofelemer was not teratogenic in pregnant rabbits following oral administration at doses up to 400 mg/kg/day during the period of organogenesis. At a dose level of 400 mg/kg/day, which is 96 times the recommended daily human dose of 4.2 mg/kg/day, crofelemer produced an increase in fetal resorptions and abortions compared to controls. However, it is not clear whether these effects are related to the maternal toxicity (decreased body weight and decreased food consumption) observed. 8.2 Lactation Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. There are no data on the presence of crofelemer in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for HIV transmission and adverse effects on a breastfed infant, instruct mothers not to breastfeed if they are taking MYTESI. 8.4 Pediatric Use The safety and effectiveness of MYTESI have not been established in pediatric patients. 8.5 Geriatric Use Clinical studies with MYTESI did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. 8.6 Use in Patients with Low CD4 Counts and High Viral Loads No dose modifications are recommended with respect to CD4 cell count and HIV viral load, based on the findings in subgroups of patients defined by CD4 cell count and HIV viral load. The safety profile of MYTESI was similar in patients with baseline CD4 cell count less than 404 cells/microL (lower limit of normal range) (N=388) and patients with baseline CD4 cell counts greater than or equal to 404 cells/microL (N=289). The safety profile of crofelemer was similar in patients with baseline HIV viral loads less than 400 copies/mL (N = 412) and patients with baseline HIV viral loads greater than or equal to 400 copies/mL (N = 278)."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 70564-802-60 Mytesi ™ (crofelemer) delayed-release tablets 125 mg Swallow tablet whole. Do not crush or chew. 60 enteric coated tablets Rx only PRINCIPAL DISPLAY PANEL NDC 70564-802-60 Mytesi (crofelemer) delayed-release tablets 125 mg Swallow tablet whole. Do not crush or chew. 60 enteric coated tablets Rx only"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 6-month carcinogenicity study in Tg.rasH2 transgenic mice, crofelemer at oral doses up to 125 mg/kg twice a day (250 mg/kg/day) did not produce any drug-related neoplasms in male and female animals. The 250 mg/kg/day dose is about 60 times the recommended clinical dose of 4.2 mg/kg/day (125 mg twice daily). In a 2-year oral carcinogenicity study in rats, crofelemer at doses up to 100/50 mg/kg twice a day (200/100 mg/kg/day), which is 47.6/23.8 times the recommended clinical dose, did not produce any drug-related neoplastic findings in male and female rats (due to drug-related decreased survival in male rats, 37.5 mg/kg twice daily and 100 mg/kg twice daily doses were reduced to 25 mg/kg twice daily and 50 mg/kg twice daily, respectively, at week 67). Mutagenesis Crofelemer was negative in the bacterial reverse mutation assay, chromosomal aberration assay, and rat bone marrow micronucleus assay. Impairment of Fertility Crofelemer, at oral doses of up to 738 mg/kg/day (177 times the recommended human daily dose of 125 mg twice daily), had no effects on fertility or reproductive performance of male and female rats."]},"tags":[{"label":"Antidiarrheal","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Anoctamin-1","category":"target"},{"label":"ANO1","category":"gene"},{"label":"CFTR","category":"gene"},{"label":"A07XA06","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Active","category":"status"},{"label":"Non-infective diarrhea","category":"indication"},{"label":"Napo Pharms Inc","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"commonSideEffects":[{"effect":"Upper respiratory tract infection","drugRate":"6%","severity":"common","_validated":true},{"effect":"Bronchitis","drugRate":"4%","severity":"common","_validated":true},{"effect":"Cough","drugRate":"4%","severity":"common","_validated":true},{"effect":"Flatulence","drugRate":"3%","severity":"common","_validated":true},{"effect":"Increased bilirubin","drugRate":"3%","severity":"common","_validated":true},{"effect":"Nausea","drugRate":"3%","severity":"common","_validated":true},{"effect":"Back pain","drugRate":"3%","severity":"common","_validated":true},{"effect":"Arthralgia","drugRate":"3%","severity":"common","_validated":true},{"effect":"Urinary tract infection","drugRate":"2%","severity":"common","_validated":true},{"effect":"Nasopharyngitis","drugRate":"2%","severity":"common","_validated":true},{"effect":"Musculoskeletal pain","drugRate":"2%","severity":"common","_validated":true},{"effect":"Hemorrhoids","drugRate":"2%","severity":"common","_validated":true},{"effect":"Giardiasis","drugRate":"2%","severity":"common","_validated":true},{"effect":"Anxiety","drugRate":"2%","severity":"common","_validated":true},{"effect":"Increased alanine aminotransferase","drugRate":"2%","severity":"common","_validated":true},{"effect":"Abdominal distension","drugRate":"2%","severity":"common","_validated":true},{"effect":"Increased aspartate aminotransferase","drugRate":"reported","severity":"unknown"},{"effect":"Increased conjugated bilirubin","drugRate":"reported","severity":"unknown"},{"effect":"Increased unconjugated blood bilirubin","drugRate":"reported","severity":"unknown"},{"effect":"Constipation","drugRate":"reported","severity":"unknown"},{"effect":"Depression","drugRate":"reported","severity":"unknown"},{"effect":"Dermatitis","drugRate":"reported","severity":"unknown"},{"effect":"Dizziness","drugRate":"reported","severity":"unknown"},{"effect":"Dry mouth","drugRate":"reported","severity":"unknown"},{"effect":"Dyspepsia","drugRate":"reported","severity":"unknown"},{"effect":"Gastroenteritis","drugRate":"reported","severity":"unknown"},{"effect":"Herpes zoster","drugRate":"reported","severity":"unknown"},{"effect":"Nephrolithiasis","drugRate":"reported","severity":"unknown"},{"effect":"Pain in extremity","drugRate":"reported","severity":"unknown"},{"effect":"Pollakiuria","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Lactation":"The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. There are no data on the presence of crofelemer in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for HIV transmission and adverse effects on breastfed infant, instruct mothers not to breastfeed if they are taking MYTESI.","Pregnancy":"Crofelemer is minimally absorbed systemically by the oral route of administration and maternal use is not expected to result in fetal exposure to the drug. In pregnant rats, no adverse fetal effects were observed with oral administration of crofelemer at doses up to 177 times the recommended clinical dose during the period of organogenesis. In pregnant rabbits, an increase in fetal resorptions and abortions compared to controls were observed with crofelemer at dose of 96 times the recommended clinical dose.","Geriatric use":"Clinical studies with MYTESI did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.","Paediatric use":"The safety and effectiveness of MYTESI have not been established in pediatric patients."}},"trials":[],"aliases":[],"company":"Napo Pharms Inc","patents":[{"applNo":"N202292","source":"FDA Orange Book","status":"Active","expires":"Oct 31, 2031","useCode":"U-1319","territory":"US","drugProduct":false,"patentNumber":"9585868","drugSubstance":false},{"applNo":"N202292","source":"FDA Orange Book","status":"Active","expires":"Oct 31, 2031","useCode":"U-1319","territory":"US","drugProduct":false,"patentNumber":"8962680","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CROFELEMER","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:35:45.734119+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:35:45.734012+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Crofelemer","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:35:52.200964+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:35:50.793938+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:35:44.724558+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CROFELEMER","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:35:51.146811+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:35:43.928593+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:35:43.928617+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:35:43.928622+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Anoctamin-1 blocker","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:35:52.200911+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108184/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:35:51.859410+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA202292","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:35:43.928625+00:00"}},"allNames":"mytesi","offLabel":[],"synonyms":["crofelemer","fulyzaq"],"timeline":[{"date":"2012-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SALIX PHARMS to Napo Pharms Inc"},{"date":"2012-12-31","type":"positive","source":"DrugCentral","milestone":"FDA approval (Salix Pharms)"}],"aiSummary":"Mytesi (CROFELEMER) is a small molecule antidiarrheal medication originally developed by Salix Pharmaceuticals and currently owned by Napo Pharmaceuticals Inc. It targets the anoctamin-1 receptor to treat non-infectious diarrhea. Mytesi is a patented medication with no generic manufacturers available. It was FDA-approved in 2012 for its approved indications. Key safety considerations include the need for monitoring of liver function and potential interactions with other medications.","approvals":[{"date":"2012-12-31","orphan":false,"company":"SALIX PHARMS","regulator":"FDA"}],"brandName":"Mytesi","ecosystem":[{"indication":"Non-infective diarrhea","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Anoctamin-1","novelty":"Follow-on","targets":[{"gene":"ANO1","source":"DrugCentral","target":"Anoctamin-1","protein":"Anoctamin-1"},{"gene":"CFTR","source":"DrugCentral","target":"Cystic fibrosis transmembrane conductance regulator","protein":"Cystic fibrosis transmembrane conductance regulator"}],"modality":"Small Molecule","drugClass":"Antidiarrheal [EPC]","explanation":"Crofelemer is an inhibitor of both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl) channel, and the calcium-activated Cl channels (CaCC) at the luminal membrane of enterocytes. The CFTR Cl channel and CaCC regulate Cl and fluid secretion by intestinal epithelial cells. Crofelemer acts by blocking Cl secretion and accompanying high volume water loss in diarrhea, normalizing the flow of Cl and water in the gastrointestinal tract.","oneSentence":"Mytesi works by blocking the action of a specific protein called anoctamin-1, which helps regulate the movement of water and electrolytes in the intestines.","technicalDetail":"Mytesi (CROFELEMER) is a selective inhibitor of the anoctamin-1 (ANO1) channel, which is involved in the regulation of chloride and water secretion in the intestinal epithelium.","_target_confidence":0.5},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Crofelemer","title":"Crofelemer","extract":"Crofelemer is an antidiarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Other possible uses include diarrhea in children, acute infectious diarrhea, and diarrhea in patients with irritable bowel syndrome. It is a purified oligomeric proanthocyanidin from \"dragon's blood\", the sap of the South American tree Croton lechleri."},"commercial":{"launchDate":"2012","_launchSource":"DrugCentral (FDA 2012-12-31, SALIX PHARMS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4744","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CROFELEMER","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CROFELEMER","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Crofelemer","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":"2026-03-30T10:23:16.545523","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:36:10.280683+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"elexacaftor","drugSlug":"elexacaftor","fdaApproval":"2019-10-10","relationship":"same-target"},{"drugName":"felodipine","drugSlug":"felodipine","fdaApproval":"1991-07-25","genericCount":13,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"glibenclamide","drugSlug":"glibenclamide","fdaApproval":"1984-05-01","relationship":"same-target"},{"drugName":"ivacaftor","drugSlug":"ivacaftor","fdaApproval":"2012-01-31","patentExpiry":"Nov 20, 2027","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"lumacaftor","drugSlug":"lumacaftor","fdaApproval":"2015-07-02","relationship":"same-target"},{"drugName":"tezacaftor","drugSlug":"tezacaftor","fdaApproval":"2018-02-12","relationship":"same-target"}],"genericName":"crofelemer","indications":{"approved":[{"name":"Non-infective diarrhea","source":"DrugCentral","snomedId":69980003,"regulator":"FDA","eligibility":"Adult patients with HIV/AIDS on anti-retroviral therapy"}],"offLabel":[],"pipeline":[]},"currentOwner":"Napo Pharms Inc","drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"elexacaftor","brandName":"elexacaftor","genericName":"elexacaftor","approvalYear":"2019","relationship":"same-target"},{"drugId":"felodipine","brandName":"felodipine","genericName":"felodipine","approvalYear":"1991","relationship":"same-target"},{"drugId":"glibenclamide","brandName":"glibenclamide","genericName":"glibenclamide","approvalYear":"1984","relationship":"same-target"},{"drugId":"ivacaftor","brandName":"ivacaftor","genericName":"ivacaftor","approvalYear":"2012","relationship":"same-target"},{"drugId":"lumacaftor","brandName":"lumacaftor","genericName":"lumacaftor","approvalYear":"2015","relationship":"same-target"},{"drugId":"tezacaftor","brandName":"tezacaftor","genericName":"tezacaftor","approvalYear":"2018","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT04486326","phase":"PHASE4","title":"Crofelemer for Functional Diarrhea","status":"TERMINATED","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2020-08-20","conditions":["Diarrhea"],"enrollment":17,"completionDate":"2022-09-23"},{"nctId":"NCT03898856","phase":"PHASE4","title":"Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients","status":"COMPLETED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2019-04-01","conditions":["Chronic Diarrhea of Unknown Origin"],"enrollment":93,"completionDate":"2025-01-30"},{"nctId":"NCT06326645","phase":"EARLY_PHASE1","title":"Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome","status":"RECRUITING","sponsor":"Lindsey Russell, MD","startDate":"2025-03-03","conditions":["Short Bowel Syndrome"],"enrollment":6,"completionDate":"2026-02-01"},{"nctId":"NCT03094052","phase":"PHASE2","title":"Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2018-10-09","conditions":["HER2-positive Breast Cancer","Breast Adenocarcinoma","Stage II Breast Cancer AJCC v6 and v7","Stage IIA Breast Cancer AJCC v6 and v7","Stage IIB Breast Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage IIIA Breast Cancer AJCC v7","Stage IIIB Breast Cancer AJCC v7","Stage IIIC Breast Cancer AJCC v7"],"enrollment":11,"completionDate":"2022-10-31"},{"nctId":"NCT06721871","phase":"PHASE2","title":"Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID)","status":"RECRUITING","sponsor":"Napo Pharmaceuticals, Inc.","startDate":"2025-05-01","conditions":["Microvillus Inclusion Disease","Congenital Disorders","Rare Diseases"],"enrollment":12,"completionDate":"2026-03"},{"nctId":"NCT06904872","phase":"PHASE2","title":"Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)","status":"RECRUITING","sponsor":"Napo Therapeutics, S.p.A.","startDate":"2025-05-29","conditions":["Short Bowel Syndrome","Malabsorption Syndromes","Short Gut Syndrome","Post-Op Complication","Functional Gastrointestinal Disorders"],"enrollment":18,"completionDate":"2026-02"},{"nctId":"NCT04538625","phase":"PHASE3","title":"Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy","status":"COMPLETED","sponsor":"Napo Pharmaceuticals, Inc.","startDate":"2020-10-07","conditions":["Cancer Therapy-Related Diarrhea","Chemotherapy-related Diarrhea","Adult Solid Tumor","Prophylaxis of Diarrhea","Symptomatic Relief of Diarrhea","Targeted Therapy-related Diarrhea"],"enrollment":287,"completionDate":"2023-10-30"},{"nctId":"NCT02910219","phase":"PHASE2","title":"Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients","status":"COMPLETED","sponsor":"Sandra Swain","startDate":"2017-01-31","conditions":["Breast Cancer"],"enrollment":53,"completionDate":"2020-11-23"},{"nctId":"NCT04192487","phase":"PHASE4","title":"Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea","status":"COMPLETED","sponsor":"Napo Pharmaceuticals, Inc.","startDate":"2019-10-22","conditions":["Acquired Immunodeficiency Syndrome","Healthy Volunteers","HIV/AIDS","HIV Diarrhea","Human Immunodeficiency Virus"],"enrollment":17,"completionDate":"2021-08-31"},{"nctId":"NCT00547898","phase":"PHASE3","title":"Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2007-10","conditions":["HIV Associated Diarrhea"],"enrollment":374,"completionDate":"2011-07-11"},{"nctId":"NCT01374490","phase":"PHASE3","title":"Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2011-06-07","conditions":["HIV Enteropathy","Diarrhea With HIV"],"enrollment":250,"completionDate":"2012-10-31"},{"nctId":"NCT00101725","phase":"PHASE2","title":"A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2004-12","conditions":["Irritable Bowel Syndrome","Colonic Diseases","Diarrhea","Gastrointestinal Disease"],"enrollment":245,"completionDate":"2005-11"},{"nctId":"NCT00461526","phase":"PHASE2","title":"Diarrhea Predominant Irritable Bowel Syndrome in Females","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2006-10","conditions":["Irritable Bowel Syndrome"],"enrollment":240,"completionDate":"2007-12"},{"nctId":"NCT00002310","phase":"NA","title":"SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir","status":"COMPLETED","sponsor":"Shaman 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Part A"},{"date":"2023 Oct 16","pmid":"37643022","title":"Patient-derived enteroids provide a platform for the development of therapeutic approaches in microvillus inclusion disease.","journal":"The Journal of clinical investigation"},{"date":"2023 Oct","pmid":"37474374","title":"Crofelemer for the Management of Neratinib-Associated Diarrhea in Patients With HER2+ Early-Stage Breast Cancer.","journal":"Clinical breast cancer"},{"date":"2023 Jan 29","pmid":"36747680","title":"Therapy Development for Microvillus Inclusion Disease using Patient-derived Enteroids.","journal":"bioRxiv : the preprint server for biology"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Napo Pharms Inc","companyId":"napo-pharms-inc","modality":"Small 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