{"id":"obeticholic-acid","rwe":[],"tags":[{"label":"Farnesoid X Receptor Agonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Bile acid receptor","category":"target"},{"label":"NR1H4","category":"gene"},{"label":"GPBAR1","category":"gene"},{"label":"A05AA04","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Generic Available","category":"availability"},{"label":"LOE Approaching","category":"status"},{"label":"Primary cholangitis","category":"indication"},{"label":"Intercept Pharms Inc","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"safetySignals":[{"llr":3021.885,"date":"","count":1235,"signal":"Pruritus","source":"DrugCentral FAERS","actionTaken":"Reported 1,235 times (LLR=3022)"},{"llr":233.12,"date":"","count":102,"signal":"Therapy cessation","source":"DrugCentral FAERS","actionTaken":"Reported 102 times (LLR=233)"},{"llr":229.942,"date":"","count":209,"signal":"Product dose omission issue","source":"DrugCentral FAERS","actionTaken":"Reported 209 times (LLR=230)"},{"llr":226.513,"date":"","count":395,"signal":"Fatigue","source":"DrugCentral FAERS","actionTaken":"Reported 395 times (LLR=227)"},{"llr":209.948,"date":"","count":138,"signal":"Hospitalisation","source":"DrugCentral FAERS","actionTaken":"Reported 138 times (LLR=210)"},{"llr":207.024,"date":"","count":108,"signal":"Blood alkaline phosphatase increased","source":"DrugCentral FAERS","actionTaken":"Reported 108 times (LLR=207)"},{"llr":190.843,"date":"","count":87,"signal":"Therapy interrupted","source":"DrugCentral FAERS","actionTaken":"Reported 87 times (LLR=191)"},{"llr":159.82,"date":"","count":34,"signal":"Blood alkaline phosphatase abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 34 times (LLR=160)"},{"llr":140.362,"date":"","count":70,"signal":"Hepatic cirrhosis","source":"DrugCentral FAERS","actionTaken":"Reported 70 times (LLR=140)"},{"llr":110.041,"date":"","count":145,"signal":"Constipation","source":"DrugCentral FAERS","actionTaken":"Reported 145 times (LLR=110)"},{"llr":77.671,"date":"","count":29,"signal":"Hepatic fibrosis","source":"DrugCentral FAERS","actionTaken":"Reported 29 times (LLR=78)"},{"llr":72.877,"date":"","count":19,"signal":"Emergency care","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=73)"},{"llr":68.695,"date":"","count":26,"signal":"Insurance issue","source":"DrugCentral FAERS","actionTaken":"Reported 26 times (LLR=69)"},{"llr":66.449,"date":"","count":49,"signal":"Jaundice","source":"DrugCentral FAERS","actionTaken":"Reported 49 times (LLR=66)"},{"llr":64.783,"date":"","count":24,"signal":"Varices oesophageal","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=65)"}],"commonSideEffects":[],"specialPopulations":{"Lactation":"There is no information on the presence of obeticholic acid in human milk, the effects on the breast-fed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for OCALIVA and any potential adverse effects on the breastfed infant from OCALIVA or from the underlying maternal condition.","Pregnancy":"The limited available human data on the use of obeticholic acid during pregnancy are not sufficient to inform drug-associated risk. In animal reproduction studies, no developmental abnormalities or fetal harm was observed when pregnant rats or rabbits were administered obeticholic acid during the period of organogenesis at exposures approximately 13-times and 6-times human exposures, respectively, at the maximum recommended human dose (MRHD) of 10 mg.","Geriatric use":"Of the 201 patients in clinical trials of OCALIVA who received the recommended dosage (5 mg or 10 mg once daily), 41 (20%) were 65 years of age and older, while (4%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between these subjects and subjects less than 65 years of age, but greater sensitivity of some older individuals cannot be ruled out.","Paediatric use":"The safety and effectiveness of OCALIVA in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Intercept Pharms Inc","patents":[{"applNo":"N207999","source":"FDA Orange Book","status":"Active","expires":"Sep 6, 2033","useCode":"U-1854","territory":"US","drugProduct":false,"patentNumber":"10047117","drugSubstance":false},{"applNo":"N207999","source":"FDA Orange Book","status":"Active","expires":"Apr 26, 2036","useCode":"U-2945","territory":"US","drugProduct":false,"patentNumber":"10758549","drugSubstance":false},{"applNo":"N207999","source":"FDA Orange Book","status":"Active","expires":"Jun 17, 2033","useCode":"","territory":"US","drugProduct":false,"patentNumber":"10174073","drugSubstance":true},{"applNo":"N207999","source":"FDA Orange Book","status":"Active","expires":"Apr 26, 2036","useCode":"","territory":"US","drugProduct":true,"patentNumber":"10751349","drugSubstance":false},{"applNo":"N207999","source":"FDA Orange Book","status":"Active","expires":"Feb 21, 2027","useCode":"","territory":"US","drugProduct":true,"patentNumber":"RE48286","drugSubstance":true},{"applNo":"N207999","source":"FDA Orange Book","status":"Active","expires":"Apr 26, 2036","useCode":"","territory":"US","drugProduct":true,"patentNumber":"10052337","drugSubstance":false},{"applNo":"N207999","source":"FDA Orange Book","status":"Active","expires":"Jun 17, 2033","useCode":"","territory":"US","drugProduct":true,"patentNumber":"9238673","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=OBETICHOLIC ACID","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:47:11.808999+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T03:47:11.808798+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Obeticholic Acid","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:47:20.369598+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:47:18.524308+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:47:11.850747+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=OBETICHOLIC ACID","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:47:19.248033+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL266340/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:47:20.257421+00:00"}},"allNames":"ocaliva","offLabel":[],"synonyms":["obeticholic acid","ocaliva","6-ECDCA","6ECDCA","INT-747"],"timeline":[{"date":"2016-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from INTERCEPT PHARMACEUTICALS INC to Intercept Pharms Inc"},{"date":"2016-05-27","type":"positive","source":"DrugCentral","milestone":"FDA approval (Intercept Pharmaceuticals Inc)"},{"date":"2016-12-12","type":"positive","source":"DrugCentral","milestone":"EMA approval (Intercept Pharma Ltd)"},{"date":"2023-05-30","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 3 manufacturers approved"},{"date":"2027-02-21","type":"negative","source":"FDA Orange Book","milestone":"Substance patent RE48286 expires"},{"date":"2033-06-17","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 10174073 expires"}],"aiSummary":"Ocaliva, also known as obeticholic acid, is a small molecule used to treat certain conditions, including Primary Biliary Cirrhosis, as per a Phase 3 clinical trial. It is administered as an intervention to patients with these conditions.","approvals":[{"date":"2016-05-27","orphan":false,"company":"INTERCEPT PHARMACEUTICALS INC","regulator":"FDA"},{"date":"2016-12-12","orphan":true,"company":"Intercept Pharma Ltd","regulator":"EMA"}],"brandName":"Ocaliva","ecosystem":[{"indication":"Primary cholangitis","otherDrugs":[],"globalPrevalence":648000}],"mechanism":{"target":"Bile acid receptor","novelty":"Follow-on","targets":[{"gene":"NR1H4","source":"DrugCentral","target":"Bile acid receptor","protein":"Bile acid receptor"},{"gene":"GPBAR1","source":"DrugCentral","target":"G-protein coupled bile acid receptor 1","protein":"G-protein coupled bile acid receptor 1"}],"moaClass":"Farnesoid X Receptor Agonists","modality":"Small Molecule","drugClass":"Farnesoid X Receptor Agonist","explanation":"","oneSentence":"","technicalDetail":"Ocaliva acts as a farnesoid X receptor agonist, binding to the FXR protein and activating its transcriptional activity, which in turn regulates the expression of genes involved in bile acid synthesis and transport."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Obeticholic_acid","title":"Obeticholic acid","extract":"Obeticholic acid (OCA), sold under the brand name Ocaliva, is a semi-synthetic bile acid analogue which has the chemical structure 6α-ethyl-chenodeoxycholic acid. It is used as a medication used to treat primary biliary cholangitis. Intercept Pharmaceuticals Inc. hold the worldwide rights to develop OCA outside Japan and China, where it is licensed to Dainippon Sumitomo Pharma.","wiki_society_and_culture":"== Society and culture ==\n\n=== Legal status ===\nIn June 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency concluded its review of the medicine Ocaliva (obeticholic acid) and recommended that the medicine's marketing authorization be revoked, because its benefits are no longer considered to outweigh its risks. Ocaliva is used to treat adults with primary biliary cholangitis, an autoimmune condition that causes gradual destruction of the bile ducts in the liver, which can lead to liver failure and increase the risk of liver cancer."},"commercial":{"launchDate":"2016","_launchSource":"DrugCentral (FDA 2016-05-27, INTERCEPT PHARMACEUTICALS INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5155","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=OBETICHOLIC%20ACID","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=OBETICHOLIC ACID","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Obeticholic_acid","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"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T13:03:27.803835","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:47:22.131704+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"chenodiol","drugSlug":"chenodiol","fdaApproval":"1983-07-28","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ursodiol","drugSlug":"ursodiol","fdaApproval":"1987-12-31","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"cholic acid","drugSlug":"cholic-acid","fdaApproval":"2015-03-17","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"obeticholic acid","indications":{"approved":[{"name":"Primary cholangitis","source":"DrugCentral","snomedId":17266006,"regulator":"FDA","usPrevalence":null,"globalPrevalence":648000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (22245904[PMID])"}],"offLabel":[],"pipeline":[]},"currentOwner":"Intercept Pharms Inc","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"chenodiol","brandName":"chenodiol","genericName":"chenodiol","approvalYear":"1983","relationship":"same-class"},{"drugId":"ursodiol","brandName":"ursodiol","genericName":"ursodiol","approvalYear":"1987","relationship":"same-class"},{"drugId":"cholic-acid","brandName":"cholic acid","genericName":"cholic acid","approvalYear":"2015","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05223036","phase":"PHASE2","title":"Testing Obeticholic Acid for Familial Adenomatous Polyposis","status":"SUSPENDED","sponsor":"National Cancer Institute (NCI)","startDate":"2023-01-19","conditions":["Attenuated Familial Adenomatous Polyposis","Colorectal Carcinoma","Duodenal Carcinoma","Familial Adenomatous Polyposis"],"enrollment":80,"completionDate":"2029-02-21"},{"nctId":"NCT04939051","phase":"PHASE2","title":"Obeticholic Acid for Prevention in Barrett's Esophagus","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-01-03","conditions":["Barrett Esophagus","Esophageal Adenocarcinoma"],"enrollment":30,"completionDate":"2027-09-01"},{"nctId":"NCT04594694","phase":"PHASE2","title":"Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2019-10-02","conditions":["Primary Biliary Cholangitis"],"enrollment":75,"completionDate":"2025-10-14"},{"nctId":"NCT06488911","phase":"PHASE3","title":"To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2024-07-01","conditions":["Primary Biliary Cholangitis"],"enrollment":63,"completionDate":"2025-10-21"},{"nctId":"NCT06121375","phase":"PHASE2,PHASE3","title":"Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2024-09-02","conditions":["Biliary Atresia"],"enrollment":28,"completionDate":"2025-10-21"},{"nctId":"NCT05239468","phase":"PHASE2","title":"Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC","status":"COMPLETED","sponsor":"Intercept Pharmaceuticals","startDate":"2022-03-21","conditions":["Primary Biliary Cholangitis"],"enrollment":72,"completionDate":"2025-09-01"},{"nctId":"NCT06247735","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kowa Research Institute, Inc.","startDate":"2024-02-07","conditions":["Primary Biliary Cholangitis"],"enrollment":46,"completionDate":"2026-06"},{"nctId":"NCT07104786","phase":"PHASE2","title":"Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease","status":"COMPLETED","sponsor":"King Edward Medical University","startDate":"2023-08-24","conditions":["Non Alcoholic Fatty Liver Disease"],"enrollment":90,"completionDate":"2024-05-23"},{"nctId":"NCT05292872","phase":"","title":"Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients","status":"COMPLETED","sponsor":"Intercept Pharmaceuticals","startDate":"2015-06-01","conditions":["Primary Biliary Cholangitis"],"enrollment":4577,"completionDate":"2021-12-31"},{"nctId":"NCT05573204","phase":"PHASE2","title":"Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Tanta University","startDate":"2021-09-01","conditions":["Non-alcoholic Steatohepatitis"],"enrollment":59,"completionDate":"2026-12-30"},{"nctId":"NCT06715319","phase":"PHASE3","title":"Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis","status":"COMPLETED","sponsor":"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.","startDate":"2021-10-09","conditions":["PBC"],"enrollment":100,"completionDate":"2024-04-29"},{"nctId":"NCT06691412","phase":"PHASE3","title":"Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomes","status":"NOT_YET_RECRUITING","sponsor":"Assiut University","startDate":"2024-11-15","conditions":["Hepatitis B Virus","Steatosis"],"enrollment":100,"completionDate":"2026-03-01"},{"nctId":"NCT02548351","phase":"PHASE3","title":"Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2015-09-22","conditions":["Non Alcoholic Steatohepatitis (NASH)"],"enrollment":2477,"completionDate":"2023-09-15"},{"nctId":"NCT02430077","phase":"PHASE2","title":"Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients","status":"COMPLETED","sponsor":"Abhimanyu Garg","startDate":"2016-06","conditions":["Familial Partial Lipodystrophy"],"enrollment":10,"completionDate":"2022-12"},{"nctId":"NCT05450887","phase":"PHASE3","title":"Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis","status":"COMPLETED","sponsor":"Nanjing Chia-tai Tianqing Pharmaceutical","startDate":"2021-09-23","conditions":["Primary Biliary Cholangitis"],"enrollment":108,"completionDate":"2024-04-09"},{"nctId":"NCT00550862","phase":"PHASE2","title":"Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2007-10","conditions":["Liver Cirrhosis, Biliary"],"enrollment":165,"completionDate":"2010-12"},{"nctId":"NCT03439254","phase":"PHASE3","title":"Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis","status":"COMPLETED","sponsor":"Intercept Pharmaceuticals","startDate":"2017-08-30","conditions":["Compensated Cirrhosis","Nonalcoholic Steatohepatitis"],"enrollment":919,"completionDate":"2022-09-08"},{"nctId":"NCT05293938","phase":"","title":"A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients","status":"WITHDRAWN","sponsor":"Intercept Pharmaceuticals","startDate":"2022-03-28","conditions":["Primary Biliary Cholangitis"],"enrollment":0,"completionDate":"2023-07"},{"nctId":"NCT04076527","phase":"","title":"Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis","status":"UNKNOWN","sponsor":"University of Leipzig","startDate":"2019-09-19","conditions":["PBC","Primary Biliary Cholangitis"],"enrollment":1200,"completionDate":"2024-03"},{"nctId":"NCT02654236","phase":"NA","title":"Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling","status":"COMPLETED","sponsor":"Suthat Liangpunsakul","startDate":"2016-04","conditions":["Alcohol Consumption"],"enrollment":30,"completionDate":"2019-09"},{"nctId":"NCT05321524","phase":"PHASE2","title":"Obeticholic Acid in Pediatric Subjects With Biliary Atresia","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2015-07-01","conditions":["Biliary Atresia"],"enrollment":7,"completionDate":"2023-03-09"},{"nctId":"NCT01585025","phase":"PHASE2","title":"Obeticholic Acid in Bile Acid Diarrhoea","status":"COMPLETED","sponsor":"Imperial College Healthcare NHS Trust","startDate":"2012-04","conditions":["Primary Bile Acid Malabsorption","Secondary Bile Acid Malabsorption","Chronic Diarrhoea"],"enrollment":35,"completionDate":"2014-02"},{"nctId":"NCT02308111","phase":"PHASE4","title":"Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2014-12-26","conditions":["Liver Cirrhosis, Biliary"],"enrollment":334,"completionDate":"2021-12-23"},{"nctId":"NCT05740631","phase":"NA","title":"The Effect of Obeticholic Acid in Healthy Volunteers","status":"UNKNOWN","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2022-08-22","conditions":["Healthy"],"enrollment":12,"completionDate":"2023-07-22"},{"nctId":"NCT05133830","phase":"PHASE1","title":"Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2021-11-23","conditions":["Pruritus"],"enrollment":52,"completionDate":"2022-05-31"},{"nctId":"NCT03633227","phase":"PHASE4","title":"Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2018-06-22","conditions":["Liver Cirrhosis, Biliary"],"enrollment":22,"completionDate":"2021-07-09"},{"nctId":"NCT01865812","phase":"PHASE2","title":"Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis","status":"COMPLETED","sponsor":"Intercept Pharmaceuticals","startDate":"2013-12-03","conditions":["Primary Biliary Cirrhosis"],"enrollment":27,"completionDate":"2016-09-12"},{"nctId":"NCT03836937","phase":"NA","title":"Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT","status":"COMPLETED","sponsor":"Sir Salimullah Medical College Mitford Hospital","startDate":"2019-03-05","conditions":["Non-Alcoholic Fatty Liver Disease"],"enrollment":70,"completionDate":"2021-12-31"},{"nctId":"NCT04956328","phase":"PHASE3","title":"Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)","status":"UNKNOWN","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2021-07-22","conditions":["Primary Biliary Cirrhosis"],"enrollment":120,"completionDate":"2023-09-20"},{"nctId":"NCT02177136","phase":"PHASE2","title":"Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)","status":"COMPLETED","sponsor":"Intercept Pharmaceuticals","startDate":"2015-02-09","conditions":["Primary Sclerosing Cholangitis (PSC)"],"enrollment":77,"completionDate":"2018-03-22"},{"nctId":"NCT00570765","phase":"PHASE2","title":"Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)","status":"COMPLETED","sponsor":"Intercept Pharmaceuticals","startDate":"2008-01-17","conditions":["Liver Cirrhosis, Biliary"],"enrollment":60,"completionDate":"2017-09-25"},{"nctId":"NCT01473524","phase":"PHASE3","title":"Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis","status":"COMPLETED","sponsor":"Intercept Pharmaceuticals","startDate":"2012-01","conditions":["Primary Biliary Cirrhosis"],"enrollment":217,"completionDate":"2018-12-17"},{"nctId":"NCT02532335","phase":"PHASE1","title":"Obeticholic Acid in Morbidly Obese Patients and Healthy Volunteers","status":"UNKNOWN","sponsor":"Sahlgrenska University Hospital","startDate":"2015-08","conditions":["Obesity"],"enrollment":40,"completionDate":"2021-06"},{"nctId":"NCT04053023","phase":"PHASE1","title":"Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-08-27","conditions":["Cholestasis"],"enrollment":19,"completionDate":"2019-11-25"},{"nctId":"NCT02039219","phase":"PHASE2","title":"Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)","status":"TERMINATED","sponsor":"Naga P. Chalasani","startDate":"2014-11-03","conditions":["Alcoholic Hepatitis"],"enrollment":19,"completionDate":"2018-01-29"},{"nctId":"NCT03253276","phase":"EARLY_PHASE1","title":"Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT","status":"COMPLETED","sponsor":"University of Aarhus","startDate":"2016-05-19","conditions":["Primary Biliary Cirrhosis"],"enrollment":8,"completionDate":"2018-09-20"},{"nctId":"NCT03703076","phase":"","title":"A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life","status":"UNKNOWN","sponsor":"SAMEY","startDate":"2018-04-10","conditions":["Primary Biliary Cholangitis"],"enrollment":150,"completionDate":"2019-04"},{"nctId":"NCT02633956","phase":"PHASE2","title":"Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)","status":"COMPLETED","sponsor":"Intercept 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