{"id":"obeticholic-acid-tablets-oca","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Pruritus (itching)"},{"rate":"10-20","effect":"Fatigue"},{"rate":"5-15","effect":"Abdominal pain"},{"rate":"5-10","effect":"Diarrhea"},{"rate":"5-10","effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL266340","moleculeType":"Small molecule","molecularWeight":"420.63"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"OCA activates the farnesoid X receptor, a nuclear receptor that regulates bile acid homeostasis and metabolic pathways. By activating FXR, the drug reduces hepatic bile acid synthesis, decreases liver inflammation, and improves markers of cholestasis and fibrosis. This mechanism makes it particularly useful in cholestatic liver diseases where bile acid accumulation drives hepatocellular injury.","oneSentence":"Obeticholic acid is a farnesoid X receptor (FXR) agonist that reduces bile acid synthesis and improves liver function by modulating nuclear receptor signaling.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:50:31.680Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary biliary cholangitis (PBC)"},{"name":"Primary sclerosing cholangitis (PSC)"},{"name":"Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)"}]},"trialDetails":[{"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},{"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},{"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},{"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},{"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},{"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},{"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},{"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},{"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},{"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},{"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},{"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},{"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},{"nctId":"NCT02633956","phase":"PHASE2","title":"Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)","status":"COMPLETED","sponsor":"Intercept Pharmaceuticals","startDate":"2015-12-04","conditions":"Nonalcoholic Steatohepatitis","enrollment":84},{"nctId":"NCT01914562","phase":"PHASE1","title":"Effect of Food on Pharmacokinetics of Obeticholic Acid (OCA)","status":"COMPLETED","sponsor":"Intercept Pharmaceuticals","startDate":"2013-08","conditions":"Healthy","enrollment":32}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Obeticholic Acid Tablets（OCA）","genericName":"Obeticholic Acid Tablets（OCA）","companyName":"Nanjing Chia-tai Tianqing Pharmaceutical","companyId":"nanjing-chia-tai-tianqing-pharmaceutical","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Obeticholic acid is a farnesoid X receptor (FXR) agonist that reduces bile acid synthesis and improves liver function by modulating nuclear receptor signaling. Used for Primary biliary cholangitis (PBC), Primary sclerosing cholangitis (PSC), Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}