{"id":"a4250-odevixibat","safety":{"commonSideEffects":[{"rate":null,"effect":"Pruritus"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By blocking IBAT (also known as SLC10A2), odevixibat prevents the reabsorption of bile acids in the terminal ileum, forcing them to be excreted in feces. This reduces the enterohepatic circulation of bile acids, leading to decreased serum bile acid levels. The mechanism is designed to alleviate pruritus and other symptoms associated with cholestatic liver diseases where bile acid accumulation causes tissue damage and itching.","oneSentence":"Odevixibat inhibits the ileal bile acid transporter (IBAT) to reduce bile acid reabsorption and increase fecal excretion, thereby lowering serum bile acids.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:43:59.237Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Progressive familial intrahepatic cholestasis type 1 (PFIC1)"},{"name":"Bile acid diarrhea"}]},"trialDetails":[{"nctId":"NCT07497724","phase":"","title":"Retrospective Observational Study of Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)","status":"NOT_YET_RECRUITING","sponsor":"Ipsen","startDate":"2026-04-01","conditions":"PFIC - Progressive Familial Intrahepatic Cholestasis","enrollment":200},{"nctId":"NCT04336722","phase":"PHASE3","title":"Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Albireo, an Ipsen Company","startDate":"2020-07-08","conditions":"Biliary Atresia","enrollment":254},{"nctId":"NCT05035030","phase":"PHASE3","title":"Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome","status":"RECRUITING","sponsor":"Albireo, an Ipsen Company","startDate":"2021-09-03","conditions":"Alagille Syndrome","enrollment":70},{"nctId":"NCT03659916","phase":"PHASE3","title":"Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC","status":"COMPLETED","sponsor":"Albireo, an Ipsen Company","startDate":"2018-09-28","conditions":"Progressive Familial Intrahepatic Cholestasis","enrollment":116},{"nctId":"NCT05426733","phase":"PHASE3","title":"An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia","status":"ENROLLING_BY_INVITATION","sponsor":"Albireo, an Ipsen Company","startDate":"2022-07-05","conditions":"Biliary Atresia","enrollment":180},{"nctId":"NCT03566238","phase":"PHASE3","title":"This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2","status":"COMPLETED","sponsor":"Albireo","startDate":"2018-05-16","conditions":"PFIC1, PFIC2","enrollment":62},{"nctId":"NCT04483531","phase":"","title":"Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis","status":"APPROVED_FOR_MARKETING","sponsor":"Albireo","startDate":"","conditions":"Progressive Familial Intrahepatic Cholestasis","enrollment":""},{"nctId":"NCT04674761","phase":"PHASE3","title":"Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome","status":"COMPLETED","sponsor":"Albireo","startDate":"2021-03-19","conditions":"Alagille Syndrome","enrollment":52}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"A4250 (odevixibat)","genericName":"A4250 (odevixibat)","companyName":"Albireo","companyId":"albireo","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Odevixibat inhibits the ileal bile acid transporter (IBAT) to reduce bile acid reabsorption and increase fecal excretion, thereby lowering serum bile acids. Used for Progressive familial intrahepatic cholestasis type 1 (PFIC1), Bile acid diarrhea.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}