{"id":"a3309","safety":{"commonSideEffects":[{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Abdominal discomfort"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_fixedAt":"2026-03-30T17:59:51.209732","_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"By sequestering bile acids in the gut, A3309 prevents their reabsorption in the terminal ileum, leading to increased fecal bile acid loss. This triggers compensatory bile acid synthesis from cholesterol, which can lower cholesterol levels and modulate farnesoid X receptor (FXR) and G-protein coupled bile acid receptor 1 (TGR5) signaling pathways involved in metabolic regulation.","oneSentence":"A3309 is a bile acid sequestrant that binds bile acids in the intestine to increase their fecal excretion and modulate metabolic pathways.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T02:28:06.397Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cholestasis-related pruritus in progressive familial intrahepatic cholestasis (PFIC)"},{"name":"Bile acid diarrhea"}]},"_fixedFields":["modality→Small Molecule"],"trialDetails":[{"nctId":"NCT04006145","phase":"PHASE2","title":"A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH","status":"COMPLETED","sponsor":"Albireo","startDate":"2019-06-06","conditions":"NAFLD, NASH","enrollment":47},{"nctId":"NCT06436833","phase":"NA","title":"Comparison of Bowel Preparation Using 2 Liter Polyethylene Glycol Regimen Plus Elobixibat Versus 4-Liter Polyethylene Glycol Regimen","status":"RECRUITING","sponsor":"Department of Medical Services Ministry of Public Health of Thailand","startDate":"2024-05-24","conditions":"Bowel Preparation Solution, Colonoscopy","enrollment":360},{"nctId":"NCT01069783","phase":"PHASE2","title":"Study of A3309 in Patients With Dyslipidemia","status":"COMPLETED","sponsor":"Albireo","startDate":"2010-02","conditions":"Dyslipidemia","enrollment":36},{"nctId":"NCT05895877","phase":"PHASE3","title":"Evaluate the Efficacy and Safety of Goofice® (Elobixibat) in Patients With Chronic Constipation","status":"UNKNOWN","sponsor":"Synmosa Biopharma Corp.","startDate":"2021-12-21","conditions":"Constipation","enrollment":351},{"nctId":"NCT05703464","phase":"PHASE4","title":"Elobixibat for Chronic Constipation Without Defecation Desire","status":"TERMINATED","sponsor":"International University of Health and Welfare","startDate":"2023-02-09","conditions":"Chronic Constipation","enrollment":40},{"nctId":"NCT04784780","phase":"PHASE4","title":"Long-term Elobixibat for Chronic Constipation","status":"UNKNOWN","sponsor":"Yokohama City University","startDate":"2021-08-06","conditions":"Chronic Constipation","enrollment":100},{"nctId":"NCT05165199","phase":"PHASE4","title":"Elobixibat for Chronic Constipation Without Defecation Desire","status":"UNKNOWN","sponsor":"Yokohama City University","startDate":"2022-03-01","conditions":"Chronic Constipation","enrollment":40},{"nctId":"NCT04235205","phase":"PHASE2","title":"Efficacy and Safety of Elobixibat in Combination With Cholestyramine for Nonalcoholic Fatty Liver Disease","status":"COMPLETED","sponsor":"Yokohama City University","startDate":"2020-01-29","conditions":"Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis","enrollment":102},{"nctId":"NCT01038687","phase":"PHASE2","title":"Effect of Ileal Bile Acid Transporter Inhibitor in Functional Constipation","status":"COMPLETED","sponsor":"Michael Camilleri, MD","startDate":"2010-01","conditions":"Functional Constipation","enrollment":36},{"nctId":"NCT01007123","phase":"PHASE2","title":"Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation","status":"COMPLETED","sponsor":"Albireo","startDate":"2009-11","conditions":"Constipation, Chronic Constipation","enrollment":190},{"nctId":"NCT01895543","phase":"PHASE3","title":"Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation","status":"COMPLETED","sponsor":"Ferring Pharmaceuticals","startDate":"2013-09","conditions":"Chronic Idiopathic Constipation","enrollment":411},{"nctId":"NCT01833065","phase":"PHASE3","title":"Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation","status":"TERMINATED","sponsor":"Ferring Pharmaceuticals","startDate":"2013-04","conditions":"Chronic Idiopathic Constipation","enrollment":314},{"nctId":"NCT01827592","phase":"PHASE3","title":"26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic Constipation","status":"TERMINATED","sponsor":"Ferring Pharmaceuticals","startDate":"2013-04","conditions":"Chronic Idiopathic Constipation","enrollment":376},{"nctId":"NCT02392546","phase":"PHASE2","title":"Elobixibat Colonic Motor Function Study","status":"WITHDRAWN","sponsor":"Ferring Pharmaceuticals","startDate":"2015-04","conditions":"Chronic Idiopathic Constipation","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Elobixibat"],"phase":"phase_2","status":"active","brandName":"A3309","genericName":"A3309","companyName":"Albireo","companyId":"albireo","modality":"Small molecule","firstApprovalDate":"","aiSummary":"A3309 is a bile acid sequestrant that binds bile acids in the intestine to increase their fecal excretion and modulate metabolic pathways. Used for Cholestasis-related pruritus in progressive familial intrahepatic cholestasis (PFIC), Bile acid diarrhea.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}