{"id":"acoramidis-ag10","safety":{"commonSideEffects":[{"rate":null,"effect":"Peripheral edema"},{"rate":null,"effect":"Dyspnea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Acoramidis is a selective transthyretin stabilizer that binds to the TTR protein and increases its thermodynamic stability, preventing dissociation and subsequent misfolding into amyloid fibrils. By stabilizing the native TTR tetramer, the drug reduces amyloid formation and deposition in tissues, thereby slowing or halting disease progression in transthyretin amyloidosis.","oneSentence":"Acoramidis stabilizes transthyretin (TTR) protein to prevent its misfolding and aggregation, which causes amyloid disease.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:44:07.195Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Transthyretin amyloid cardiomyopathy (ATTR-CM)"},{"name":"Hereditary transthyretin amyloidosis (hATTR)"}]},"trialDetails":[{"nctId":"NCT04958135","phase":"PHASE1","title":"Study to Assess the Effect of Food on a Single Dose of Acoramidis in Healthy Adult Participants","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2021-05-30","conditions":"Healthy","enrollment":18},{"nctId":"NCT06563895","phase":"PHASE3","title":"Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant","status":"RECRUITING","sponsor":"Eidos Therapeutics, a BridgeBio company","startDate":"2025-05-12","conditions":"Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis","enrollment":582},{"nctId":"NCT04622046","phase":"PHASE3","title":"A Phase 3 Study of ALXN2060 in Japanese Participants With Symptomatic ATTR-CM","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2020-11-13","conditions":"Symptomatic Transthyretin Amyloid Cardiomyopathy","enrollment":25},{"nctId":"NCT04988386","phase":"PHASE3","title":"Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Eidos Therapeutics, a BridgeBio company","startDate":"2021-10-27","conditions":"Amyloid Cardiomyopathy, Transthyretin-Related","enrollment":389},{"nctId":"NCT07116473","phase":"PHASE3","title":"To Evaluate the Long-term Safety and Tolerability of Acoramidis in Participants With Newly Diagnosed ATTR-CM (ACT-EARLY OLE)","status":"NOT_YET_RECRUITING","sponsor":"Eidos Therapeutics, a BridgeBio company","startDate":"2025-11","conditions":"Amyloidosis in Transthyretin (TTR), Amyloidosis, Familial, Amyloid Cardiomyopathy","enrollment":250},{"nctId":"NCT04769479","phase":"PHASE1","title":"A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects","status":"COMPLETED","sponsor":"Eidos Therapeutics, a BridgeBio company","startDate":"2021-03-28","conditions":"Amyloidosis","enrollment":14},{"nctId":"NCT04882735","phase":"PHASE3","title":"Efficacy and Safety of Acoramidis (AG10) in Subjects with Transthyretin Amyloid Polyneurophathy (ATTRibute-PN)","status":"WITHDRAWN","sponsor":"Eidos Therapeutics, a BridgeBio company","startDate":"2021-09-08","conditions":"Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy","enrollment":""},{"nctId":"NCT03860935","phase":"PHASE3","title":"Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy","status":"COMPLETED","sponsor":"Eidos Therapeutics, a BridgeBio company","startDate":"2019-03-19","conditions":"Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis","enrollment":632}],"_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":["ALXN2060","AG10","ALXN 2060"],"phase":"phase_3","status":"active","brandName":"Acoramidis (AG10)","genericName":"Acoramidis (AG10)","companyName":"Eidos Therapeutics, a BridgeBio company","companyId":"eidos-therapeutics-a-bridgebio-company","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Acoramidis (AG10) is a small molecule drug that stabilizes transthyretin, a protein associated with amyloidosis. It is being studied for the treatment of conditions such as amyloid cardiomyopathy and familial amyloidosis.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}