{"id":"efanesoctocog-alfa-bivv001","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombotic events"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BIVV001 is engineered to simultaneously bind Factor IX and Factor X, effectively bypassing the need for Factor VIII by reconstituting the tenase complex that generates Factor Xa. This allows patients with hemophilia A to generate thrombin through an alternative pathway, restoring hemostatic capacity without requiring exogenous Factor VIII replacement therapy.","oneSentence":"Efanesoctocog alfa (BIVV001) is a bispecific antibody that bridges Factor IX and Factor X to restore the intrinsic tenase complex activity in hemophilia A patients lacking functional Factor VIII.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:46:14.000Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (with or without Factor VIII inhibitors)"}]},"trialDetails":[{"nctId":"NCT06579144","phase":"PHASE1","title":"Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A","status":"RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2025-02-24","conditions":"Hemophilia A","enrollment":24},{"nctId":"NCT06716814","phase":"PHASE3","title":"Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa","status":"RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2025-03-06","conditions":"Severe Haemophilia A","enrollment":104},{"nctId":"NCT06941870","phase":"PHASE4","title":"Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy","status":"RECRUITING","sponsor":"Sanofi","startDate":"2025-09-23","conditions":"Factor VIII Deficiency","enrollment":35},{"nctId":"NCT05817812","phase":"PHASE3","title":"A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa","status":"ACTIVE_NOT_RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2023-07-31","conditions":"Hemophilia A, Severe","enrollment":93},{"nctId":"NCT06684314","phase":"","title":"A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan","status":"RECRUITING","sponsor":"Sanofi","startDate":"2024-11-11","conditions":"Hemophilia A","enrollment":100},{"nctId":"NCT05911763","phase":"","title":"A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2023-06-30","conditions":"Hemophilia A","enrollment":200},{"nctId":"NCT04770935","phase":"PHASE1","title":"To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2021-05-03","conditions":"Von Willebrand's Disease (VWD)","enrollment":6},{"nctId":"NCT05042440","phase":"PHASE1","title":"Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A","status":"COMPLETED","sponsor":"Sanofi","startDate":"2021-08-11","conditions":"Hemophilia A","enrollment":13},{"nctId":"NCT04161495","phase":"PHASE3","title":"A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2019-11-19","conditions":"Factor VIII Deficiency","enrollment":159},{"nctId":"NCT04759131","phase":"PHASE3","title":"Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2021-02-19","conditions":"Hemophilia A","enrollment":74},{"nctId":"NCT04644575","phase":"PHASE3","title":"Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bioverativ, a Sanofi company","startDate":"2021-02-23","conditions":"Hemophilia A","enrollment":261}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ALTUVIIIO"],"phase":"phase_3","status":"active","brandName":"Efanesoctocog Alfa BIVV001","genericName":"Efanesoctocog Alfa BIVV001","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Efanesoctocog alfa (BIVV001) is a bispecific antibody that bridges Factor IX and Factor X to restore the intrinsic tenase complex activity in hemophilia A patients lacking functional Factor VIII. Used for Hemophilia A (with or without Factor VIII inhibitors).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}