{"id":"bivv009","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombotic events"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":{"chemblId":"CHEMBL4297832","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BIVV009 blocks TFPI, a natural anticoagulant that suppresses the initiation phase of coagulation. By neutralizing TFPI, the drug allows tissue factor and factor VIIa to more efficiently activate factor X, thereby bypassing the need for factors VIII or IX and restoring effective thrombin generation in hemophilia A and B patients regardless of inhibitor status.","oneSentence":"BIVV009 is a monoclonal antibody that inhibits tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and restore hemostasis in hemophilia patients.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:43:16.090Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A with inhibitors"},{"name":"Hemophilia B with inhibitors"}]},"trialDetails":[{"nctId":"NCT05132127","phase":"PHASE3","title":"Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan","status":"COMPLETED","sponsor":"Sanofi","startDate":"2021-11-11","conditions":"Cold Agglutinin Disease","enrollment":7},{"nctId":"NCT03275454","phase":"PHASE1","title":"A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP)","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2017-08-14","conditions":"Purpura, Thrombocytopenic, Idiopathic","enrollment":12},{"nctId":"NCT03347422","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2018-03-17","conditions":"Cold Agglutinin Disease","enrollment":42},{"nctId":"NCT03347396","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2018-03-05","conditions":"Agglutinin Disease, Cold","enrollment":24},{"nctId":"NCT02502903","phase":"PHASE1","title":"Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders","status":"COMPLETED","sponsor":"Bioverativ, a Sanofi company","startDate":"2015-07-13","conditions":"Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA)","enrollment":122}],"_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":["Sutimlimab"],"phase":"phase_3","status":"active","brandName":"BIVV009","genericName":"BIVV009","companyName":"Bioverativ, a Sanofi company","companyId":"bioverativ-a-sanofi-company","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BIVV009 is a monoclonal antibody that inhibits tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and restore hemostasis in hemophilia patients. Used for Hemophilia A with inhibitors, Hemophilia B with inhibitors.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}