{"id":"bt524-part-ii","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombotic events"},{"rate":null,"effect":"Infusion-related reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BT524 works by inhibiting TFPI, a natural anticoagulant that suppresses the tissue factor-initiated coagulation cascade. By blocking TFPI, the drug allows increased thrombin generation, which promotes clot formation and hemostasis. This mechanism is intended to improve bleeding control in patients with severe bleeding disorders or those requiring hemostatic support.","oneSentence":"BT524 is a human monoclonal antibody that binds to and neutralizes tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and hemostasis.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T00:54:24.047Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Severe bleeding or hemostatic support in patients with coagulopathies"}]},"trialDetails":[{"nctId":"NCT02065882","phase":"PHASE3","title":"Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency","status":"COMPLETED","sponsor":"Biotest","startDate":"2013-03","conditions":"Congenital Afibrinogenemia, Congenital Hypofibrinogenemia","enrollment":67}],"_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":["Human Fibrinogen Concentrate"],"phase":"phase_3","status":"active","brandName":"BT524 (Part II)","genericName":"BT524 (Part II)","companyName":"Biotest","companyId":"biotest","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BT524 is a human monoclonal antibody that binds to and neutralizes tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and hemostasis. Used for Severe bleeding or hemostatic support in patients with coagulopathies.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}