{"id":"bt524-part-i","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombotic events"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":{"chemblId":"CHEMBL1201595","moleculeType":"Enzyme"},"_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 restores or enhances thrombin generation, promoting clot formation in patients with bleeding disorders. This mechanism is intended to improve hemostatic function in conditions characterized by impaired coagulation.","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":"2026-03-28T01:41:52.194Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Rare bleeding disorders associated with TFPI dysregulation"},{"name":"Hemophilia or other coagulation factor deficiencies (investigational)"}]},"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 I)","genericName":"BT524 (Part I)","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 Rare bleeding disorders associated with TFPI dysregulation, Hemophilia or other coagulation factor deficiencies (investigational).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}