{"id":"bt524","safety":{"commonSideEffects":[{"rate":null,"effect":"Thrombotic events"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Injection site 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 and fibrin formation, thereby promoting clot formation. This mechanism is designed to improve hemostasis in patients with bleeding disorders or those at risk of excessive bleeding.","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":"2026-03-28T01:41:52.260Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Rare bleeding disorders associated with TFPI dysregulation"},{"name":"Hemophilia or other coagulation 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},{"nctId":"NCT03444324","phase":"PHASE3","title":"Adjusted Fibrinogen Replacement Strategy","status":"COMPLETED","sponsor":"Biotest","startDate":"2018-04-03","conditions":"Bleeding Disorder, Hypofibrinogenemia; Acquired","enrollment":222}],"_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","genericName":"BT524","companyName":"Biotest","companyId":"biotest","modality":"Biologic","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 deficiencies (investigational).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}