{"id":"bt595","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":"BT595 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 designed to improve bleeding control in patients with severe bleeding disorders or those requiring hemostatic support.","oneSentence":"BT595 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":"2026-03-28T00:54:24.541Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Severe bleeding or hemostatic support in patients with bleeding disorders"}]},"trialDetails":[{"nctId":"NCT02810444","phase":"PHASE3","title":"Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID","status":"COMPLETED","sponsor":"Biotest","startDate":"2016-10-04","conditions":"Primary Immunodeficiency Disease","enrollment":81},{"nctId":"NCT02859909","phase":"PHASE3","title":"This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)","status":"COMPLETED","sponsor":"Biotest","startDate":"2016-11","conditions":"Immune Thrombocytopenia","enrollment":34}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Human Immunoglobulin"],"phase":"phase_3","status":"active","brandName":"BT595","genericName":"BT595","companyName":"Biotest","companyId":"biotest","modality":"Biologic","firstApprovalDate":"","aiSummary":"BT595 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 bleeding disorders.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}