{"id":"coagadex-r","safety":{"commonSideEffects":[{"rate":null,"effect":"Thromboembolism"},{"rate":null,"effect":"Hypersensitivity reactions"},{"rate":null,"effect":"Inhibitor formation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Factor X is a critical serine protease in the intrinsic and extrinsic coagulation pathways. Coagadex provides active Factor X to patients with congenital or acquired Factor X deficiency, enabling formation of the prothrombinase complex and restoration of thrombin generation. This corrects the bleeding tendency associated with Factor X insufficiency.","oneSentence":"Coagadex is a recombinant human vitamin K-dependent clotting factor X that replaces deficient or dysfunctional Factor X to restore blood coagulation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:06:31.101Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Congenital Factor X deficiency"},{"name":"Acquired Factor X deficiency"}]},"trialDetails":[{"nctId":"NCT06963216","phase":"PHASE3","title":"A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis","status":"RECRUITING","sponsor":"Kedrion S.p.A.","startDate":"2026-02","conditions":"Acquired Factor X Deficiency","enrollment":15},{"nctId":"NCT04569279","phase":"PHASE3","title":"Rivaroxaban vs. Warfarin in CVT Treatment","status":"COMPLETED","sponsor":"Damascus University","startDate":"2017-09-01","conditions":"Cerebral Vein Thrombosis","enrollment":71}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":351,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Coagadex(R)","genericName":"Coagadex(R)","companyName":"Kedrion S.p.A.","companyId":"kedrion-s-p-a","modality":"Biologic","firstApprovalDate":"","aiSummary":"Coagadex is a recombinant human vitamin K-dependent clotting factor X that replaces deficient or dysfunctional Factor X to restore blood coagulation. Used for Congenital Factor X deficiency, Acquired Factor X deficiency.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}