{"id":"intravenous-infusions-of-xyntha","safety":{"commonSideEffects":[{"rate":null,"effect":"Inhibitor development (factor VIII antibodies)"},{"rate":null,"effect":"Hypersensitivity reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Xyntha is a recombinant human coagulation factor VIII produced using a modified Chinese hamster ovary cell line. It functions as a cofactor in the intrinsic coagulation pathway, working with factor IX to activate factor X and initiate the cascade leading to thrombin generation and fibrin clot formation. In hemophilia A patients who lack functional factor VIII, intravenous infusion of Xyntha restores the ability to form stable blood clots.","oneSentence":"Xyntha is a recombinant coagulation factor VIII that replaces deficient or dysfunctional factor VIII to restore blood clotting ability in hemophilia A patients.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:49:53.750Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (congenital factor VIII deficiency) for control and prevention of bleeding episodes"},{"name":"Perioperative management in hemophilia A patients undergoing surgery"}]},"trialDetails":[{"nctId":"NCT06111638","phase":"PHASE2, PHASE3","title":"Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs","status":"RECRUITING","sponsor":"Shanghai Xinzhi BioMed Co., Ltd.","startDate":"2024-01-03","conditions":"Hemophilia A","enrollment":55},{"nctId":"NCT05662319","phase":"PHASE3","title":"A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2023-02-01","conditions":"Hemophilia","enrollment":91},{"nctId":"NCT07129343","phase":"PHASE3","title":"A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD)","status":"RECRUITING","sponsor":"Takeda","startDate":"2025-10-13","conditions":"Von Willebrand Disease (VWD)","enrollment":20},{"nctId":"NCT06738485","phase":"PHASE3","title":"Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products","status":"RECRUITING","sponsor":"CSL Behring","startDate":"2025-01-09","conditions":"Congenital Hemophilia A","enrollment":60},{"nctId":"NCT05582993","phase":"PHASE3","title":"A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease 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Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A","status":"COMPLETED","sponsor":"Green Cross Corporation","startDate":"2004-12","conditions":"Hemophilia A","enrollment":71}],"_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":["Xyntha (Moroctocog-alfa (AF-CC)"],"phase":"marketed","status":"active","brandName":"Intravenous infusions of Xyntha","genericName":"Intravenous infusions of Xyntha","companyName":"Pfizer","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Xyntha is a recombinant coagulation factor VIII that replaces deficient or dysfunctional factor VIII to restore blood clotting ability in hemophilia A patients. Used for Hemophilia A (congenital factor VIII deficiency) for control and prevention of bleeding episodes, Perioperative management in hemophilia A patients undergoing surgery.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}