{"id":"moroctocog-alfa-af-cc","safety":{"commonSideEffects":[{"rate":null,"effect":"Inhibitor development (factor VIII antibodies)"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Hypersensitivity reactions"}]},"_chembl":{"chemblId":"CHEMBL2109137","moleculeType":"Protein"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Factor VIII is a critical cofactor in the intrinsic coagulation cascade that works with von Willebrand factor to activate factor X, ultimately leading to thrombin generation and fibrin clot formation. Moroctocog alfa (AF-CC) is a B-domain deleted recombinant factor VIII with an added albumin fusion domain to extend half-life. By providing functional factor VIII, it corrects the coagulation defect in hemophilia A, enabling normal hemostasis and reducing bleeding episodes.","oneSentence":"Moroctocog alfa is a recombinant human coagulation factor VIII that replaces deficient or dysfunctional factor VIII to restore blood clotting ability in hemophilia A patients.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:55:49.617Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (congenital factor VIII deficiency) for treatment and prevention of bleeding episodes"}]},"trialDetails":[{"nctId":"NCT04396639","phase":"PHASE4","title":"Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Hemophilia A Patients","status":"COMPLETED","sponsor":"Pfizer","startDate":"2020-01-25","conditions":"Hemophilia A","enrollment":50},{"nctId":"NCT00543439","phase":"PHASE3","title":"Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII","status":"COMPLETED","sponsor":"Pfizer","startDate":"2007-12","conditions":"Hemophilia A","enrollment":66},{"nctId":"NCT02492984","phase":"PHASE4","title":"PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A","status":"COMPLETED","sponsor":"Pfizer","startDate":"2015-04","conditions":"Hemophilia A","enrollment":85},{"nctId":"NCT00914459","phase":"PHASE4","title":"Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients","status":"COMPLETED","sponsor":"Pfizer","startDate":"2009-12","conditions":"Hemophilia A","enrollment":37},{"nctId":"NCT02461992","phase":"PHASE1","title":"Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A","status":"COMPLETED","sponsor":"Pfizer","startDate":"2015-07","conditions":"Hemophilia A","enrollment":13},{"nctId":"NCT00884390","phase":"PHASE4","title":"Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings","status":"TERMINATED","sponsor":"Pfizer","startDate":"2009-05","conditions":"Hemophilia A","enrollment":208},{"nctId":"NCT01579903","phase":"PHASE1","title":"Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-08","conditions":"Hemophilia A","enrollment":16},{"nctId":"NCT00765726","phase":"PHASE4","title":"Study Evaluating The Safety Of Xyntha In Usual Care Settings","status":"TERMINATED","sponsor":"Pfizer","startDate":"2009-02","conditions":"Hemophilia A","enrollment":12}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":11,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Xyntha","ReFacto AF"],"phase":"marketed","status":"active","brandName":"Moroctocog alfa (AF-CC)","genericName":"Moroctocog alfa (AF-CC)","companyName":"Pfizer","companyId":"pfizer","modality":"Biologic","firstApprovalDate":"","aiSummary":"Moroctocog alfa is a recombinant human 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) — treatment and prophylaxis of bleeding episodes.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}