{"id":"rfix","safety":{"commonSideEffects":[{"rate":null,"effect":"Inhibitor development (anti-Factor IX antibodies)"},{"rate":null,"effect":"Thrombotic events"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Hemophilia B is caused by deficiency or dysfunction of Factor IX, a critical serine protease in the intrinsic coagulation cascade. rFIX is produced through recombinant DNA technology and functions as a direct replacement therapy, enabling the formation of the tenase complex and restoration of normal thrombin generation. This allows patients to achieve hemostasis and prevent or treat bleeding episodes.","oneSentence":"rFIX is a recombinant human coagulation factor IX that replaces deficient or dysfunctional Factor IX to restore blood clotting ability in hemophilia B patients.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:52:21.425Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia B (Factor IX deficiency) — prevention and treatment of bleeding episodes"},{"name":"Hemophilia B — perioperative management"}]},"trialDetails":[{"nctId":"NCT05281718","phase":"EARLY_PHASE1","title":"Factor IX as Adjunctive Therapy to Emicizumab (EMIX)","status":"COMPLETED","sponsor":"Tulane University","startDate":"2022-08-01","conditions":"Hemophilia A","enrollment":12},{"nctId":"NCT03565237","phase":"PHASE4","title":"RIXUBIS PMS India (RIXUBIS PMS)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2018-12-07","conditions":"Hemophilia B","enrollment":25},{"nctId":"NCT01286779","phase":"PHASE3","title":"BAX 326 (rFIX) Continuation Study","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2011-04-12","conditions":"Hemophilia B","enrollment":117},{"nctId":"NCT01174446","phase":"PHASE3","title":"Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2010-07-29","conditions":"Hemophilia B","enrollment":86},{"nctId":"NCT02922231","phase":"","title":"Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2017-01-06","conditions":"Hemophilia B","enrollment":57},{"nctId":"NCT02796222","phase":"","title":"Factor Product Utilization and Health Outcomes in Patients With Hemophilia","status":"COMPLETED","sponsor":"University of British Columbia","startDate":"2016-04","conditions":"Hemophilia A, Congenital, Hemophilia B, Congenital","enrollment":61},{"nctId":"NCT00768287","phase":"PHASE2, PHASE3","title":"Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B","status":"COMPLETED","sponsor":"Medexus Pharma, Inc.","startDate":"2009-01","conditions":"Hemophilia B","enrollment":77},{"nctId":"NCT01027364","phase":"PHASE3","title":"Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B","status":"COMPLETED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2009-12","conditions":"Severe Hemophilia B","enrollment":123},{"nctId":"NCT02392156","phase":"","title":"Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes","status":"TERMINATED","sponsor":"Bioverativ Therapeutics Inc.","startDate":"2015-07","conditions":"Hemophilia A, Hemophilia B","enrollment":3},{"nctId":"NCT00956345","phase":"PHASE1","title":"Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2009-08","conditions":"Congenital Bleeding Disorder, Haemophilia B","enrollment":18},{"nctId":"NCT00364182","phase":"PHASE3","title":"Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B","status":"COMPLETED","sponsor":"Pfizer","startDate":"2007-05","conditions":"Hemophilia B","enrollment":50},{"nctId":"NCT00093171","phase":"PHASE3","title":"Study Evaluating rFIX; BeneFIX® in Hemophilia B","status":"COMPLETED","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","startDate":"","conditions":"Hemophilia B","enrollment":23},{"nctId":"NCT00037557","phase":"PHASE3","title":"Study Evaluating rFIX; BeneFIX in Severe Hemophilia B","status":"COMPLETED","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","startDate":"2002-09","conditions":"Hemophilia B","enrollment":20},{"nctId":"NCT00093210","phase":"PHASE3","title":"Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B","status":"COMPLETED","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","startDate":"","conditions":"Hemophilia B","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":189,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Recombinant Factor IX","BeneFIX®"],"phase":"phase_3","status":"active","brandName":"rFIX","genericName":"rFIX","companyName":"Wyeth is now a wholly owned subsidiary of Pfizer","companyId":"wyeth-is-now-a-wholly-owned-subsidiary-of-pfizer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"rFIX is a recombinant human coagulation factor IX that replaces deficient or dysfunctional Factor IX to restore blood clotting ability in hemophilia B patients. Used for Hemophilia B (Factor IX deficiency) — prevention and treatment of bleeding episodes, Hemophilia B — perioperative management.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}