{"id":"bax-326","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":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BAX 326 is a pegylated recombinant factor VIII product that provides the missing clotting factor in hemophilia A patients. The pegylation extends the half-life of the factor VIII molecule, potentially allowing for less frequent dosing compared to conventional factor VIII products. It restores the intrinsic coagulation pathway by enabling the formation of the tenase complex, which is essential for thrombin generation and clot formation.","oneSentence":"BAX 326 is a recombinant human coagulation factor VIII designed to treat hemophilia A by replacing deficient or dysfunctional factor VIII.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:41.715Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemophilia A (treatment and prophylaxis of bleeding episodes)"}]},"trialDetails":[{"nctId":"NCT02937831","phase":"","title":"RIXUBIS Drug Use-Result Survey (Japan)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2016-11-16","conditions":"Hemophilia B","enrollment":6},{"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":"NCT01488994","phase":"PHASE2, PHASE3","title":"BAX 326 Pediatric Study","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2011-12-20","conditions":"Hemophilia B","enrollment":23},{"nctId":"NCT01507896","phase":"PHASE3","title":"BAX 326 Surgery Study in Hemophilia B Patients","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2011-12-19","conditions":"Hemophilia B","enrollment":30},{"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":"NCT01128881","phase":"PHASE4","title":"IMMUNINE Pre-Treatment Study","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2010-05-31","conditions":"Hemophilia B","enrollment":57}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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 (rFIX)","RIXUBIS"],"phase":"phase_3","status":"active","brandName":"BAX 326","genericName":"BAX 326","companyName":"Baxalta now part of Shire","companyId":"baxalta-now-part-of-shire","modality":"Biologic","firstApprovalDate":"","aiSummary":"BAX 326 is a recombinant human coagulation factor VIII designed to treat hemophilia A by replacing deficient or dysfunctional factor VIII. Used for Hemophilia A (treatment and prophylaxis of bleeding episodes).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}