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BAX 326
BAX 326 is a recombinant human coagulation factor VIII designed to treat hemophilia A by replacing deficient or dysfunctional factor VIII.
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).
At a glance
| Generic name | BAX 326 |
|---|---|
| Also known as | Recombinant factor IX (rFIX), RIXUBIS |
| Sponsor | Baxalta now part of Shire |
| Drug class | Recombinant coagulation factor VIII |
| Target | Coagulation factor VIII |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Hemophilia A (treatment and prophylaxis of bleeding episodes)
Common side effects
- Inhibitor development (factor VIII antibodies)
- Injection site reactions
- Headache
- Hypersensitivity reactions
Key clinical trials
- RIXUBIS Drug Use-Result Survey (Japan)
- RIXUBIS PMS India (RIXUBIS PMS) (PHASE4)
- BAX 326 (rFIX) Continuation Study (PHASE3)
- Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients (PHASE3)
- BAX 326 Pediatric Study (PHASE2, PHASE3)
- BAX 326 Surgery Study in Hemophilia B Patients (PHASE3)
- Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
- IMMUNINE Pre-Treatment Study (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BAX 326 CI brief — competitive landscape report
- BAX 326 updates RSS · CI watch RSS
- Baxalta now part of Shire portfolio CI