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RIXUBIS: On-Demand
RIXUBIS is a recombinant Factor IX that replaces deficient or dysfunctional clotting factor IX to restore blood coagulation in patients with hemophilia B.
RIXUBIS is a recombinant Factor IX that replaces deficient or dysfunctional clotting factor IX to restore blood coagulation in patients with hemophilia B. Used for Hemophilia B (Factor IX deficiency) — on-demand treatment and control of bleeding episodes.
At a glance
| Generic name | RIXUBIS: On-Demand |
|---|---|
| Also known as | BAX326, Recombinant Factor IX, rFIX, Coagulation Factor IX [Recombinant], rFactor IX |
| Sponsor | Baxalta now part of Shire |
| Drug class | Recombinant coagulation factor |
| Target | Coagulation Factor IX (FIX) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Hemophilia B is caused by deficiency or dysfunction of coagulation Factor IX, a vitamin K-dependent serine protease essential for the intrinsic pathway of blood coagulation. RIXUBIS is a recombinant human Factor IX produced in Chinese hamster ovary cells that directly substitutes for the missing or defective endogenous factor, enabling the formation of the tenase complex and restoration of normal thrombin generation and clot formation.
Approved indications
- Hemophilia B (Factor IX deficiency) — on-demand treatment and control of bleeding episodes
Common side effects
- Inhibitor development (anti-Factor IX antibodies)
- Thrombotic events
- Injection site reactions
- Headache
- Fever
Key clinical trials
- RIXUBIS PMS India (RIXUBIS PMS) (PHASE4)
- Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients (PHASE3)
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:
- RIXUBIS: On-Demand CI brief — competitive landscape report
- RIXUBIS: On-Demand updates RSS · CI watch RSS
- Baxalta now part of Shire portfolio CI