Last reviewed · How we verify
RIXUBIS
At a glance
| Generic name | RIXUBIS |
|---|---|
| Also known as | Coagulation Factor IX [Recombinant], BAX 326, Recombinant factor IX, BAX326, rFIX |
| Sponsor | Baxalta now part of Shire |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
- Dysgeusia
- Pain in extremity
- Positive furin antibody test
Key clinical trials
- RIXUBIS Drug Use-Result Survey (Japan)
- RIXUBIS PMS India (RIXUBIS PMS) (PHASE4)
- ATHN 2: Factor Switching Study
- BAX 326 Pediatric Study (PHASE2,PHASE3)
- Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients (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
- Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS
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 CI brief — competitive landscape report
- RIXUBIS updates RSS · CI watch RSS
- Baxalta now part of Shire portfolio CI