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rFIX
rFIX is a recombinant human coagulation factor IX that replaces deficient or dysfunctional Factor IX to restore blood clotting ability in hemophilia B patients.
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.
At a glance
| Generic name | rFIX |
|---|---|
| Also known as | Recombinant Factor IX, BeneFIX® |
| Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Drug class | Recombinant coagulation factor replacement |
| Target | Coagulation Factor IX (FIX) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Hemophilia B (Factor IX deficiency) — prevention and treatment of bleeding episodes
- Hemophilia B — perioperative management
Common side effects
- Inhibitor development (anti-Factor IX antibodies)
- Thrombotic events
- Injection site reactions
- Headache
- Fever
Key clinical trials
- Factor IX as Adjunctive Therapy to Emicizumab (EMIX) (EARLY_PHASE1)
- 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)
- Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
- Factor Product Utilization and Health Outcomes in Patients With Hemophilia
- Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B (PHASE2, PHASE3)
- Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B (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 |