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Recombinant factor IX
Recombinant factor IX replaces the missing or deficient clotting factor IX to restore the intrinsic coagulation pathway and enable normal blood clot formation.
Recombinant factor IX replaces the missing or deficient clotting factor IX to restore the intrinsic coagulation pathway and enable normal blood clot formation. Used for Hemophilia B (factor IX deficiency) — prevention and treatment of bleeding episodes, Hemophilia B — perioperative management and surgical prophylaxis.
At a glance
| Generic name | Recombinant factor IX |
|---|---|
| Also known as | BAX326, RIXUBIS |
| Sponsor | Baxalta now part of Shire |
| Drug class | Recombinant clotting factor |
| Target | Coagulation factor IX (F9) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Factor IX is a vitamin K-dependent serine protease essential for the intrinsic and common coagulation pathways. In hemophilia B (Christmas disease), factor IX is deficient or dysfunctional, leading to impaired thrombin generation and bleeding. Recombinant factor IX is produced via recombinant DNA technology and functions as a direct replacement therapy, restoring the ability to form stable blood clots.
Approved indications
- Hemophilia B (factor IX deficiency) — prevention and treatment of bleeding episodes
- Hemophilia B — perioperative management and surgical prophylaxis
Common side effects
- Thrombosis (deep vein thrombosis, pulmonary embolism)
- Inhibitor development (anti-factor IX antibodies)
- Injection site reactions
- Headache
- Fever
Key clinical trials
- An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
- Dosage and PD Study of Eftrenonacog-alfa
- SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis (PHASE3)
- SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors (PHASE4)
- Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy (PHASE3)
- Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion
- Treatment of Hemophilia A Patients With FVIII Inhibitors
- A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants (PHASE1)
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 |