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FIX
FIX is a recombinant coagulation Factor IX that replaces deficient or dysfunctional Factor IX to restore the intrinsic coagulation pathway in patients with hemophilia B.
FIX is a recombinant coagulation Factor IX that replaces deficient or dysfunctional Factor IX to restore the intrinsic coagulation pathway in patients with hemophilia B. Used for Hemophilia B (Factor IX deficiency) — prevention and treatment of bleeding episodes, Hemophilia B — perioperative management.
At a glance
| Generic name | FIX |
|---|---|
| Also known as | Factor IX |
| Sponsor | Bioverativ Therapeutics Inc. |
| Drug class | Recombinant coagulation factor replacement |
| Target | Factor IX (coagulation cascade) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Hemophilia B is caused by deficiency or dysfunction of Factor IX, a critical serine protease in the intrinsic coagulation cascade. FIX (recombinant Factor IX) directly replaces this missing clotting factor, enabling the formation of the tenase complex and restoration of 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
- Hypersensitivity reactions
Key clinical trials
- Rosacea and Ivermectin (PHASE2)
- "Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition" (NA)
- Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants (PHASE1)
- Immediate Restoration of a New Implant With High Primary Stability (NA)
- Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE. (PHASE2)
- Effect of a Driving Pressure Adjustment Procedure for High-Frequency Jet Ventilation in Patients Undergoing Tumor Thermal Ablation in Interventional Radiology (NA)
- Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES) (NA)
- Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma (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:
- FIX CI brief — competitive landscape report
- FIX updates RSS · CI watch RSS
- Bioverativ Therapeutics Inc. portfolio CI