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rIX-FP
rIX-FP is a recombinant, humanized monoclonal antibody that targets factor VIII to prevent bleeding in patients with hemophilia A.
rIX-FP is a recombinant, humanized monoclonal antibody that targets factor VIII to prevent bleeding in patients with hemophilia A. Used for Prevention of bleeding in patients with hemophilia A.
At a glance
| Generic name | rIX-FP |
|---|---|
| Sponsor | CSL Behring |
| Drug class | Factor VIII replacement therapy |
| Target | Factor VIII |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
rIX-FP works by binding to factor VIII, which is a clotting factor that is deficient or defective in patients with hemophilia A. By binding to factor VIII, rIX-FP helps to prevent excessive bleeding in these patients. This is achieved through a process called immune tolerance induction, where the body's immune system is gradually desensitized to factor VIII, allowing for the production of endogenous factor VIII and reducing the need for frequent infusions of factor VIII replacement therapy.
Approved indications
- Prevention of bleeding in patients with hemophilia A
Common side effects
- Headache
- Nausea
- Injection site reaction
Key clinical trials
- Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy (PHASE3)
- A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B (PHASE3)
- The Effectiveness of Recombinant Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients (PHASE4)
- A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B (PHASE1, PHASE2)
- A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B (PHASE2, PHASE3)
- A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B (PHASE3)
- Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- rIX-FP CI brief — competitive landscape report
- rIX-FP updates RSS · CI watch RSS
- CSL Behring portfolio CI