Last reviewed · How we verify
OBIZUR
OBIZUR is a recombinant human Factor VIII that replaces deficient or dysfunctional Factor VIII to restore blood clotting ability in patients with hemophilia A.
OBIZUR is a recombinant human coagulation factor VIII that replaces deficient or dysfunctional factor VIII to restore blood clotting ability in hemophilia A patients. Used for Hemophilia A (congenital factor VIII deficiency) for routine prophylaxis and treatment of bleeding episodes.
At a glance
| Generic name | OBIZUR |
|---|---|
| Also known as | Recombinant pFVIII, Porcine Sequence, rpFVIII, Antihemophilic Factor (Recombinant), Susoctocog Alpha |
| Sponsor | Baxalta now part of Shire |
| Drug class | Recombinant coagulation factor VIII |
| Target | Coagulation factor VIII |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
OBIZUR is a recombinant antihemophilic factor (rAHF) produced using a human cell line (PER.C6), which provides Factor VIII protein identical to the natural human clotting factor. It bypasses the need for donor plasma-derived Factor VIII and reduces infection risk while restoring the intrinsic coagulation pathway in hemophilia A patients.
Approved indications
- Hemophilia A (congenital Factor VIII deficiency) for routine prophylaxis and on-demand treatment of bleeding episodes
Common side effects
- Inhibitor development (Factor VIII antibodies)
- Injection site reactions
- Headache
- Hypersensitivity reactions
Key clinical trials
- Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa (PHASE4)
- A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
- Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A (PHASE3)
- Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle" (PHASE1, PHASE2)
- An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
- A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease (PHASE3)
- An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
- Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs (PHASE2, 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:
- OBIZUR CI brief — competitive landscape report
- OBIZUR updates RSS · CI watch RSS
- Baxalta now part of Shire portfolio CI