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BE1116
BE1116 is a recombinant human albumin-von Willebrand factor (VWF) fusion protein that replaces or augments deficient VWF function in von Willebrand disease.
BE1116 is a recombinant human albumin-von Willebrand factor (VWF) fusion protein that replaces or augments deficient VWF function in von Willebrand disease. Used for Von Willebrand disease (prophylaxis and treatment of bleeding episodes).
At a glance
| Generic name | BE1116 |
|---|---|
| Also known as | 4-Factor Prothrombin Complex, Kcentra®, Beriplex®, 4F-PCC |
| Sponsor | CSL Behring |
| Drug class | Recombinant coagulation factor / von Willebrand factor replacement |
| Target | von Willebrand factor (VWF) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
BE1116 combines human serum albumin with recombinant von Willebrand factor to provide sustained hemostatic support in patients with von Willebrand disease. The fusion design aims to improve the pharmacokinetic profile and duration of action compared to plasma-derived VWF products, reducing bleeding episodes and the need for frequent infusions.
Approved indications
- Von Willebrand disease (prophylaxis and treatment of bleeding episodes)
Common side effects
- Injection site reactions
- Headache
- Thrombotic events
- Allergic reactions
Key clinical trials
- Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) (PHASE3)
- Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study ) (PHASE3)
- Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects (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:
- BE1116 CI brief — competitive landscape report
- BE1116 updates RSS · CI watch RSS
- CSL Behring portfolio CI