From August 18th 2026, GtoPdb will require users to register to use the website. Please see our blog post for more information.

efanesoctocog alfa   Click here for help

GtoPdb Ligand ID: 13086

Synonyms: ALTUVIIIO® | Altuvoct® | BIVV-001 | BIVV001 | Fc-VWF-XTEN
Approved drug
efanesoctocog alfa is an approved drug (FDA (2023), EMA (2024))
Compound class: Peptide
Comment: Efanesoctocog alfa (BIVV-001) is a recombinant protein that fuses factor VIII (FVIII) to a human IgG1 Fc domain. It was designed as a long-acting FVIII replacement therapy [4]. Pharmacodynamic effects of efanesoctocog alfa (clot formation) are identical to those elicited by recombinant FVIII [1].
No information available.
Summary of Clinical Use Click here for help
Efanesoctocog alfa was first approved by the FDA in February 2023 [2], as a once-weekly infusion for individuals with congenital FVIII deficiency (haemophilia A). It is also a clinical candidate for the treatment of Von Willebrand's disease (VWD).
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT05817812 A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa Phase 3 Interventional Swedish Orphan Biovitrum
NCT04644575 Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A Phase 3 Interventional Sanofi
NCT04161495 A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A Phase 3 Interventional Sanofi 5