Bulevirtide
Overview
Bulevirtide (brand: Hepcludex; bulevirtide-gmod) is a 47-amino-acid myristoylated lipopeptide derived from the pre-S1 domain of the HBV surface protein. It binds and inactivates the sodium taurocholate co-transporting polypeptide (NTCP), the entry receptor used by HBV and HDV, blocking viral entry into hepatocytes. Administered by subcutaneous injection. FDA granted accelerated approval on May 22, 2026 — the first and only approved treatment for chronic HDV in the United States — based on HDV RNA reduction and ALT normalization in the Phase 3 MYR301 trial. Previously granted Breakthrough Therapy, Orphan Drug, and Priority Review designations; approved in the EU since 2020.
Protocols & dosing
Detailed dosing protocols have not yet been catalogued.
FDA & legal status
Bulevirtide is approved by the U.S. Food and Drug Administration for one or more clinical indications. Refer to the prescribing information for full safety and dosing details.
| Country | Status |
|---|---|
| United States | FDA approved |
| United Kingdom | Prescription-only / not licensed |
| Canada | Prescription-only / Schedule F if licensed |
| Australia | TGA-scheduled |
Vendor information
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References
No external sources have been catalogued for this article yet.