Drug intelligence / Profile preview

bulevirtide

Development stage
Approved
Lead developer
Gilead Sciences
Modality
Peptides
Administration
Subcutaneous
01

Overview

**Bulevirtide** is a first-in-class **entry inhibitor peptide** for chronic hepatitis delta virus infection. It is a synthetic lipopeptide derived from the pre-S1 domain of hepatitis B virus large surface protein and works by binding the hepatocyte receptor **sodium taurocholate co-transporting polypeptide**, thereby blocking entry of both HDV and HBV into liver cells and limiting viral spread. The drug originated at MYR and was later acquired and developed commercially by Gilead. It is marketed as **Hepcludex** and has been studied extensively in chronic hepatitis delta, including the Phase 3 MYR301 program and real-world studies in compensated and selected decompensated cirrhosis populations. Public sources support approval in Europe for chronic HDV with compensated liver disease and U.S. accelerated approval in 2026 for adults without cirrhosis or with compensated cirrhosis.

Brand names
Hepcludex
Other names
bulevirtide-gmod
02

Targets

NTCP (Na+-taurocholate cotransporting polypeptide)OATP1B1 (Organic anion transporting polypeptide 1B1)SLCO1B3 (Organic anion transporting polypeptide 1B3)

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