← All approvals · Infections & vaccines · 2026
Hepcludex (bulevirtide-gmod)
The FDA approved Hepcludex (bulevirtide-gmod) on May 22, 2026 to treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis.
- Brand name
- Hepcludex
- Generic name
- bulevirtide-gmod
- FDA approval date
- May 22, 2026
- Approved use (FDA wording)
- To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis
- Company
- Gilead Sciences Inc.
- Application
- BLA761468
- Dosage form / route
- INJECTION · POWDER,FOR SOLUTION
- Boxed warning on label
- Yes (see the FDA label)
- Category on this site
- Infections & vaccines
Indications and usage, from the FDA label
HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization [see Clinical Studies (14) ] . An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). HEPCLUDEX is a sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor indicated for the treatment of chronic HDV infection in adults w…