← Back to The Docket MAY 22 2026
APPROVED · 12 DAYS AGO
— Hepcludex (bulevirtide-gmod)
$GILD
for Chronic hepatitis delta virus (HDV) infection
BLA
FDA approved Hepcludex (bulevirtide-gmod) injection — the first treatment for chronic hepatitis delta virus infection — in adults without cirrhosis or with compensated cirrhosis.
About
Hepatitis D is a viral infection that only occurs alongside hepatitis B, often accelerating liver damage compared to HBV alone. Hepcludex (bulevirtide-gmod) blocks HDV from entering liver cells by mimicking the virus's docking site, preventing it from hijacking the host's machinery. This interference may reduce viral replication and slow liver disease progression in patients with chronic HDV infection.