← Back to The Docket MAY 22 2026
APPROVED · 131 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 liver infection caused by the hepatitis delta virus, which can only survive and multiply alongside hepatitis B, so it spreads through coinfection or by infecting someone who already carries hepatitis B. Hepcludex is an injected drug that blocks the receptor the virus uses to get into liver cells, essentially locking the door the virus needs to enter. Because that entry step is required for the virus to spread, blocking it may reduce the amount of virus in the liver and limit further damage.