← Back to The Docket MAY 22 2026
APPROVED · 70 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 serious liver infection that can only occur alongside a hepatitis B infection, often leading to severe liver damage. Hepcludex (bulevirtide-gmod) is an injectable drug that blocks the hepatitis delta virus from entering healthy liver cells. By preventing the virus from infecting new cells, this treatment may help control the infection and slow the progression of liver disease.