Gilead Sciences Receives Approval for Hepcludex as the Treatment for Chronic HDV
Monday, May 25, 2026
Gilead Sciences has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Hepcludex (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection.
Chronic HDV is considered the most severe form of viral hepatitis and is linked to rapid liver disease progression, liver failure and increased mortality. In the United States, HDV is estimated to affect around 40,000 to 80,000 people who are also living with chronic hepatitis B virus (HBV) infection.
The MYR301 trial evaluated the efficacy and safety of Hepcludex in adults with chronic HDV. Patients received treatment for up to 144 weeks, followed by a 96-week off-treatment follow-up period. The study met its primary endpoint at Week 48, while long-term treatment demonstrated sustained efficacy and acceptable tolerability.
Hepcludex is indicated for adults with chronic HDV infection who do not have cirrhosis or who have compensated cirrhosis. The therapy is administered as a once-daily subcutaneous injection at a dose of 8.5 mg.
The therapy becomes the first and only approved treatment for HDV in the United States.
The approval was based mainly on results from the Phase 3 MYR301 study, which showed that Hepcludex significantly improved virologic and biochemical responses compared with delayed treatment at Week 48. The FDA noted that continued approval may depend on confirmation of long-term clinical benefit in future studies.
The medicine works by blocking the entry of both HDV and HBV into liver cells, targeting an important stage of the viral lifecycle. Gilead has also started a confirmatory long-term outcomes study as part of the accelerated approval requirements.
The treatment is already approved in the European Economic Area and several other countries in a 2 mg formulation for people living with chronic HDV.
Source: gilead.com
