Gilead Sciences has announced that the US Food and Drug Administration (FDA) has granted accelerated approval to its antiviral, Hepcludex (bulevirtide-gmod), for the treatment of adults with chronic hepatitis delta virus (HDV) without cirrhosis or with compensated cirrhosis. Hepcludex is now the first and only approved treatment for HDV patients in the US, marking a significant milestone for HDV patients and the HDV market.
Hepcludex was first approved in 2020 when the European Commission (EC) granted the drug conditional marketing authorisation. The launch of Hepcludex in Europe marked the entrance of the first therapeutic specifically approved for the treatment of HDV throughout the world. Today, Hepcludex is approved in other markets, including Australia, Canada, and Israel. Worldwide, the only other approved therapy for HDV is Huayunuo (libevitug), a monoclonal antibody marketed by Huahui Health in China, which received approval in January 2026.
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Gilead Sciences first submitted a biologics licence application (BLA) to the FDA for Hepcludex in late 2021 but received a complete response letter (CRL) in 2022 citing concerns over the manufacturing and delivery of the drug. Hepcludex, which was the recipient of both breakthrough therapy designation and orphan drug designation from the FDA, received its accelerated approval in May 2026. Until Hepcludex, there were no treatments for chronic HDV in the US, leaving patients vulnerable to the severe effects of HBV-HDV co-infection.
HDV can only occur in patients who are infected with the hepatitis B virus (HBV). While chronic HBV can be managed with antiviral medication, there is currently no cure for the virus. HBV-HDV co-infection is regarded as the most severe presentation of chronic viral hepatitis. This is due to the rapid deterioration of the liver, including liver fibrosis, cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Mortality rates in chronic HDV patients suffering from complications can reach as high as 50% within five years.
Hepcludex’s FDA approval was supported by data from the pivotal Phase III MYR301 (NCT03852719) trial. MYR301 evaluated the safety and efficacy of Hepcludex in 150 adult patients 18–65 years of age with chronic HDV. At Week 48, Hepcludex met its primary endpoint, demonstrating a statistically significant improvement versus the control group as observed by reductions in HDV RNA and normalisation of alanine aminotransferase (ALT). Additional analyses, including a confirmatory trial, may still be necessary for continued approval of the drug.
The lack of available therapies for HDV patients remains a serious unmet need. However, according to GlobalData, there are 12 HDV therapeutics in the active development pipeline (Phases I–III), and nine in late-stage development (Phases II–III). The drugs in Phase III development include Vir Biotechnology’s antisense RNAi oligonucleotide elebsiran and monoclonal antibody tobevibart, Eiger InnoTherapeutics’ small-molecule antiviral lonafarnib, and Mirum Pharmaceuticals’ monoclonal antibody brelovitug. At present, the FDA approval of Hepcludex marks a significant milestone for HDV patients and the HDV market in the US, with Gilead Sciences maintaining its role as the leading player in the hepatitis D market.
