FDA Approves Hepcludex (Bulevirtide), the First Treatment for Chronic Hepatitis Delta Virus Infection

On May 22, 2026, the FDA approved Hepcludex (bulevirtide-gmod) to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. In its press announcement, the FDA highlighted the decision as the first FDA-approved treatment for chronic HDV infection.

Bulevirtide is a 47-amino-acid lipopeptide entry inhibitor. Since it was approved as a biologic and slightly exceeds the usual 40-residue peptide definition, it is best described as a lipopeptide rather than as a typical small peptide. Peptide-approval trackers include it in the peptide category for that reason.

The FDA stated the approval was granted under the accelerated approval pathway. The product also carried Breakthrough Therapy and Orphan Drug designations and received priority review, with the approval granted to Gilead Sciences, according to the FDA announcement.

As with every FDA approval, the decision applies to the specific product, Hepcludex, and the specific indication on its label. It does not extend to compounded formulations, research compounds, or any other use of the molecule.

For readers tracking peptide regulation, the approval adds a new therapeutic area to the list of conditions with an approved peptide-related product. The regulatory fact is narrow and specific: one product, one labeled population, and one approval date of May 22, 2026.