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bulevirtide   Click here for help

GtoPdb Ligand ID: 12775

Synonyms: BLV | bulevirtide-gmod | formerly Myrcludex B | Hepcludex®
Approved drug
bulevirtide is an approved drug (EMA (2020), UK HMRA (2021))
Compound class: Peptide
Comment: Bulevirtide is a lipopeptide antiviral agent. It blocks entry of the hepatitis-causing viruses HBV and HDV into hepatocytes [1]. The peptide structure of bulevirtide is derived from the pre-S1 domain of the large envelope protein of HBV surface antigen (HBsAg) [4], that binds to the hepatocyte expressed surface protein sodium/bile acid and sulphated solute cotransporter 1 (NTCP; SLC10A1) to mediate viral entry into host cells. Bulevirtide functionally blocks this entry process [3].
No information available.
Summary of Clinical Use Click here for help
Bulevirtide was evaluated as a treatment for chronic hepatitis D infection with the aim of reducing HDV-mediated acceleration of HBV-associated liver disease progression (cirrhosis, liver failure, and hepatocellular carcinoma). Treatment of chronic HDV infection with bulevirtide was granted EMA orphan designation in 2015, and was fully approved by the EMA for this indication in 2020 [2]. FDA approval was granted i May 2026.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT03852719 Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD) Phase 3 Interventional Gilead Sciences 5
NCT05760300 A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function Phase 1 Interventional Gilead Sciences
NCT05718700 Study of Bulevirtide in Participants With Chronic Hepatitis D Infection Observational [Patient Registry] Gilead Sciences
External links Click here for help
For extended ADME data see the following:

Electronic Medicines Compendium (eMC)
European Medicines Agency (EMA)