Hepcludex FDA Approval Status

FDA Approved: No
Brand name: Hepcludex
Generic name: bulevirtide
Company: Gilead Sciences, Inc.
Treatment for: Hepatitis D

Bulevirtide is a novel virion entry inhibitor in development for the treatment of adults with chronic hepatitis delta virus (HDV) infection.

Development timeline for Hepcludex

Date	Article
Jun 6, 2024	Gilead Announces New England Journal of Medicine Publication of Data that Demonstrate Bulevirtide with PegIFN Achieved Post-Treatment Undetectable HDV RNA
Jun 23, 2023	Hepcludex (bulevirtide) Demonstrates Sustained Efficacy and Safety Profile in People With Chronic Hepatitis Delta Virus at 96 Weeks
Oct 27, 2022	Gilead Receives Complete Response Letter from U.S. FDA for Bulevirtide for the Treatment of Adults with Hepatitis Delta Virus
Nov 19, 2021	Gilead Submits Biologics License Application to U.S. Food and Drug Administration for Bulevirtide, an Investigational Treatment for People Living With Chronic Hepatitis Delta
Jun 24, 2021	Treatment With Hepcludex (bulevirtide) Was Shown to Achieve Significant Response in Chronic Hepatitis Delta Virus After 24 Weeks

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