Is Bulevirtide approved by the US FDA?

Drugs@FDA lists 1 application product line for Bulevirtide, including HEPCLUDEX (Prescription).

Is Bulevirtide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Bulevirtide: Hepcludex.

Active substance

Bulevirtide

US FDA 1
EMA 1
Health Canada 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
HEPCLUDEX	8.5MG	injection · powder,for solution	GILEAD SCIENCES INC	Prescription	22 May 2026

EMA European Union — centrally authorised medicines

Hepcludex Gilead Sciences Ireland UC · Authorised · authorised 31 Jul 2020 · ATC J05A

Therapeutic indication (EMA)

Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult and paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
HEPCLUDEX	02560178	2 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	GILEAD SCIENCES CANADA INC

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.