Hepcludex
Hepcludex ingredients
| Active ingredient | Strength |
|---|---|
| Bulevirtide Acetate | 8.5 mg/1 |
What Hepcludex is used for
The FDA lists the approved uses on the official label (below). In the EU, bulevirtide is approved as Hepcludex for:
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.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Hepcludex
- Generic name
- Bulevirtide
- Made by
- Gilead Sciences, Inc.
- Forms
- Injection, Powder, Lyophilized, For Solution
- Given
- Subcutaneous
- FDA approval
- Biologic licence (BLA) BLA761468
- On the US market since
- 2026
Official information
- Hepcludex prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Bulevirtide)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Hepcludex?
Hepcludex (Bulevirtide) is a specialist medicine made by Gilead Sciences, Inc., approved by the US FDA.
What are the ingredients of Hepcludex?
Hepcludex contains Bulevirtide Acetate (8.5 mg/1).
Is Hepcludex approved in Europe?
The same active substance is approved in the EU as Hepcludex.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA