Hepcludex
What Hepcludex is used 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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- PRIME: a priority medicine that the EMA supported early because it may meet an unmet need.
Key facts
- Brand
- Hepcludex
- Active substance
- bulevirtide
- Disease area
- Hepatitis D, Chronic
- Medicine group
- Antivirals for systemic use
- ATC code
- J05A
- Marketing authorisation holder
- Gilead Sciences Ireland UC
- Authorised in the EU since
- 2020
Official information
In the USA
Same active substance: Hepcludex
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 used 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.
What is the active substance in Hepcludex?
Hepcludex contains bulevirtide.
Who makes Hepcludex?
The EU marketing authorisation holder is Gilead Sciences Ireland UC.
Is Hepcludex an orphan medicine?
Yes. Hepcludex is designated an orphan medicine in the EU, for a rare disease (Hepatitis D, Chronic).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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