Hepcludex (bulevirtide)
OrphanPRIMEAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- bulevirtide
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- Hepatitis D, Chronic
- EU approval
- Fri 31 Jul 2020
- Designations
- Orphan, PRIME, Additional monitoring
- Application
- EMEA/H/C/004854
- ATC
- J05A
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
Fri 22 May 2026🇺🇸 FDA approval
FDA approves Hepcludex (bulevirtide-gmod), a new medicine
Gilead Sciences Inc; BLA761468; New biologic, Priority review; injection · source
Same substance in other markets
- 🇺🇸 Hepcludex Approved · Gilead Sciences Inc
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.