Quick answers
- What is Bulevirtide used for?
- The FDA-approved label (Hepcludex, Gilead Sciences, Inc., May 22, 2026) says: “HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization […]. An improvement in disease-related clinical outcomes has not been established. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bulevirtide have a boxed warning?
- Yes. The FDA label for Hepcludex has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Bulevirtide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bulevirtide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Bulevirtide?
- 1 company lists prescription products of Bulevirtide in the FDA NDC Directory, including Gilead Sciences, Inc..
What Bulevirtide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization […]. An improvement in disease-related clinical outcomes has not been established. …
— FDA label: Hepcludex, Gilead Sciences, Inc., effective May 22, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Hepcludex |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Gilead Sciences, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761468 HEPCLUDEX | Gilead Sciences Inc | May 22, 2026 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2743611, 2743617 |
|---|---|
| SPL set ID of the quoted label | 12391cc2-38c2-4cf5-86d3-2be9370127fc |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761468 |
| Active ingredients (FDA) | BULEVIRTIDE ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Hepcludex, Gilead Sciences, Inc., effective May 22, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →