What Was Approved?
On May 22, 2026, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) for the treatment of chronic hepatitis delta virus, or HDV, infection in adults:
- Without cirrhosis, or
- With compensated cirrhosis
Hepcludex is the first FDA-approved treatment specifically for chronic HDV infection in the United States.
What Is Hepatitis Delta?
Hepatitis delta is a serious liver infection caused by the hepatitis delta virus.
HDV can only infect people who also have hepatitis B virus, or HBV.
Chronic HDV infection can cause progressive liver damage and may increase the risk of complications such as cirrhosis, liver failure, and liver cancer.
How Does Hepcludex Work?
Hepcludex is an NTCP-directed HDV attachment inhibitor.
It blocks a liver-cell protein called sodium taurocholate co-transporting polypeptide, or NTCP, which HDV and HBV use to enter liver cells.
By blocking this entry pathway, Hepcludex helps interfere with ongoing HDV infection.
How Is Hepcludex Given?
Hepcludex is given by subcutaneous injection.
Patients should follow the exact dose and administration instructions provided in the FDA-approved prescribing information and by their healthcare professional.
Does Hepcludex Have a Boxed Warning?
Yes.
Hepcludex carries a boxed warning for severe acute worsening of hepatitis D and hepatitis B after treatment is stopped.
The FDA label recommends close clinical and laboratory monitoring for at least six months after discontinuation, including monitoring of liver function and HDV and HBV viral levels.
Who Is Hepcludex Not Approved For?
The FDA-approved indication applies to adults without cirrhosis or with compensated cirrhosis.
It is not approved under this indication for patients with decompensated cirrhosis.
Why Is This Approval Important?
Before this approval, there was no FDA-approved treatment specifically for chronic HDV infection in the United States.
Because HDV can cause rapid and serious liver disease, Hepcludex provides a new targeted treatment option for eligible adults.
Bottom Line
Hepcludex (bulevirtide-gmod) is the first FDA-approved treatment for chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis.
Because stopping treatment can cause severe worsening of hepatitis D and hepatitis B, treatment and discontinuation require careful medical monitoring.
Sources
- U.S. Food and Drug Administration (FDA) — FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection, May 22, 2026.
- U.S. Food and Drug Administration (FDA) — Hepcludex (bulevirtide-gmod) Prescribing Information, 2026.
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2026.