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OCT 28 2026
UPCOMING · 89 DAYS TO PDUFA

GSK bepirovirsen $GSK

for chronic hepatitis B infection

NDA · Priority Review · Breakthrough · Fast Track

Accepted APR 28 2026.

About

Chronic hepatitis B is a viral infection that attacks the liver and can become a persistent, long-term illness. Bepirovirsen is an antisense oligonucleotide designed to bind to and degrade the virus's specific genetic material (mRNA). By silencing this viral blueprint, the drug aims to reduce the amount of virus in the body, which could potentially lead to a functional cure for the infection.

Pivotal trial

NCT05630807 Phase 3 completed NCT05630807

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks

Source: ClinicalTrials.gov

Also in development