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OCT 28 2026
UPCOMING · 147 DAYS TO PDUFA

GSK bepirovirsen $GSK

for chronic hepatitis B infection

NDA · Priority Review · Breakthrough

Accepted APR 28 2026.

About

Hepatitis B is a viral infection that attacks the liver and can lead to lifelong illness if the virus persists. Bepirovirsen is an antisense oligonucleotide that binds to and silences HBV messenger RNA, preventing the virus from making proteins needed to replicate. By interrupting this viral production cycle, the drug may help control chronic HBV infection and reduce liver damage over time.

Pivotal trial

B-Well 2 Phase 3 completed NCT05630820

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

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