Bepirovirsen
Chronic hepatitis B · Adults with chronic hepatitis B
GSK · GSK plc
Regulatory designations
Full timeline
7 milestonesFDA decision expected
FDA assigned an October 26, 2026 PDUFA goal date to the bepirovirsen NDA.
GSK — NDA acceptance and PDUFA date↗Detailed Phase 3 B-Well results were reported
Across B-Well 1 and B-Well 2, 19% of qualifying participants achieved functional cure at week 72 with bepirovirsen plus standard of care versus 0% with placebo plus standard of care.
GSK — Detailed B-Well 1 and B-Well 2 results↗FDA accepted the NDA with Priority Review
FDA accepted the application, granted Breakthrough Therapy designation and established the October goal date.
GSK — NDA acceptance and regulatory designations↗Both Phase 3 B-Well trials met their primary endpoints
Bepirovirsen plus standard of care produced statistically significant and clinically meaningful functional-cure rates versus standard of care alone in B-Well 1 and B-Well 2.
GSK — Positive topline B-Well results↗Related News
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