FDA Approves GSK and Ionis’s Bepirovirsen (Hibsago), the First Antisense ‘Functional Cure’ for Hepatitis B

Oct 21 , 2026
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Oct 21, 2026 —

The FDA has approved Hibsago (bepirovirsen), an antisense oligonucleotide from GSK and Ionis, for chronic hepatitis B. It is the first antisense therapy approved for the disease and is described as a functional cure, meaning sustained control of the virus and loss of hepatitis B surface antigen after a course of treatment.

Bepirovirsen is a subcutaneously administered antisense oligonucleotide that targets hepatitis B viral RNA, lowering production of viral proteins. Chronic hepatitis B affects hundreds of millions of people worldwide and has long lacked a treatment that works after patients stop taking it.

The approval is another marker of antisense and RNA-targeting medicines moving into large chronic diseases, a modality category adjacent to the vector and genetic-medicine work at the center of the field.

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