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Hepatology · Infectious disease

Hibsago (bepirovirsen) in Chronic Hepatitis B: market forecast and verdict

GSK (licensed from Ionis) · FDA approved 20 October 2026

OUR VERDICTA genuine first, limited by who can get it.It is the first drug to deliver functional cure in a meaningful share of patients, but a narrow label and liver monitoring will keep early use in specialist centres.
~USD 480M
Base case US net revenue, 2031Range USD 180M to 910M · Zaash Labs estimate
19% vs 0%
functional cure vs placebo, B-Well 1 and 2 pooled
<1%
functional cure on standard antivirals after one year
~1.7M
people living with chronic hepatitis B in the US

What was approved and why it matters

GSK's Hibsago (bepirovirsen), licensed from Ionis, is the first antisense therapy for chronic hepatitis B. It is a fixed 24 week course of weekly injections added to standard antivirals, and it aims at functional cure rather than lifelong suppression.

Frequently asked questions

When was Hibsago approved?

The FDA approved Hibsago (bepirovirsen) on 20 October 2026 for adults with chronic hepatitis B without cirrhosis, on antiviral therapy with suppressed HBV DNA and HBsAg at or below 3,000 IU/mL.

What are Hibsago's projected sales?

Zaash Labs' base case is about USD 480 million of US net revenue in 2031, within a range of USD 180 million to 910 million. Price is not yet disclosed.

How effective is bepirovirsen?

In the pooled B-Well trials, 19% of label eligible patients reached functional cure against 0% on placebo, rising to 26% among patients with HBsAg at or below 1,000 IU/mL.

Figures are company reported or from published sources unless marked as Zaash Labs estimates. Sources are listed in the executive summary and the full report. Market research to support business decisions; not investment advice.