GSK Ends Hepatitis B Trial Following FDA Approval
The company stops its phase 1 study for GSK3965193 as it brings the new chronic hepatitis B drug Hibsago to the market.
Updated on Oct. 21, 2026 in Biotech
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GSK has terminated the phase 1 clinical trial for its hepatitis B drug candidate GSK3965193. The decision comes as the FDA approves the company's separate hepatitis B treatment, Hibsago, for adults without cirrhosis.
Why it matters
The move represents a strategic consolidation of the company's hepatitis B pipeline following the recent regulatory approval of a lead asset. GSK continues to refine its therapeutic focus by abandoning older experimental programs to prioritize late-stage development.
The halted candidate, GSK3965193, was a PAPD5/PAPD7 inhibitor designed to target mechanisms involved in viral replication. GSK previously discontinued the development of its TLR8 agonist GSK5251738, indicating a shift in its molecular target priorities.
The players
GSK
A global pharmaceutical company focused on vaccines and specialty medicines including hepatitis B therapeutics.
FDA
The United States federal agency responsible for regulating food, tobacco, and medical products.
The details
GSK3965193 acted as an inhibitor of PAPD5 and PAPD7, which are enzymes involved in the polyadenylation process of viral RNA. By targeting these polymerases, the candidate aimed to interfere with the maintenance of the hepatitis B virus genome within infected cells. The trial termination concludes a research program that began in 2022.
Timeline
The phase 1 study of GSK3965193 began in 2022.
The FDA approved the drug bepirovirsen on October 20, 2026.
The termination of the clinical trial was confirmed on October 21, 2026.
The Tech Race
This decision marks a continued narrowing of the company's research focus within its hepatitis B portfolio. The firm is now streamlining its efforts around its newly approved drug while maintaining a secondary candidate, GSK5637608, in phase 2 development.
Adults living with chronic hepatitis B without cirrhosis gain access to a newly approved treatment option in Hibsago. The discontinuation of the phase 1 trial will have no immediate impact on current clinical standards or patient treatment pathways.
The takeaway
GSK is signaling a move away from experimental PAPD5/PAPD7 inhibition toward commercializing its approved antiviral. Stakeholders should track the phase 2 results of GSK5637608 as the next benchmark for the company's remaining pipeline.
Further reading
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Source note: This article includes information reported by FierceBiotech - free daily biotech briefing.
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