GlaxoSmithKline (GSK) received a CHMP positive opinion on 23 July 2026 recommending EU marketing authorization for linerixibat (Lynavoy), making it the first approved therapy specifically indicated for cholestatic pruritus in adult patients with primary biliary cholangitis. The opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use follows a completed Phase III programme and, if confirmed by the European Commission, would address a condition for which no licensed treatment has previously existed, with clinicians currently relying on off-label agents with limited evidence bases.
The pivotal data supporting the opinion came from the GLISTEN trial (NCT04950127), a two-part, randomised, double-blind, placebo-controlled, multicenter Phase III study enrolling 230 participants with moderate to severe cholestatic pruritus associated with PBC. Over 24 weeks, linerixibat demonstrated a statistically significant improvement in the Monthly Itch Score versus placebo, with a least squares mean difference of -0.68 (95% CI: -1.14 to -0.23; p = 0.003). Improvements in pruritus-related sleep interference corroborated the primary finding. The most commonly reported adverse events were diarrhoea, abdominal pain, and transaminase elevations — a profile consistent with the drug's gut-localized mechanism. A long-term safety and tolerability study remains in progress.
Linerixibat inhibits the ileal bile acid transporter (IBAT/ASBT), blocking reabsorption of bile acids from the terminal ileum and thereby reducing their recirculation — a mechanism believed to interrupt the pruritogenic signalling cascade in cholestatic liver disease. The drug is formulated as a 40 mg film-coated tablet and is described as minimally systemically absorbed, which limits off-target hepatic or systemic exposure. Cholestatic pruritus is often severe enough to impair sleep, reduce quality of life, and in some cases lead patients to seek liver transplantation despite otherwise stable liver disease.