Linerixibat: First Approval.

Linerixibat (LYNAVOY®) is an orally administered reversible ileal bile acid transporter (IBAT) inhibitor developed by GSK for the treatment of cholestatic pruritus. In March 2026, linerixibat received its first approval for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients in the USA. It is the first US FDA-approved therapy for this indication. Subsequently, linerixibat was approved in May 2026 in the UK for the treatment of cholestatic pruritus in adult patients with PBC. A regulatory review of linerixibat is currently underway in Canada, China and the EU for the treatment of cholestatic pruritus associated with PBC. This article summarizes the milestones in the development of linerixibat leading to these first approvals.