Linerixibat FDA Approval Status
Last updated by Judith Stewart, BPharm on June 11, 2025.
FDA Approved: No
Generic name: linerixibat
Company: GlaxoSmithKline
Treatment for: Primary Biliary Cholangitis
Linerixibat is an ileal bile acid transporter (IBAT) inhibitor in development for the treatment of cholestatic pruritus in patients with primary biliary cholangitis.
- Primary biliary cholangitis (PBC) is a cholestatic liver disease characterized by inflammation of the bile ducts and disruption of bile flow from the liver. The resulting accumulation of excess bile acids in PBC can cause a severe internal itching known as cholestatic pruritus.
- Linerixibat is an IBAT inhibitor that works in the treatment of cholestatic pruritus associated with PBC by inhibiting bile acid re-uptake, thereby reducing multiple mediators of pruritus.
- A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for linerixibat based on positive data from the double-blind, randomised, placebo-controlled, phase III GLISTEN trial (NCT04950127; GSK study 212620), which met both primary and key secondary endpoints, demonstrating a rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference compared to placebo.
- The NDA for linerixibat has been accepted for review by the FDA, and has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 24, 2026.
Development timeline for linerixibat
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.