Overview
Linerixibat, an investigational inhibitor of the ileal bile acid transporter (IBAT), is being developed to treat cholestatic pruritus in patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. The drug aims to reduce mediators of cholestatic pruritus, a persistent and severe itch.
Clinical Trial Data
The application for Linerixibat's use is based on positive results from the GLISTEN phase III trial, which were presented at the European Association for the Study of the Liver (EASL) Congress. The trial met both primary and key secondary endpoints, showing rapid, significant, and sustained improvement in cholestatic pruritus and itch-related sleep interference compared to placebo. The safety profile was consistent with previous studies and the mechanism of IBAT inhibition.
Impact and Prevalence
Cholestatic pruritus in PBC is a serious condition that can lead to sleep disturbances and impaired quality of life, sometimes necessitating liver transplants in the absence of liver failure. In China, around 280,000 people are affected by PBC, with up to 89% experiencing cholestatic pruritus during their disease course.
Regulatory Status
Linerixibat has been granted Orphan Drug Designation in the US, EU, and Japan for treating cholestatic pruritus in PBC patients. Marketing applications are under review by health authorities in the US, EU, UK, and Canada. Currently, Linerixibat is not approved for use anywhere in the world.
