Business
Linerixibat accepted for priority review in China
GSK plc announced that its new drug application for linerixibat, an investigational treatment for cholestatic pruritus in primary biliary cholangitis, has been accepted for priority review by China's National Medical Products Administration. This submission is supported by positive data from the GLISTEN phase III trial, which demonstrated significant and sustained improvement in pruritus and sleep disturbance compared to placebo. Linerixibat has also received Orphan Drug Designation in the US, EU, and Japan, with marketing applications currently under review in the US, EU, UK, and Canada. Approximately 280,000 people in China are affected by PBC, with up to 89% experiencing cholestatic pruritus. Disclaimer*
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 26 February 2026, London UK\n \nLinerixibat accepted for priority review in China for cholestatic pruritus in patients with primary biliary cholangitis\n \n· Submission based on data from positive GLISTEN phase III trial\n· Linerixibat demonstrated significant and sustained improvement in cholestatic pruritus versus placebo\n· Regulatory reviews underway in US, EU, UK and Canada\n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that its new drug application for the use of linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease, has been accepted for priority review by China's National Medical Products Administration. Linerixibat is an investigational inhibitor of the ileal bile acid transporter (IBAT), developed to reduce mediators of cholestatic pruritus - an internal and relentless itch.\n \nThe application is based on positive data from the GLISTEN phase III trial, presented last year at the European Association for the Study of the Liver (EASL) Congress.1 GLISTEN met both primary and key secondary endpoints demonstrating a rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference versus placebo. The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition.2\n \nCholestatic pruritus in PBC is a serious and debilitating condition, with patients experiencing sleep disturbance and impaired quality of life and sometimes requiring liver transplant in the absence of liver failure.3,4,5 In China, approximately 280,000 people are affected by PBC, and cholestatic pruritus, for which there are few effective treatment options, is estimated to impact up to 89% of PBC patients during the course of their disease.3, 6-9\n \nLinerixibat has also been granted Orphan Drug Designation in the US, EU and Japan for the treatment of cholestatic pruritus in patients with PBC. Marketing applications for linerixibat are currently under Health Authority review in the US, EU, UK and Canada. Linerixibat is currently not approved anywhere in the world.\n \nAbout linerixibat\nLinerixibat is an IBAT inhibitor, a targeted oral agent to treat cholestatic pruritus associated with the rare autoimm...