China Grants Priority Review to GSK’s Linerixibat

GSK plc has announced that China’s drug regulator has accepted its new drug application for linerixibat to treat cholestatic pruritus in patients with primary biliary cholangitis (PBC), granting the therapy priority review status. The decision by the National Medical Products Administration marks a significant regulatory milestone for the investigational medicine in one of the world’s largest healthcare markets.

Linerixibat is an oral inhibitor of the ileal bile acid transporter (IBAT), designed to reduce the buildup of bile acids believed to drive cholestatic pruritus—an intense, persistent internal itch associated with PBC. Primary biliary cholangitis is a rare autoimmune liver disease that progressively damages bile ducts in the liver. While treatments exist to slow disease progression, options specifically targeting the severe itching that accompanies the condition remain limited.

The Chinese filing is supported by positive results from the Phase III GLISTEN trial, which were presented at the European Association for the Study of the Liver Congress last year. In the study, linerixibat met both its primary and key secondary endpoints, demonstrating rapid, statistically significant and sustained improvements in itch severity and sleep disturbance compared with placebo. The safety findings were consistent with previous clinical data and aligned with the known effects of IBAT inhibition.

Cholestatic pruritus can be debilitating, leading to chronic sleep disruption, psychological distress and diminished quality of life. In severe cases, some patients pursue liver transplantation primarily to alleviate symptoms, even in the absence of liver failure. In China alone, an estimated 280,000 people are living with PBC, and up to 89% may experience cholestatic pruritus during the course of their illness.

Linerixibat has already received Orphan Drug Designation in the United States, European Union and Japan for this indication. Regulatory applications are currently under review in multiple regions, including the US, EU, UK and Canada. The drug has not yet been approved in any country.

If authorized, linerixibat could offer a much-needed targeted treatment option for patients in China struggling with the burdensome symptoms of PBC-related itching.