GSK has announced that China’s National Medical Products Administration (NMPA) has accepted its new drug application for linerixibat for priority review. The investigational therapy is being evaluated for the treatment of cholestatic pruritus in patients with Primary Biliary Cholangitis (PBC), a rare autoimmune liver disease.

Linerixibat is an oral inhibitor of the Ileal Bile Acid Transporter (IBAT), designed to reduce circulating mediators responsible for cholestatic pruritus — a persistent and debilitating internal itch commonly experienced by patients with PBC.

The regulatory submission is supported by positive results from the Phase III GLISTEN trial, which were presented at the European Association for the Study of the Liver (EASL) Congress last year. The study met its primary and key secondary endpoints, demonstrating rapid, significant and sustained improvements in itch severity and itch-related sleep interference compared with placebo. The safety profile was consistent with earlier studies and aligned with the known mechanism of IBAT inhibition.

Cholestatic pruritus remains a serious and life-disrupting complication of PBC, often leading to severe sleep disturbance and reduced quality of life. In some cases, patients may require liver transplantation even in the absence of liver failure. In China, approximately 280,000 individuals are affected by PBC, and up to 89 percent experience cholestatic pruritus during the course of the disease, with limited effective treatment options currently available.

Linerixibat has received Orphan Drug Designation in the United States, European Union and Japan for this indication. Marketing applications are also under review in the US, EU, UK and Canada. The therapy is not yet approved in any country.