On March 9, 2026, GSK and Alfasigma S.p.A. announced a licensing agreement, under which Alfasigma will obtain global exclusive rights to linerixibat for the development, manufacture and commercialization of the drug.

According to reports, linerixibat is an investigational ileal bile acid transporter (IBAT) inhibitor being developed for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC).

Linerixibat has been granted Orphan Drug Designation in the United States, the European Union and Japan, as well as Priority Review in China for the treatment of cholestatic pruritus in PBC patients. Based on positive data from the Phase III GLISTEN trial, marketing applications for linerixibat are currently under regulatory review in the United States, the European Union, the United Kingdom, China and Canada.

The GLISTEN trial met its primary endpoint and key secondary endpoints, demonstrating rapid, significant and sustained improvements in cholestatic pruritus and pruritus-related sleep disturbance compared with placebo. The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition.

Linerixibat has not yet been approved for marketing in any region globally.

Under the terms of the agreement, GSK will receive an upfront payment of US$300 million and US$100 million upon approval by the U.S. FDA, which is expected prior to the completion of the transaction based on the current PDUFA goal date of March 24, 2026. In addition, GSK will receive US$20 million upon approval in the EU and UK, and is eligible for up to US$270 million in sales-based milestone payments. GSK will also receive tiered double-digit royalties on global net sales.

The transaction is subject to customary conditions, including applicable regulatory approvals such as those required under relevant U.S. antitrust laws.

Notably, this collaboration coincides with the global withdrawal of obeticholic acid (Ocaliva), the core product of Intercept Pharmaceuticals, a subsidiary of Alfasigma. In 2024, the European Commission revoked its marketing authorization and the FDA refused full approval, and in September 2025, Intercept Pharmaceuticals formally withdrew the drug from the U.S. market. With a global treatment gap emerging in PBC care, the accelerated advancement of linerixibat is regarded by the industry as a timely strategic replacement.