- Alfasigma acquires global rights to linerixibat, an IBAT inhibitor for cholestatic pruritus in PBC.
- GSK receives $300 million upfront, $100 million upon US FDA approval, and up to $270 million in sales-based milestones.
- Linerixibat is under regulatory review in the US, EU, UK, China, and Canada.
- US FDA approval expected by 24 March 2026.
Agreement Overview
GSK and Alfasigma have entered a license agreement granting Alfasigma exclusive worldwide rights to develop, manufacture, and commercialize linerixibat, an investigational IBAT inhibitor for treating cholestatic pruritus in primary biliary cholangitis (PBC).
Financial Terms
Under the agreement, GSK will receive an upfront payment of $300 million, with an additional $100 million upon US FDA approval, expected by 24 March 2026. GSK is also eligible for $20 million upon EU and UK approval and up to $270 million in sales-based milestone payments, along with tiered double-digit royalties on global net sales.
Regulatory Status
Linerixibat has been granted Orphan Drug Designation in the US, EU, and Japan, and priority review in China. Marketing applications are under review in the US, EU, UK, China, and Canada, based on positive results from the GLISTEN phase III trial.
Clinical Data
The GLISTEN trial demonstrated that linerixibat significantly improved cholestatic pruritus and itch-related sleep interference compared to placebo, with a safety profile consistent with previous studies.
About Cholestatic Pruritus in PBC
Cholestatic pruritus in PBC is caused by disrupted bile flow from the liver, leading to excess bile acids in circulation. This condition can cause severe itching, sleep disturbance, fatigue, and impaired quality of life, sometimes necessitating liver transplantation in the absence of liver failure.
