GSK Licences Worldwide Rights to Linerixibat to Alfasigma in Deal Worth Up to USD 690 Million
GSK plc (LSE/NYSE: GSK), headquartered in London, and Bologna-based Alfasigma S.p.A. have entered into a licence agreement under which Alfasigma will acquire worldwide exclusive rights to develop, manufacture, and commercialise linerixibat, an oral ileal bile acid transporter (IBAT) inhibitor being developed for cholestatic pruritus in patients with primary biliary cholangitis (PBC). Under the deal, GSK will receive an upfront payment of USD 300 million, with additional regulatory and sales-based milestones bringing the total potential value to approximately USD 690 million, excluding royalties. Linerixibat is not currently approved in any market.
The financial structure includes a USD 100 million milestone tied to US FDA approval, which GSK expects prior to transaction closing based on a PDUFA target date of 24 March 2026. A further USD 20 million is payable upon EU and UK approval, with up to USD 270 million in sales-based milestone payments. GSK will also receive tiered double-digit royalties on worldwide net sales. The transaction is subject to customary conditions, including clearance under the Hart-Scott-Rodino Act. No equity component, co-promotion arrangement, or territorial carve-out was disclosed; GSK retains no operational role in the asset's commercialisation.
Deal Context
Linerixibat (GSK2330672) is a small molecule that selectively inhibits the ileal bile acid transporter (IBAT/SLC10A2) in the gut, reducing reabsorption of bile acids into the enterohepatic circulation. In PBC, impaired bile flow leads to accumulation of bile acids systemically, which is thought to drive cholestatic pruritus — a persistent internal itch that can cause sleep disturbance, fatigue, and reduced quality of life. By lowering circulating bile acid levels, linerixibat addresses a mechanistic link between bile acid excess and pruritus severity. Marketing applications are under regulatory review in the US, EU, UK, China, and Canada, based on data from the Phase III GLISTEN trial, which met its primary and key secondary endpoints. Linerixibat holds Orphan Drug Designation in the US, EU, and Japan, and priority review status in China.
For GSK, the out-licensing represents a strategic narrowing of its hepatology portfolio toward chronic hepatitis B, metabolic dysfunction-associated steatohepatitis (MASH), and alcohol-associated liver disease (ALD). For Alfasigma, the deal adds a late-stage PBC asset to a portfolio already anchored in hepatology following the company's approximately USD 750 million acquisition of Intercept Pharmaceuticals in 2023, which brought obeticholic acid (Ocaliva), a farnesoid X receptor (FXR) agonist approved for primary biliary cholangitis treatment. The linerixibat PBC drug licence gives Alfasigma a second distinct mechanism in the same disease. This GSK licence agreement with Alfasigma appears to be the first publicly reported deal between the two companies, including Alfasigma's predecessor entities Alfa Wassermann and Sigma-Tau.