Alfasigma has agreed to buy the global rights to GSK’s experimental liver disease drug in a deal worth up to $690m.
As per the agreement, Italy-based Alfasigma will acquire worldwide development, manufacturing, and commercialisation duties for linerixibat, GSK’s ileal bile acid transporter (IBAT) inhibitor being developed for cholestatic pruritus in primary biliary cholangitis (PBC).
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Whether the full amount is paid to GSK largely hinges on future approvals and how well the drug sells once at market. A payment of $300m will be made upfront, while US Food and Drug Administration (FDA) approval will add another $100m to the deal. GSK said that approval in the US is expected prior to the transaction closing, with a Prescription Drug User Fee Act (PDUFA) target approval date set for 24 March 2026.
Additionally, GSK is eligible to receive $20m upon EU and UK approval, and up to $270 million in sales-based milestone payments. The UK drugmaker will also earn tiered double-digit royalties on net sales worldwide.
PBC is a type of cholestatic liver disease where bile flow from the liver is disrupted. The resulting excess bile acids in circulation are thought to play a causal role in cholestatic pruritus, an internal itch that cannot be relieved by scratching. Pruritus can occur at any stage of PBC disease and can occur in up to 90% of patients. Cholestyramine, a bile acid sequestrant, is a first-line option for cholestatic pruritus, though conclusions on its efficacy and tolerability vary.
Linerixibat is being reviewed by agencies based on data from the Phase III GLISTEN trial (NCT04950127). GSK’s drug significantly improved itch versus placebo over 24 weeks of treatment, meeting the study’s primary endpoint. The trial also met key secondary endpoints, including itch score at week two and decreasing itch-related sleep interference. Linerixibat is a targeted oral drug that works by inhibiting bile acid reuptake.
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By GlobalDataLinerixibat has been granted orphan drug designation in the US, EU and Japan, and priority review in China, for the treatment of cholestatic pruritus in patients with PBC.
GSK’s chief scientific officer, Tony Wood, said: “We believe Alfasigma, given their expertise in PBC, is the right partner to take this medicine forward for patients. This agreement sharpens GSK’s focus to deliver our next wave of liver disease innovation, including potential treatments for chronic hepatitis B, metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-related liver disease (ALD), which account for two million deaths annually and have a major impact on healthcare utilisation.”
Alfasigma significantly expanded its PBC portfolio after acquiring Intercept Pharmaceuticals for $794m in 2023. The buyout, however, has not materialised into long-term success. Intercept’s Ocaliva (obeticholic acid), the company’s only approved product, was pulled from PBC markets following data re-evaluations.
Alfasigma’s most recent licensing deal came in January 2025, when the Italian pharma company earmarked up to €125m ($144m) for the global rights to Innovative Molecules’ herpes simplex virus (HSV) encephalitis candidate.
