GSK has entered a licence agreement with Alfasigma for the worldwide rights to linerixibat, an investigational treatment for cholestatic pruritus in primary biliary cholangitis. The deal includes an upfront payment of $300 million and potential milestones, reflecting strategic portfolio prioritisation as GSK focuses on other liver disease programmes.
GSK has agreed to transfer worldwide exclusive rights for its investigational drug linerixibat to Alfasigma, according to a joint statement. The compound, an ileal bile acid transporter inhibitor, is being developed for cholestatic pruritus in patients with primary biliary cholangitis (PBC). Alfasigma will assume responsibility for development, manufacturing, and commercialisation across global markets.
The financial structure includes an upfront payment of $300 million to GSK, with an additional $100 million contingent on US FDA approval expected by March 2026. Further milestone payments of $20 million for EU and UK approvals and up to $270 million in sales-based milestones could bring the total consideration to $690 million. GSK is also eligible for tiered double-digit royalties on worldwide net sales. Linerixibat has received Orphan Drug Designation in the US, EU, and Japan, with priority review status in China. Regulatory applications are currently under review in multiple jurisdictions based on phase III data showing significant improvement in pruritus and sleep interference compared to placebo.
The drug is not yet approved in any market. For the pharmaceutical industry, this transaction highlights continued strategic refocusing among major drugmakers, with GSK concentrating resources on hepatitis B, MASH, and alcohol-related liver disease programmes. Alfasigma, which has established hepatology expertise and commercial presence in over 100 countries, gains a late-stage asset aligned with its rare disease portfolio.
The deal structure, combining upfront payments with regulatory and commercial milestones, represents a typical risk-sharing model in specialised therapeutics transactions. The agreement is subject to customary regulatory clearances, including US antitrust review. Completion would transfer a compound addressing a condition with limited treatment options, potentially expanding therapeutic access for PBC patients globally.
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