GSK has licensed global rights to linerixibat, an investigational treatment for cholestatic pruritus in primary biliary cholangitis, to Alfasigma in a deal valued at up to $690 million
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
GSK plc has entered a global licensing agreement with Alfasigma S.p.A. granting Alfasigma exclusive worldwide rights to develop, manufacture, and commercialize linerixibat, an investigational therapy being studied for cholestatic pruritus in patients with Primary Biliary Cholangitis (PBC).
Linerixibat (GSK2330672) is an oral ileal bile acid transporter (IBAT) inhibitor designed to reduce circulating bile acids that are believed to contribute to severe itching associated with cholestatic liver diseases. The drug is currently under regulatory review in several regions including the United States, European Union, United Kingdom, China, and Canada.
The licensing agreement reflects a strategic shift for GSK as the company prioritizes other liver disease programs in its pipeline.
According to GSK’s Chief Scientific Officer, Tony Wood, the company played a central role in discovering and advancing linerixibat but believes Alfasigma’s hepatology expertise positions it well to lead the therapy’s future development and commercialization.
Linerixibat has received orphan drug designation in the US, EU, and Japan for the treatment of cholestatic pruritus in PBC. Regulatory submissions are supported by results from the Phase III GLISTEN trial (NCT04950127), which met its primary and key secondary endpoints. The findings from the Phase III GLISTEN trial were also published in the journal The Lancet Gastroenterology & Hepatology, reporting that linerixibat significantly improved itch severity and itch-related sleep disturbance in patients with primary biliary cholangitis compared with placebo.
The safety profile remained consistent with previous clinical studies and the drug’s mechanism of IBAT inhibition. The therapy has not yet received regulatory approval in any country.
For Alfasigma, the agreement strengthens its focus on specialty and rare disease therapeutics, particularly in hepatology. The company already markets several liver disease treatments globally and operates in more than 100 markets.
Chief Executive Officer Francesco Balestrieri said the partnership aligns with the company’s strategy to expand access to innovative therapies addressing complex medical conditions.
Under the financial terms of the deal, GSK will receive an upfront payment of $300 million. The company is also eligible for an additional $100 million if linerixibat receives approval from the US FDA, which is expected before the transaction closes based on the current PDUFA target date of March 24, 2026.
Additional regulatory milestones include $20 million tied to approvals in the EU and UK, as well as up to $270 million in sales-based milestones.
GSK will also receive tiered double-digit royalties on global net sales.
The transaction remains subject to customary regulatory clearances, including review under the Hart-Scott-Rodino Act in the United States.
Primary biliary cholangitis is a chronic autoimmune liver disease that disrupts the normal flow of bile from the liver. The resulting buildup of bile acids in circulation is believed to contribute to cholestatic pruritus, a severe internal itching sensation that cannot be relieved by scratching.
The symptom can occur at any stage of PBC and may significantly affect patients’ quality of life, often causing sleep disturbance, fatigue, and psychological distress.
Studies suggest that itch symptoms are frequently underreported or undocumented in medical records, and up to one-third of patients with clinically significant pruritus may not receive treatment.
Through inhibition of the ileal bile acid transporter, linerixibat aims to reduce the reabsorption of bile acids in the intestine, thereby lowering circulating levels of itch-mediating compounds and potentially relieving symptoms associated with PBC-related pruritus.
Reference
GSK and Alfasigma announce agreement on worldwide rights for linerixibat, 09 March 2026, GSK and Alfasigma announce agreement on worldwide rights for linerixibat | GSK
GSK and Alfasigma announce agreement on worldwide rights for linerixibat, 09 March 2026, https://www.alfasigma.com/corporate/gsk-and-alfasigma-announce-agreement-on-worldwide-rights-for-linerixibat/
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN), ClinicalTrials.gov ID NCT04950127, https://clinicaltrials.gov/study/NCT04950127
Hirschfield GM et al, Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Jan;11(1):22-33. Epub 2025 Oct 28. PMID: 41173016, https://doi.org/10.1016/s2468-1253(25)00192-x
About the Writer
Karthik Teja Macharla is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. He focuses on interpreting medical evidence and presenting complex scientific information in a clear and structured manner. His work centers on evidence-based medical communication, with particular interest in drug safety, clinical studies, and developments in pharmaceutical research.