GSK licenses investigational liver disease treatment linerixibat to Alfasigma for global development and commercialisation

GSK licenses investigational liver disease treatment linerixibat to Alfasigma for global development and commercialisation

(IN BRIEF) GSK and Alfasigma have signed a licensing agreement granting Alfasigma worldwide exclusive rights to develop, manufacture and commercialise linerixibat, an investigational IBAT inhibitor for the treatment of cholestatic pruritus in patients with primary biliary cholangitis. The therapy is currently under regulatory review in multiple regions, including the United States, European Union, United Kingdom, China and Canada, following positive results from the Phase III GLISTEN trial demonstrating improvements in itching symptoms and sleep disruption. Linerixibat has received Orphan Drug Designation in the US, EU and Japan and priority review in China but has not yet been approved for use. Under the agreement, GSK will receive an upfront payment of $300 million, additional regulatory milestone payments, potential sales-based milestones of up to $270 million and tiered double-digit royalties on global net sales. The partnership allows Alfasigma to lead global commercialisation of the treatment while enabling GSK to focus on advancing its broader liver disease pipeline.

(PRESS RELEASE) LONDON, 10-Mar-2026 — /EuropaWire/ — GSK plc has entered into a licensing agreement with Alfasigma S.p.A. granting the Italian pharmaceutical company worldwide exclusive rights to develop, manufacture and commercialise linerixibat, an investigational treatment currently under development for cholestatic pruritus associated with primary biliary cholangitis (PBC).

Linerixibat is an ileal bile acid transporter (IBAT) inhibitor designed to address itching caused by cholestatic liver disease, a condition that significantly affects quality of life for patients with PBC. Under the agreement, Alfasigma will take responsibility for advancing the therapy through regulatory review and bringing the treatment to patients globally.

Alfasigma operates internationally with a strong focus on specialty care and rare diseases and has extensive experience in the development and commercialization of therapies targeting serious liver conditions. The company currently markets products in more than 100 countries and has established expertise in hepatology, including treatments related to primary biliary cholangitis.

Tony Wood, Chief Scientific Officer at GSK, highlighted the company’s role in the discovery and development of linerixibat and emphasized the importance of partnering with an organisation that has deep experience in the field. According to Wood, Alfasigma’s capabilities in treating liver diseases position the company well to advance the medicine and make it available to patients. He added that the agreement enables GSK to further concentrate on its pipeline of treatments addressing liver diseases such as chronic hepatitis B, metabolic dysfunction-associated steatohepatitis (MASH), and alcohol-related liver disease (ALD), which together contribute to millions of deaths worldwide and place significant pressure on healthcare systems.

Linerixibat has received Orphan Drug Designation in the United States, the European Union and Japan for the treatment of cholestatic pruritus in patients with PBC. In China, the therapy has been granted priority review status. Regulatory submissions for linerixibat are currently under review in the United States, European Union, United Kingdom, China and Canada.

These submissions are supported by results from the Phase III GLISTEN clinical trial. The study achieved its primary and key secondary endpoints, demonstrating rapid and sustained improvements in itching symptoms and sleep disruption associated with cholestatic pruritus compared with placebo. The safety profile observed during the trial was consistent with earlier studies and aligned with the expected mechanism of action of IBAT inhibition.

The therapy has not yet been approved for use in any market.

Francesco Balestrieri, Chief Executive Officer of Alfasigma, stated that the agreement reflects the company’s commitment to developing innovative treatments for complex and underserved medical conditions. He noted that Alfasigma’s global presence and experience in hepatology will support the worldwide commercialisation of linerixibat and contribute to improving outcomes for patients living with rare liver diseases.

Under the terms of the agreement, GSK will receive an upfront payment of $300 million. The company is also expected to receive an additional $100 million upon approval of linerixibat by the U.S. Food and Drug Administration, which is anticipated before the completion of the transaction based on the current target action date of 24 March 2026. Additional milestone payments include $20 million linked to approvals in the European Union and the United Kingdom, as well as up to $270 million in payments tied to future sales performance. GSK will also receive tiered double-digit royalties on global net sales of the product.

Completion of the transaction remains subject to customary closing conditions, including regulatory clearances such as review under the Hart-Scott-Rodino Act in the United States.

About cholestatic pruritus in PBC

In PBC, a cholestatic liver disease, 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 or biochemical control.2 It is a serious condition that can be debilitating, with patients experiencing sleep disturbance, fatigue, impaired quality of life and even sometimes requiring liver transplantation in the absence of liver failure.3–5  Data from the US indicate that itch is frequently undocumented in medical records and up to one-third of patients experiencing clinically significant itch do not receive any treatment.6

About linerixibat (GSK2330672)

Linerixibat is an IBAT inhibitor, a targeted oral agent with potential to treat cholestatic pruritus (itch) associated with the rare autoimmune liver disease PBC.1 By inhibiting bile acid re-uptake, linerixibat reduces multiple mediators of pruritus in circulation.7

About GSK research in hepatology

GSK is extending its expertise in inflammation to develop a next wave of innovation for the millions of people affected by chronic and life-threatening fibro-inflammatory liver conditions. Harnessing the science of the immune system and advanced technologies, GSK is committed to advancing its hepatology pipeline with potential therapies for chronic hepatitis B and steatotic liver disease (SLD), including metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-associated liver disease (ALD).

About Alfasigma

Alfasigma is a global pharmaceutical company headquartered in Italy with products in over 100 markets across Europe, North and South America, Asia, and Africa. Alfasigma is dedicated to research, development, production, and distribution of medicinal products, contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical food and nutraceuticals. Visit www.alfasigma.com.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Annual Report for 2025.

References

1. Hirschfield GM, et al. Lancet Gastroenterol Hepatol. 2026; 11(1): 22–33. doi: 10.1016/S2468-1253(25)00192-X
2. Düll MM, Kremer AE. Clin Liver Dis. 2022; 26(4):727-45. doi: 10.1016/j.cld.2022.06.009
3. Smith H, et al. Hepatol Commun. 2025; 9(3):e0635. doi: 10.1097/HC9.0000000000000635
4. Mayo MJ, et al. Dig Dis Sci. 2023;68(3):995-1005. doi: 10.1007/s10620-022-07581-x
5. Lindor KD, et al. Hepatol. 2019;69(1):394-419. doi: 10.1002/hep.30145
6. Gungabissoon U, et al. BMJ Open Gastroenterol. 2024; 11;e001287. doi: 10.1136/bmjgast-2023-001287
7. Kremer A, et al. Hepatol. 2025; 82(S1); S204. doi: 10.1097/HEP.0000000000001493

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SOURCE: GlaxoSmithKline plc