REG - GSK PLC - GSK and Alfasigma agree global linerixibat rights

GSKAnnouncement

09/03/2026 07:00

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RNS Number : 8360V  GSK PLC  09 March 2026

Issued: 9 March 2026, London UK

 

GSK and Alfasigma announce agreement on worldwide rights for linerixibat

 

GSK plc (LSE/NYSE: GSK) and Alfasigma S.p.A. today announced a licence
agreement under which Alfasigma will acquire worldwide exclusive rights to
develop, manufacture and commercialise linerixibat, an investigational ileal
bile acid transporter (IBAT) inhibitor being developed for cholestatic
pruritus in primary biliary cholangitis (PBC).

 

Alfasigma is a global pharmaceutical company with established capabilities in
specialty care and rare diseases. The company has significant experience in
developing and commercialising therapies for serious liver diseases, including
PBC, and has products in more than 100 markets worldwide.

 

Tony Wood, Chief Scientific Officer, GSK said: "We're proud of the role GSK
has played discovering and developing linerixibat to advance treatment in this
rare disease with high unmet need. 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, MASH and
ALD, which account for two million deaths annually and have a major impact on
healthcare utilisation."

 

Linerixibat 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. Marketing applications for linerixibat are currently under
regulatory review in the US, EU, UK, China and Canada, based on positive data
from the GLISTEN phase III trial. GLISTEN met primary and key secondary
endpoints, demonstrating a rapid, significant and sustained improvement in
cholestatic pruritus and itch-related sleep interference versus placebo. The
safety profile of linerixibat was consistent with previous studies and the
mechanism of IBAT inhibition.(1)

 

Linerixibat is not currently approved anywhere in the world.

 

Francesco Balestrieri, Chief Executive Officer, Alfasigma, said: "Alfasigma is
committed to advancing rare and specialty care by developing and delivering
innovative solutions that address some of the most complex healthcare
challenges. With our deep hepatology expertise and strong global footprint, we
are uniquely positioned to lead the worldwide commercialization of
linerixibat. This agreement underscores our strategic focus on bringing
meaningful new treatments to patients and improving outcomes for communities
around the world."

 

Financial considerations

Under the terms of the agreement, GSK will receive an upfront payment of $300
million, plus $100 million upon US FDA approval (expected prior to transaction
closing, based on current PDUFA target approval date of 24 March 2026).
Additionally, GSK is eligible to receive $20 million upon EU and UK approval,
and up to $270 million in sales-based milestone payments. GSK will also earn
tiered double-digit royalties on net sales worldwide.

 

This transaction is subject to customary conditions, including applicable
regulatory agency clearances such as under the Hart-Scott-Rodino Act in the
US.

 

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 (http://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.

 

 GSK enquiries
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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 2025.

 

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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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