REG - GSK PLC - Linerixibat accepted for priority review in China

GSKAnnouncement

26/02/2026 07:05

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260226:nRSZ4532Ua&default-theme=true

RNS Number : 4532U  GSK PLC  26 February 2026

Issued: 26 February 2026, London UK

 

Linerixibat accepted for priority review in China for cholestatic pruritus in
patients with primary biliary cholangitis

 

·   Submission based on data from positive GLISTEN phase III trial

·   Linerixibat demonstrated significant and sustained improvement in
cholestatic pruritus versus placebo

·   Regulatory reviews underway in US, EU, UK and Canada

 

 

GSK plc (LSE/NYSE: GSK) today announced that its new drug application for the
use of linerixibat for the treatment of cholestatic pruritus in patients with
primary biliary cholangitis (PBC), a rare autoimmune liver disease, has been
accepted for priority review by China's National Medical Products
Administration. Linerixibat is an investigational inhibitor of the ileal bile
acid transporter (IBAT), developed to reduce mediators of cholestatic pruritus
- an internal and relentless itch.

 

The application is based on positive data from the GLISTEN phase III trial,
presented last year at the European Association for the Study of the Liver
(EASL) Congress.(1) GLISTEN met both 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.(2)

 

Cholestatic pruritus in PBC is a serious and debilitating condition, with
patients experiencing sleep disturbance and impaired quality of life and
sometimes requiring liver transplant in the absence of liver failure.(3,4,5)
In China, approximately 280,000 people are affected by PBC, and cholestatic
pruritus, for which there are few effective treatment options, is estimated to
impact up to 89% of PBC patients during the course of their disease.(3, 6-9)

 

Linerixibat has also been granted Orphan Drug Designation in the US, EU and
Japan for the treatment of cholestatic pruritus in patients with PBC.
Marketing applications for linerixibat are currently under Health Authority
review in the US, EU, UK and Canada. Linerixibat is currently not approved
anywhere in the world.

 

About linerixibat

Linerixibat is an IBAT inhibitor, a targeted oral agent to treat cholestatic
pruritus associated with the rare autoimmune liver disease PBC.(2) By
inhibiting bile acid re-uptake, linerixibat reduces multiple mediators of
pruritus in circulation.(10)

 

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 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 www.gsk.com
(https://www.gsk.com) .

 

 GSK enquiries
 Media:               Tim Foley          +44 (0) 20 8047 5502  (London)
                      Sarah Clements     +44 (0) 20 8047 5502  (London)
                      Kathleen Quinn     +1 202 603 5003       (Washington DC)
                      Lyndsay Meyer      +1 202 302 4595       (Washington DC)

 Investor Relations:  Constantin Fest    +44 (0) 7831 826525   (London)
                      James Dodwell      +44 (0) 20 8047 2406  (London)
                      Mick Readey        +44 (0) 7990 339653   (London)
                      Steph Mountifield  +44 (0) 7796 707505   (London)
                      Sam Piper          +44 (0) 7824 525779   (London)
                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco   +1 215 751 3126       (Philadelphia)

 

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 Q4 Results for 2025.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

79 New Oxford Street

London

WC1A 1DG

 

References

1.     Hirschfield GM, et al. J Hepatol. 2025; 82(S1); S4-5. doi:
10.1016/S0168-8278(25)00303-4 (https://doi.org/10.1016/S0168-8278(25)00303-4)

2.     Hirschfield GM, et al. Lancet Gastroenterol Hepatol. 2026; 11(1):
22-33. doi: 10.1016/S2468-1253(25)00192-X

3.     Mayo MJ, et al. Dig Dis Sci. 2023;68:995-1005. doi:
10.1007/s10620-022-07581-x

4.     Smith HT, et al. Hepatol Commun. 2025; 9(3):e0635. doi:
10.1097/HC9.0000000000000635

5.     Lindor KD, et al. Hepatol. 2019;69(1):394-419. doi:
10.1002/hep.30145

6.     Zeng N, et al. Hepatol Int. 2019;13(6):788-99. doi:
10.1007/s12072-019-09984-x

7.     Hegade VS, et al. Clin Gastroenterol Hepatol. 2019;17(7):1379-87.
doi: 10.1016/j.cgh.2018.12.00

8.     de Veer RC, et al. Hepatol Res. 2023;53:401-8. doi:
10.1111/hepr.13880

9.     Gungabissoon U, et al. BMJ Open Gastroenterol. 2024;11;e001287.
doi: 10.1136/bmjgast-2023-001287

10.    Kremer A, et al. Hepatol. 2025; 82(S1); S204. doi:
10.1097/HEP.0000000000001493

 

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCGGGDDGXDDGLL



            Copyright 2019 Regulatory News Service, all rights reserved