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Home > News & Media > Linerixibat recommended for EU approval by the CHMP for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC).

Linerixibat recommended for EU approval by the CHMP for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC).

The information contained within this press release is for the purpose of scientific exchange.   

It is intended for scientific and investor media only.  

  • If approved, it will be the first IBAT inhibitor for cholestatic pruritus in adult patients with PBC. Recommendation is based on positive data from the GLISTEN phase III study. 

Bologna/Milan. 24 July 2026. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of linerixibat in the EU for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC). The European Commission (EC) is expected to make a final decision on the Marketing Authorisation Application (MAA) in the coming months. 

Cholestatic pruritus is a common and burdensome symptom experienced by up to 89% of people living with PBC, a rare autoimmune liver disease that can progress to cirrhosis, liver failure and the need for liver transplantation. 1-6  It significantly impacts patient sleep disturbance, fatigue, and impaired quality of life. 4,6  

The positive CHMP opinion is based on positive data from the GLISTEN phase III study. 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 inhibition1 .

Francesco Balestrieri, CEO of Alfasigma, commented: “The CHMP’s positive opinion for linerixibat is an important milestone for people living with primary biliary cholangitis who experience cholestatic pruritus, a debilitating symptom that can significantly impact quality of life. This recommendation brings us one step closer to making a new treatment option available to appropriate patients, subject to regulatory approval and local access pathways, while supporting Alfasigma’s strategy to grow its rare and specialty care business focused on complex healthcare challenges in gastroenterology and immunology.” 

 

About Alfasigma 

Alfasigma is a privately owned, medium-sized, global pharmaceutical company, headquartered in Italy with offices in Bologna and Milan. Its products are distributed in more than 100 markets worldwide. The company employs approximately 4,000 people. Alfasigma continues to expand its international presence and portfolio through acquisitions, partnerships, and licensing agreements. Its portfolio ranges from consumer healthcare products and primary care treatments to specialty and rare disease medications, with key therapeutic focus on gastroenterology, immunology and vascular health. Visit www.alfasigma.com. Visit www.alfasigma.com. 

Forward-Looking Statements 
This press release contains forward‑looking statements, including statements regarding the development, regulatory approval, and commercial potential of linerixibat. Actual results may differ materially due to various risks and uncertainties, including regulatory outcomes and market conditions. 

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 Clin Liver Dis. 2022; 26(4):727-45. doi: 10.1016/j.cld.2022.06.009
  3. Smith H, et Hepatol Commun. 2025; 9(3):e0635. doi: 10.1097/HC9.0000000000000635
  4. Mayo MJ, et Dig Dis Sci. 2023;68(3):995-1005. doi: 10.1007/s10620-022-07581-x
  5. Invernizzi P. et al, Expert review of gastroeneterology & hepatology 2026, VOL. 20, NO. 1, 17–28
  6. Gungabissoon U, et al. BMJ Open Gastroenterol 2024;11:e001287. doi:10.1136/bmjgast-2023-001287