Linerixibat accepted for review by the EMA for cholestatic pruritus in patients with primary biliary cholangitis

GSK

23 June 2025 - Submission based on data from positive GLISTEN Phase 3 trial

GSK today announced that the EMA has accepted for review the marketing authorisation application for the use of linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter, for the treatment of cholestatic pruritus in patients with primary biliary cholangitis, a rare auto-immune liver disease.

Read GSK press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier