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A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)

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Trial Profile

A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Apr 2026

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At a glance

  • Drugs Linerixibat (Primary)
  • Indications Primary biliary cirrhosis; Pruritus
  • Focus Registrational; Therapeutic Use
  • Acronyms GLISTEN
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK

Most Recent Events

  • 19 Mar 2026 According to the GSK media release, regulatory reviews for this trial are underway in the EU, UK, Canada and China.
  • 19 Mar 2026 According to a GSK media release, based on positive results of this trial, the USFDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC.
  • 26 Feb 2026 According to a GlaxoSmithKline media release, the company announced that based on positive data from the GLISTEN phase III trial 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 Chinas National Medical Products Administration.

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