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Linerixibat - GSK

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Drug Profile

Linerixibat - GSK

Alternative Names: GSK 2330672; GSK 672

Latest Information Update: 01 Sep 2025

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At a glance

  • Originator GlaxoSmithKline
  • Developer GSK
  • Class Antihyperglycaemics; Antipruritics; Benzene derivatives; Carboxylic acids; Ethers; Small molecules; Thiazepines
  • Mechanism of Action Sodium-bile acid cotransporter inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Primary biliary cirrhosis
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Pruritus
  • Phase II Primary biliary cirrhosis; Type 2 diabetes mellitus
  • No development reported Cholestasis

Most Recent Events

  • 02 Jun 2025 FDA assigns PDUFA action date of 24/03/2026 for Linerixibat for Pruritus
  • 02 Jun 2025 Preregistration for Pruritus (In the elderly, In adults) in USA (PO)
  • 02 Jun 2025 The US FDA accepts NDA for Linerixibat for Pruritus for review

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