linerixibat: the GSK drug in development for cholestatic pruritus (relentless itch) in primary biliary cholangitis (PBC)

Linerixibat is an ileal bile acid transporter (IBAT) inhibitor, a targeted oral agent with potential to treat cholestatic pruritus (itch) associated with the rare autoimmune liver disease known as primary biliary cholangitis (PBC).

By inhibiting bile acid re-uptake, linerixibat aims to address a root cause of cholestatic pruritus.

The US Food and Drug Administration and the European Medicines Agency have granted orphan drug designation for linerixibat in the treatment of cholestatic pruritus associated with PBC.

• Earnings call materials reiterated that positive linerixibat results from the Ph3 GLISTEN trial (N=238; PCD: Oct 2024) were announced in H2 2024
• Earnings call materials reiterated anticipated global regulatory submission and approval timelines for linerixibat:
  • Regulatory submissions:
    • US and EU regulatory submissions in H1 2025 
    • JP regulatory submission H2 2025 
    • CN regulatory submission H2 2025 (prev. H1 2025)
  • Regulatory decision timeline:
    • US approval expected in H2 2025 
    • EU, CN, and JP approval expected in 2026 

Assessment:

• Data from the Ph3 GLISTEN trial will be presented during an oral presentation at EASL (May 7-10; Amsterdam, NL):
  • Oral presentation [GS-011]: Linerixibat significantly improves cholestatic pruritus in primary biliary cholangitis: results of the pivotal phase 3 GLISTEN trial
  • Data presented is expected to be in line with Phase 2b GLIMMER trial published in 2023
• Estimated linerixibat launch timelines continue to be aligned with company statements (i.e., US approval in late 2025 with other markets following in 2026), despite muted pre-launch activities

Sources: [Press Release, Presentation Deck, Pipeline, Webcast, Pre-Announcement Aide, Infographic, US dollar translation]