linerixibat (IBAT inhibitor) for cholestatic pruritus in PBC updates

GSK’s earnings call presentation provided global regulatory submission and approval timelines for linerixibat:

• • Regulatory submissions:
    • US and EU regulatory submissions were accepted in Q2 2025
    • CN regulatory submission acceptance continues to be expected in H2 2025
    • JP regulatory submission acceptance is now expected in H1 2026 (previously, H2 2025)
  • Regulatory decision timeline:
    • US approval remains expected in H1 2026 (Mar 24^th, 2026 PDUFA) 
    • EU approval remains expected in H2 2026
    • JP and CN approval estimations have been removed (previously, guided for H2 2026)

CI Assessment:

• With US approval expected in March 2026, linerixibat is poised to become the first IBAT inhibitor for cholestatic pruritus in PBC
  • regulatory review and potential approvals for linerixibat in PBC are supported by data from the Phase 3 GLISTEN trial (N=238; PCD: Oct 2024), presented at EASL 2025
    • Data demonstrated a statistically significant reduction in pruritus severity vs placebo over 24 weeks, despite a large placebo effect
    • Follow-up data from GLISTEN will be presented at AASLD 2025 (Nov 7^th-11^th, Washington DC), including biomarker analyses (Abs# 4393, 214) and pooled safety results (Abs# 4402); see abstract book, here

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