The US FDA has accepted for review the NDA application of linerixibat for cholestatic pruritus in PBC patients

On June 2^nd, 2025, GSK announced that the FDA accepted its NDA for linerixibat for the treatment of cholestatic pruritus in patients with PBC and assigned a PDUFA date of March 24, 2026

Key Takeaways:

• The NDA for linerixibat for the treatment of cholestatic pruritus in patients with PBC is now under FDA review with a PDUFA date set for March 24^th, 2026
• GSK’s application was based on data from the Phase 3 GLISTEN trial (N=238; PCD: Oct 2024), which was read out at EASL 2025
• Recall, at EASL 2025, GSK presented topline Phase 3 GLISTEN trial data in an oral session, reporting that linerixibat significantly improved pruritus and pruritus-related sleep interference versus placebo, with no new safety signals observed

Additional Insights:

• Linerixibat’s March 24, 2026 PDUFA date is slightly delayed from GSK’s most recent guidance from its Q1 2025 earnings call, which claimed a regulatory decision would occur in Q4 2025
• Linerixibat is not expected to compete directly with Livdelzi, given linerixiabat's non-significant impact on markers of PBC disease progression (i.e., ALP, TB, etc.)