Prodotti competitors / Area Liver
The US FDA has accepted for review the NDA application of linerixibat for cholestatic pruritus in PBC patients

On June 2nd, 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 24th, 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
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.)
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