GSK's Linerixibat Shows Promise in Phase 3 Liver Disease Trial

GSK has unveiled promising phase 3 data for its investigational drug linerixibat, demonstrating significant improvements in managing cholestatic pruritus associated with primary biliary cholangitis (PBC). The results, presented at the European Association for the Study of the Liver Congress 2025, highlight the potential of this IBAT inhibitor to address an unmet need in liver disease treatment.

Significant Itch Reduction Observed

In a 238-patient trial, linerixibat demonstrated statistically significant reductions in itching compared to placebo. After 24 weeks of oral dosing, patients receiving linerixibat reported a 2.86-point decrease on a 10-point itch scale, compared to a 2.15-point reduction in the placebo group. Notably, the onset of relief was rapid, with a statistically significant difference observed as early as two weeks into treatment.

The efficacy of linerixibat was further underscored by secondary endpoint data. More patients in the linerixibat group (56%) achieved a clinically meaningful three-point or greater improvement in itch compared to the placebo group (43%). Additionally, 41% of linerixibat-treated patients experienced a four-point or greater improvement, versus 29% in the placebo cohort.

Safety Profile and Side Effects

While linerixibat showed promising efficacy, the trial also revealed some adverse effects. Diarrhea was significantly more common in the treatment group, affecting 61% of patients compared to 18% in the placebo group. This led to a 4% discontinuation rate due to gastrointestinal side effects. Abdominal pain was also reported more frequently among linerixibat recipients.

Competitive Landscape and Regulatory Outlook

GSK's positive results set a benchmark for competitors in the field. Mirum Pharmaceuticals, developing its own IBAT inhibitor called volixibat, reported placebo-adjusted changes of around 2.3 points on the same 10-point ItchRO scale in an interim analysis of its phase 2b trial.

With these encouraging results, GSK is positioning itself for regulatory submissions. The company aims to secure FDA approval for linerixibat in the United States in the second half of 2025, with plans to pursue approvals in China, the European Union, and Japan in 2026.