GSK announces results from trial of IBAT inhibitor for itch in PBC patients

GSK has reported positive results from the Phase III GLISTEN trial of linerixibat, a targeted inhibitor of the ileal bile acid transporter (IBAT), in treating cholestatic pruritus in adults with primary biliary cholangitis (PBC). The trial, which involved 238 subjects, met its primary endpoint by significantly reducing monthly itch scores compared to a placebo over 24 weeks. Key secondary endpoints were also achieved, including rapid improvement in itch by week two and reductions in itch-related sleep interference.

At week 24, 56% of subjects treated with linerixibat showed a meaningful improvement in itch, compared to 43% in the placebo group. The safety profile aligned with previous studies. Linerixibat has not yet been approved for use, though it has received orphan drug designation for treating cholestatic pruritus in PBC patients from both the FDA and EMA. The global trial included participants from 19 countries, including Japan, Europe, China, and the Americas.

12-05-2025