FDA Approves First Therapy for Cholestatic Pruritus in Primary Biliary Cholangitis
March 19, 2026 – The Food and Drug Administration (FDA) has approved linerixibat (Lynavoy, GSK), marking the first medication specifically for cholestatic pruritus in adult patients with primary biliary cholangitis (PBC).
Linerixibat is an ileal bile acid transporter inhibitor designed to reduce several mediators of pruritus. The approval is based on data from the phase 3 GLISTEN trial, which demonstrated significant improvement in cholestatic pruritus at week 2 and up to 24 weeks, as well as improvement in itch-related sleep interference, compared with placebo.
Researchers in the GLISTEN trial randomly assigned 238 patients with PBC and moderate to severe pruritus to receive 40 mg of oral linerixibat (n = 119) or placebo (n = 119) twice daily. The primary endpoint was change in pruritus over 24 weeks, measured on a 0-10 numerical itching scale. Results showed patients receiving linerixibat experienced significant improvement in pruritus compared with placebo (least-squares mean difference = –0.72. 95% CI, –1.15 to –0.28).
“The approval of linerixibat represents an important opportunity to improve the lives of people with [primary biliary cholangitis (PBC)] and who struggle with uncontrolled and often debilitating pruritus,” Christopher Bowlus, MD, Lena Valente Professor and Chief of Gastroenterology and Hepatology at University of California Davis, said in a press release. “The impact of itch on people living with PBC can be profound and treatment options have until now been limited. The FDA’s decision marks a major milestone in PBC pruritus care that addresses a critical area of unmet need.”
The most common adverse events reported in the linerixibat arm were diarrhea (61%) and abdominal pain (18%), both generally mild to moderate in severity. Treatment discontinuation due to diarrhea occurred in 4% of patients receiving linerixibat.
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