Innovative Anti-Itch Treatment Approved by FDA

The U.S. FDA has approved a new drug called linerixibat to treat itching in adults with signs of primary biliary cholangitis which is marketed as Lynavoy. Lineixibat is an ileal bile acid transporter inhibitor which is largely used for chronic itching in PBC patients. It is one of the kind of drugs approved by the U.S. FDA to manage the symptoms of cholestatic pruritus, which profoundly showed results in 89% of patients suffering from PBC disease.

On account of this unmatched outcome, the chief of gastroenterology and hepatology at the University of California, Dr. Christopher Bowlus stated that, “The approval of linerixibat represents an important opportunity to improve the lives of people with PBC and who struggle with uncontrolled and often debilitating pruritus. The impact of itching on people living with PBC can be profound, and treatment options have until now been limited.”

According to Precedence Research, the cholestatic pruritus market size accounted for USD 1.40 billion in 2025 and is predicted to increase from USD 1.49 billion in 2026 to approximately USD 2.55 billion by 2035 expanding at a CAR of 6.20% from 2026 to 2035 due to the increasing prevalence of liver disease, advanced diagnostic capabilities and increasing demand for novel, targeted therapies.

The approval is based on results from a phase 3 clinical trial named GLISTEN, which tested the safety, efficacy and impact based on quality health offered by linerixibit as compared to placebo. The trail adds 238 patients with PBC and with an age group of 18-80 years having moderate to severe itching. The primary result of this study was the mean change in weekly itch score at week 2 from starting. It has a key endpoint which includes the mean change in monthly sleep score over 24 weeks from baseline. This trial showed that patients that had been treated with linerixibat had significant and sustained improvements in cholestatic pruritus and sleep interference.

A recent report by Precedence Research highlights that the cholestatic pruritus market is benefiting from the introduction of innovative and targeted therapies to treat cholestatic pruritus and enhanced diagnostic capabilities.