Skip to main content

Seladelpar Beneficial for Patients With Primary Biliary Cholangitis

Medically reviewed by Carmen Pope, BPharm. Last updated on Feb 26, 2024.

By Elana Gotkine HealthDay Reporter

MONDAY, Feb. 26, 2024 -- For patients with primary biliary cholangitis, more receiving the peroxisome proliferator-activated receptor delta (PPARδ) agonist seladelpar have a biochemical response and alkaline phosphatase normalization, according to a study published online Feb. 21 in the New England Journal of Medicine.

Gideon M. Hirschfield, Ph.D., from the University Health Network in Toronto, and colleagues conducted a phase 3, 12-month, double-blind placebo-controlled trial involving patients with primary biliary cholangitis with inadequate response to or who had a history of unacceptable side effects with ursodeoxycholic acid. One hundred ninety-three patients were randomly assigned to receive oral seladelpar at a dose of 10 mg daily or placebo in a 2:1 ratio. The primary end point was a biochemical response.

The researchers found that the percentage of patients with a biochemical response was higher in the seladelpar group versus the placebo group (61.7 versus 20.0 percent). In addition, significantly more patients who received seladelpar had normalization of the alkaline phosphatase level (25.0 versus 0 percent). Compared with placebo, seladelpar resulted in a greater reduction in the score on the pruritus numerical rating scale (least-squares mean change from baseline, −3.2 versus −1.7). Overall, 86.7 and 84.6 percent of patients in the seladelpar and placebo groups, respectively, had adverse events; for serious adverse events, the corresponding values were 7.0 and 6.2 percent.

"The selective PPARδ agonist seladelpar elicited biochemical responses while also reducing pruritus in patients with primary biliary cholangitis who had had an inadequate response to or who had a history of unacceptable side effects with ursodeoxycholic acid," the authors write.

The study was funded by CymaBay Therapeutics, which manufactures seladelpar.

Abstract/Full Text (subscription or payment may be required)

Editorial 1 (subscription or payment may be required)

Editorial 2 (subscription or payment may be required)

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2024 HealthDay. All rights reserved.

Posted February 2024

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.