Skip to main content

Seladelpar FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 10, 2024.

FDA Approved: No
Generic name: seladelpar
Company: CymaBay Therapeutics, Inc.
Treatment for: Primary Biliary Cholangitis

Seladelpar is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist in development for the treatment of primary biliary cholangitis.

Development timeline for seladelpar

DateArticle
Jun  5, 2024Gilead’s Seladelpar Demonstrated a Sustained and Consistent Long-Term Efficacy and Safety Profile in Primary Biliary Cholangitis
May 18, 2024Investigational Seladelpar Demonstrates Significant Improvements in Liver Disease Progression and Reduced Itching in Primary Biliary Cholangitis
Jan  3, 2024New Published Data Demonstrates Correlation Between Itch Cytokine Interleukin-31 Reduction and Pruritis Improvement in Primary Biliary Cholangitis in Phase 3 Post-Hoc Analysis of CymaBay's Seladelpar
Feb 15, 2019CymaBay Therapeutics Announces Seladelpar Granted Breakthrough Therapy Designation by the FDA for the Treatment of Primary Biliary Cholangitis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.