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# FDA Lifts 3 Seladelpar Clinical Holds
- URL: https://www.fdaweb.com/fda-lifts-3-seladelpar-clinical-holds/
- Published: 2020-07-23T12:00:00.000Z
- Updated: 2026-09-14T16:22:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147265

FDA has lifted its clinical holds on CymaBay Therapeutics’ seladelpar for its three IND applications for nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and primary sclerosing cholangitis. The company [says](https://www.globenewswire.com/news-release/2020/07/23/2066548/0/en/FDA-Lifts-All-Clinical-Holds-on-Seladelpar.html?ref=fdaweb.com) it stopped all seladelpar clinical trials 11/25/19 after atypical histologic findings with no clinical or laboratory correlates were identified at the planned end of treatment biopsy review of a 52-week Phase 2 NASH study.

An expert panel found no clinical, biochemical, or histological evidence of seladelpar-related liver injury in the NASH study and unanimously supported reinitiating clinical development of the drug pending FDA approval, the company says.

CymaBay says it will first reinitiate clinical development in a Phase 3 PBC trial.