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# CymaBay Therapeutics Plans NDA for Seladelpar
- URL: https://www.fdaweb.com/cymabay-therapeutics-plans-nda-for-seladelpar/
- Published: 2023-09-07T12:00:00.000Z
- Updated: 2026-09-14T18:54:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155271

CymaBay Therapeutics says it will seek FDA approval for seladelpar after reporting positive data from its pivotal Phase 3 RESPONSE study that evaluated the drug for treating adult patients with primary biliary cholangitis (PBC). In the study, 61.7% of patients on seladelpar 10 mg (n=128) met the primary composite endpoint related to serum alkaline phosphatase and bilirubin at 12 months versus 20.0% on placebo (n=65; p<0.0001),” the company says. “The anti-cholestatic effect of seladelpar was supported by the normalization of alkaline phosphatase at 12 months (key secondary endpoint) in 25.0% of patients on seladelpar vs. zero on placebo (p<0.0001),” it adds.

The company also says that safety was comparable between placebo and seladelpar groups and was consistent with previous studies. “Treatment-emergent adverse events, serious adverse events, and patient discontinuations were generally balanced across the treatment and placebo arms,” it says, adding that no treatment-related serious adverse events in the study were reported.