Zydus Therapeutics reports positive saroglitazar trial results for PBC

Zydus Therapeutics achieved its primary composite endpoint in the EPICS-III Phase 2(b)/3 clinical trial, with Saroglitazar 1mg demonstrating a statistically significant treatment difference in biochemical response compared to placebo (P<0.001). The trial, which evaluated Saroglitazar in adult patients with PBC, showed a 48.5% biochemical response favoring Saroglitazar 1mg. Biochemical response was defined by specific improvements in alkaline phosphatase (ALP) and total bilirubin at 52 weeks.

Saroglitazar, an investigational alpha/gamma Peroxisome Proliferator-Activated Receptor (PPAR) agonist, was generally well tolerated, with adverse events balanced between treated and placebo groups. The trial also met its key secondary endpoint, with a proportion of subjects achieving complete normalization of ALP at 52 weeks.

Zydus Therapeutics, the US-based innovation arm of Zydus Lifesciences, intends to submit a U.S. regulatory application for Saroglitazar in the first quarter of 2026. Saroglitazar has previously received Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration for PBC treatment.