Zydus Therapeutics' Saroglitazar Achieves Breakthrough in PBC Treatment

Zydus Therapeutics announced positive results from the EPICS-III Phase 2/3 trial for Saroglitazar, an investigational treatment for Primary Biliary Cholangitis (PBC). The trial met its primary endpoint, showing a significant improvement in biochemical response. Zydus plans to submit a regulatory application in 2026.

Zydus Therapeutics, a division of Zydus Lifesciences, has reported groundbreaking results from its EPICS-III clinical trial evaluating Saroglitazar, a PPAR agonist, for Primary Biliary Cholangitis (PBC).

The trial met its primary endpoint with significant statistical outcomes, favoring Saroglitazar over placebo. The investigational drug was well-tolerated, balancing adverse effects between study groups.

Zydus plans to submit a regulatory application for Saroglitazar to U.S. authorities by 2026, aiming to expand treatment options for patients with chronic liver disease.