Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences, has announced positive topline results from its pivotal EPICS-III Phase 2(b)/3 trial evaluating Saroglitazar, an investigational PPAR alpha/gamma agonist, in adults with Primary Biliary Cholangitis (PBC) who had an inadequate response or intolerance to ursodeoxycholic acid (UDCA), the current standard therapy.

The study met its primary endpoint, showing a 48.5% treatment difference in biochemical response with Saroglitazar 1 mg compared to placebo (P<0.001). Biochemical response was defined by improvement in alkaline phosphatase (ALP) and bilirubin, key markers of PBC progression. The trial also achieved its secondary endpoint, with more patients achieving complete ALP normalisation at 52 weeks.

Safety outcomes were favourable, with adverse events balanced between treatment and placebo groups.

Zydus plans to submit a U.S. regulatory application in Q1 2026.

Pankaj Patel, Chairman of Zydus Lifesciences, said Saroglitazar is the first PPAR alpha/gamma agonist to demonstrate positive Phase 3 data in PBC, highlighting its potential as a new treatment option. Raj Vuppalanchi, MD, Global Principal Investigator, noted that the results could significantly improve care for patients unresponsive to first-line therapy.

Full trial data will be presented at an upcoming scientific congress.