Zydus Therapeutics announces positive phase 2b/3 results for Saroglitazar in primary biliary cholangitis

New Delhi: Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd., has announced encouraging topline results from its pivotal EPICS-III Phase 2b/3 clinical trial of Saroglitazar Magnesium in adult patients with Primary Biliary Cholangitis (PBC) who had an inadequate response or intolerance to ursodeoxycholic acid (UDCA), the current standard-of-care.

The trial achieved its primary endpoint, demonstrating a statistically significant treatment difference in the percentage of patients achieving a meaningful biochemical response with Saroglitazar compared to placebo. The therapy was generally well tolerated, with adverse events balanced across both Saroglitazar- and placebo-treated groups. Based on these results, Zydus Therapeutics plans to submit a U.S. regulatory application for Saroglitazar in the first quarter of 2026.

In the study, Saroglitazar 1mg showed a 48.5% treatment difference in biochemical response over placebo (p<0.001) at 52 weeks. Biochemical response was defined as alkaline phosphatase (ALP) <1.67x ULN, a ≥15% ALP reduction from baseline, and normal bilirubin levels. The trial also met a key secondary endpoint with a significant proportion of patients achieving complete ALP normalization.

Commenting on the results, Pankaj Patel, Chairman of Zydus Lifesciences, said, “The EPICS-III findings highlight our commitment to developing innovative treatments for chronic liver diseases. Saroglitazar is the first PPAR alpha/gamma agonist to demonstrate positive Phase 3 data in PBC, offering potential new hope for patients and their physicians. We are eager to advance regulatory discussions and bring this therapy closer to patients in need.”

Raj Vuppalanchi, MD, Professor of Medicine at Indiana University School of Medicine and Global Principal Investigator for EPICS-III, added, “Many patients with PBC continue to struggle despite standard therapy. Expanding treatment options with new therapies like Saroglitazar could meaningfully improve patient care. We are deeply grateful to the patients, their families, and investigators who made this trial possible.”

Full data from EPICS-III will be presented at an upcoming scientific congress.