Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd., today announced encouraging topline results from its pivotal EPICS-III Phase 2(b)/3 clinical trial of Saroglitazar, a novel dual PPAR alpha/gamma agonist, for 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 met its primary and key secondary endpoints, with a statistically significant improvement in clinically meaningful biochemical markers of liver function. Notably, 48.5% of patients treated with Saroglitazar 1 mg achieved a composite biochemical response, favoring Saroglitazar over placebo (P<0.001). The biochemical response was defined as alkaline phosphatase (ALP) less than 1.67 times the upper limit of normal (ULN), at least a 15% decrease from baseline, and total bilirubin within normal limits at 52 weeks.

Saroglitazar was generally well tolerated, with the incidence of adverse events balanced between treatment and placebo groups. The results reinforce Zydus’ commitment to advancing novel therapies to address high unmet needs in chronic liver diseases.

“The EPICS-III results reinforce our commitment to advancing novel treatments for chronic liver disease — an area of growing global impact,” said Pankaj Patel, Chairman of Zydus Lifesciences Ltd. “Saroglitazar is the first PPAR alpha/gamma agonist to demonstrate positive Phase 3 data in patients with PBC and has the potential to bring real value both to patients and healthcare providers who need more options.”

Full clinical trial data will be presented at an upcoming scientific congress. Zydus Therapeutics intends to submit a New Drug Application to the U.S. Food and Drug Administration in the first quarter of 2026.