Zydus Therapeutics Reports Positive Topline Results from EPICS-III Phase 2(b)/3 Trial of Saroglitazar Magnesium in Patients with Primary Biliary Cholangitis

Ahmedabad, Gujarat, India & Pennington, N.J., United States – Business Wire India Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd., a global innovation led healthcare company, today announced positive topline results from the pivotal EPICS-III Phase 2(b)/3 clinical trial. In this trial, the safety and efficacy of Saroglitazar, an investigational alpha/gamma Peroxisome Proliferator-Activated Receptor (PPAR) agonist, was evaluated for the treatment of adult patients with Primary Biliary Cholangitis (PBC) who had an inadequate response or intolerance to ursodeoxycholic acid (UDCA), the current standard-of-care.

• Trial met the primary endpoint, with a statistically significant treatment difference in the percentage of patients achieving a clinically meaningful biochemical response with Saroglitazar compared to placebo.

• Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients.

• Zydus Therapeutics, the US-based innovation-focused specialty arm of Zydus Lifesciences Ltd, intends to submit a U.S. regulatory application for Saroglitazar in the first quarter of 2026.

The trial met its primary composite endpoint, with a treatment difference in achieving a biochemical response of 48.5%, favoring Saroglitazar 1mg compared to those treated with placebo (P