Zydus Therapeutics, a US-based subsidiary of India-based global healthcare company Zydus Lifesciences Ltd, on Friday reported 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.

The company says that the 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.

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

Zydus Therapeutics intends to submit a US regulatory application for Saroglitazar in the first quarter of 2026.

Full data from the EPICS-III trial will be presented at a future scientific congress.