Zydus Therapeutics, the US-based specialty arm of Zydus Lifesciences, has announced positive results from its pivotal EPICS-III Phase 2b/3 trial evaluating Saroglitazar Magnesium in patients with Primary Biliary Cholangitis (PBC), a rare autoimmune liver disease.
The Ahmedabad-based drugmaker plans to file for USFDA approval in the first quarter of 2026, targetting a market projected to reach $10.8 billion by 2026, growing at a CAGR of 36.3%.
The trial met its primary endpoint, with 48.5% of patients on Saroglitazar 1mg achieving a meaningful biochemical response compared with the placebo. The drug also met other key results including complete normalization of alkaline phosphatase (ALP), a critical marker of disease progression.
The trial enrolled 149 patients across multiple centers and was designed as a seamless study. Full data will be presented at an upcoming scientific congress, the company said.
“Saroglitazar is the first PPAR alpha/gamma agonist to demonstrate positive Phase 3 data in PBC,” said Pankaj Patel, Chairman of Zydus Lifesciences. “It has the potential to bring real value to patients and providers who need more options.”
PBC affects thousands globally and is often resistant to first-line of therapy using ursodeoxycholic acid (UDCA). Saroglitazar, which targets both bile acid toxicity and liver inflammation, has received Orphan Drug and Fast Track designations from the USFDA.
“In clinical practice, we often see patients who continue to struggle despite being on standard therapy,” said Dr. Raj Vuppalanchi, Global Principal Investigator for the EPICS-III study. “Expanding our treatment options could significantly change how we personalize care for PBC.”
Zydus Therapeutics is focused on rare and serious liver conditions, including PBC and Non-Alcoholic Steatohepatitis (NASH). The company leverages a global R&D network of over 1,300 researchers and 30 manufacturing sites.
Shares of Zydus Lifesciences rose 0.88% and were trading at Rs.985.45 on BSE at 12.05 pm on Friday, the benchmark Sensex rose 0.13% to 80,182.51 points.
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