Zydus Therapeutics Reports Positive Phase 3 Results for Saroglitazar in Rare Liver Disease; Eyes $10.8 Bn Market

Zydus Therapeutics, the US-based specialty arm of Zydus Lifesciences, announced encouraging results from its pivotal EPICS-III Phase 2b/3 trial of Saroglitazar Magnesium in patients with Primary Biliary Cholangitis (PBC), a rare autoimmune liver disorder. The drug met its primary endpoint, with 48.5% of patients on Saroglitazar 1mg achieving meaningful biochemical response vs placebo, along with key secondary outcomes such as normalization of alkaline phosphatase (ALP)—a critical marker of disease progression. The study enrolled 149 patients across multiple centers, with full data set to be presented at an upcoming medical congress. Pankaj Patel, Chairman of Zydus Lifesciences, said: “Saroglitazar is the first PPAR alpha/gamma agonist to show positive Phase 3 results in PBC. It holds the potential to deliver real value to patients and providers.” Zydus plans to file for USFDA approval in Q1 2026, aiming at a $10.8 billion market by 2026 (CAGR: 36.3%). The drug has already secured Orphan Drug and Fast Track designations from the USFDA. Global Principal Investigator Dr. Raj Vuppalanchi noted that many patients remain unresponsive to current standard therapy (ursodeoxycholic acid), stressing the need for new options like Saroglitazar. Zydus Therapeutics, focused on rare and serious liver diseases including PBC and NASH, operates through a global R&D network of over 1,300 researchers and 30 manufacturing sites. On Friday, shares of Zydus Lifesciences rose 0.88% to ₹985.45 on the BSE, even as the Sensex gained 0.13% to 80,182.51 points. #ZydusTherapeutics #Saroglitazar #ClinicalTrials #LiverDisease #PBC #USFDA #PharmaNews #BiotechInnovation