Zydus Therapeutics Reports Positive Phase 3 Data for Saroglitazar in Rare Liver Disease; Eyes USFDA Nod by 2026

Zydus Therapeutics, the US-based specialty arm of Zydus Lifesciences, announced encouraging 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-headquartered drugmaker said the trial achieved its primary endpoint, with 48.5% of patients on Saroglitazar 1mg showing significant biochemical improvement compared with placebo. Key secondary outcomes, including complete normalization of alkaline phosphatase (ALP), were also met. Enrolling 149 patients across multiple global centers, the trial was designed as a seamless study. Zydus plans to file for USFDA approval in the first quarter of 2026, targeting the PBC therapy market projected to reach $10.8 billion by 2026, growing at a CAGR of 36.3%. Pankaj Patel, Chairman of Zydus Lifesciences, said: “Saroglitazar is the first PPAR alpha/gamma agonist to demonstrate positive Phase 3 data in PBC. It has the potential to bring real value to patients and providers who need more options.” Saroglitazar has received Orphan Drug and Fast Track designations from the USFDA. Experts note that the drug could address an unmet need, as many PBC patients remain resistant to first-line therapy with ursodeoxycholic acid (UDCA). At 12:05 pm Friday, shares of Zydus Lifesciences were trading 0.88% higher at ₹985.45 on the BSE, while the benchmark Sensex was up 0.13% at 80,182.51. Hashtags: #Zydus #Biotech #PharmaNews #LiverDisease #USFDA #ClinicalTrials #Healthcare #Investing