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Informist, Monday, Aug. 31, 2026

--Zydus Life completes phase-II(b) trial of saroglitazar mg successfully 

NEW DELHI – Zydus Lifesciences Ltd. Monday said its global Phase II(b) EVIDENCES-X clinical trial of Saroglitazar Mg in patients with metabolic dysfunction-associated steatohepatitis and fibrosis has been successfully completed. The trial achieved resolution of steatohepatitis with no worsening of fibrosis at week 52, with a treatment difference of 26.5%, the company said in the exchange filing. The liver biopsy-driven trial enrolled 189 patients, who were randomised in a 1:1:1 ratio to receive Saroglitazar 2 mg, Saroglitazar 4 mg, or placebo for 52 weeks.
 

The study also showed encouraging findings across key secondary and exploratory endpoints, including improvements in liver histology parameters, steatosis, inflammation, and ballooning assessments, Zydus said. Further details will be presented at an upcoming Liver Congress. 
 

"Saroglitazar Mg was approved by the Drug Controller General of India, for the treatment of MASH and MASLD in India in 2020. Saroglitazar Mg is an investigational compound in the United States and has not yet been approved by the U.S. Food & Drug Administration (FDA) or the European Medicines Agency (EMA) for the treatment of MASH (Metabolic dysfunction-associated steatohepatitis) and MASLD (Metabolic dysfunction-associated steatotic liver disease)," the company said in the exchange filing. The EVIDENCES-X trial was conducted across the US, Turkey, and Argentina. 

For the June quarter, Zydus Lifesciences reported a consolidated net profit of INR 9.40 billion on revenues of INR 80.17 billion. At 1112 IST, shares of the company traded down 2.6% at INR 1,160.50 on the National Stock Exchange.  End

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

Reported by Gunjan Rajput 

Edited by Deepshikha Bhardwaj 

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