Zydus Lifesciences Share Price in Focus; Reports Positive Phase II(b) Trial Results for Saroglitazar Mg in MASH

Zydus Lifesciences has announced positive topline results from its completed EVIDENCES-X Phase II(b) trial of Saroglitazar Magnesium in patients with MASH and fibrosis, as per an exchange filing dated August 31, 2026.  

The study met its primary endpoint after 52 weeks of treatment, showing resolution of steatohepatitis without worsening of fibrosis. The reported treatment difference was 26.5%.  

Trial Covered Three Countries 

The trial enrolled 189 patients from the US, Turkey and Argentina. They were divided equally into three groups and received either Saroglitazar 2 mg, Saroglitazar 4 mg or a placebo. The primary endpoint was assessed through liver biopsy at the end of the treatment period.  

The EVIDENCES-X study was a global, multicentre, randomised, double-blind and placebo-controlled Phase II(b) trial. It examined both the efficacy and safety of Saroglitazar Magnesium in patients with MASH and fibrosis. 

Other Findings from the Study 

The study also recorded results across secondary and exploratory endpoints. These included changes in liver histology, steatosis, inflammation and ballooning assessments. Zydus said more details from the trial would be presented at the upcoming Liver Congress.  

The trial was led by Professor Naga Chalasani of Indiana University School of Medicine and Professor Arun J. Sanyal of Virginia Commonwealth University as co-principal investigators.  

MASH and Its Disease Burden 

MASH is a progressive form of Metabolic dysfunction Associated Steatotic Liver Disease, or MASLD. It is associated with fat accumulation, inflammation and liver cell injury, and may progress to fibrosis, cirrhosis, liver failure and liver cancer.  

Zydus cited estimates showing that around 25% of adults worldwide are affected by MASLD, while MASH affects an estimated 5% to 20% of the adult population. 

Data to Be Presented 

The company said data from EVIDENCES-X will be presented at upcoming scientific meetings and submitted to a peer-reviewed medical journal. The results follow earlier Phase II studies of Saroglitazar in MASH and MASLD patients.  

Saroglitazar Mg has been approved in India for MASH and MASLD since 2020. In the US, it remains an investigational compound and has not been approved by the FDA or EMA for these conditions. 

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Zydus Lifesciences Share Price Performance  

As of August 31, 2026, 2:50 pm, Zydus Lifesciences Ltd share price was trading at ₹1,163.70, a 2.29% decrease from the previous closing price. 

Conclusion 

Zydus will present detailed EVIDENCES-X trial data at scientific meetings and submit the findings for publication in a peer-reviewed medical journal. 

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