Saroglitazar Mg just delivered a defining moment for Zydus Lifesciences' liver disease ambitions.
The company's EVIDENCES-X Phase II(b) trial met its primary endpoint, and the numbers tell a compelling story, patients receiving Saroglitazar achieved a 26.5 per cent treatment difference over placebo in resolving steatohepatitis without worsening fibrosis.
Zydus enrolled 189 subjects across three treatment arms, tracked them for 52 weeks, and confirmed results through liver biopsies rather than surrogate markers.
Two respected US hepatologists co-led the study, and Zydus now positions itself to challenge established players in the global MASH treatment race. This single trial reshapes the entire MASH conversation worldwide.
Zydus Lifesciences Limited built EVIDENCES-X on biopsy-confirmed evidence, not estimates. Researchers randomized 189 subjects in a 1:1:1 split into Saroglitazar 2 mg, Saroglitazar 4 mg, and placebo groups, then followed each patient for 52 weeks.
Prof. Naga Chalasani of Indiana University School of Medicine and Prof. Arun J. Sanyal of Virginia Commonwealth University co-led the trial, lending it strong academic credibility. This design choice matters because liver biopsies remain the gold standard for confirming steatohepatitis resolution, and Zydus leaned on that rigor to validate its Saroglitazar Mg results.
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Beyond the headline number, Zydus reported encouraging secondary and exploratory findings across liver histology parameters. Patients showed measurable improvements in steatosis, inflammation, and ballooning, the three components clinicians use to diagnose and grade steatohepatitis severity. These supporting results reinforce the primary endpoint and suggest Saroglitazar works across multiple disease markers, not just one isolated metric.
India's drug regulator, the DCGI, approved Saroglitazar Mg for MASH and MASLD treatment back in 2020, giving Zydus a five-year commercial head start at home. The USFDA and the European EMA, however, still classify the drug as investigational for these indications. This latest Phase II(b) data now builds the case Zydus needs to advance toward Phase III trials and pursue approval in these larger, more lucrative markets.
Zydus plans to present full trial data at the upcoming Liver Congress and submit findings to a peer-reviewed medical journal. Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, called the trial completion a critical milestone and reaffirmed the company's commitment to chronic liver disease treatment. With MASH still lacking sufficient approved therapies worldwide, Zydus now carries real momentum into its next development phase.
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