Zydus Therapeutics Announces Positive Results from Saroglitazar Trial for Liver Disease

What's Happening?

Zydus Therapeutics has reported positive topline results from the EPICS-III Phase 2(b)/3 trial of Saroglitazar Magnesium in patients with Primary Biliary Cholangitis (PBC). The trial demonstrated a statistically significant treatment difference in achieving a biochemical response with Saroglitazar compared to placebo. Saroglitazar, an investigational PPAR alpha/gamma agonist, was well tolerated, with adverse events balanced between treatment and placebo groups. Zydus Therapeutics plans to submit a regulatory application to the U.S. FDA in early 2026. The trial's success highlights Saroglitazar's potential as a novel treatment option for PBC, a rare autoimmune liver disease.

Why It's Important?

The positive results from the EPICS-III trial are a significant development in the treatment of Primary Biliary Cholangitis, a disease with limited therapeutic options. Saroglitazar's success in achieving a biochemical response offers hope for patients who do not respond to current standard treatments. The trial's outcomes could lead to the introduction of a new class of drugs for PBC, potentially improving patient outcomes and quality of life. The planned regulatory submission to the FDA marks a critical step towards making Saroglitazar available to patients, underscoring Zydus Therapeutics' commitment to addressing unmet medical needs in liver diseases.

What's Next?

Zydus Therapeutics intends to discuss the trial results with regulatory agencies and proceed with a submission to the U.S. FDA in the first quarter of 2026. If approved, Saroglitazar could become a new treatment option for PBC, offering an alternative for patients who are resistant or intolerant to existing therapies. The company may also explore further clinical trials to expand the use of Saroglitazar in other liver diseases. The full data from the EPICS-III trial will be presented at an upcoming scientific congress, providing more detailed insights into the drug's efficacy and safety profile.