Zydus Therapeutics, the U.S.-based innovation arm of Zydus Lifesciences Ltd., has achieved a significant milestone in its drug development pipeline with the announcement of positive topline results from the pivotal EPICS-III Phase 2(b)/3 trial of Saroglitazar Magnesium. The company disclosed the results on August 29, 2025, highlighting the potential of this investigational therapy to address a major unmet need in patients suffering from Primary Biliary Cholangitis (PBC).

The Trial Overview

The EPICS-III trial was designed as a multicenter, randomized, double-blind, placebo-controlled Phase 2b/3 study. It evaluated the safety and efficacy of Saroglitazar Magnesium, a novel Peroxisome Proliferator-Activated Receptor (PPAR) alpha/gamma agonist, in adult patients with PBC who showed inadequate response or intolerance to the current standard therapy, ursodeoxycholic acid (UDCA).

The trial included 149 patients randomized in a 2:1 ratio to receive either Saroglitazar 1mg or placebo. The study focused on biochemical markers such as alkaline phosphatase (ALP) and bilirubin, which are key predictors of PBC progression.

Positive Topline Results

The primary composite endpoint of the trial was successfully met. Results showed a treatment difference of 48.5% favoring Saroglitazar 1mg compared to placebo (P<0.001) in achieving a clinically meaningful biochemical response at 52 weeks.

The definition of biochemical response included:

• ALP less than 1.67 times the upper limit of normal (ULN)

• At least 15% reduction in ALP from baseline

• Total bilirubin or direct bilirubin within normal limits

In addition, the trial also met its key secondary endpoint, which measured the proportion of patients achieving complete normalization of ALP (≤ ULN) at 52 weeks.

Safety Profile

The trial data indicated that Saroglitazar was generally well tolerated. The incidence of adverse events was comparable between the Saroglitazar and placebo groups, confirming its acceptable safety profile.

This safety result is critical, given that many existing therapies for liver disease come with significant side effects that limit long-term use.

Strategic Significance and Regulatory Plans

Zydus Therapeutics emphasized that these results will form the foundation of a regulatory submission to the U.S. Food and Drug Administration (FDA) in the first quarter of 2026. The submission is expected to cover the complete data set from EPICS-III and highlight Saroglitazar’s potential as the first PPAR alpha/gamma agonist to demonstrate successful Phase 3 outcomes in PBC patients.

Pankaj Patel, Chairman of Zydus Lifesciences, stated that this success reinforces the company’s commitment to advancing novel treatments for chronic liver disease. He added that the results could bring real value to patients and healthcare providers, particularly for those patients who do not respond adequately to standard therapy.

Clinical Expert Commentary

The global principal investigator of the EPICS-III trial, Dr. Raj Vuppalanchi of Indiana University School of Medicine, noted that PBC patients often continue to struggle even on standard therapy. He emphasized that new therapeutic options such as Saroglitazar can significantly improve personalized treatment strategies for such patients.

Understanding Primary Biliary Cholangitis (PBC)

Primary Biliary Cholangitis is a rare, progressive autoimmune disease that damages the bile ducts of the liver. This leads to bile accumulation, progressive fibrosis, and in severe cases, cirrhosis, liver failure, or the need for transplantation.

Symptoms include:

• Pruritus (intense itching)

• Severe fatigue

• Liver enzyme abnormalities

If untreated, PBC can be life-threatening, which underscores the importance of innovative treatment options like Saroglitazar.

About Saroglitazar

Saroglitazar’s dual PPAR alpha/gamma mechanism makes it a unique investigational therapy. Its biological profile targets bile acid toxicity and liver inflammation, both central drivers of disease progression in PBC.

The compound has already received Orphan Drug Designation and Fast Track Designation from the U.S. FDA for PBC, which highlights its potential to address this high unmet medical need.

About Zydus Therapeutics and Zydus Lifesciences

Zydus Therapeutics, headquartered in Pennington, New Jersey, is focused on developing specialty medicines for serious liver diseases such as PBC and Non-Alcoholic Steatohepatitis (NASH). Leveraging the global R&D strength of Zydus Lifesciences, which has over 1,500 scientists and 30 manufacturing sites worldwide, the company is at the forefront of innovation-driven therapies.

Zydus Lifesciences Ltd., the parent company, employs 28,000 people globally and is engaged in developing, manufacturing, and marketing a broad portfolio of healthcare products. Its mission is to unlock new possibilities in life sciences, empowering patients with better treatment choices and healthier lives.

Investor and Industry Implications

For investors and stakeholders, the success of the EPICS-III trial positions Zydus Lifesciences as a strong player in the rare disease and specialty drug market. The company’s regulatory filing in 2026 will be a crucial step toward bringing Saroglitazar to market, potentially expanding Zydus’s footprint in the U.S. biopharmaceutical space.

The positive outcome not only boosts confidence in the company’s R&D capabilities but also demonstrates its ability to deliver breakthrough therapies in areas of high unmet need.

Conclusion

The positive Phase 2b/3 results of Saroglitazar Magnesium in Primary Biliary Cholangitis patients mark a landmark achievement for Zydus Therapeutics and Zydus Lifesciences. With plans to seek FDA approval in 2026, the company has strengthened its innovation-driven strategy in liver disease therapeutics.

For patients, these results provide new hope in managing PBC, a debilitating and life-threatening autoimmune disease. For investors, it represents a strategic milestone that could unlock significant value as Zydus continues its journey of global innovation in healthcare.

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