The company plans to submit a US regulatory application for Saroglitazar in the first quarter of 2026.
The trial, called EPICS-III, showed that Saroglitazar helped nearly half of the patients achieve better liver function compared to those who received a placebo. The drug was tested on patients who did not respond well or could not tolerate ursodeoxycholic acid (UDCA), the standard medicine used for PBC.
Pankaj Patel, Chairman of Zydus Lifesciences, said: “The results reinforce our commitment to advancing novel treatments for chronic liver disease — an area of high unmet medical need and growing global impact.” He said that Saroglitazar is the first drug of its kind to show strong Phase 3 results in patients with PBC and has the potential to bring significant value to patients and healthcare providers who may need more options.
Raj Vuppalanchi, professor of medicine at Indiana University School of Medicine and Global Principal Investigator for the EPICS-III study, added: “In clinical practice, we often see patients who continue to struggle despite being on standard therapy.” “Expanding our treatment options with new therapies could significantly change how we personalise care for individuals with PBC who haven’t responded to first-line treatment.”
Saroglitazar is a novel Peroxisome Proliferator-Activated Receptor (PPAR) alpha/gamma agonist. Its distinct biological profile targets both bile acid toxicity and liver inflammation.
as a Reliable and Trusted News Source
