Saroglitazar Mg is the 1st drug approved in India for treating NAFLD & NASH

Saroglitazar is a novel Peroxisome Proliferator-Activated Receptor (PPAR) alpha / gamma agonist, currently approved in India is a prescription medicine for the treatment of Hypertriglyceridemia, Diabetic Dyslipidemia in Patients with Type 2 Diabetes not controlled by statins, Type 2 Diabetes and Non-Alcoholic Steatohepatitis (NASH) & Non Alcoholic Fatty Liver Disease (NAFLD) with comorbidities.

Saroglitazar Mg is an investigational new drug in the United States of America, and is currently being evaluated in Phase II clinical trials for the treatment of Non-Alcoholic Steatohepatitis (NASH). We have completed enrolment of Phase 2b/3 EPICS III trial of Saroglitazar Mg in patients with Primary Biliary Cholangitis (PBC). The USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for Primary Biliary Cholangitis (PBC). Saroglitazar Mg has received Orphan Status from EMA for PBC.