Zydus update on clinical trial of Saroglitazar Magnesium

For treatment of chronic liver disease

Zydus today announced that it has randomised the First patient into the Phase 2(b) Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled clinical trial to evaluate Efficacy and Safety of Saroglitazar Magnesium in subjects with Non-Alcoholic Steatohepatitis and Fibrosis. Zydus had earlier received permission from the USFDA.

NASH is a chronic liver disease characterised by fat accumulation and inflammation in the liver, which can progress to liver cirrhosis, need for liver transplant or death. Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA). The USFDA has granted 'Orphan Drug Designation' and 'Fast Track Designation' to Saroglitazar Mg for PBC. The European Medicines Agency (EMA) has designated "Saroglitazar magnesium" with Orphan status for Treatment of Primary Biliary Cholangitis.

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