Zydus to start phase-II clinical trial for saroglitazar in US

Ahmedabad-based Zydus Cadila on Saturday announced that USFDA has approved the company’s plan to initiate a Phase-II clinical trial of Saroglitazar in patients with Non-Alcoholic Steatohepatitis (NASH) of the liver. 

This randomised, double-blind Phase-II trial will evaluate Saroglitazar. 

An estimated 6.5 million adults in the United States (US) and five major European countries having advanced NASH, which is a liver disease in which fat accumulates in the liver. 

Obesity, insulin resistance, diabetes and lipid disorders lead to NAFLD, which progresses to a lethal NASH situation. It ranks as one of the major causes of cirrhosis in America, behind Hepatitis C and alcoholic liver disease. The Biotech analysts estimates the worldwide market for NASH medicines to reach $35-40 billion by 2025.

 

Speaking on the development, Pankaj Patel, chairman and managing director of Zydus Cadila said: “NASH is an area of unmet healthcare need as there are currently no drugs approved for the treatment of NASH. With a Phase-III trial in biopsy proven NASH patients ongoing in India and a Phase-II trial in NASH patients planned in US, we are committed towards developing this drug for millions of patients suffering from NASH”.

This trial will be conducted across several medical sites in the US.

Zydus had earlier initiated a 52 week Phase-III clinical trial of Lipaglyn in India to treat patients with biopsy proven NASH. 

The recently concluded phase-II studies of Saroglitazar in patients with biopsy proven NASH has shown improvement in liver enzymes along with favorable effects on lipid and glycemic indices.

Lipaglyn™ (Saroglitazar) is currently approved in India as a prescription medicine for the treatment of Hypertriglyceridemia and Diabetic Dyslipidemia in patients with Type-II Diabetes not controlled by statins. 

Lipaglyn™ (Saroglitazar) was launched in India during September 2013. Since, then more than 3,00,000 patients have been treated with Lipaglyn in India to date. 

A post-marketing phase-IV study is currently underway in patients suffering from hypertriglyceridemia in India.