Zydus Cadila initiates phase 2 clinical trial for drug to treat NAFLD in women with PCOS

New Delhi: Zydus Cadila on Wednesday said it has initiated phase 2 clinical trial for evaluating the effect of Saroglitazar Mg in the treatment of non-alcoholic fatty liver disease (NAFLD) in women with polycystic ovary syndrome. The trial is currently recruiting patients across several clinical sites in the United States of America and Mexico.

Research suggests that in women with polycystic ovary syndrome (PCOS), there is increased risk for non-alcoholic fatty liver disease, Zydus Cadila said in a regulatory filing.

PCOS affects fertility and also significantly increases metabolic complications, it added.

Zydus Group Chairman Pankaj R Patel said the company's research programme aims to bring innovative therapies that make a difference to human lives in keeping with our mission to create healthier communities.

There is a high prevalence of PCOS in the general population affecting 1 in 10 women of childbearing age, causing infrequent or prolonged menstrual periods or excess male hormone.

"There are currently no treatments approved by the US Food and Drug Administration (USFDA) for treatment of NAFLD," Zydus Cadila said.

Shares of Cadila Healthcare, listed entity of the group, were trading 1.39 per cent lower at Rs 216.40 apiece on BSE.