Zydus gets USFDA nod for diabetes drug trial

Ahmedabad based drug major Cadila Healthcare has received USFDA approval to conduct clinical trials for its new molecule ZYGK1 that will be used to treat diabetes.

The company will initiate phase I clinical trials for ZYGK1 soon that will test the efficacy and side effects of the molecule on a limited human sample. The new molecular entity (NME) has been developed by the Zydus Research Centre. It is a potent and orally administered small molecule glucokinase activator. ZYGK1 is an investigational new drug (IND) application that is orally administered and acts as a glucose sensor in pancreas and regulates glucose metabolism in the liver, Zydus said in a statement.

Pankaj Patel, chairman and managing director, Cadila Healthcare said in a statement, "We have been building a promising pipeline of new molecular entities.Our efforts would help us address the unmet healthcare needs in the focus areas of metabolic disorders and cardiovascular diseases."

Glucokinase is the enzyme that acts as a glucose sensor in the pancreas and regulates glucose metabolism in the liver. When circulating glucose levels rise above a certain threshold, the glucokinase enzyme enhances insulin release from pancreas and decreased glucose production in liver. In normal individuals, the pancreas secrete insulin in response to increased levels of glucose in the blood. In patients with Type 2 diabetes, there is a reduction of Glucokinase activity in the pancreas and the liver.

Cadila Healthcare has several NMEs in various stages of clinical trial.Cadila's ZYH1 molecule for treating dyslipidemia was undergoing phase-III trials. The company's turnover has touched the $1billion (Rs 4,500 crore) mark in the 2010-11 financial year. From a turnover of $400 million in 2007, the Ahmedabad-based pharmaceutical player has become a $1 billion firm in just seven years. It is now the fifth largest pharma company in the country, the other four being Cipla, Ranbaxy, GSK and Piramal Group.