Zydus files IND application for trials for treating dyslipidemia & metabolic disorders
Continuing with its successful research programme, Zydus Cadila has filed yet another IND (Investigational New Drug) application for seeking DCGI's permission for conducting clinical trials for its new molecular entity (NME) - ZYH7, a novel drug candidate for treating dyslipidemia and metabolic disorders.
Conceptualised and developed by scientists at Zydus research centre, the recently concluded pre-clinical studies on ZYH7 have reported interesting and encouraging findings which indicate a novel molecule to treat dyslipidemia and associated metabolic disorders.
With an increasing correlation between several endocrine and metabolic disorders, there has been considerable emphasis in recent times on metabolic syndrome. The metabolic components of cardiovascular disease, diabetes and obesity, are linked in numerous ways with each having an impact on the other. For instance, it is also well known that patients with type 2 diabetes have a two to four-fold excess risk of coronary heart disease and that these patients very often have increased cardiovascular risk factors even before the onset of their diabetes.
Diabetes, a worldwide health problem, affects more than 150 million people which is expected to double by 2025. People with diabetes are especially at high risk for dyslipidemia, particularly high triglyceride levels and low HDL levels. Dyslipidemia is also a key independent risk factor for cardiovascular disease (CVD), which is the largest therapeutic segment in the world pharmaceutical market.
Speaking on the new development, Pankaj Patel, chairman and managing director, Zydus Cadila said, "We have been building a promising pipeline of new molecular entities at the Zydus Research Centre and ZYH7 is an important step in this direction. It reflects our ongoing commitment to new research initatives that can help meet unmet healthcare needs in the focus areas of metabolic disorders, cardiovascular diseases, pain and inflammation. With every effort that opens the doors to new possibilities and therapies, we reinforce our mission of creating healthier communities, globally".
Starting with its first IND filing in 2005, Zydus has four INDs in various stages of clinical trials. NME - ZYH1 for treating dyslipidemia and ZYI1 for treating pain and inflammation are undergoing phase II trials. ZYH2 for treating diabetes and the novel CB-1 antagonist, ZYO1 for treating obesity, are undergoing phase I trials.
Zydus Research Centre which was set up in the year 2000, has a dedicated team of over 230 research scientists working on its NME research programme. Under this, the focus has been on metabolic disorders, which includes dyslipidemia, diabetes and obesity, cardiovascular disorders and pain and inflammatory disorders.