Zydus Cadila has received permission from the Drug Controller General of India (DCGI) to conduct phase I clinical trials on its new molecular entity - ZYH1. Zydus Cadila had filed its first IND (investigational new drug) application for ZYH1 with the DCGI in January 2005.
This agent for treatment of metabolic disorders has been designed and developed by Zydus Research Centre, the research wing of Zydus Cadila. The phase I studies will focus on evaluating the safety profile of ZYH1. The clinical trials will be conducted at Zydus Research Centre which has capabilities to conduct phase I clinical trials. The company says that extensive pre-clinical studies on ZYH1 indicated that the NME may be free from the side effects that are seen with the glitazones, fibrates and statins, which are currently used in the treatment of dyslipidemia and glucose intolerance. The NME has the potential to correct dyslipidemia, improve insulin resistance and lower blood glucose in diabetic mellitus and metabolic syndrome, it says.
With changes in lifestyle in the entire world, including the developing countries, metabolic disorders such as dyslipidemia, diabetes and obesity and inflammatory diseases, are increasing rapidly. Problems associated with the patients having dyslipidemia, one of the major health problems, have not been addressed adequately. "ZYH1 is expected to address the issue related to patients suffering from dyslipidemia in both diabetic and non-diabetic condition," says Dr B B Lohray, president, Zydus Research Centre.
Zydus Research Centre which was set up in the year 2000, has a team of 230 research scientists. NME Research is one of the three focus areas of Zydus Research Programme. Apart from NME research, ZRC is also focussed on novel drug delivery systems and biologics.