Cadila gets DCGI nod for phase I trial of NME

EPP News Bureau - Mumbai

Cadila Healthcare Ltd has received permission from Drug Controller General of India (DCGI) to conduct phase I clinical trials on its New Molecular Entity (NME)-ZYH1. This novel agent for treatment of metabolic disorders has been designed and developed by Zydus Research Centre, the research wing of the company. The company had filed its first IND (Investigational New Drug) application for ZYH1 in January 2005, a press release said.

The phase I studies will focus on evaluating the safety profile of ZYH1. The clinical trails will be conducted at Zydus Research Centre, which has capabilities to conduct phase I clinical trials. 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 dislipidemia and glucose intolerance. The NME has the potential to correct dislipidemia, improve insulin resistance and lower blood glucose in diabetic mellitus and metabolic syndrome, according to the release.

‘‘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.