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Cadila recieves USFDA nod
8 April 2011: Cadila Healthcare has received approval from the the United States Food and Drug Administration (USFDA) to carry out clinical trials of its new drug molecule, ‘ZYGK1’, aimed at treating diabetes.
The company got the approval by the USFDA for an investigational new drug (IND) application for ZYGK1. The company will now initiate Phase-I clinical trials for ZYGK 1. Phase-I clinical trials are the first step of testing the efficacy and possible side-effects of a molecule on a limited human sample.
ZYGK1 is a new molecular entity (NME), which is a ‘potent and orally administered small molecule glucokinase activator’. In multiple pre-clinical models of Type 2 diabetes, ZYGK1 was found to be effective in controlling both fasting and non-fasting blood glucose.
A NME is a molecule developed by the innovator company in the early drug discovery stage, which after undergoing clinical trials could translate into a drug.
Source: Hindu Business Line