Zudus Cadila to commence Phase I clinical trials on ZYH2
Mumbai, July 27 (UNI) Pharma major Cadila Healthcare Ltd has received permission from Drug Controller General of India (DCGI) to conduct Phase I clinical trials on its new molecular entity - ZYH2.
Announcing this, the company informed BSE that the novel agent for treating diabetes has been designed and developed by Zydus Research Centre, the research wing of the company.
The group now has two INDs - 2YII (for inflammation) and ZYH2 in Phase 1 clinical trials and another IND ZYH1 (for dyslipidemia) in Phase 2 clinical trials.
'ZY H2', has displayed a unique profile in pre-clinical studies.
The NME has the potential to improve insulin resistance and lower blood glucose in diabetic conditions without causing hypoglycemia.
It also works favourably to lower the elevated lipid levels.
It is estimated that there are 30 to 33 million diabetics in India now, and every fourth diabetic in the world today is an Indian.
Indians are genetically more susceptible to diabetes and the World Health Organisation (WHO) predicts the number of diabetics in India would go up to 40 million by 2010 and 74 million by 2025, making it the diabetes capital of the world.
Presently, glitazones (rosigliiazone and pioglitazone) are used to manage Type II diabetes as insulin sensitizer. The pre-clinical studies on ZYH2 indicate that this NME may be more effective for diabetics by improving insulin resistance and lowering blood glucose levels without causing hypoglycemia and in also controlling the elevated tryglycerides level which is commonly found in such patients and may require specific intervention.
NME Research is one of the three focus areas of Zydus Research Programme. Under this, the focus has been on metabolic disorders, which includes dyslipidemia, diabetes and obesity and inflammatory disorders.
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