Zydus Cadila files IND application for NME - ZYH2
Cadila has filed another IND (Investigational New Drug) application for the
New Molecular Entity (NME) ZYH2 with the Drug Controller General of India
(DCGI). The novel agent for treating diabetes has been designed and developed
by Zydus Research Centre, the research wing of Zydus Cadila. With this filing,
Zydus Cadila has filed three INDs - ZYH1, ZYH and ZYH2. The NME - ZYH1 has now
entered Phase II 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 Organization 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.
In recent times, glitazones (rosiglitazone and pioglitazone) have been launched
to treat increasing prevalence of insulin resistance in Type - II diabetes.
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 are commonly found in such patients and may require special intervention.