Zydus files new drug papers with DCGI

Zydus Cadila has filed its first investigational new drug (IND) application for a new molecular entity (NME) - ZY H1 - with the Drug Controller General of India (DCGI).

According to a release issued to the BSE today, the NME for treatment of metabolic disorders has been designed and developed by Zydus Research Centre (ZRC), the research with of Zydus Cadila.

"ZY H1 has displayed a unique profile in pre-clinical studies. The NME has the potential to correct dyslipidemia, improve insulin resistance and lower blood glucose in diabetic conditions," the release added.

The metabolic syndrome or Syndrome X represents a cluster of major metabolic disorders including type-2 diabetes, dyslipidemia, obesity and cardiovascular diseases, the release said, adding that "so for, no single therapy is available well suited to treat the disease."

"The pre-clinical studies indicate that the NME may be free from side effects that are seen with glitazones, fibrates and statins, which are currently used in the treatment of dislipidemia and diabetes," the release said.