Zydus Cadila files its first IND application for new molecule

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 press release from the company, this novel agent for treatment of metabolic disorders has been designed and developed by Zydus Research Centre (ZRC), the research wing of Zydus Cadila. In pre-clinical studies, ZY H1 has shown the potential to correct dyslipidemia, improve insulin resistance and lower blood glucose in diabetic conditions.

Metabolic syndrome or 'syndrome X' represents a cluster of major metabolic disorders including type-2 diabetes, dyslipidemia, obesity and cardiovascular diseases. So far, no single therapy is available which is well suited to treat these diseases.

In recent times, glitazones (rosiglitazone and pioglitazone) have been launched to treat increasing prevalence of insulin resistance in type-2 diabetes. Fibrates (fenofibrate, gemfibrozil and bezafibrate) are known to moderately regulate dyslipidemic condition. Several statins have been developed to treat hypercholesterolemia. However, an effective therapy to treat multiple manifestations of the metabolic syndrome in clinics remains elusive. Several side effects have been seen with the existing therapy, some of which may even be lethal. Pre-clinical studies on ZY H1 indicate that the NME may be free from the side effects that are seen with glitazones, fibrates and statins.

NME research is one of the three focus areas of the Zydus Research Programme. The focus has been on metabolic disorders, which includes dyslipidemia, diabetes and obesity, as well as inflammatory disorders. ZRC, set up in 2000, and focuses on novel drug delivery systems and discovery biology research.