Cadila files first IND for new molecule

The Ahmedabad-based Rs 1170 crore Zydus Cadila Healthcare Ltd has filed its first ever investigational new drug (IND) application for the new molecular entity, 'ZY H1' with the Drug Controller General of India (DCGI).

The novel agent for treatment of metabolic disorders has been designed and developed by Zydus' Research Centre (ZRC), the research wing of Cadila in Ahmedabad.

"We have filed the IND application for NME, 'ZY H1' with the DCGI. We have filed the dossier with the DCGI and, if every thing goes well, we expect to receive the approval from the government to go ahead for clinical trials in next three months. It may take as long as six years to conduct all phases of clinical trials and get the medicine finally into the market," Vidya B Lohray, senior vice president, medicine chemistry and process research, ZRC said on Monday.

"The pre-clinical studies on 'ZY H1' indicate that the NME may be free from the side effects that are seen with the glitazones, fibrates and statins that are currently used in the treatment of dislipidemia and diabetes," Lohray said.

With changes in lifestyle, the metabolic diseases are increasing rapidly and becoming major health problem world over.

The 'Metabolic Syndrome' or 'Syndrome X' represents a cluster of major metabolic disorders including type-two diabetes, dyslipidemia, obesity and cardiovascular diseases.

So far no single therapy is available, which is well suited to treat these diseases.

"The NME has displayed a unique profile in pre-clinical studies. It has the potential to correct dyslipidemia, improve insulin resistance and lower blood glucose in diabetic conditions. The research centre has been working in this area since the inception of the centre in 2000. The centre, at present, is also working in the metabolic disorder segment and pain management segment, among others," said Lohray.

According to a company release issued here, glitazones (rosiglitazone and pioglitazone) have been launched to treat increasing prevalence of insulin resistance in type-two diabetes.

Fibrates (fenofibrate, gemfibrozil and bezafibrate) are known to moderately regulate dyslipidemic condition.

Several statins have been developed to treat hypercholesterolemia. However, it has been elusive to treat multiple manifestations of the metabolic syndrome in clinics and several side effects have been seen with the existing therapy, some of which may even be lethal.

"We have worked on the molecule taking lessons from the past history of the molecule, the problems faced by others in the pre-clinical trials and we tried to sort out those problems. We believe the molecule is non-toxic and free from any side effects," said Lohray.

NME research is one of the three focus areas of Zydus research programme, under which the focus has been on metabolic disorders, which includes dyslipidemia, diabetes and obesity and inflammatory disorders.

ZRC was set up in the year 2000, has a team of 230 research scientists. Apart from NME research, ZRC is also focused on novel drug delivery systems and discovery biology research.