Tuesday, June 22, 2010

Cadila Gets DCGI Approval For ZYOG1 Clinical Trial

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Cadila announced that it has received phase I clinical trial permission from the Drug Controller General of India for ZYOG1, a novel, oral, anti-diabetic molecule, which represents next generation
Glucagon Like Peptide-I (GLP-I) agents that can be taken orally. 

ZYOG1, the latest addition to the group's strong research pipeline of new molecular entities (NMEs) in clinical development, was developed at the Cadila's Research Centre using a unique discovery platform technology.

The new class of anti-diabetic drugs called GLP-1 agonists are used to treat type 2 diabetes patients who have not been able to control their blood sugar levels with oral medicines. It is an injectible which acts like natural hormones in the body that lowers blood sugar.


Dr. Neal Barnard's Program for Reversing Diabetes: The Scientifically Proven System for Reversing Diabetes without Drugs
When administered by oral route, ZYOG1 demonstrated beneficial effects in preclinical models on glucose reduction, HbA1c reduction and showed an added benefit of weight loss, Cadila said. The tests also displayed a differentiated preclinical safety profile with no nausea-like symptoms in the preclinical studies, it added.

Cadila's CMD Pankaj R. Patel said, " The discovery of ZYOG1 is a significant achievement for us. This novel molecule would address unmet medical needs in treating diabetes and holds promising potential in the anti-diabetic and anti-obesity market."

Research in the field of anti-diabetic therapy seeks to address problems such as hypoglycemia, GI side effects, lactic acidosis, weight gain, CV risks, edema and potential immunogenicity. which pose a major challenge in the treatment of diabetes. 

According to estimates given by the company, there are now 246 million diabetics in the world, with 41 million or 16.6% of the affected living in India. The global anti-diabetic market was estimated at $24 billion in 2008.

Updating their drug discovery and development, Cadila said that its NME-ZYH1 for treating dyslipidemia is undergoing Phase III clinical trials. 

ZYI1, its anti-inflammatory and pain management compound is currently in Phase II clinical trials, while ZYO1, another novel drug candidate for treating obesity and related disorders, has completed Phase I clinical trials.


Source: Cadila Pharmaceuticals

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