Zydus Cadila, a global healthcare provider and on of India's leading healthcare companies, has received an approval from the US FDA for its IND application of ZYGK1 for treating diabetes. Designed and developed at the Zydus Research Centre, the NME is a potent and orally administered small molecule glucokinase activator. The company will now initiate phase I clinical trials of ZYGK1.
Glucokinase (GK) is the enzyme that acts as a glucose sensor in the pancreas and regulates glucose metabolism in the liver. When circulating glucose levels rise above a certain threshold, the glucokinase enzyme enhances insulin release from pancreas and decreases glucose production in liver. In normal individuals, the pancreas secrete insulin in response to increased levels of glucose in the blood. In patients with type 2 diabetes, there is a reduction of GK activity in the pancreas and the liver.
Pankaj R Patel, chairman and managing director, Zydus Caidla, said, “We have been building a promising pipeline of new molecular entities at the Research Centre and with each step forward, we are moving closer to our goal of becoming a research driven pharma major. We believe that these susained efforts will help us address unmet healthcare needs in the focus areas of metabolic disorders and cardiovascular diseases.”
In multiple pre-clinical models of type 2 diabetes, ZYGK1 was found to be effective in controlling both fasting and non-fasting blood glucose. ZYGK1 showed very good safety profile in pre-clinical studies. Activating GK with small molecules such as ZYGK1 lower blood glucose levels by enhancing the ability of the pancreas to sense glucose, which lead to increased insulin production. Simultaneously, glucokinase activators increase the net uptake of blood glucose by the liver. Glucokinase activators, such as ZYGK1, represent a promising new class of drugs for the treatment of type 2 diabetes.
Starting with its first IND filing in 2005, Zydus today has several NMEs in various stages of clinical trials. The NME – ZYH1, for treating dyslipidemia is undergoing phase III clinical trials and ZY11, the anti-inflammatory and pain management compound is currently in phase II clinical trials. The Zydus Research Centre has over 20 discovery programmes on with several candidates in the pre-clinical development stage focused on metabolic, cardiovascular, pain and inflammation therapeutic areas. With over 400 research professionals spearheading its research programme.