Zydus Cadila, a global healthcare provider and one of India's leading healthcare companies, has filed the IND application for ZYD1 - a novel GLP-1 agonist molecule with the DCGI. The novel candidate is designed and developed at the Zydus Research Centre in the class of anti-diabetic agents known as incretin mimetics and has displayed a better efficacy and safety profile.
Ineretin mimetics are poised to dominate the future of anti-diabetic therapy and presents a huge opportunity in bridging unmet medical needs that still continues to dodge the treatment and care of diabetes. The new class of drugs called incretins came to the fore in May 2005 when the world's first GLP-1 agonist was approved by the US FDA.
ZYD1 has demonstrated beneficial effects in preclinical animal models on glucose reduction, HbA1c reduction and added benefits of weight loss. It displayed a differentiated preclinical safety profile with no nausea-like symptoms and absence of antibody generation in the preclinical studies.
Pankaj Patel, chairman and managing director, said, "The discovery of the novel GLP-1 agonist, ZYD1, using our discovery platform technology is an important achievement for us. We believe that it holds promising commercial potential as a best-in-class candidate due to unmet medical needs in the treatment of diabetes."
ZYD1 is the latest addition to the group's strong research pipeline of 6 NMEs which are in various stages of clinical trials. The NME - ZYH1, for treating dyslipidemia is undergoing phase-III clinical trials. ZYI1, a novel drug candidate for treating obesity and related disorders has completed Phase I clinical trials. ZYH7, a novel drug candidate for treating dyslipidemia and metabolic disorders, ZYH2, the novel agent for treat diabetes and ZYTT, a novel drug candidate for treating dyslipidemia are in Phase I clinical trials.
The research centre has over 20 discovery programmes ongoing with several candidates in the pre-clinical development stage focused on metabolic, cardiovascular, pain and inflammation, therapeutic area. With over 375 research professionals spearheading its research programme, Zydus has in-house capabilities to conduct discovery research from concept to IND enabling pre-clinical development and human proof-of-concept clinical trials.