Indian pharmaceutical company Zydus Cadila has received approval from the USFDA to conduct Phase-1 clinical trials of ZYDPLA 1. ZYDPLA 1 is a novel compound which blocks the enzyme Dipeptidyl Peptidase-4 (DPP-4), to treat type 2 diabetis.
The USFDA approval for trials comes close on the heels of Zydus' launch of NCE - Lipaglyn, the world's first drug to be approved for the treatment of diabetic dislipidemia.
The new compound ZYDPLA 1 glucose-dependently increases insulin secretion and lowers glucagon secretion. This results in overall improvement in the glucose homoeostasis, including reduction in blood sugar levels.
The uniqueness of ZYDPLA 1 lies in the fact that patients need to take just one dose a week. Currently, all available DPP-4 inhibitors are dosed once-daily.
Speaking on the new development, Mr Pankaj R Patel, Chairman and MD, Zydus Group, said, "We take another leap forward in the area of diabetic research and long term management of type 2 diabetes with ZYDPLA 1. The IND approval by USFDA is another milestone for us. We believe that ZYDPLA 1 would take us closer to our mission of reducing the burden of chronic diseases and addressing unmet medical needs in the treatment of diabetes".
There are currently over 360 million diabetics in the world. By 2025, nearly half of the world's diabetic population will be from India, China, Brazil, Russia and Turkey. Sales of DPP-4 inhibitors are thus expected to peak at around $14 billion by 2022.