Zydus gets USFDA nod for phase-I clinical trial of diabetes drug

This new chemical entity will offer once-a-week oral treatment option, a significant benefit to type-2 diabetic patients

Ahmedabad-based Zydus Group today said that it has received the nod from the US drug regulator to start phase-I clinical trials for ZYDPLA1, a new molecule aimed at treating diabetes.

A company statement here said," Close on the heels of launching Lipaglyn, the breakthrough therapy to treat diabetic dyslipidemia and  India’s first new chemical entity (NCE) to reach the market, the Zydus group announced the Phase I clinical trial approval from the US Food and Drug Administration (USFDA) for ZYDPLA1 - a next generation, long-acting DPP-4 inhibitor."

ZYDPLA1 is an orally active, small molecule NCE, discovered and developed by the Zydus Research Centre, the NCE research wing of Zydus Group. Pankaj Patel, chairman and managing director, Zydus Group, said, "After a promising start with Lipaglyn, we take another big leap forward in the area of diabetic research and long term management of Type 2 diabetes. The IND approval by USFDA is another major regulatory milestone for us. We believe that ZYDPLA1 holds promise and would take us closer to our mission of reducing the burden of chronic diseases and addressing unmet medical needs in the treatment of diabetes."

ZYDPLA1 is a novel compound in the Gliptin class of antidiabetic agents. "Currently, all available DPP-4 inhibitors are dosed once-daily. ZYDPLA1 with a once-a-week dosing regimen, would provide diabetic patients with a more convenient treatment alternative. ZYDPLA1 will offer sustained action, which will result in an improved efficacy profile," the statement added.

Earlier this year, Zydus had launched its own patented NCE, Lipaglyn for the treatment of dyslipidemia.

The number of diabetics in the world is estimated to be over 360 million. In 2025 nearly half of the world’s diabetic population will be from India, China, Brazil, Russia and Turkey. The sales of the DPP-IV inhibitors is expected to peak at almost $14 billion (approximately Rs 86245 crore)  by 2022.

The Zydus Research Centre has over 20 discovery programmes ongoing with several candidates in the pre-clinical development stage focused on metabolic, cardiovascular, pain, inflammation and oncology therapeutic areas.