Zydus gets USFDA nod for clinical trial anti-diabetes molecule
New Delhi: Drug firm Cadila Healthcare today said the Zydus group has received approval from the US health regulator for initiating Phase I clinical trial for ZYDPLA1 - a new molecule aimed for diabetes treatment.
Zydus group has received approval to conduct phase-I clinical trials from the US Food and Drug Administration (USFDA) for its new chemical entity (NCE), ZYDPLA, a next generation, long-acting DPP-4 inhibitor to treat type 2 diabetes, the company said in a statement.
"This novel next generation new chemical entity (NCE) would offer once-a-week oral treatment option, a significant benefit to type-2 diabetic patients," Cadila Healthcare said.
Commenting on the development, Zydus group Chairman and Managing Director Pankaj Patel said: "The IND (investigative new drug) approval by the 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 the unmet needs in treatment of diabetes."
In June, Cadila Healthcare, a part of the Zydus Group, had received regulatory approval to market its diabetes drug Lipaglyn in India.
Patel had said Zydus group expected at least two molecules out of 20 under its discovery research programmes to become successful by 2020.