Piramal Enterprises today said it has received approval from the US health regulator for its investigational new drug (IND), P11187, that aims to target diabetes.
The company has received approval from the US Food and Drug Administration (USFDA) for P11187 that will enable it to initiate a Phase I clinical trial of new chemical entity (NCE) in healthy volunteers in the US.
"It is a potential therapeutic target for Type 2 Diabetes Mellitus (T2DM). T2DM is an emerging worldwide health crisis with an incidence rate of 300 million by 2025 as predicted by the WHO and accounts for about 90 per cent of the diabetic population," Piramal Enterprises said.
It will be tested for safety and its glucose-lowering properties for the first time in humans. Both properties having been well-established in company's preclinical studies, it added.
Commenting on the development Piramal Enterprises Vice Chairperson Swati Piramal said: "P11187's IND approval by the US FDA, recognises our untiring efforts to identify candidates that would translate into more efficacious drugs for the effective management of diabetes."
Piramal Enterprise's NCE research division focuses on the discovery and development of innovative small molecule medicines for patients suffering from cancer, metabolic disorders and inflammatory conditions, the company said.