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US FDA nod for trial on Piramal's diabetes molecule

Drug used in management of metabolic disorders such as lipid abnormalities and diabetes

Reghu Balakrishnan  |  Mumbai 

Enterprises Limited has received approval from the US FDA for its Investigational New Drug (IND) P7435, for treatment of metabolical disorders.

P7435 has been developed by the NCE Research Division of PEL for the management of metabolic disorders such as lipid abnormalities and It is well-established that increased lipid levels (including triglycerides) is one of the major risk factors for cardiovascular disease (CVD), said the company statement.

According to World Health Organisation, CVD is the number one cause of deaths globally, representing approximately 30% of all deaths.

Swati Piramal, Vice Chairperson, Enterprises Limited said, “With P7435 we are looking at addressing a serious need for effective and well-tolerated drugs that treat lipid disorders, which are commonly associated with and CVDs. Expansion of this trial will allow testing this NCE in a wider population, which is critical to the development of this drug and will provide therapeutic solutions not just to India but also to the rest of the world.”

The NCE (new chemical entity) Research division of Enterprises Limited focuses on the discovery and development of innovative small molecule medicines to improve the lives of patients suffering from cancer, metabolic disorders and inflammatory conditions.

First Published: Tue, August 06 2013. 12:30 IST