Piramal Enterprises gets USFDA nod for Lipid Disorders and Diabetes drug

07 Aug 2013 Evaluate

Piramal Enterprises (PEL) has received an approval from the USFDA for its Investigational New Drug (IND) P7435. This is a novel, potent and highly selective, oral diacylglycerol acyltransferase 1 (DGAT1) inhibitor. P7435 has been developed by the NCE Research Division of the company for the management of metabolic disorders such as lipid abnormalities and diabetes.

P7435 has demonstrated its lipid lowering potential in various preclinical studies by showing significant reduction in triglyceride levels, glucose and insulin levels, and decrease in food intake and body weight gain - factors which are associated with lipid abnormalities and metabolic disorders.

The company has established the safety and tolerability of P7435 in a Phase I trial recently completed in India. This extension trial in the US will further evaluate the safety and efficacy of P7435 in a larger population.

Piramal Enterprises is one of India’s largest diversified companies, with a presence in pharmaceutical, financial services and information management sectors.

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