Piramal Enterprises Limited receives IND approval for P7435

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Piramal Enterprises Limited receives IND approval for P7435

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India

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Piramal Enterprises Limited receives IND approval for P7435, its novel DGAT1 inhibitor for treatment of Lipid Disorders and Diabetes Piramal Enterprises Limited announced that it has received approval from the US FDA 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 PEL for the management of metabolic disorders such as lipid abnormalities and diabetes. It is well-established that increased lipid levels’ (including triglycerides) is one of the major risk factors for cardiovascular disease (CVD). It has been reported by the World Health Organisation, that CVD, is the number one cause of deaths globally, representing approximately 30% of all deaths. Currently, there is a significant medical need for effective and safe drugs for the management of lipid abnormalities and metabolic disorders. 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. PEL 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. http://www.piramalenterprises.com/NCE/UploadedImages/Files/Press%20Release_P7435_6%20August.pdf Project Name Piramal Enterprises Limited receives IND approval for P7435 Location India Commence 2013 Completion -NA- Estimated Investment -NA- Capacity -NA- Key Players Piramal Enterprises Limited