Extended Phase I trial in US to be initiated shortly : PEL

Piramal Enterprises Limited receives IND approval for P7435, its novel DGAT1 inhibitor for treatment of Lipid Disorders and Diabetes


Investiagational New Drug (IND) P7435 is novel, potent and highly selective, oral diacylglycerolacyltransferase 1 (DGAT1) inhibitor.

"The NCE Research division of Piramal Enterprises Ltd (PEL) continues its ambitious diabetes/metabolicdisorders programme to discover and develop NCEs to fight against diseases like diabetes and lipid disorders. With P7435 we are targeting at addressing a serious need for effective and well-tolerated drugs that treat lipid disorders. 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 to the whole world" commented Dr Swati Piramal, Vice Chairperson, PEL on successful approval from USFDA.

PEL has achieved 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 on a large group of population.

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