08.06.13
Piramal Enterprises Ltd. has received approval from the FDA for its IND for P7435, a novel, potent and highly selective, oral diacylglycerolacyltransferase 1 (DGAT1) inhibitor for treatment of lipid disorders and diabetes.
P7435 has demonstrated its lipid lowering potential in various preclinical studies, showing a reduction in triglyceride levels, glucose and insulin levels, and decrease in food intake and body weight gain. Piramal has established the safety and tolerability of P7435 in a Phase I trial recently completed in India. This extension trial in the U.S. will further evaluate the safety and efficacy of P7435 in a larger population.
Dr. Swati Piramal, vice chairperson of Piramal, said, “The NCE Research division of Piramal continues its ambitious diabetes/metabolic disorders program to discover and develop NCEs to fight against diseases like diabetes and lipid disorders. 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 diabetes 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.”
P7435 has demonstrated its lipid lowering potential in various preclinical studies, showing a reduction in triglyceride levels, glucose and insulin levels, and decrease in food intake and body weight gain. Piramal has established the safety and tolerability of P7435 in a Phase I trial recently completed in India. This extension trial in the U.S. will further evaluate the safety and efficacy of P7435 in a larger population.
Dr. Swati Piramal, vice chairperson of Piramal, said, “The NCE Research division of Piramal continues its ambitious diabetes/metabolic disorders program to discover and develop NCEs to fight against diseases like diabetes and lipid disorders. 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 diabetes 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.”