Piramal Enterprises gets USFDA nod for Lipid Disorders and Diabetes drug

Piramal Enterprises Limited

5162   Pre Project Activities Underway

Project Information

Organization Name
Piramal Enterprises Limited
Project Title
Piramal Enterprises gets USFDA nod for Lipid Disorders and Diabetes drug
Project Detail
Piramal 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 diabetes. It is well-established that an increased lipid level (including triglycerides) is one of the major risk factors for cardiovascular disease (CVD). Piramal Enterprises has established the safety and tolerability of ''P7435'' in a phase I trial recently completed in India. It is now planning to initiate extended phase I trial in the US to further evaluate the safety and efficacy of the new chemical entity in a larger population. Piramal Enterprises Vice Chairperson Swati Piramal said: "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 company''s R&D division has been focusing on discovery and development of medicines to target disease such as cancer, metabolic disorders and inflammatory conditions.
Project Status
Pre Project Activities Underway
Project State
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