Nicholas Piramal gets FDA nod for ‘P 276-00’

Nicholas Piramal India Limited (NPIL) recently announced the FDA approval for IND application for its NCE ‘P 276-00’ which is targeted towards multiple myeloma. This is said to be the first IND nod from FDA for a NCE in Cancer therapeutics developed in India.

In Dr. (Mrs) Swathi Piramal, Director, Strategic Alliances & Communications, NPIL’s words "It is a proud moment for Indian research and an important milestone because a drug discovered in Mumbai India, with global patents is now approved for Clinical studies in world- renowned cancer hospitals in the USA. It is a testament to the world-class quality of the regulatory dossiers and preclinial studies which were completed entirely by the Indian scientific team. It also shows NPIL is delivering on the investments being made in research."

'P 276-00' is already in Phase1/Phase 2 clinical trials in India and Canada ( identifier NCT00407498 ). 'P 276-00' is a selective cyclin dependent Kinase inhibitor targeted towards refractory neoplasms.

Multiple Myeloma is one of the most common hematological malignancies. It does have a chronic phase and relapses with a median survival rate of 4-5 years.

The Company has said that the clinical trials will be co-ordinated by Dr Kenneth Anderson, a world renowned expert in the field and will be cnducted in the top cancer centers of US. NPIL also has a robust pipeline with more than 4-5 drug candidates in different phases of drug development which also includes a potent antibiotic lead.

Seeji, Pharm House


  1. Fda Pharmaceutical says

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