India-made new prostate cancer drug files for IND with US FDA

A new drug to treat prostate cancer, developed by Bangalore-based Jubilant Biosys, along with its US-based collaborator Endo Pharmaceuticals, has crossed a major milestone with the US regulator FDA accepting its application to treat it as a novel molecule


Jubilant Biosys has announced that US regulator FDA has accepted the investigational new drug(IND) filing application which is the first regulatory stage of acceptance of the potential of the new molecule and the clinical trials of the product will start later this year. A subsidiary of Jubilant Life Sciences, Biosys has developed the new drug in collaboration with Endo Pharmaceuticals in the US.

"We are pleased and elated with this successful outcome, which is the result of excellent collaboration between the scientists at Endo and Jubilant Biosys," said Dr Subir Kumar Basak, president, global drug discovery services of Jubilant Life Sciences. "

Both the companies started working on the development of this new molecule three years ago. The IND filing will take the product to the next stage of development and is a major progress in drug development.

" I congratulate the Jubilant and Endo teams on achieving this important milestone," said Dr Sandeep Gupta, senior VP at Endo Pharamceuticals." This further validates Endo's unique collaborative drug discovery approach which aims at unmet medical needs and improve patient outcomes."

Prostate cancer is the second most reported form of cancer in the US and many other countries. New drug development in this field is going on strongly and at least 333 companies with their partners are working on developing 402 drugs to treat prostate cancer currently.

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