About the API
Nilotinib, the active ingredient of nilotinib , belongs to the class of molecules termed antineoplastic agents, which inhibit the maturation, growth or spread of tumor cells. It is used for the treatment of chronic myeloid leukemia (CML) in patients exhibiting an abnormal chromosome called the Philadelphia chromosome.
This chromosome is present in most cases of CML. In the past, Nilotinib was used only as a second-line drug, for treatment of CML patients who exhibited resistance or intolerance to prior therapy. As studies relating to its potency surfaced, it became approved as a first-line drug as well.
Currently, it is used to treat adult patients who have been newly diagnosed with CML, or who have chronic or accelerated phase CML and are resistant or intolerant to prior therapy including imatinib.
Nilotinib was approved by the FDA in 2010 as a first-line drug and in 2007 as a second-line drug. It is synthesized through a multi-step chemical process.