Nilotinib

Drug Profile

Nilotinib

Alternative Names: AMN-107; Tasigna; XS 003

Latest Information Update: 21 Nov 2017

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At a glance

  • Originator Novartis Pharmaceuticals Corporation
  • Developer Dana-Farber Cancer Institute; Hospital for Special Surgery; Novartis Pharmaceuticals Corporation; Seoul St. Mary's Hospital; University Health Network of Toronto
  • Class Antineoplastics; Benzamides; Imidazoles; Pyridines; Pyrimidines; Small molecules
  • Mechanism of Action Bcr-abl tyrosine kinase inhibitors; Platelet derived growth factor alpha receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Proto oncogene protein c-kit inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Chronic myeloid leukaemia; Gastrointestinal stromal tumours
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic myeloid leukaemia
  • Phase II Acute lymphoblastic leukaemia; Malignant melanoma
  • Phase I/II Acute myeloid leukaemia
  • No development reported Gastrointestinal stromal tumours; Systemic scleroderma
  • Discontinued Eosinophilia

Most Recent Events

  • 20 Nov 2017 Registered for Chronic myeloid leukaemia (First-line therapy, In adolescents, In children, In infants, Second-line therapy or greater) in European Union, Norway, Liechtenstein, Iceland (PO, Capsule)
  • 20 Nov 2017 Updated efficacy and adverse events data from two prospective paediatric studies in Chronic myeloid leukaemia released by Novartis
  • 04 Nov 2017 No recent reports of development identified for phase-I development in Acute-lymphoblastic-leukaemia(In adolescents, In children, Second-line therapy or greater) in USA (PO, Capsule)
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