Drug Profile


Alternative Names: AMN-107; Tasigna; XS 003

Latest Information Update: 10 Sep 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

  • 06 Jul 2017 Additional efficacy and adverse events data from the phase III ENESTfreedom and ENESTop trials in Chronic myeloid leukaemia presented at the 22nd Congress of the European Haematology Association (EHA-2017)
  • 25 Jun 2017 Novartis terminates the phase II NordDutchCML009 trial as the recruitment of patients was difficult in Chronic myeloid leukaemia (Combination therapy, Second-line therapy) in Denmark, Finland, Netherlands, Norway and Sweden (PO)
  • 06 Jun 2017 The European Commission approves the inclusion of Treatment-free Remission (TFR) data from the phase II ENESTfreedom and ENESTop trials in Chronic myeloid leukaemia, in the nilotinib Summary of Product Characteristics (SmPC)
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