Drug Profile


Alternative Names: AMN-107; Tasigna; XS 003

Latest Information Update: 08 Jun 2017

Price : $50

At a glance

  • Originator Novartis Pharmaceuticals Corporation
  • Developer Dana-Farber Cancer Institute; Hospital for Special Surgery; Novartis Pharmaceuticals Corporation; 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 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)
  • 08 Feb 2017 Novartis completes a phase III extension trial for Chronic myeloid leukaemia in China (NCT02272777)
  • 03 Dec 2016 Efficacy and safety data from the phase III ENESTPath trial in Chronic myeloid leukaemia presented at the 58th Annual Meeting and Exposition of the American Society of Haematology (ASH-2016)
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at so we can help.

Back to top