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Nilotinib - Novartis Pharmaceuticals Corporation

Drug Profile

Nilotinib - Novartis Pharmaceuticals Corporation

Alternative Names: AMN-107; Nilotinib-nanoparticle-formulation-Xspray-Pharma; RightSize-nilotinib; Tasigna

Latest Information Update: 25 Sep 2019

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At a glance

  • Originator Novartis Pharmaceuticals Corporation
  • Developer Centre Hospitalier Univeristaire De Lille; Dana-Farber Cancer Institute; Hospital for Special Surgery; Novartis Pharmaceuticals Corporation; Seoul St. Mary's Hospital; University Health Network of Toronto; University of California, San Diego
  • 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 Glioblastoma; Graft-versus-host disease; Malignant melanoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Phase I/II Acute myeloid leukaemia
  • No development reported Colorectal cancer; Gastrointestinal stromal tumours; Head and neck cancer; Systemic scleroderma
  • Discontinued Eosinophilia

Most Recent Events

  • 21 Aug 2019 Novartis completes the phase III ENESTnd trial in Chronic myeloid leukaemia (First-line therapy) in USA, Argentina, Austria, Belgium, Brazil, Canada, Czech Republic, Colombia, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, Italy, Japan, South Korea, Slovakia, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, the United Kingdom, and Venezuela (NCT00471497)
  • 14 Jun 2019 Efficacy and adverse events data from a phase II ENESTop trial in Chronic myeloid leukaemia released by Novartis Pharmaceuticals
  • 13 Jun 2019 Updated efficacy and adverse events data from the phase II DIALOGUE 1 trial in Chronic myeloid leukaemia (First-line therapy, In adolescents, In children, In infants, Second-line therapy or greater) presented at 24th Congress of the European Haematology Association (EHA-2019)
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