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Midostaurin - Novartis Oncology

Drug Profile

Midostaurin - Novartis Oncology

Alternative Names: 4-N-benzoyl staurosporine; Benzoylstaurosporine; CGP 41251; N-benzoyl-staurosporine; PKC412; PKC412A; Rydapt

Latest Information Update: 24 Oct 2021

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At a glance

  • Originator Novartis
  • Developer Massachusetts General Hospital; Mayo Clinic; National Cancer Institute (USA); Novartis; Novartis Oncology; Ohio State University Comprehensive Cancer Center
  • Class Antineoplastics; Carbazoles; Eye disorder therapies; Indole alkaloids; Skin disorder therapies; Small molecules
  • Mechanism of Action Fms-like tyrosine kinase 3 inhibitors; Platelet derived growth factor alpha receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Protein kinase C inhibitors; Proto oncogene protein c-kit inhibitors; Vascular endothelial growth factor receptor-2 antagonists
  • Orphan Drug Status

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

    Yes - Acute myeloid leukaemia; Systemic mastocytosis
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Acute myeloid leukaemia; Systemic mastocytosis
  • No development reported Rectal cancer
  • Discontinued Acute biphenotypic leukaemia; Colorectal cancer; Diabetic macular oedema; Gastrointestinal stromal tumours; Multiple myeloma

Most Recent Events

  • 09 Jul 2021 Novartis Oncology completes a phase III trial for Acute myeloid leukaemia (Combination therapy, First-line therapy) in Bulgaria, Croatia, Czech Republic, Estonia, Finland, France, Greece, Hungary, Italy, Lithuania, Norway, Slovakia, Romania, Spain, Serbia and Sweden (NCT03379727) (EudraCT2016-004440-12)
  • 23 Feb 2021 University of Jena terminated its phase II MAURITIUS in Acute myeloid leukaemia (Second-line therapy or greater) in Germany (PO, Capsule) due to insufficient recruitment (NCT03951961) (EudraCT2019-000136-26)
  • 22 Feb 2021 Novartis Pharmaceuticals completes a phase III trial in Acute myeloid leukaemia (Combination therapy, First-line therapy, Newly diagnosed, In adults, In the elderly) in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Norway, Poland, Portugal, Spain, Switzerland, Taiwan, Turkey, USA (PO) (NCT03512197; EudraCT2017-003540-21)
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