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: 04 Nov 2018

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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
  • Phase I Rectal cancer
  • Discontinued Acute biphenotypic leukaemia; Colorectal cancer; Diabetic macular oedema; Gastrointestinal stromal tumours; Multiple myeloma

Most Recent Events

  • 22 Oct 2018 University of Florida and Novartis withdraw a phase II trial for Acute myeloid leukaemia (Second-line therapy or greater, Refractory metastatic disease, Combination therapy) in USA prior to enrolment, due to insufficient funding (NCT03207334)
  • 24 Jul 2018 Novartis Pharmaceuticals plans a phase II trial for Acute Myeloid Leukaemia (First-line therapy) in October 2018 , (NCT03591510)
  • 02 Jul 2018 Phase-III clinical trials in Acute myeloid leukaemia (Combination therapy, First-line therapy, Newly diagnosed, In adults, In the elderly) in Belgium, Hungary, Portugal (PO) (NCT03512197; EudraCT2017-003540-21)
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