Drug Profile


Alternative Names: ASP-2215; ASP2215 hemifumarate; Gilteritinib fumarate

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Astellas Pharma
  • Class Amides; Aniline compounds; Antineoplastics; Piperazines; Piperidines; Pyrans; Pyrazines; Small molecules
  • Mechanism of Action Axl receptor tyrosine kinase inhibitors; Fms-like tyrosine kinase 3 inhibitors; 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.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Acute myeloid leukaemia
  • Phase I/II Non-small cell lung cancer; Solid tumours

Most Recent Events

  • 01 Mar 2017 Astellas Pharma initiates an expanded access of gilteritinib for Acute myeloid leukaemia (NCT03070093)
  • 15 Dec 2016 Astellas Pharma, National Heart, Lung, and Blood Institute and Blood and Marrow Transplant Clinical Trials Network plan a phase III trial for Acute myeloid leukaemia (Monotherapy, Second-line therapy or greater) in Italy, South Korea, Poland, Greece, Belgium, Germany, Canada, Australia, USA, Denmark, Taiwan, France, Japan, Spain and United Kingdom (PO) (NCT02997202)
  • 08 Dec 2016 Astellas Pharma terminates a phase I/II trial in Non-small cell lung cancer (Combination therapy, Second-line therapy or greater, Metastatic disease, Late-stage disease) in Japan due to adverse events related to the combination therapy (PO) (NCT02495233)
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