Gilteritinib - Astellas Pharma

Drug Profile

Gilteritinib - Astellas Pharma

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

Latest Information Update: 30 Jan 2018

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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
  • Orphan Drug Status

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

    Yes - Acute myeloid leukaemia
  • 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

  • 24 Jan 2018 Astellas Pharma initiates an expanded-access programme for Acute myeloid leukaemia (Second-line therapy or greater) in USA (NCT03409081)
  • 23 Jan 2018 Gilteritinib - Astellas Pharma receives Orphan Drug status for Acute myeloid leukaemia in European Union
  • 11 Dec 2017 Adverse events data from a phase I trial in Acute myeloid leukaemia presented at the Annual Meeting of the American Society of Haematology (ASH-2017)
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