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Gilteritinib - Astellas Pharma

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Drug Profile

Gilteritinib - Astellas Pharma

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

Latest Information Update: 28 Feb 2024

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At a glance

  • Originator Astellas Pharma; Kotobuki Pharmaceutical
  • Developer AbbVie; Astellas Pharma; Genentech
  • Class Amides; Aniline compounds; Antineoplastics; Piperazines; Piperidines; Pyrans; Pyrazines; Small molecules
  • Mechanism of Action Anaplastic lymphoma kinase inhibitors; 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

  • Marketed Acute myeloid leukaemia
  • Discontinued Non-small cell lung cancer; Solid tumours

Most Recent Events

  • 28 Feb 2024 No recent reports of development identified for phase-I development in Acute-myeloid-leukaemia(In volunteers) in Bulgaria (PO, Tablet)
  • 19 Feb 2024 Astellas Pharma completes a phase III trial in Acute myeloid leukaemia in United Kingdom, Turkey, Taiwan, Sweden, Spain, Serbia, Portugal, Portugal, Poland, Romania, Japan, South Korea, Italy, Israel, Hungary, Greece, Germany, France, Denmark, Czech Republic, Croatia, Chile, Canada, Brazil, Argentina, Australia, USA (PO) (post-chemo maintenance therapy) (NCT02927262)
  • 09 Jun 2023 Efficacy data from a phase III MORPHO trial in Acute myeloid leukemia released by Astellas Pharma
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