Glasdegib - Pfizer

Drug Profile

Glasdegib - Pfizer

Alternative Names: PF 04; PF-04449913; PF-4449913

Latest Information Update: 30 Jul 2018

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At a glance

  • Originator Pfizer
  • Developer Grupo Espanol de Trasplante Hematopoyetico y Terapia Celular; H. Lee Moffitt Cancer Center and Research Institute; Netherlands Cancer Institute; Pfizer
  • Class Antineoplastics; Benzimidazoles; Phenylurea compounds; Piperidines; Small molecules
  • Mechanism of Action Hedgehog cell-signalling pathway inhibitors; SMO protein inhibitors
  • Orphan Drug Status

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

    Yes - Myelodysplastic syndromes; Acute myeloid leukaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Acute myeloid leukaemia
  • Phase II Chronic myeloid leukaemia; Colorectal cancer; Myelodysplastic syndromes; Myelofibrosis; Non-small cell lung cancer
  • Phase I/II Chronic myelomonocytic leukaemia; Glioblastoma; Graft-versus-host disease
  • Phase I Cancer; Haematological malignancies
  • No development reported Solid tumours

Most Recent Events

  • 27 Jun 2018 Preregistration for Acute myeloid leukaemia (Combination therapy, First-line therapy) in USA (PO)
  • 27 Jun 2018 FDA assigns PDUFA action date of December 2018 for glasdegib for Acute myeloid leukaemia (Combination therapy, First-line therapy)
  • 27 Jun 2018 The US FDA grants a Priority Review status for glasdegib's NDA in Acute myeloid leukaemia (Combination therapy, First-line therapy) in USA (PO)
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