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Axatilimab - Syndax Pharmaceuticals

Drug Profile

Axatilimab - Syndax Pharmaceuticals

Alternative Names: Anti-CSF-1R monoclonal antibody - Syndax Pharmaceuticals; Axatilamab; INCA-34176; SNDX-6352; UCB 6352

Latest Information Update: 25 Mar 2024

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At a glance

  • Originator UCB
  • Developer AstraZeneca; Incyte Corporation; Syndax Pharmaceuticals
  • Class Antifibrotics; Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Macrophage colony stimulating factor receptor antagonists
  • Orphan Drug Status

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

    Yes - Graft-versus-host disease; Idiopathic pulmonary fibrosis
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Graft-versus-host disease
  • Phase II Cholangiocarcinoma; Hodgkin's disease; Idiopathic pulmonary fibrosis; SARS-CoV-2 acute respiratory disease; Triple negative breast cancer
  • No development reported Cancer; Solid tumours

Most Recent Events

  • 20 Mar 2024 Incyte Corporation plans a phase-I/II trial for Solid tumours (Combination therapy, Second-line therapy or greater, Metastatic disease) in USA (IV) (NCT06320405)
  • 29 Feb 2024 FDA assigns PDUFA action date of (28/08/2024) for Axatilimab for Graft-verses-host-disease
  • 27 Feb 2024 Axatilimab receives priority review status for Graft-verses-host-review in USA
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