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Pexidartinib - Plexxikon

Drug Profile

Pexidartinib - Plexxikon

Alternative Names: Pexidartinib hydrochloride; Plexxikon 3397; PLX-3397

Latest Information Update: 07 Feb 2019

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At a glance

  • Originator Plexxikon
  • Developer Array BioPharma; AstraZeneca; Barbara Ann Karmanos Cancer Institute; Centre Leon Berard; Columbia University; Memorial Sloan-Kettering Cancer Center; Merck & Co; National Cancer Institute (USA); Plexxikon; University of California at San Francisco
  • Class 2 ring heterocyclic compounds; Antineoplastics; Fluorine compounds; Pyridines; Pyrroles; Small molecules
  • Mechanism of Action Fms-like tyrosine kinase 3 inhibitors; Macrophage colony stimulating factor inhibitors; Macrophage colony stimulating factor receptor antagonists; 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.

    Yes - Giant cell tumour of tendon sheath; Pigmented villonodular synovitis
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Pigmented villonodular synovitis
  • Phase II Alzheimer's disease; Glioblastoma; Malignant melanoma; Prostate cancer
  • Phase I/II Acute myeloid leukaemia; Breast cancer; Leukaemia; Peripheral nervous system diseases; Sarcoma; Solid tumours
  • Phase I Colorectal cancer; Gastrointestinal stromal tumours; Pancreatic cancer
  • No development reported Neurological disorders; Rheumatoid arthritis
  • Discontinued Hodgkin's disease

Most Recent Events

  • 05 Feb 2019 Preregistration for Pigmented villonodular synovitis in USA (PO)
  • 05 Feb 2019 Pexidartinib receives priority review status for Pigmented villonodular synovitis in USA
  • 05 Feb 2019 The US FDA sets planned Prescription Drug User Fee Act (PDUFA) date for Pigmented villonodular synovitis to 03 August 2019 for priority NDA review of pexidartinib
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