Pexidartinib

Drug Profile

Pexidartinib

Alternative Names: PLX-3397

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Plexxikon
  • Developer AstraZeneca; Barbara Ann Karmanos Cancer Institute; Centre Leon Berard; Columbia University; 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; Immunomodulators; Macrophage colony stimulating factor receptor antagonists; Proto oncogene protein c-akt inhibitors; 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Pigmented villonodular synovitis
  • Phase II Glioblastoma; Malignant melanoma; Prostate cancer
  • Phase I/II 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 Acute myeloid leukaemia; Hodgkin's disease

Most Recent Events

  • 30 Nov 2016 Plexxikon plans a phase I/II trial for Malignant melanoma (Inoperable/Unresectable, Metastatic disease, Late-stage disease) in South Korea and China (PO) (NCT02975700)
  • 21 Oct 2016 Daiichi Sankyo, based on recommendation from a Data Monitoring Committee, discontinues further enrolment in the phase III ENLIVEN trial in Pigmented villonodular synovitis in US, Australia, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain and the UK
  • 01 Jun 2016 Phase-I clinical trials in Solid tumours (Second-line therapy or greater, late-stage disease) in Taiwan (PO) (NCT02734433)
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