Enzalutamide

Drug Profile

Enzalutamide

Alternative Names: ASP 9785; MDV 3100; Xtandi

Latest Information Update: 01 Dec 2016

Price : $50

At a glance

  • Originator University of California at Los Angeles; University of Texas M. D. Anderson Cancer Center
  • Developer Astellas Pharma; H. Lee Moffitt Cancer Center and Research Institute; M. D. Anderson Cancer Center; Medivation; National Cancer Institute (USA); Queen Mary University of London; The Prostate Cancer Clinical Trials Consortium; University of California, Davis; University of Chicago
  • Class Antineoplastics; Benzamides; Fluorobenzenes; Imidazolidines; Nitriles; Small molecules; Thiones
  • Mechanism of Action Androgen receptor antagonists; Apoprotein stimulants; Apoptosis stimulants
  • Orphan Drug Status

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

    No
  • 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

  • Marketed Prostate cancer
  • Phase III Breast cancer
  • Phase II Endometrial cancer; Hepatocellular carcinoma; Salivary gland cancer
  • Phase I Pancreatic cancer

Most Recent Events

  • 14 Nov 2016 Expanded access phase II trial for Prostate cancer is no longer available in Australia, Belgium, Canada, Chile, Czech Republic, Denmark, France, Georgia, Germany, Moldova, Netherlands, Russia, South Africa, Spain, United Kingdom, USA as the treatment is approved for sale to the public (PO, Capsule) (EudraCT2016-001694-32; NCT02960022)
  • 01 Nov 2016 Astellas Pharma Global Development initiates an expanded access phase II trial for Prostate cancer in Australia, Belgium, Canada, Chile, Czech Republic, Denmark, France, Georgia, Germany, Moldova, Netherlands, Russia, South Africa, Spain, United Kingdom, USA (PO, Capsule) (EudraCT2016-001694-32; NCT02960022)
  • 21 Oct 2016 US FDA approves sNDA to update enzalutamide label for Prostrate cancer
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