Apalutamide - Janssen Research and Development

Drug Profile

Apalutamide - Janssen Research and Development

Alternative Names: ARN-509; JNJ-56021927; JNJ-927

Latest Information Update: 26 Dec 2017

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At a glance

  • Originator University of California System
  • Developer Case Comprehensive Cancer Center; Dana-Farber Cancer Institute; Institut Paoli-Calmettes; Janssen Research & Development; Singapore General Hospital
  • Class Antiandrogens; Antihormones; Antineoplastics; Aza compounds; Benzamides; Pyridines; Small molecules; Spiro compounds; Sulfhydryl compounds; Thiohydantoins
  • Mechanism of Action Androgen receptor antagonists; Hormone inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Prostate cancer

Most Recent Events

  • 28 Dec 2017 NRG Oncology and National Cancer Institute plan a phase II trial in Prostate cancer (Late-stage disease) in USA in February 2018 (NCT03371719)
  • 21 Dec 2017 Apalutamide receives priority review status for Prostate cancer (Hormone refractory, Second-line therapy or greater)
  • 21 Dec 2017 FDA assigns PDUFA action date of 01/04/2018 for apalutamide for non-metastatic castration-resistant Prostate cancer
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