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Apalutamide - Janssen Research and Development

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Drug Profile

Apalutamide - Janssen Research and Development

Alternative Names: ARN-509; ERLEADA; Erleada; ERLYAND; JNJ-56021927; JNJ-927

Latest Information Update: 21 Mar 2025

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At a glance

  • Originator Aragon Pharmaceuticals; University of California
  • Developer Aragon Pharmaceuticals; Case Comprehensive Cancer Center; Dana-Farber Cancer Institute; Duke University Medical Center; Instituto do Cancer do Estado de Sao Paulo; Janssen Research & Development; M. D. Anderson Cancer Center; Singapore General Hospital
  • Class Antiandrogens; Antineoplastics; Aza compounds; Benzamides; Pyridines; Small molecules; Spiro compounds; Sulfhydryl compounds; Thiohydantoins
  • Mechanism of Action Androgen receptor antagonists
  • 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

  • Marketed Prostate cancer
  • Phase II Adenocarcinoma; Salivary gland cancer

Most Recent Events

  • 10 Feb 2025 Janssen Research & Development completes a phase I pharmacokinetic trial (In volunteers) in USA (PO) (NCT04154774)
  • 09 Jul 2024 Janssen and Duke University Medical Center completes the phase II PANTHER trial for Adenocarcinoma (First line therapy, Metastatic disease, Hormone refractory, Late-stage disease, Combination therapy) in USA (NCT03098836)
  • 31 May 2024 Efficacy and adverse events data from the phase II trial in Prostate cancer presented at the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO-2024)

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