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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: 02 Apr 2026

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At a glance

  • Originator Aragon Pharmaceuticals; University of California
  • Developer Aragon Pharmaceuticals; Case Comprehensive Cancer Center; Dana-Farber Cancer Institute; 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 Salivary gland cancer

Most Recent Events

  • 16 Mar 2026 Janssen and M. D. Anderson Cancer Center terminates a phase II trial in Prostate cancer (Combination therapy, Hormone refractory, Metastatic disease, Second-line therapy or greater) in USA (PO), due to less than 70 per participation (NCT03360721)
  • 22 Jan 2026 Janssen Pharmaceuticals, Memorial Sloan Kettering Cancer Center, University of Michigan and Weill Medical College of Cornell University complete the phase II AASUR trial for Prostate cancer (Combination therapy) in USA (PO) (NCT02772588)
  • 17 Oct 2025 Efficacy data from a phase III LIBERTAS trial in Prostate cancer presented at the 50th European Society for Medical Oncology Congress (ESMO-2025)

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