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Darolutamide - Bayer HealthCare/Orion

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Drug Profile

Darolutamide - Bayer HealthCare/Orion

Alternative Names: BAY-1841788; Darramamide; NUBEQA; ODM 201

Latest Information Update: 26 Aug 2025

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At a glance

  • Originator Orion
  • Developer Bayer HealthCare; Dana-Farber Cancer Institute; Latin American Cooperative Oncology Group; Orion; UNICANCER
  • Class Amides; Antiandrogens; Antineoplastics; Chlorobenzenes; Nitriles; Pyrazoles; Small molecules
  • 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 III Cancer
  • Phase II Triple negative breast cancer

Most Recent Events

  • 21 Aug 2025 Launched for Prostate cancer (Combination therapy, Metastatic disease, Hormone refractory) in Canada (PO)
  • 21 Aug 2025 Registered for Prostate cancer (Metastatic disease, Combination therapy, Hormone refractory) in Canada (PO)
  • 21 Jul 2025 Launched for Prostate cancer (Metastatic disease, Adjunctive treatment) in European Union (PO), prior to July 2025

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