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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: 25 Jun 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 II Triple negative breast cancer

Most Recent Events

  • 20 Jun 2025 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommends approval of Darolutamide for Prostate cancer (Combination therapy, Metastatic disease) in European Union (PO)
  • 20 Jun 2025 Updated efficacy and adverse events data from a phase III ARANOTE trial in Prostate cancer released by Bayer
  • 03 Jun 2025 Registered for Prostate cancer (Adjunctive treatment, Metastatic disease, In adults) in USA (PO)

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