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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: 16 Mar 2026

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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

  • 16 Mar 2026 Bayer completes the phase III ARANOTE trial in Prostate cancer (Adjunctive treatment, Metastatic disease) inAustralia, Brazil, Canada, Chile, China, India, Latvia, Lithuania, New Zealand, Peru, Russia, South Africa, Spain, Taiwan, Ukraine(PO) (NCT04736199)
  • 03 Mar 2026 Bayer plans a phase II CHINANEO trial for Prostate Cancer(Neoadjuvant therapy, Combination therapy, First-line therapy or greater) in China (PO) in April 2026 (NCT07450599)
  • 03 Feb 2026 Registered for Prostate cancer (Combination therapy, Metastatic disease) in China (PO)

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