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Darolutamide - Bayer HealthCare/Orion

Drug Profile

Darolutamide - Bayer HealthCare/Orion

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

Latest Information Update: 26 Mar 2024

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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.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Prostate cancer
  • Phase II Triple negative breast cancer

Most Recent Events

  • 13 Mar 2024 Swiss Group for Clinical Cancer Research terminates a phase II trial in Prostate cancer (Metastatic disease, Second-line therapy or greater, Hormone refractory) in France, Italy, Spain and Switzerland (PO), due to lack of financial support from the decision board (NCT02933801)
  • 25 Jan 2024 Updated efficacy and adverse events data from a phase III ARASENS trial in Prostate cancer presented at the 2024 Genitourinary Cancers Symposium (ASCO-GeCS-2024)
  • 20 Oct 2023 Efficacy data from the phase III ARAMIS trial in Prostate cancer presented at the 48th European Society for Medical Oncology Congress (ESMO-2023)
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