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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: 22 Jul 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Prostate cancer
  • Phase II Triple negative breast cancer

Most Recent Events

  • 17 Jul 2024 Bayer plans to meet US FDA for the submission of NDA application for the treatment of Prostate cancer (Adjunctive treatment, Metastatic disease) in USA
  • 17 Jul 2024 Efficacy and adverse events data from a phase III trial in Prostate cancer released by the company
  • 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)

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