Darolutamide - Bayer HealthCare/Orion
Alternative Names: BAY-1841788; Darramamide; NUBEQA; ODM 201Latest Information Update: 23 Jul 2025
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
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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
- 21 Jul 2025 Launched for Prostate cancer (Metastatic disease, Adjunctive treatment) in European Union (PO), prior to July 2025
- 21 Jul 2025 Launched for Prostate cancer (Metastatic disease, Combination therapy, Adjunctive treatment, Newly diagnosed) in European Union (PO), prior to July 2025
- 21 Jul 2025 Registered for Prostate cancer (Metastatic disease, Adjunctive treatment) in Liechtenstein, Iceland, Norway, European Union (PO)