Darolutamide - Bayer HealthCare/Orion
Alternative Names: BAY-1841788; Darramamide; NUBEQA; ODM 201Latest Information Update: 22 Jul 2024
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
- 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)