Drug profile · INN
darolutamide
NUBEQA
darolutamide (NUBEQA) is a androgen receptor antagonist. Associated with Bayer Australia Ltd. Route of administration: oral. Current US regulatory status: approved.
Drug details — darolutamide
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L02)
- Route
- ORAL
- Patents
- 2
- Programs
- 16
- Data quality
- 0.84
Quick answer
darolutamide (NUBEQA) is a androgen receptor antagonist. Associated with Bayer Australia Ltd. Route of administration: oral. Current US regulatory status: approved.
Key facts
Mechanism of action
Androgen Receptor antagonist
Primary target: Androgen receptor
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
| PMDA | approved | — |
Pipeline programs
Related & competitor drugs
Related patents
Frequently asked questions
What is darolutamide?
darolutamide (NUBEQA) is a androgen receptor antagonist. Associated with Bayer Australia Ltd. Route of administration: oral. Current US regulatory status: approved.
What is the brand name for darolutamide?
NUBEQA is a marketed brand name for darolutamide. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of darolutamide?
darolutamide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.