NDAORALTABLETPriority Review
Approved
Jul 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
45
Data completeness
6/8 — Strong
Priority Review
NUBEQA (darolutamide) by Bayer is (ar) inhibitor. Approved for prostate cancer, metastatic hormone-sensitive prostate cancer, non-metastatic castration-resistant prostate cancer. First approved in 2019.
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUBEQA (darolutamide) is an oral androgen receptor (AR) inhibitor approved by the FDA on July 30, 2019, for the treatment of prostate cancer. The drug competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription, with its major metabolite ketodarolutamide demonstrating similar in vitro activity. Darolutamide also exhibits progesterone receptor antagonist activity at approximately 1% relative to AR activity. It represents a key therapeutic option in the non-metastatic castration-resistant prostate cancer (nmCRPC) treatment landscape.
$0.6BPart D
16.1 years to LOEMechanism of Action
(AR) inhibitor. Darolutamide competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. A major metabolite, ketodarolutamide, exhibited similar in vitro activity to darolutamide. In addition, darolutamide functioned as a progesterone receptor (PR) antagonist…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.