NDAORALTABLETPriority Review
Approved
Jul 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
43
Data completeness
6/8 — Strong
Priority Review
NUBEQA (darolutamide) by Bayer is (ar) inhibitor. First approved in 2019.
Drug data last refreshed Yesterday · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUBEQA (darolutamide) is an oral androgen receptor (AR) inhibitor approved in 2019 for prostate cancer. It competitively blocks androgen binding, AR nuclear translocation, and AR-mediated transcription, with a major active metabolite (ketodarolutamide) that mirrors its mechanism. The drug demonstrated efficacy in reducing prostate cancer cell proliferation and tumor volume in preclinical models.
$0.576BPart D
Peak16.0 years to LOENUBEQA is in peak revenue phase with established market presence and sustained spending, supporting mid-to-large team infrastructure.
Mechanism 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…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (43)
An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment
Started Jun 2026
800 enrolled
Non-metastatic Castration-resistant Prostate Cancer
Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
Started May 2026
40 enrolled
Prostate CancerHigh-risk Prostate Cancer
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
Started Apr 2026
250 enrolled
High-Risk Localized Prostate Cancer
How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany
Started Apr 2026
500 enrolled
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
Started Mar 2026
60 enrolled
Metastatic Castration-resistant Prostate Cancer
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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.