NDAORALTABLETPriority Review
Approved
Jul 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
51
Data completeness
6/8 — Strong
Priority Review
NUBEQA (darolutamide) by Bayer is (ar) inhibitor. First approved in 2019.
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUBEQA (darolutamide) is an oral androgen receptor (AR) inhibitor approved for prostate cancer that competitively blocks androgen binding, AR nuclear translocation, and AR-mediated transcription. It demonstrates activity comparable to its major metabolite ketodarolutamide and functions as a weak progesterone receptor antagonist, reducing prostate cancer cell proliferation in preclinical models.
$0.576BPart D
Peak15.7 years to LOENUBEQA is at peak commercial stage with substantial Medicare spending (~$576M in 2023), suggesting stable market presence and mature team structure.
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 (51)
A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India
Started Oct 2026
50 enrolled
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC
Started Sep 2026
254 enrolled
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC)
Started Sep 2026
4,700 enrolled
Metastatic Castration Sensitive Prostate Cancer (mCSPC)
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Started Aug 2026
600 enrolled
Metastatic Castration Resistant Prostate Cancer
Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer.
Started Aug 2026
200 enrolled
Prostate CancerProstateProstate Cancer Patients
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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.