NDAORALTABLETPriority Review
Approved
Jul 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
46
Data completeness
6/8 — Strong
Priority Review
NUBEQA (darolutamide) by Bayer is (ar) inhibitor. First approved in 2019.
Drug data last refreshed 4h ago · AI intelligence enriched 1mo 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
Peak15.9 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 (46)
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
PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC
Started Aug 2026
254 enrolled
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
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 Jul 2026
800 enrolled
Non-metastatic Castration-resistant Prostate Cancer
177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial
Started Jul 2026
20 enrolled
Prostate CancerProstate Cancer Patients
A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide
Started Jun 2026
3,000 enrolled
Prostate Cancer
Worked on NUBEQA at Bayer? Share your interview experience or compensation data (+7 days Pro)
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.