NDAORALCAPSULEPriority Review
Approved
Aug 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
XTANDI (enzalutamide) by Astellas is androgen receptor antagonists [moa]. Approved for androgen receptor inhibitor [epc]. First approved in 2012.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XTANDI (enzalutamide) is an oral androgen receptor antagonist approved in 2012 for the treatment of prostate cancer. It works by blocking androgen receptor signaling, a key driver of prostate cancer cell growth. The drug is indicated for men with castration-resistant prostate cancer (CRPC) and other androgen-sensitive disease states.
$2.6BPart D
PeakStable
10.4 years to LOEPeak lifecycle status indicates stable commercial operations with established market penetration; brand team size likely mature but not in growth-phase hiring mode.
Mechanism of Action
Androgen Receptor Antagonists
Pharmacologic Class:
Androgen Receptor Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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 How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer
Started Aug 2026
56 enrolled
Prostate Cancer
A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy
Started Aug 2026
60 enrolled
Metastatic Castrate Resistant Prostate Cancer (mCRPC)Prostate Cancer (Adenocarcinoma)
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
Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Started Jun 2026
20 enrolled
Castration-Resistant Prostate CarcinomaMetastatic Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
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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.