NDAORALCAPSULEPriority Review
Approved
Aug 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
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 5h ago · AI intelligence enriched 1mo 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
10.3 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)
Deutenzalutamide and Hormone Therapy Before and After Surgery With Docetaxel Before Surgery for High-Risk Localized or Locally Advanced Prostate Cancer
Started Nov 2026
37 enrolled
Prostate Cancer (Adenocarcinoma)
A Phase 3 Study of Deutenzalutamide in Patients With High-Risk BCR Prostate Cancer
Started Oct 2026
1,044 enrolled
High Risk Biochemical Recurrence (BCR)Deutenzalutamide Soft Capsules
A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer
Started Sep 2026
56 enrolled
Prostate Cancer
AXT-1003 Combination With Enzalutamide in Participants With mCRPC
Started Sep 2026
105 enrolled
mCRPC
A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC)
Started Aug 2026
4,700 enrolled
Metastatic Castration Sensitive Prostate Cancer (mCSPC)
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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.