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 42m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XTANDI (enzalutamide) is an oral androgen receptor antagonist that blocks androgen signaling in prostate cancer cells. It is indicated for patients with castration-resistant prostate cancer and works by inhibiting androgen receptor nuclear translocation and DNA binding. The drug represents a key treatment option in the hormonal therapy landscape for advanced prostate cancer.
$2.6BPart D
PeakStable
10.7 years to LOEEstablished peak-cycle product with strong commercial revenue and stable patient claims, indicating mature team infrastructure and sustained resource allocation.
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 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)
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
A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate
Started May 2026
126 enrolled
Prostate Cancer (Adenocarcinoma)mCRPC (Metastatic Castration-resistant Prostate Cancer)
This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
Started Sep 2025
1,000 enrolled
Metastatic Castration Sensitive Prostate Cancer (mCSPC)Hormone Sensitive Prostate CancerProstate Cancer+1 more
Study of TYK-00540 Combined With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer（mCRPC）
Started Aug 2025
48 enrolled
mCRPC
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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.