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 Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XTANDI (enzalutamide) is an oral small-molecule androgen receptor antagonist approved by the FDA on August 31, 2012, for the treatment of prostate cancer. It works by inhibiting androgen receptor signaling, a key driver of prostate cancer cell growth. XTANDI is indicated for patients with castration-resistant prostate cancer and represents a foundational therapy in the androgen deprivation treatment landscape.
$2.6BPart D
10.8 years to LOEMechanism 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)
Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Started Jun 2026
39 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
A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)
Started Jul 2025
1,300 enrolled
Metastatic Castration Sensitive Prostate Cancer (mCSPC)Cancer of the ProstateProstate Neoplasms+1 more
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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.