NDAORALTABLETPriority Review
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 6h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ERLEADA (apalutamide) is an oral small-molecule androgen receptor inhibitor approved for the treatment of prostate cancer in multiple disease states, including non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). It works by blocking androgen receptor signaling, a key driver of prostate cancer progression.
$1.1BPart D
PeakStable
14.3 years to LOEERLEADA is at peak commercial maturity with $1.1B in annual Part D spending (2023), indicating a large, established brand team managing a mature oncology asset.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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 How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer
Started Aug 2026
56 enrolled
Prostate Cancer
Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
Started Aug 2026
25 enrolled
Castration-Resistant Prostate Cancer (CRPC)Castration-Resistant Prostate CancerProstate Cancer+1 more
Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.
Started Jun 2026
320 enrolled
Metastatic Hormone-sensitive Prostate Cancer
A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
Started Dec 2025
540 enrolled
Prostatic NeoplasmsMetastatic Hormone-sensitive Prostate Cancer
Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
Started Dec 2025
1,260 enrolled
Castration-Sensitive 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.