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 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ERLEADA (apalutamide) is an oral small-molecule androgen receptor (AR) inhibitor approved in February 2018 for the treatment of prostate cancer. The drug works by binding directly to the ligand-binding domain of the AR, inhibiting nuclear translocation, DNA binding, and AR-mediated transcription, thereby decreasing tumor cell proliferation and increasing apoptosis. ERLEADA is positioned as a first-line therapy in the prostate cancer treatment landscape, competing against other AR inhibitors and hormone-based therapies.
$1.1BPart D
14.7 years to LOEMechanism 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)
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 Mar 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
270 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
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
Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer
Started Apr 2025
78 enrolled
Metastatic Castrate-Resistant Prostate Cancer (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.