ERLEADA

Peak

apalutamide

NDAORALTABLETPriority Review
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

(AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. A major metabolite, N-desmethyl apalutamide, is a less potent inhibitor of AR, and exhibited one-third the activity…

Indications (1)

Clinical Trials (5)

NCT07451002N/ARecruiting

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
NCT06931340Phase 3Recruiting

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
NCT07086651N/ACompleted

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
NCT07002320Phase 1/2Recruiting

Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer

Started Apr 2025
78 enrolled
Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
NCT06274047Phase 3Recruiting

PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.

Started Sep 2024
120 enrolled
Androgen Axis SuppressionProstatectomyProstate Cancer

Loss of Exclusivity

LOE Date
Jan 30, 2040
169 months away
Patent Expiry
Jan 30, 2040

Patent Records (5)

Patent #ExpiryTypeUse Code
8802689
Mar 27, 2027
U-2624
9987261
Mar 27, 2027
Product
9388159
Mar 27, 2027
SubstanceProduct
8445507
Sep 15, 2030
SubstanceProduct
U-2624
9481663
Jun 4, 2033
SubstanceProduct
U-2237