TheraRadar
Data updated: May 26, 2026

ERLEADA (apalutamide)

Trial Activity: Growth 42 active trials
Priority Review Fast Track
Oncology Approved 2018-02-14

Erleada treats patients with specific forms of prostate cancer, including cases that have spread to other parts of the body and remain sensitive to hormone therapy. It is also used for patients whose cancer has not spread but has become resistant to standard testosterone-lowering treatments. This medication helps patients manage both metastatic castration-sensitive and non-metastatic castration-resistant stages of the disease.

Source: FDA Label • Johnson & Johnson
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ERLEADA Works

This medication works by binding directly to androgen receptors to block the hormonal signals that drive cancer growth. It prevents these receptors from entering the cell nucleus and binding to DNA, which stops the genetic instructions that allow tumor cells to multiply. This process helps increase cancer cell death and can lead to a reduction in tumor volume.

Source: FDA Label

Development Insights

Janssen Research & Development, LLC conducting 12 trials (16%)
69 indications explored (Broad Platform)
→ prostate cancer (21 trials)
→ prostate adenocarcinoma (10 trials)
→ prostatic neoplasms (10 trials)
5
Indications
--
Phase 3 Trials
3
Priority Reviews
8
Years on Market

Details

Status
Prescription
First Approved
2018-02-14
Patent Cliff
2041
Revenue
$980M (Q4-2025)

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

Johnson & Johnson
Active Ingredient: APALUTAMIDE

ERLEADA Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
30 FDA actions from 2018 to 2026 · 4 indication expansions
Mar 2026 SUPPL
Label · Labeling
FDA Letter Label
Aug 2024 SUPPL
Label · Labeling
FDA Letter Label
Jul 2024 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What ERLEADA Treats

2 indications

ERLEADA is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Metastatic Castration-Sensitive Prostate Cancer
  • Non-Metastatic Castration-Resistant Prostate Cancer
Source: FDA Label

ERLEADA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

4

Same target(s) AND same indication — head-to-head.

NUBEQA
Bayer
2019 1 indic.
XTANDI
ASTELLAS
2012 3 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

RYBREVANT FASPRO
Johnson &
2025 1 indic.
HYRNUO
Bayer
2025 1 indic.
Unlock 10 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in ERLEADA's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ERLEADA treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to ERLEADA

3 of 4

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

APALUTAMIDE
APALUTAMIDE
2 shared
ZYDUS
Shared indications:
Metastatic Castration-Sensitive Prostate CancerNon-Metastatic Castration-Resistant Prostate Cancer
ABIRATERONE ACETATE
ABIRATERONE ACETATE
1 shared
Teva
Shared indications:
Metastatic Castration-Sensitive Prostate Cancer
XTANDI
ENZALUTAMIDE
1 shared
ASTELLAS
Shared indications:
Metastatic Castration-Sensitive Prostate Cancer
View all 4 similar drugs Pro
📋

Clinical Trial Registry

77 trials
Trial Sponsor ID Phase Status Title
NCT01946204 SPARTAN results posted CR102931 ARN-509-003; 56021927PCR1007, 2012-004322-24 Ph 3 active not recruiting A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
NCT02257736 results posted CR105505 56021927PCR3001, 2014-001718-25 Ph 3 active not recruiting An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT04108208 results posted CR108660 56021927PCR4007 Ph 4 active not recruiting A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)
NCT02489318 TITAN results posted CR107614 56021927PCR3002, 2015-000735-32 Ph 3 active not recruiting A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
NCT06931340 A032302 NCI-2025-00838 Ph 3 recruiting Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
NCT04662580 ARX517 ARX517-2011 ARX517-2011 Ph 1 active not recruiting ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer
NCT04557059 PRIMORDIUM CR108705 56021927PCR3015, 2019-002957-46 Ph 3 active not recruiting A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
NCT03523442 CR107444 56021927PCR1013 Ph 1 active not recruiting A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer
NCT05818683 CR109321 78278343PCR1003, 2022-503132-14-00 Ph 1 recruiting A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
NCT03767244 PROTEUS CR108535 56021927PCR3011, 2018-001746-34 Ph 3 active not recruiting A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
NCT04325828 YATAGARASU results posted CR108758 56021927SGT2001 Ph 2 active not recruiting A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
NCT02531516 CR106935 56021927PCR3003, 2015-003007-38 Ph 3 active not recruiting An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
NCT04134260 NRG-GU008 NCI-2019-06838, NRG-GU008 Ph 3 recruiting Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial
NCT04423211 EA8191 NCI-2020-02686, EA8191 Ph 3 recruiting Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
NCT06095089 CR109330 87189401PCR1001, 2023-504063-17-00 Ph 1 recruiting A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
NCT04513717 NRG-GU009 NCI-2020-04705, NRG-GU009 Ph 3 active not recruiting Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial
NCT03436654 17-646 PCCTC #: c16-183 Ph 2 active not recruiting Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma
NCT06274047 2023-0409 NCI-2024-01553 Ph 3 recruiting 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.
NCT04530552 results posted NCI-2020-06322 NCI-2020-06322, 2102475889 Ph 2 active not recruiting Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland
NCT04523207 results posted CR108875 56021927PCR2041 Ph 2 completed A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
NCT06378866 DIVINE MC230502 R01CA286127, 23-012176 Ph 2 recruiting Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
NCT02913196 1509016578 Ph 1 completed Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC
NCT03821792 2018-0533 NCI-2018-03599, 2018-0533 Ph 2 active not recruiting Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer
NCT07002320 ASpiRE CCR6041 1008729 Ph 1, Ph 2 recruiting Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer
NCT06592924 TRIPLE-SWITCH CCTG-PR26 CCTG-PR26, NCI-2024-07535 Ph 3 recruiting Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
NCT05960578 RG1123487 NCI-2023-04887, FHIRB0020135 Ph 2 active not recruiting Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study
NCT03088124 PC-ARN PC-ARN IPC-2015-025 Ph 2 completed Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer
NCT03412396 results posted 2015-0693 NCI-2018-00902, 2015-0693 Ph 2 active not recruiting Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy
NCT03360721 2017-0060 NCI-2018-01054, 2017-0060 Ph 2 terminated Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer
NCT05751941 MCC-22003 Ph 2 recruiting Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer
NCT05884398 LIBERTAS CR109327 56021927PCR3020, 2022-502686-24-00 Ph 3 active not recruiting A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
NCT02703623 2014-0386 NCI-2016-00670, 2014-0386 Ph 2 active not recruiting Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
NCT04947254 2020-1039 NCI-2021-05724, 2020-1039 Ph 2 recruiting Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer
NCT03902951 18-001037 NCI-2019-00337 Ph 2 active not recruiting Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer
NCT05534646 IIT2021-06-Posadas-APA105 Ph 2 recruiting Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
NCT03503344 PILLAR results posted 175519 NCI-2018-00572 Ph 2 completed Apalutamide With or Without Stereotactic Body Radiation in Treating Castration-Resistant Prostate Cancer
NCT04267887 STUDY00016728 NCI-2020-00598, STUDY00016728 Ph 2 active not recruiting Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer
NCT03371719 NRG-GU006 NCI-2017-01268, NRG-GU006 Ph 2 active not recruiting Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial
NCT03009981 AFT-19 Ph 3 completed A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
NCT05367440 PETRANHA D9720C00003 2023-508536-64-00, 2021-006289-19 Ph 1, Ph 2 active not recruiting Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer
NCT04666129 MVT-601-049 Ph 1 completed Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
NCT03298087 results posted ONCA-013-16F Ph 2 completed Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer
NCT04181203 CARLHA-2 GETUG-AFU33 UC-0160/1702 2017-000155-21 Ph 3 active not recruiting Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy
NCT04154774 CR108714 56021927PCR1026 Ph 1 completed A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function
NCT06067269 HEATWAVE 23-000429 NCI-2023-06647 Ph 2 recruiting Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial
NCT02903368 results posted 16-223 Ph 2 completed Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy
NCT04926181 results posted 21553 NCI-2021-05986 Ph 2 terminated Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer
NCT03903835 ProBio EudraCT No 2018-002350-78 Ph 3 recruiting ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
NCT04421222 EPI-7386 EPI-7386-CS-001 Ph 1 terminated Oral EPI-7386 in Patients with Castration-Resistant Prostate Cancer
NCT03802682 CR108562 2018-003774-27, 56021927PCR1024 Ph 1 completed A Study of Apalutamide Administered Orally as Whole Tablets and as a Mixture in Applesauce in Healthy Participants

Showing 50 of 77 trials

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ERLEADA FDA Label Details

Indications & Usage

FDA Label (PDF)

ERLEADA is indicated for the treatment of Metastatic Castration-Sensitive Prostate Cancer; Non-Metastatic Castration-Resistant Prostate Cancer.

View full patent landscape →
12 OB patents · 6 families · 471 international docs across 50 countries

ERLEADA Patents & Exclusivity

Latest Patent: Jan 2041

Patents (14 active)

US11723898 Expires Jan 14, 2041
US12303497 Expires Jan 30, 2040
US11963952 Expires Jan 30, 2040
US10702508 Expires Apr 30, 2038
US12303493 Expires Dec 3, 2035
US9884054 Expires Sep 23, 2033
USRE50642 Expires Sep 23, 2033
USRE49353 Expires Sep 23, 2033
US10849888 Expires Sep 23, 2033
US9481663 Expires Jun 4, 2033
US8445507 Expires Sep 15, 2030
US8802689 Expires Mar 27, 2027
US9987261 Expires Mar 27, 2027
US9388159 Expires Mar 27, 2027
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for ERLEADA

Revenue Insights

  • • Q4-2025: $980M
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2041
  • • 72 active patents

Trial Analysis

  • • 76 total trials
  • • Stage: Growth

Competitive Landscape

  • • 4 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA210951 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment