Erleada

(Apalutamide)

ApprovedSmall molecule

Apalutamide is used to treat prostate cancer by blocking male hormones that help cancer cells grow. It is given to men with prostate cancer that has spread to other parts of the body or is at high risk of spreading.[2] Erleada is currently approved and in use across 18 indications[4].[1]

Erleada is one of 299 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Approved.

Indications

107

Total Trials

Active Trials

298

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Prostate AdenocarcinomaApproved

Prostate CarcinomaActive, not recruiting

AdenocarcinomaActive, not recruiting

Metastatic Prostate CancerActive, not recruiting

Liver DiseaseApproved

Prostate CancerActive, not recruiting

Bladder CancerActive, not recruiting

Metastatic Castration-Resistant Prostate CancerRecruiting

Metastatic Castration-Resistant Prostate NeoplasmsRecruiting

Prostatic NeoplasmsActive, not recruiting

Prostate AdenocarcinomaApproved

Approved

Prostate CarcinomaApproved

Active, not recruiting

AdenocarcinomaPhase 2

Active, not recruiting

Metastatic Prostate CancerPhase 3

Active, not recruiting

Liver DiseaseApproved

Approved

Prostate CancerApproved

Active, not recruiting

Bladder CancerPhase 1

Active, not recruiting

Metastatic Castration-Resistant Prostate CancerPhase 3

Recruiting

Metastatic Castration-Resistant Prostate NeoplasmsPhase 1

Recruiting

Prostatic NeoplasmsPhase 3

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Erleada

Johnson & Johnson

Approved

56 2

Mekinist

Novartis

Preclinical

3 3

Trexall

Alnylam Pharmaceuticals

Preclinical

—4

Prednisone/prednisolone

Roche

Preclinical

3 5

Triptorelin Pamoate

Ipsen

Preclinical

2 6

Osmitrol

BB. Braun Medical Inc.

Preclinical

—7

Ifex

BBaxter Healthcare Corporation

Preclinical

—8

Therapeutic Hydrocortisone

EEastern Cooperative Oncology Group

Preclinical

9 9

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Xylocaine

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Prostate

NCT05683964

Recruiting

Prostatic Neoplasms

NCT07406282

Q4 2026

Phase 1Active, not recruiting

Abiraterone Acetate

NCT02913196

Phase 2Active, not recruiting

Metastatic Prostate Cancer

NCT03821792

Phase 2Active, not recruiting

Recurrent Prostate Carcinoma

NCT03371719

Phase 3Active, not recruiting

Prostate Adenocarcinoma

NCT04134260

Clinical

Trials by Indication[1]

Prostate Cancer56 trials

A Study of Cetrelimab (JNJ-63723283), a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, Administered in Combination With Apalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03551782·33 enrolled

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

Recruiting·IInstitute of Cancer Research, United Kingdom·Phase 1/2·NCT07002320·78 enrolled

Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT03279250·86 enrolled

Show 53 more trials

Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT04585932

TherApeutics in Early ProState Cancer (TAPS02)

Recruiting·—·Phase 2·NCT05191680·90 enrolled

PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06652607·152 enrolled

Adjuvant Apalutamide in Subjects With High-risk Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy

Active, not recruiting·UUniversität Münster·Phase 2·NCT04295447·190 enrolled

Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

Recruiting·UUniversity of British Columbia·Phase 2·NCT04812366·315 enrolled

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.

Not yet recruiting·AAlianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD·Phase 3·NCT07333066·320 enrolled

A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer

Terminated·—·Phase 2·NCT03093272·9 enrolled

A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT04034095·979 enrolled

A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely

Completed· Bayer logo

Bayer··NCT05202301·13,779 enrolled

An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings

Completed· Bayer logo

Bayer··NCT06013475·1,375 enrolled

Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels

Completed·LLatin American Cooperative Oncology Group·Phase 2·NCT02867020·128 enrolled

Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study

Active, not recruiting·UUniversity of Washington·Phase 2·NCT05960578·8 enrolled

An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer

No longer available·AAragon Pharmaceuticals, Inc.··NCT03523338

A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)

Completed· Pfizer logo

Pfizer··NCT07086651·1,300 enrolled

Apalutamide With Radiotherapy and Androgen Deprivation Therapy in Prostate Cancer

Withdrawn·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT03488810

Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases

Recruiting·ZZhujiang Hospital·N/A·NCT05740488·30 enrolled

Oral EPI-7386 in Patients with Castration-Resistant Prostate Cancer

Terminated·EESSA Pharmaceuticals·Phase 1·NCT04421222·71 enrolled

A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT04108208·75 enrolled

Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

Recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05406999·900 enrolled

Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT03360721·7 enrolled

Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

Recruiting·—·Phase 2·NCT05534646·100 enrolled

Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03412396·45 enrolled

A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson··NCT05901649·504 enrolled

Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance

Terminated·UUniversity of Washington·Phase 2·NCT02721979·24 enrolled

Apalutamide With or Without Stereotactic Body Radiation in Treating Castration-Resistant Prostate Cancer

Completed·UUniversity of California, San Francisco·Phase 2·NCT03503344·26 enrolled

Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer

Completed·SSingapore General Hospital·Phase 2·NCT03124433·30 enrolled

Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer

Terminated·RRahul Aggarwal·Phase 2·NCT04926181·2 enrolled

Apalutamide and Leuprolide in Intermediate and High-risk Prostate Cancer

Completed·—·Phase 2·NCT02770391·54 enrolled

A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02924766·34 enrolled

Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1·NCT04666129·48 enrolled

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

Recruiting·MMayo Clinic·Phase 2·NCT06378866·532 enrolled

Surgical Treatment With or Without Apalutamide in Subjects With High Risk Prostate Cancer Who Are Candidates for Radical Prostatectomy and Staged as Oligometastatic With PSMA-PET

Recruiting·MMarco Oderda·Phase 2·NCT06758882·94 enrolled

Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

Recruiting·CCanadian Cancer Trials Group·Phase 3·NCT06592924·830 enrolled

Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer

Terminated·—·Phase 3·NCT04409288·74 enrolled

Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02703623·196 enrolled

Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy

Completed·—·Phase 2·NCT02903368·118 enrolled

A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02906605

Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy

Active, not recruiting·UUNICANCER·Phase 3·NCT04181203·490 enrolled

ARN 509 Plus Everolimus in Men With Progressive Metastatic Castration-Resistant Prostate Cancer After Treatment With Abiraterone Acetate

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT02106507·9 enrolled

Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

Recruiting·EECOG-ACRIN Cancer Research Group·Phase 3·NCT04423211·804 enrolled

A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy

Completed·UUniversity of Washington·Phase 2·NCT02849990·22 enrolled

Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer

Completed·IInstituto do Cancer do Estado de São Paulo·Phase 2·NCT02789878·64 enrolled

A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05295927·3 enrolled

Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial

Recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT06067269·95 enrolled

Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.

Not yet recruiting·JJames J. Peters Veterans Affairs Medical Center·Phase 2·NCT05422911·200 enrolled

Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer

Withdrawn·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02811809

An Observational Study, Called DEAR, to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Men With Non-metastatic Castration-resistant Prostate Cancer in Real World Settings

Completed· Bayer logo

Bayer··NCT05362149·870 enrolled

Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer

Completed·IInstitut Paoli-Calmettes·Phase 2·NCT03088124·93 enrolled

A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR)

Completed·—·Phase 2·NCT03311555·39 enrolled

Therapeutics in Active Prostate Cancer Surveillance

Completed·CCCTU- Cancer Theme·Phase 2·NCT03365297·11 enrolled

A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

Completed·AAlliance Foundation Trials, LLC.·Phase 3·NCT03009981·504 enrolled

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Active, not recruiting·AAragon Pharmaceuticals, Inc.·Phase 3·NCT02489318·1,052 enrolled

A Phase II Randomized Study of Sipuleucel-T With or Without Continuing New Hormonal Agents (NHA) in Metastatic Prostate Cancer With PSA Progression While on NHA and LHRH Analog

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT05751941·26 enrolled

Metastatic Prostate Cancer15 trials

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04523207·108 enrolled

Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer

Active, not recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT04267887·7 enrolled

Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients

Recruiting·SSanta Chiara Hospital··NCT06473259·3,000 enrolled

Show 12 more trials

An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer

Recruiting·ZZhujiang Hospital·N/A·NCT04997252·50 enrolled

Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer

Unknown status·FFudan University·Phase 2·NCT05212857·160 enrolled

Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT05367440·174 enrolled

Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

Completed·VVA Office of Research and Development·Phase 2·NCT03298087·28 enrolled

Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland

Completed· Pfizer logo

Pfizer··NCT05701007·1,083 enrolled

An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States

Completed· Bayer logo

Bayer··NCT06204302·1,800 enrolled

Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer

Active, not recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT03902951·28 enrolled

ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

Recruiting·KKarolinska Institutet·Phase 3·NCT03903835·750 enrolled

Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study

Not yet recruiting·MMedical University of Vienna··NCT06430411·500 enrolled

Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03821792·60 enrolled

An Open-Label, Phase 1/1b Study of ORIC-944 as a Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer

Recruiting·OORIC Pharmaceuticals·Phase 1·NCT05413421·275 enrolled

A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of ARX517 as Monotherapy and in Combination With Androgen Receptor Pathway Inhibitors in Subjects With Metastatic Prostate Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04662580·183 enrolled

Prostatic Neoplasms8 trials

Double-DARE: Analysis of Doublet and Triplet Therapy With Darolutamide and Other Androgen Receptor Pathway Inhibitors in de Novo mHSPC Patients Seen in Urology Clinics in the USA

Recruiting· Bayer logo

Bayer··NCT07406282·1,400 enrolled

A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04557059·692 enrolled

A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Active, not recruiting·AAragon Pharmaceuticals, Inc.·Phase 3·NCT02257736·982 enrolled

Show 5 more trials

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT06095089·355 enrolled

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

Active, not recruiting·AAragon Pharmaceuticals, Inc.·Phase 3·NCT01946204·1,207 enrolled

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03767244·2,517 enrolled

ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy

Active, not recruiting·AAragon Pharmaceuticals, Inc.·Phase 3·NCT02531516·1,503 enrolled

A Phase 1 Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Subjects With Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03523442·19 enrolled

Androgen Deprivation Therapy2 trials

Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT

Terminated·—·Phase 3·NCT03777982·12 enrolled

Micro RNAs to Predict Response to Androgen Deprivation Therapy

Completed·MMedical College of Wisconsin··NCT02366494·42 enrolled

Abiraterone Acetate2 trials

Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients

Withdrawn·UUniversity of Athens·Phase 2·NCT03173859

Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC

Active, not recruiting·WWeill Medical College of Cornell University·Phase 1·NCT02913196·16 enrolled

22 more indications

Prostate Carcinoma2 trials

A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide With Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) Following PSA Response in Participants With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05884398·420 enrolled

Phase II Trial of Primary Radiotherapy With Androgen Ablation With or Without Adjuvant Niraparib for Selected High-Risk Locoregional Prostate Cancer

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04947254·200 enrolled

Prostate Adenocarcinoma2 trials

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)

Active, not recruiting·NNRG Oncology·Phase 3·NCT04513717·2,753 enrolled

Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging Into Salvage Treatment for Patients With Node-Positive Prostate Cancer After Radical Prostatectomy (INNOVATE*) *INtensifying Treatment for NOde Positive Prostate Cancer by VArying the Hormonal ThErapy

Active, not recruiting·NNRG Oncology·Phase 3·NCT04134260·586 enrolled

Recurrence1 trial

Adjutant Apalutamide Plus ADT in Post-RP Patients With High Risk of Recurrence (ARES Study)

Not yet recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05778097·103 enrolled

Prostate1 trial

Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

Active, not recruiting·—·Phase 1·NCT05683964·9 enrolled

Adenocarcinoma1 trial

Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03436654·102 enrolled

Biochemical Recurrence1 trial

Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP

Unknown status·CCancer Research Antwerp·Phase 2·NCT03899077·202 enrolled

ctDNA1 trial

Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan

Unknown status·KKindai University·Phase 4·NCT04601441·100 enrolled

Oral1 trial

A Study of Apalutamide Administered Orally as Whole Tablets and as a Mixture in Applesauce in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03802682·12 enrolled

Metastases1 trial

Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment

Not yet recruiting·FFudan University·Phase 2·NCT05717582·47 enrolled

First Line Therapy1 trial

PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.

Completed·FFirst Affiliated Hospital of Wenzhou Medical University··NCT07428642·168 enrolled

Randomized1 trial

Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509)

Active, not recruiting·—·Phase 2·NCT03141671·345 enrolled

Hepatic Impairment1 trial

A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04154774·18 enrolled

Cancer1 trial

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Recruiting·HHelsinki University Central Hospital·Phase 2·NCT05159245·250 enrolled

Recurrent Prostate Carcinoma1 trial

A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-Androgen Therapy With Apalutamide in Recurrent Prostate Cancer (BALANCE*)

Active, not recruiting·NNRG Oncology·Phase 2·NCT03371719·298 enrolled

Non-Muscle Invasive Bladder Urothelial Carcinoma1 trial

A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer

Recruiting·UUniversity of Wisconsin, Madison·Phase 1·NCT05521698·80 enrolled

Salivary Gland Neoplasms1 trial

An Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Apalutamide in Combination With Gonadotropin-releasing Hormone (GnRH) Agonist in Subjects With Locally Advanced or Recurrent/Metastatic and Androgen Receptor (AR) Expressing Salivary Gland Carcinoma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04325828·31 enrolled

Metastatic Castration-resistant Prostate Neoplasms1 trial

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05818683·300 enrolled

Castration-Sensitive Prostate Carcinoma1 trial

Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 3·NCT06931340·1,260 enrolled

Metastatic Castration-Resistant Prostate Cancer1 trial

A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07611110·670 enrolled

Androgen Axis Suppression1 trial

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.

Recruiting·MM.D. Anderson Cancer Center·Phase 3·NCT06274047·120 enrolled

Localized Prostate Carcinoma1 trial

Clinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for Prostatectomy

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT04530552·34 enrolled

Unspecified1 trial

A JNJ-56021927 (ARN-509; Apalutamide) QT/QTc Study

Completed·AAragon Pharmaceuticals, Inc.·Phase 1·NCT02578797·45 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 14, 2018

ERLEADA

NDA NDA210951

Sources

References

[1]
ClinicalTrials.gov — 107 trial records for Apalutamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Erleada drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Apalutamide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Apalutamide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210951). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Erleada. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Androgen Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Johnson & Johnson

Patent Landscape[6]

Patent Cliff

Mar 27, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8802689Mar 27, 2027

9388159Mar 27, 2027

9987261Mar 27, 2027

8445507Sep 15, 2030

9481663Jun 4, 2033

9 more patents

RE50642Sep 23, 2033

9884054Sep 23, 2033

RE49353Sep 23, 2033

10849888Sep 23, 2033

12303493Dec 3, 2035

10702508Apr 30, 2038

11963952Jan 30, 2040

12303497Jan 30, 2040

11723898Jan 14, 2041

Erleada

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Prostate Cancer56 trials

Metastatic Prostate Cancer15 trials

Prostatic Neoplasms8 trials

Androgen Deprivation Therapy2 trials

Abiraterone Acetate2 trials

Prostate Carcinoma2 trials

Prostate Adenocarcinoma2 trials

Recurrence1 trial

Prostate1 trial

Adenocarcinoma1 trial

Biochemical Recurrence1 trial

ctDNA1 trial

Oral1 trial

Metastases1 trial

First Line Therapy1 trial

Randomized1 trial

Hepatic Impairment1 trial

Cancer1 trial

Recurrent Prostate Carcinoma1 trial

Non-Muscle Invasive Bladder Urothelial Carcinoma1 trial

Salivary Gland Neoplasms1 trial

Metastatic Castration-resistant Prostate Neoplasms1 trial

Castration-Sensitive Prostate Carcinoma1 trial

Metastatic Castration-Resistant Prostate Cancer1 trial

Androgen Axis Suppression1 trial

Localized Prostate Carcinoma1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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