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Drug

Apalutamide

Approved · FDA / EMA
ClassAndrogen Receptor antagonistEmerging researchLate-stage development

Also known as Erleada.

RxNorm1999574ChEMBLCHEMBL3183409ATCL02BB05UNII4T36H88UA7
2
Research papers
46
Active clinical trials
Androgen receptor
Primary target
17
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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*)

Clinical trial2026-07-10Results posted · ClinicalTrials.gov

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

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

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

Clinical trial2026-07-06Results expected Q2 2027 · ClinicalTrials.gov

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

Clinical trial2026-07-06Results expected Q4 2026 · ClinicalTrials.gov

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

Clinical trial2026-07-06Results expected Q3 2027 · ClinicalTrials.gov

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)

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

Label change: APALUTAMIDE (NDA210951)

Regulatory2026-06-29FDA

Label change: APALUTAMIDE (NDA210951)

Regulatory2026-03-05FDA

Label change: APALUTAMIDE (NDA210951)

Regulatory2024-08-02FDA

Supplemental approval: APALUTAMIDE (NDA210951)

Regulatory2024-07-09FDA

Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer.

Research2019-05-31The New England journal of medicine

Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer.

Research2018-02-08The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Apalutamide
Aliases & brands
Erleada
RxNorm CUI
1999574
ChEMBL ID
CHEMBL3183409
ATC codes
L02BB05
UNII
4T36H88UA7
Primary mechanism
Androgen Receptor antagonist
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Androgen receptor
AR · P10275
ANTAGONISTAndrogen Receptor antagonist

Regulatory timeline

17 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2018-02-14 → 2019-09-17)
Earliest approval
2018-02-14
Latest approval
2024-07-09
Authorities
FDA · EMA
Total events
17
fdaU.S. Food and Drug Administration· 16 events
2026-06-29Label change
Label change: APALUTAMIDE (NDA210951)
Evidence ↗
2026-03-05Label change
Label change: APALUTAMIDE (NDA210951)
Evidence ↗
2024-08-02Label change
Label change: APALUTAMIDE (NDA210951)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2019-01-14ApprovalMulti-authority
Approval: Erleada (EMA)
Indication: Erleada is indicated: in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. in… Show full indication

Erleada is indicated: in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

88 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
88
registered trials across all phases
LATEST COMPLETION 2026
46
Active studies
21
Recruiting
24
Late-stage (III+)
23
Completed
19
Discontinued
PHASE DISTRIBUTIONn = 88
Phase 114Phase 1 / 22Phase 248Phase 320Phase 42Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IV Study of Apalutamide in Chinese Participants With Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC)

Active, not recruitingPH IVJanssen Research & Development, LLCn=752026

Phase 4 Study of Exploring Circulating Tumor DNA (ctDNA) of Metastatic Castration-sensitive Prostate Cancer (mCSPC) Patients Receiving Apalutamide in Japan

Unknown statusPH IVKindai Universityn=1002025

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

RecruitingPH IIIKey trialAlliance for Clinical Trials in Oncologyn=1,2602039

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 recruitingPH IIIKey trialNRG Oncologyn=2,7532033

An Open Label, Randomized, Phase III Study, Evaluating the Efficacy of a Combination of Apalutamide With Radiotherapy and LHRH Agonist in High-risk Postprostatectomy Biochemically Relapsed Prostate Cancer Patients

Active, not recruitingPH IIIUNICANCERn=4902033

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH IINational Cancer Institute (NCI)n=342026

A Randomized, Phase II Study of Apalutamide +/- Stereotactic Body Radiotherapy (SBRT) in Castration-Resistant Prostate Cancer Patients With Oligometastatic Disease on PSMA-PET Imaging

CompletedPH IIUniversity of California, San Franciscon=262025

A Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

CompletedPH IWeill Medical College of Cornell Universityn=162025

A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

CompletedPH IIIAlliance Foundation Trials, LLC.n=5042025

A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics of Apalutamide in Subjects With Severe Hepatic Impairment Compared With Subjects With Normal Hepatic Function

CompletedPH IJanssen Research & Development, LLCn=182025

Active Surveillance With or Without a 6 Months Apalutamide Treatment in Low Risk Prostate Cancer: A Phase II Randomized Multicenter Trial

CompletedPH IIInstitut Paoli-Calmettesn=932024

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20182019
Most influential

Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer.

The New England journal of medicine · 2019 · 1,013 cites

Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer.

The New England journal of medicine · 2018 · 945 cites
Recent papers

Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer.

The New England journal of medicine · 2019 · 1,013 cites

Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer.

The New England journal of medicine · 2018 · 945 cites
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
Leading researchers
  • Chowdhury S2
  • Uemura H2
  • Yu MK2
  • Agarwal N1
  • Bjartell A1
  • Cheng S1
  • Chi KN1
  • Chung BH1
Leading institutions
free-text, unnormalised
  • From BC Cancer and Vancouver Prostate Centre1
  • From the Massachusetts General Hospital Cancer Center and Harvard Medical School1

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas
Adenocarcinoma2Exanthema2
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.