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Drug

Nilutamide

Approved medicine
ClassAndrogen Receptor antagonistResearchOngoing clinical research

Also known as Nilandron, Nilutamida, Nilutamidum.

RxNorm31805ChEMBLCHEMBL1274ATCL02BB02UNII51G6I8B902
2
Active clinical trials
Androgen receptor
Primary target
Latest activity
beta

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

A Randomized Study of Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone in Patients With Prostate Cancer Who Have PSA Progression After Prostatectomy and/or Radiotherapy

Clinical trial2026-02-20Results expected Q1 2027 · ClinicalTrials.gov

Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel

Clinical trial2025-10-31Completed · ClinicalTrials.gov

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

Clinical trial2025-09-11Results expected Q2 2028 · ClinicalTrials.gov

A Randomized Phase II Study of Either Immunotherapy With a Regimen of Recombinant Pox Viruses That Express PSA/B7.1 Plus Adjuvant GM-CSF and IL2 or Hormone Therapy With Nilutamide in Patients With Hormone Refractory Prostate Cancer and No Radiographic Evidence of Disease

Clinical trial2015-04-29Completed · ClinicalTrials.gov

A Phase II Trial of Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer

Clinical trial2013-08-01Terminated · ClinicalTrials.gov

Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate

Clinical trial2013-07-16Results posted · ClinicalTrials.gov

A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer

Clinical trial2013-01-10Completed · ClinicalTrials.gov

Phase Ib Study of Limited Androgen Ablation and Two Dose Levels of Temsirolimus (NSC#683864) in Patients With Prostate Cancer Who Have a Biochemical Relapse After Prostatectomy and/or Radiotherapy

Clinical trial2013-01-07Terminated · ClinicalTrials.gov

Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate

Clinical trial2012-01-06Completed · ClinicalTrials.gov

A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate

Clinical trial2005-06-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Nilutamide
Aliases & brands
NilandronNilutamidaNilutamidum
RxNorm CUI
31805
ChEMBL ID
CHEMBL1274
ATC codes
L02BB02
UNII
51G6I8B902
Primary mechanism
Androgen Receptor antagonist

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Androgen receptor
AR · P10275
ANTAGONISTAndrogen Receptor antagonist

Clinical trials

10 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
10
registered trials across all phases
LATEST COMPLETION 2025
2
Active studies
1
Recruiting
5
Late-stage (III+)
6
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 10
Phase 11Phase 24Phase 2 / 31Phase 34

Late-stage studies

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

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

RecruitingPH IIIKey trialSWOG Cancer Research Networkn=1,2732031

Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel

CompletedPH II/IIINRG Oncologyn=6122025

A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer

CompletedPH IIIKey trialNCIC Clinical Trials Groupn=1,3862013

Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate

CompletedPH IIINCIC Clinical Trials Groupn=3612012

A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate

CompletedPH IIIM.D. Anderson Cancer Centern=3062005

Recent completions

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

Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel

CompletedPH II/IIINRG Oncologyn=6122025

A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer

CompletedPH IIIKey trialNCIC Clinical Trials Groupn=1,3862013

Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate

CompletedPH IIINCIC Clinical Trials Groupn=3612012

Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate

CompletedPH IISWOG Cancer Research Networkn=412011

A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate

CompletedPH IIIM.D. Anderson Cancer Centern=3062005

A Randomized Phase II Study of Either Immunotherapy With a Regimen of Recombinant Pox Viruses That Express PSA/B7.1 Plus Adjuvant GM-CSF and IL2 or Hormone Therapy With Nilutamide in Patients With Hormone Refractory Prostate Cancer and No Radiographic Evidence of Disease

CompletedPH IINational Cancer Institute (NCI)2004
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials