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Drug

Bicalutamide

Approved · FDA
Emerging researchLate-stage development

Also known as Casodex, Bicalutamida, Bicalutamidum.

RxNorm83008ChEMBLCHEMBL409UNIIA0Z3NAU9DP
1
Research papers
25
Active clinical trials
7
Regulatory events
Latest activity
beta

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

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

Clinical trial2026-07-07Results expected Q2 2028 · ClinicalTrials.gov

Phase I/II Trial of Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)

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

Optimizing PSMA Imaging for Enhanced Detection of Residual and Metastatic Prostate Cancer in Low PSA Recurrence (OPERA) Study

Clinical trial2026-07-01Results expected Q3 2027 · ClinicalTrials.gov

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

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Androgen Receptor Modulation Phase II, Randomized Study of MK-2206 - Bicalutamide Combination in Patients With Rising PSA at High-Risk of Progression After Primary Therapy

Clinical trial2026-06-25Results posted · ClinicalTrials.gov

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*)

Clinical trial2026-06-25Results expected Q4 2033 · ClinicalTrials.gov

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Clinical trial2026-06-25Results expected Q4 2026 · ClinicalTrials.gov

Supplemental approval: BICALUTAMIDE (ANDA079089)

Regulatory2025-01-03FDA

Label change: BICALUTAMIDE (ANDA079089)

Regulatory2019-04-16FDA

Label change: BICALUTAMIDE (ANDA079089)

Regulatory2019-04-16FDA

Phase II trial of RAD001 and bicalutamide for castration-resistant prostate cancer.

Research2012-08-29BJU international

Label change: BICALUTAMIDE (ANDA079089)

Regulatory2012-07-19FDA

Profile

Identifiers & mechanism

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

Canonical name
Bicalutamide
Aliases & brands
CasodexBicalutamidaBicalutamidum
RxNorm CUI
83008
ChEMBL ID
CHEMBL409
UNII
A0Z3NAU9DP
Regulatory jurisdictions
fda

Regulatory timeline

7 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.

Earliest approval
2009-07-06
Latest approval
2025-01-03
Authorities
FDA
Total events
7
fdaU.S. Food and Drug Administration· 7 events
2025-01-03Supplemental approval
Supplemental approval: BICALUTAMIDE (ANDA079089)
Evidence ↗
2019-04-16Label change
Label change: BICALUTAMIDE (ANDA079089)
Evidence ↗
2019-04-16Label change
Label change: BICALUTAMIDE (ANDA079089)
Evidence ↗

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

Clinical trials

143 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
143
registered trials across all phases
LATEST COMPLETION 2026
25
Active studies
12
Recruiting
53
Late-stage (III+)
79
Completed
39
Discontinued
PHASE DISTRIBUTIONn = 143
Early Phase 12Phase 118Phase 1 / 25Phase 265Phase 2 / 32Phase 341Phase 44Phase N / A6

Late-stage studies

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

The Impact of Continuous Versus Intermittent Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients: A Multicenter, Randomized Clinical Trial

Unknown statusPH IVWonju Severance Christian Hospitaln=1642022

A Randomized Double-Blind Parallel Group Study Comparing Casodex (or Generic Equivalent) 50mg Plus Placebo to Casodex (or Generic Equivalent) 50mg Plus Dutasteride 3.5mg Administered for 18 Months to Men With Prostate Cancer Who Have Failed First-Line Androgen Deprivation Therapy (Assessed by Rising PSA) Followed by a Two-Year Extension Phase

CompletedPH IVGlaxoSmithKlinen=1272013

An Open Randomised Trial to Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX Monotherapy Induced Gynaecomastia and/or Breast Pain in Prostate Cancer Patients

CompletedPH IVAstraZenecan=1252008

Longitudinal, Randomized, Open and Prospective Clinical Trial to Evaluate the Efficacy of Continuous vs Intermittent Maximum Androgen Blockade (CMAB vs IMAB) With Goserelin-Bicalutamide Combination in the Treatment of Hormonal naïve With Metastatic Prostate Cancer

WithdrawnPH IVAstraZenecan=152007

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

Recent completions

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

Androgen Receptor Modulation Phase II, Randomized Study of MK-2206 - Bicalutamide Combination in Patients With Rising PSA at High-Risk of Progression After Primary Therapy

CompletedPH IINational Cancer Institute (NCI)n=1082026

A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer

CompletedN/AStanford Universityn=1462026

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 Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer

CompletedPH IIIKey trialSWOG Cancer Research Networkn=1,3132025

A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer

CompletedPH IIIKey trialRadiation Therapy Oncology Groupn=1,5382025

Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer

CompletedPH IMedical University of South Carolinan=202023

Research activity

1 papers

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

Journals, researchers & institutions
Top journals
  • BJU international1
Leading researchers
  • Bubley GJ1
  • Buckle G1
  • Courtney KD1
  • Elfiky A1
  • Hayes JH1
  • Kantoff PW1
  • Nakabayashi M1
  • Oh WK1
Leading institutions
free-text, unnormalised
  • Lank Center for Genitourinary Oncology1
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.