Skip to main content

bicalutamide

Generic: BICALUTAMIDE·Brand: BICALUTAMIDE, CASODEX, Casodex

bicalutamide: sourced relationships with 1 company · 13 clinical trials tracked · 1 FDA decision.

bicalutamide evidence translation

What we can confirm

1 FDA record · 13 tracked trials

What it means

Source-backed records connect bicalutamide to AZN; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could bicalutamide → AZN affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 0 study sponsors

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (2)
CompanyDated record stage
ASTRAZENECA PLC (AZN)
Reported 2008-12-19 · Current development: unknownSource
Approved
ASTRAZENECA PLC (AZN)
Reported 2008-12-19 · Current development: unknownSource
Approved
Clinical Trial Registry Records (13)showing 10 most recent

Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: The REVELUTION-2 Trial

NCT06650579Registry updated 2026-02-24·Phase 3
Recruiting

Primary endpoint: Incidence of ambulatory systolic blood pressure (BP) > 140 or diastolic > 90 (measurement on 2 separate days)

InterventionalRandomizeddouble72 targetStarted 2025-01Completion 2029-074 sites · United StatesEmory University

A Multicenter Single Arm Phase II Study With Bicalutamide in Combination With Abemaciclib in 4 Cohorts of Locoregionally Advanced Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

NCT06365788Registry updated 2026-04-01·Phase 2
Recruiting

Primary endpoint: Number of participants with disease control at 16 weeks

Interventionalopen53 targetStarted 2024-04Completion 2028-126 sites · BelgiumUniversitaire Ziekenhuizen KU Leuven

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

NCT05050084Registry updated 2026-06-25·Phase 3
Active, not recruiting

Primary endpoint: Distant metastasis (DM) (De-intensification study)

InterventionalRandomizedopen2,050 targetStarted 2021-12Completion 2026-1150 sites · United StatesNRG Oncology

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*)

NCT04513717Registry updated 2026-08-17·Phase 3
Active, not recruiting

Primary endpoint: Metastasis-free survival (MFS)

InterventionalRandomizedopen2,753 enrolledStarted 2021-01Completion 2038-1250 sites · United StatesNRG Oncology

The Registry to Observe Clinical Outcomes of Patients With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

NCT04034095Registry updated 2025-12-15·N/A
Completed

Primary endpoint: Percentage of Participants who Achieve Prostate-specific Antigen (PSA) <=0.2 ng/mL Within a Year from Registration

Observational979 enrolledStarted 2019-07Completion 2024-0850 sites · JapanJanssen Pharmaceutical K.K.

STEEL: A Randomized Phase II Trial of Salvage Radiotherapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features

NCT03809000Registry updated 2025-12-30·Phase 2
Active, not recruiting

Primary endpoint: Percentage of Participants Alive Without Progression (Progression-Free Survival)

InterventionalRandomizedopen188 targetStarted 2019-04Completion 2029-0950 sites · United StatesRTOG Foundation, Inc.

A Phase II Study of Nivolumab Combined With Bicalutamide and Ipilimumab in Metastatic HER2-negative Breast Cancer

NCT03650894Registry updated 2026-04-13·Phase 2
Active, not recruiting

Primary endpoint: iRECIST Clinical Benefit Rate (the number of patients with objective response or ongoing stable disease at week 24 using iRECIST guidelines)

Interventionalopen30 targetStarted 2019-04Completion 2026-122 sites · United StatesProvidence Health & Services

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

NCT03678025Registry updated 2026-10-08·Phase 3
Recruiting

Primary endpoint: Overall survival (OS)

InterventionalRandomizedopen1,273 targetStarted 2018-09Completion 2036-10338 sites · Chile, Colombia, Mexico, Switzerland…SWOG Cancer Research Network

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

NCT03070886Registry updated 2026-09-14·Phase 2/Phase 3
Active, not recruiting

Primary endpoint: Freedom from progression (FFP) (Phase II)

InterventionalRandomizedopen612 enrolledStarted 2017-04Completion 2030-1050 sites · United StatesNRG Oncology

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

NCT02531516Registry updated 2026-02-13·Phase 3
Active, not recruiting

Primary endpoint: Metastasis-Free Survival (MFS)

InterventionalRandomizeddouble1,503 targetStarted 2015-11Completion 2028-1250 sites · United StatesAragon Pharmaceuticals, Inc.
FDA Decisions1 records
Approval(AZN)FDA ↗
NDA022310Type 6 - New Indication (no longer used)PriorityOralTablet

Frequently asked questions

Which companies have sourced relationships with bicalutamide?

bicalutamide has dated SEC/FDA relationship records for ASTRAZENECA PLC.

How many clinical trials involve bicalutamide?

BioSniper tracks 13 clinical trials involving bicalutamide.

What is bicalutamide's latest FDA decision?

The most recent tracked FDA decision for bicalutamide is Approval, dated December 19, 2008.