TheraRadar
Data updated: Jun 17, 2026

BICALUTAMIDE

Androgen Receptor Antagonists
Oncology Approved 2009-07-06

Bicalutamide tablets, USP 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets, USP 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies ]. • Bicalutamide tablet 150 mg daily is not approved for use alone or with other treatments.

Source: FDA Label • ACCORD HLTHCARE
Jump to: Indications Approvals Trials Competitors Safety Patents
6
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2009-07-06
Routes
ORAL
Dosage Forms
TABLET

Companies

ACCORD HLTHCARE Sun Pharma RISING Apotex SYNTHON PHARMS KUDCO IRELAND Fresenius Kabi ADAPTIS CHARTWELL RX Novartis WATSON LABS TEVA Teva ROXANE
Active Ingredient: BICALUTAMIDE

BICALUTAMIDE Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
52 FDA actions from 2009 to 2025
Mar 2025 SUPPL
Label · Labeling
Jan 2025 SUPPL
Mfg · Manufacturing (CMC)
Mar 2024 SUPPL
Label · Labeling

What BICALUTAMIDE Treats

6 FDA approvals

Originally approved for its first indication in 2009 . Covers 6 distinct patient populations.

  • Other (6)
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Clinical Trial Registry

59 trials
Trial Sponsor ID Phase Status Title
NCT07455903 2025-GAR-001 Ph 2 recruiting Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
NCT02531516 CR106935 56021927PCR3003, 2015-003007-38 Ph 3 active not recruiting An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
NCT03070886 NRG-GU002 NCI-2016-00963, NRG-GU002 Ph 2, Ph 3 completed Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
NCT05521698 2026-0131 P30CA014520, UG1CA242635 Ph 1 recruiting A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer
NCT05050084 NRG-GU010 NCI-2021-08760, NRG-GU010 Ph 3 active not recruiting Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial
NCT04513717 NRG-GU009 NCI-2020-04705, NRG-GU009 Ph 3 active not recruiting Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial
NCT01251861 results posted NCI-2011-02648 NCI-2011-02648, ECOG-E2809 Ph 2 active not recruiting Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer
NCT03650894 CA209-8H3 Ph 2 active not recruiting Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients
NCT05095207 GCO 21-0699 Ph 1, Ph 2 recruiting Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
NCT06365788 ABBICAR S66466 2022-502272-23-00 Ph 2 recruiting Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
NCT00936390 results posted RTOG 0815 CDR0000648194, NCI-2011-01948 Ph 3 completed Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer
NCT04943536 BiolenRT CP-002 ZIABC010850, ZIABC011552 Ph 1 active not recruiting Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
NCT06650579 STUDY00007557 P30CA138292, NCI-2024-07761 Ph 3 recruiting REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
NCT01786265 2012-0993 NCI-2018-01856, 2012-0993 Ph 2 active not recruiting Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer
NCT04734730 20476 NCI-2020-10199, 20476 Ph 2 recruiting Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
NCT03090165 BTCRC BRE15-024 Ph 1, Ph 2 active not recruiting Ribociclib and Bicalutamide in AR+ TNBC
NCT01809691 S1216 results posted S1216 SWOG-S1216, NCI-2012-02876 Ph 3 completed S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer
NCT03809000 STEEL results posted RTOG 3506 STEEL Ph 2 active not recruiting A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
NCT05327647 BicaBCa MP-20-2022-6318 Ph 2 recruiting A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
NCT04025372 19-202 Ph 2 active not recruiting INTREPId (INTermediate Risk Erection PreservatIon Trial)
NCT06528210 STUDY00025491 NCI-2024-04337, STUDY00025491 Ph 2 withdrawn Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer
NCT03678025 S1802 NCI-2018-01738, S1802 Ph 3 recruiting Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
NCT06501911 0608-24-FB Ph 1 withdrawn A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma
NCT02605486 15-207 Ph 1, Ph 2 active not recruiting Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)
NCT02299999 SAFIR02_Breast UC-0105/1304 2013-001652-36 Ph 2 active not recruiting SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer
NCT01288911 results posted 9785-CL-0222 2010-021868-15 Ph 2 completed A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
NCT03141671 16-623 Ph 2 active not recruiting Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509)
NCT03878524 STUDY00015588 NCI-2020-02743, STUDY00015588 Ph 1 terminated Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
NCT00651326 DART PR12 CAN-NCIC-PR12, CDR0000589247 Ph 3 terminated Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer
NCT00771017 CDR0000616570 ECOG-E3806 Ph 2 withdrawn Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer
NCT02058706 results posted 2013-083 NCI-2014-00212, 2013-083 Ph 2 completed LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive Prostate Cancer
NCT03043807 results posted J16151 IRB00120414 Ph 2 completed A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy
NCT02716974 oligo-mets results posted J1618 IRB00070003 Ph 2 completed A Study of Definitive Therapy to Treat Prostate Cancer
NCT02582749 results posted HCRN GU13-170 Ph 2 terminated Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases
NCT02059213 results posted UMCC 2013.117 HUM00082715 Ph 2 completed A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer
NCT02697032 NL2015.0704 Ph 2 completed FDHT PET and Bicalutamide in Metastatic Breast Cancer
NCT02085252 results posted FR-LEU-002 2012-002653-35, U1111-1146-5402 Ph 3 completed A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
NCT00528866 results posted RTOG-0621 CDR0000563917, NCI-2009-00740 Ph 2 completed Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
NCT01664923 STRIVE results posted MDV3100-09 C3431014 Ph 2 completed Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
NCT03147196 MC1552 NCI-2017-00773, MC1552 Ph 2 withdrawn Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
NCT01120236 results posted NCI-2011-02003 NCI-2011-02003, SWOG-S0925 Ph 2 completed Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer
NCT00878436 results posted 08-479 Ph 1, Ph 2 completed Safety and Efficacy Studies of Panobinostat and Bicalutamide in Patients With Recurrent Prostate Cancer After Castration
NCT02348281 Fudan BR2015-17 Ph 2 terminated Bicalutamide as A Treatment in AR-positive Metastatic Triple-Negative Breast Cancer (mTNBC) Patients
NCT00814788 UCDCC#215 results posted UCDCC#215 223646, Novartis Ph 2 completed Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer
NCT00630344 results posted 07-316 Ph 2 completed RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
NCT01200810 results posted NCI-2011-02527 CINJ-081001, CDR0000684276 Ph 2 terminated Bicalutamide and RO4929097 in Treating Patients With Previously Treated Prostate Cancer
NCT00658697 results posted 08-004 Ph 2 completed Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer
NCT00769795 6857 (FH/UWCC ID) NIH P50 CA097186, 6857 Ph 2 completed Study of Effectiveness of IMC-A12 Antibody Combined With Hormone Therapy Prior to Surgery to Treat Prostate Cancer
NCT00659438 results posted D4200C00080 2007-001891-35 Ph 2 completed Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer
NCT00776594 results posted 08-190 Ph 2 completed Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

Showing 50 of 59 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BICALUTAMIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

Bicalutamide tablets, USP 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets, USP 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies ]. • Bicalutamide tablet 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. • Bicalutamide tablet 150 mg daily is ...

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Data Sources

FDA Approval: ANDA078917 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.