Data updated: May 26, 2026
CASODEX (bicalutamide)
Androgen Receptor Antagonists
Trial Activity: Stable 21 active trials
Oncology
Approved 1995-10-04
Casodex (bicalutamide) 50 mg is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. This regimen is designed for advanced disease where the cancer is androgen-sensitive. Notably, the 150 mg daily dose of Casodex is not approved for use as monotherapy or in any other treatment combinations.
How CASODEX Works
Casodex is a non-steroidal androgen receptor inhibitor. It works by competitively inhibiting the action of androgens by binding to cytosol androgen receptors within the target prostatic tissue. Since prostate carcinoma is androgen-sensitive, this blockade counteracts the growth-promoting effects of androgens. When used in combination with an LHRH analog, Casodex inhibits the action of adrenal androgens without interfering with the LHRH analog's ability to suppress serum testosterone levels.
Development Insights
National Cancer Institute (NCI) conducting 4 trials (7%)
94 indications explored (Broad Platform)
→ prostate cancer (31 trials)
→ prostate adenocarcinoma (5 trials)
→ breast cancer (4 trials)
3
Indications
--
Phase 3 Trials
1
Priority Reviews
30
Years on Market
Details
- Status
- Prescription
- First Approved
- 1995-10-04
- Routes
- ORAL
- Dosage Forms
- TABLET
CASODEX Approval History
1996
1997
1998
1999
2000
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2002
2003
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2005
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2008
2009
2010
2011
2012
2013
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2015
2016
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2021
2022
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2024
2025
2026
Original
New Indication
New Form
Label Update
19 FDA actions from 1995 to 2017 · 1 indication expansions
Sep 2013 SUPPL
Mfg
Sep 2002 SUPPL
Mfg
Jan 2002 SUPPL
Mfg
Oct 2001 SUPPL
Mfg
Feb 2001 SUPPL
Label
Dec 2000 SUPPL
Mfg
Nov 1999 SUPPL
Mfg
Dec 1997 SUPPL
Efficacy
Nov 1997 SUPPL
Mfg
Oct 1995 ORIGINAL
New Drug
What CASODEX Treats
1 indicationsCASODEX is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic Prostate Cancer
Source: FDA Label
CASODEX Competitive Set
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Direct competitors
5
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Indication competitors
10
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What's emerging in CASODEX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CASODEX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CASODEX
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Clinical Trial Registry
62 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 |
| NCT02064036 CCRO025 | 421870 CCRO025 | Ph 1 | completed | Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate |
| 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 |
Showing 50 of 62 trials
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
CASODEX FDA Label Details
Indications & Usage
FDA Label (PDF)CASODEX is indicated for the treatment of Metastatic Prostate Cancer.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment