Casodex

(Bicalutamide)

ApprovedSmall molecule

Bicalutamide is used to treat prostate cancer by blocking male hormones that help cancer cells grow. It's often given alongside other prostate cancer treatments.[2] Casodex is currently approved and in use across 24 indications[4].[1]

Casodex is one of 483 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Approved.

Indications

139

Total Trials

Active Trials

482

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Prostate AdenocarcinomaActive, not recruiting

Prostate NeoplasmActive, not recruiting

Salivary Gland CancerActive, not recruiting

Prostate CarcinomaApproved

Triple-Negative Breast CancerTerminated

Breast NeoplasmApproved

Metastatic Prostate CancerTerminated

Precocious PubertyApproved

Polycystic Ovary SyndromeActive, not recruiting

Breast CancerActive, not recruiting

Prostate AdenocarcinomaApproved

Active, not recruiting

Prostate NeoplasmPreclinical

Active, not recruiting

Salivary Gland CancerPreclinical

Active, not recruiting

Prostate CarcinomaApproved

Approved

Triple-Negative Breast CancerPhase 2

Terminated

Breast NeoplasmApproved

Approved

Metastatic Prostate CancerApproved

Terminated

Precocious PubertyApproved

Approved

Polycystic Ovary SyndromePreclinical

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Casodex

IIstituto Clinico Humanitas

Approved

7 2

Adenocard

Astellas

Preclinical

2 3

Lexiscan

Astellas

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Spravato

WWim Janssens

Preclinical

2 6

Duragesic

CCephalon

Preclinical

1 7

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 8

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 9

Vfend

PPrism Pharmaceuticals

Rilvegostomig

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Breast Cancer

NCT03650894

Q1 2027

Phase 2Active, not recruiting

Prostate Adenocarcinoma

NCT01786265

Phase 2Active, not recruiting

PSA

NCT00544830

Q2 2027

Phase 1Recruiting

Prostate Cancer

NCT07783282

Q3 2027

Phase 1Active, not recruiting

Prostate Cancer

NCT04943536

Phase 2Recruiting

Prostate Cancer

NCT04734730

Clinical

Trials by Indication[1]

Prostate Cancer80 trials

Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00004054·397 enrolled

Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer

Withdrawn·OOHSU Knight Cancer Institute·Phase 2·NCT00244920

Efficacy and Safety Study of Vandetanib (ZD 6474) in Combination With Bicalutamide Versus Bicalutamide Alone in Patients With Chemotherapy Naive Hormone Refractory Prostate Cancer.

Completed·BBritish Columbia Cancer Agency·Phase 2·NCT00757692·74 enrolled

Show 77 more trials

Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer

Completed·NNCIC Clinical Trials Group·Phase 3·NCT00002633·361 enrolled

A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT04034095·979 enrolled

Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer

Active, not recruiting·AAlessa Therapeutics Inc.·Phase 1·NCT04943536·20 enrolled

S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

Completed·SSWOG Cancer Research Network·Phase 3·NCT00004124·983 enrolled

Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00023829·67 enrolled

Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse

Completed·UUNICANCER·Phase 3·NCT00055731·413 enrolled

Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer

Withdrawn·EEastern Cooperative Oncology Group·Phase 2·NCT00771017

Cryoablation Therapy or Radiotherapy Therapy for Stage III Prostate Cancer

Unknown status·TTianjin Medical University Cancer Institute and Hospital·N/A·NCT02605226·240 enrolled

Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer

Withdrawn·OOHSU Knight Cancer Institute·Phase 2·NCT06528210

A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03043807·26 enrolled

Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer

Recruiting·—·Phase 2·NCT04734730·70 enrolled

Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy

Completed· GSK logo

GSK·Phase 4·NCT00470834·127 enrolled

A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)

Terminated· Sanofi logo

Sanofi·Phase 3·NCT00514917·413 enrolled

A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00108732·50 enrolled

A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery

Active, not recruiting·RRTOG Foundation, Inc.·Phase 2·NCT03809000·188 enrolled

Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT01664923·396 enrolled

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

Active, not recruiting·UUniversity of Chicago·N/A·NCT01342367·74 enrolled

Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy

Completed·MMayo Clinic·Phase 2·NCT00684905·50 enrolled

Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00002874·840 enrolled

A Study of Definitive Therapy to Treat Prostate Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02716974·26 enrolled

Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer

Completed· Ferring logo

Ferring·Phase 3·NCT00833248·246 enrolled

Hormone Therapy in Treating Patients With Advanced Prostate Cancer

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00003026·966 enrolled

Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer

Terminated·NNCIC Clinical Trials Group·Phase 3·NCT00651326·48 enrolled

LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive Prostate Cancer

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 2·NCT02058706·71 enrolled

Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer

Completed·NNCIC Clinical Trials Group·Phase 3·NCT00003653·1,386 enrolled

Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer

Completed·MMayo Clinic·Phase 2·NCT00170157·112 enrolled

Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery

Unknown status·TThe Methodist Hospital Research Institute·Phase 2·NCT03541928·60 enrolled

Bicalutamide Compared With Observation Followed by Bicalutamide Plus Either Goserelin or Orchiectomy in Treating Patients With Prostate Cancer

Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00014586·110 enrolled

Bicalutamide With or Without Enzastaurin in Treating Patients With Prostate Cancer

Withdrawn·EEastern Cooperative Oncology Group·Phase 2·NCT00685633

Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00021450·819 enrolled

(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00673205·3,588 enrolled

Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer

Completed·IInstitut du Cancer de Montpellier - Val d'Aurelle·Phase 1·NCT00943956·30 enrolled

Positive Surgical Margins Rate and EGFR Family Members Expression in Prostate Cancer Treated With Bicalutamide

Completed·UUniversity of L'Aquila·Phase 2/3·NCT00421694·119 enrolled

Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

Completed·—·Phase 2·NCT00776594·102 enrolled

Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

Withdrawn·MMayo Clinic·Phase 2·NCT03147196

Bicalutamide and RO4929097 in Treating Patients With Previously Treated Prostate Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01200810·10 enrolled

Casodex vs Placebo in Non-Metastatic Early Prostate Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00672282·1,218 enrolled

SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

Completed·UUniversity of Chicago·Phase 1·NCT00026377·3 enrolled

TAK-700 in Castration Resistant Prostate Cancer

Withdrawn·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT01658527

Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

Terminated· Ferring logo

Ferring·Phase 3·NCT00831233·42 enrolled

Clinical Trial to Study Quality of Life in Prostate Cancer Patients by Randomizing Anti-androgen Versus Total Androgen Blockage Prior to Curative Intended Radiation Therapy

Completed·KKarolinska University Hospital·Phase 3·NCT02382094·110 enrolled

Bicalutamide Monotherapy Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer

Completed·WWirral University Teaching Hospital NHS Trust·N/A·NCT00551044·42 enrolled

RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

Completed·—·Phase 2·NCT00630344·36 enrolled

Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer

Completed·MMayo Clinic·Phase 1·NCT01050842·18 enrolled

Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients

Completed· Ferring logo

Ferring·Phase 3·NCT00884273·182 enrolled

Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer

Withdrawn·—·Phase 2·NCT00003517

External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 3·NCT00388804·39 enrolled

Androgen Deprivation Therapy and Vorinostat Followed by Radical Prostatectomy in Treating Patients With Localized Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00589472·19 enrolled

Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00936390·1,538 enrolled

Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer

Unknown status·TTianjin Medical University Cancer Institute and Hospital·N/A·NCT02615223·120 enrolled

Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00586898·36 enrolled

Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone, Bicalutamide Alone, and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT00086736·34 enrolled

Bevacizumab, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

Unknown status·—·Phase 2·NCT00348998·18 enrolled

A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 3·NCT03520478·654 enrolled

Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT00512668·24 enrolled

Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 2·NCT00528866·80 enrolled

Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer

Completed·MMedical University of South Carolina·Phase 1·NCT00099086·20 enrolled

Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer

Completed·—·Phase 2·NCT00658697·42 enrolled

Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00233610·180 enrolled

Radiation Therapy, Docetaxel, and Hormone Therapy in High-Risk Locally Advanced Metastasized Prostate Cancer

Completed·UUniversity of Nebraska·Phase 1·NCT00482807·9 enrolled

Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer

No longer available· AstraZeneca logo

AstraZeneca··NCT00636259

SRT Versus SRT+ADT in Prostate Cancer

Recruiting·MMarco Lorenzo Bonu·Phase 3·NCT05019846·310 enrolled

Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00030654·21 enrolled

Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT00067015·3 enrolled

Pazopanib Hydrochloride With or Without Bicalutamide in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00486642·23 enrolled

Study of Effectiveness of IMC-A12 Antibody Combined With Hormone Therapy Prior to Surgery to Treat Prostate Cancer

Completed·UUniversity of Washington·Phase 2·NCT00769795·29 enrolled

Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT03358563·30 enrolled

Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients

Unknown status·WWonju Severance Christian Hospital·Phase 4·NCT04248621·164 enrolled

Safety and Efficacy Studies of Panobinostat and Bicalutamide in Patients With Recurrent Prostate Cancer After Castration

Completed·NNYU Langone Health·Phase 1/2·NCT00878436·52 enrolled

Treatment Protocol to Monitor the Safety of a 200 mg Dose of Bicalutamide in Patients With Advanced Prostate Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00846976·101 enrolled

A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer

Completed· Takeda logo

Takeda·Phase 3·NCT02085252·116 enrolled

SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer

Completed·SSWOG Cancer Research Network·Phase 3·NCT00002651·3,040 enrolled

Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00657904·3,618 enrolled

Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00002855·306 enrolled

A Phase 1 Open-label Study to Evaluate the Effect of Enzalutamide, Apalutamide and Bicalutamide on the Pharmacokinetics of Fezolinetant in Male Participants With Prostate Cancer

Recruiting· Astellas logo

Astellas·Phase 1·NCT07783282·56 enrolled

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

Not yet recruiting·WWashington University School of Medicine·Phase 2·NCT07593079·20 enrolled

Assessing the Efficacy of Neoadjuvant Androgen Deprivation Therapy (ADT) Utilizing 18F-Flotufolastat PSMA PET/CT in Patients With High-Risk Localized Prostate Cancer (LHRPC)

Recruiting·BBaptist Health South Florida·Phase 2·NCT07455903·50 enrolled

Metastatic Prostate Cancer11 trials

Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer

Completed· Sanofi logo

Sanofi·Phase 2·NCT00659438·95 enrolled

CMAB vs IMAB in Metastatic Prostate Cancer

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 4·NCT00255268·15 enrolled

A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT02059213·72 enrolled

Show 8 more trials

Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases

Terminated·—·Phase 2·NCT02582749·16 enrolled

A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

Completed· Astellas logo

Astellas·Phase 2·NCT01288911·375 enrolled

Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01120236·211 enrolled

S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer

Completed·SSWOG Cancer Research Network·Phase 3·NCT01809691·1,313 enrolled

Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer

Completed·UUniversity of California, Davis·Phase 2·NCT00814788·24 enrolled

Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer

Terminated·TThe Methodist Hospital Research Institute·Phase 2·NCT00521781·14 enrolled

R-(-)-Gossypol and Androgen Ablation Therapy in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00666666·55 enrolled

S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer

Completed·SSWOG Cancer Research Network·Phase 2·NCT00028769·41 enrolled

Breast Cancer7 trials

Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 1/2·NCT05095207·42 enrolled

FDHT PET and Bicalutamide in Metastatic Breast Cancer

Completed·UUniversity Medical Center Groningen·Phase 2·NCT02697032·22 enrolled

Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients

Active, not recruiting·PProvidence Health & Services·Phase 2·NCT03650894·30 enrolled

Show 4 more trials

Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer

Terminated·SSun Yat-sen University·Phase 3·NCT03055312·36 enrolled

SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

Active, not recruiting·UUNICANCER·Phase 2·NCT02299999·1,460 enrolled

Bicalutamide in Treating Patients With Metastatic Breast Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00468715·28 enrolled

Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer

Unknown status·XXu fei·Phase 2·NCT02910050·58 enrolled

Prostate Adenocarcinoma5 trials

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

Active, not recruiting·NNRG Oncology·Preclinical·NCT03070886·612 enrolled

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 recruiting·NNRG Oncology·Phase 3·NCT04513717·2,753 enrolled

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

Active, not recruiting·NNRG Oncology·Phase 3·NCT05050084·2,050 enrolled

Show 2 more trials

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

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT01786265·310 enrolled

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

Completed·SStanford University·Preclinical·NCT02346253·146 enrolled

Fed3 trials

Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet in Healthy Subjects Under Fed Conditions

Completed·KKremers Urban Development Company·Phase 1·NCT01044706·60 enrolled

Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fed Conditions

Completed· Teva logo

Teva·Phase 1·NCT00972855·60 enrolled

Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fed Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00960310·36 enrolled

26 more indications

COVID-193 trials

Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

Withdrawn·UUniversity of Florida·Phase 3·NCT04509999

Camostat With Bicalutamide for COVID-19

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT04652765·6 enrolled

Trial to Promote Recovery From COVID-19 With Endocrine Therapy

Withdrawn·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT04374279

Fasting Conditions2 trials

Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00973050·60 enrolled

Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00959335·36 enrolled

Trial2 trials

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

INTREPId (INTermediate Risk Erection PreservatIon Trial)

Active, not recruiting·—·Phase 2·NCT04025372·234 enrolled

Triple-Negative Breast Cancer2 trials

Bicalutamide as A Treatment in AR-positive Metastatic Triple-Negative Breast Cancer (mTNBC) Patients

Terminated·FFudan University·Phase 2·NCT02348281·1 enrolled

Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

Recruiting·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT06365788·53 enrolled

Androgen Deprivation Therapy2 trials

Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)

Unknown status·FFudan University·Phase 2·NCT02742675·200 enrolled

Micro RNAs to Predict Response to Androgen Deprivation Therapy

Completed·MMedical College of Wisconsin··NCT02366494·42 enrolled

TNBC2 trials

AR-inhibitor Bicalutamide in Treating Patients With TNBC

Unknown status·JJinling Hospital, China·Phase 2·NCT02353988·60 enrolled

Ribociclib and Bicalutamide in AR+ TNBC

Active, not recruiting·KKari Wisinski·Phase 1/2·NCT03090165·37 enrolled

Neoadjuvant Therapy1 trial

Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

Completed·UUniversity of L'Aquila·Phase 2·NCT00418080·86 enrolled

Salivary Gland Cancer1 trial

Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer（MAPS）

Unknown status·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University··NCT05087706·182 enrolled

Randomized1 trial

Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509)

Active, not recruiting·—·Phase 2·NCT03141671·345 enrolled

Glioma1 trial

A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma

Withdrawn·UUniversity of Nebraska·Phase 1·NCT06501911

Pediatrics1 trial

Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00094328·14 enrolled

Fallopian Tube1 trial

Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00012090

Radiotherapy1 trial

RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery

Completed·UUniversity College, London·Phase 3·NCT00541047·4,236 enrolled

Women1 trial

Bicalutamide Therapy in Young Women With NAFLD and PCOS

Recruiting·UUniversity of California, San Francisco·Phase 1·NCT05979389·50 enrolled

Metastatic Urothelial Cancer1 trial

A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.

Withdrawn·—·Phase 2·NCT06018116

Phase II1 trial

Phase II Dutasteride in Combination With CAB vs CAB in SDC

Recruiting·RRadboud University Medical Center·Phase 2·NCT05513365·26 enrolled

Polycystic Ovary Syndrome1 trial

The RolE oF Androgen Excess in MUscle Energy MetaboLism in Women With PolyCystic Ovary Syndrome (REFUEL PCOS) Study 2

Unknown status·RRoyal College of Surgeons, Ireland·N/A·NCT05647356·16 enrolled

Ovarian Cancer1 trial

Signal TrAnsduction Pathway Activity Analysis in OVarian cancER

Recruiting·GGynaecologisch Oncologisch Centrum Zuid·Phase 2/3·NCT03458221·148 enrolled

Abiraterone Acetate1 trial

REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial

Recruiting·EEmory University·Phase 3·NCT06650579·72 enrolled

Prostatic Neoplasms1 trial

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

Active, not recruiting·AAragon Pharmaceuticals, Inc.·Phase 3·NCT02531516·1,503 enrolled

PSA1 trial

Androgen Deprivation and Localized Radiotherapy to Metastases in Patients With Oligometastatic Hormone - Sensitive Prostate Cancer

Active, not recruiting·CCity of Hope Medical Center·Phase 2·NCT00544830·29 enrolled

Non Muscle Invasive Bladder Cancer1 trial

A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer

Recruiting·CCHU de Quebec-Universite Laval·Phase 2·NCT05327647·160 enrolled

Castration Levels of Testosterone1 trial

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

Recruiting·SSWOG Cancer Research Network·Phase 3·NCT03678025·1,273 enrolled

Non-Muscle Invasive Bladder Urothelial Carcinoma1 trial

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

Recruiting·UUniversity of Wisconsin, Madison·Phase 1·NCT05521698·80 enrolled

Metastatic Breast Cancer (MBC)1 trial

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

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT02605486·46 enrolled

Recurrent Prostate Carcinoma1 trial

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

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01251861·108 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 4, 1995

CASODEX

NDA NDA020498

Oct 4, 1995

CASODEX

NDA NDA020498

Nov 12, 1997

CASODEX

NDA NDA020498

Dec 12, 1997

CASODEX

NDA NDA020498

Nov 4, 1999

CASODEX

NDA NDA020498

Dec 11, 2000

CASODEX

NDA NDA020498

Feb 28, 2001

CASODEX

NDA NDA020498

Oct 25, 2001

CASODEX

NDA NDA020498

Jan 25, 2002

CASODEX

NDA NDA020498

Sep 23, 2002

CASODEX

NDA NDA020498

May 11, 2005

CASODEX

NDA NDA020498

Mar 10, 2006

CASODEX

NDA NDA020498

Mar 13, 2009

CASODEX

NDA NDA020498

Mar 13, 2009

CASODEX

NDA NDA020498

Sep 15, 2010

CASODEX

NDA NDA020498

Sep 12, 2013

CASODEX

NDA NDA020498

Feb 27, 2015

CASODEX

NDA NDA020498

Mar 17, 2017

CASODEX

NDA NDA020498

Nov 1, 2017

CASODEX

NDA NDA020498

Sources

References

[1]
ClinicalTrials.gov — 139 trial records for Bicalutamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Casodex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bicalutamide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bicalutamide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020498). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Istituto Clinico Humanitas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Androgen Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: IIstituto Clinico Humanitas

Casodex

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Prostate Cancer80 trials

Metastatic Prostate Cancer11 trials

Breast Cancer7 trials

Prostate Adenocarcinoma5 trials

Fed3 trials

COVID-193 trials

Fasting Conditions2 trials

Trial2 trials

Triple-Negative Breast Cancer2 trials

Androgen Deprivation Therapy2 trials

TNBC2 trials

Neoadjuvant Therapy1 trial

Salivary Gland Cancer1 trial

Randomized1 trial

Glioma1 trial

Pediatrics1 trial

Fallopian Tube1 trial

Radiotherapy1 trial

Women1 trial

Metastatic Urothelial Cancer1 trial

Phase II1 trial

Polycystic Ovary Syndrome1 trial

Ovarian Cancer1 trial

Abiraterone Acetate1 trial

Prostatic Neoplasms1 trial

PSA1 trial

Non Muscle Invasive Bladder Cancer1 trial

Castration Levels of Testosterone1 trial

Non-Muscle Invasive Bladder Urothelial Carcinoma1 trial

Metastatic Breast Cancer (MBC)1 trial

Recurrent Prostate Carcinoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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