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 23 indications[4].[1]
Casodex is one of 460 small molecule programs targeting Glioma. It is currently in Approved.
23
Indications
138
Total Trials
27
Active Trials
459
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 23 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Casodex
IIstituto Clinico Humanitas
Approved
Tecentriq
RochePreclinical
Trodelvy
GileadPreclinical
Lexiscan
AstellasPreclinical
Adenocard
AstellasPreclinical
Zinecard
CChildren's Oncology Group
Preclinical
Sporanox
SSebela Pharmaceuticals Development LLC
Preclinical
Motexafin Gadolinium
PPharmacyclics LLC.
Preclinical
Recombinant Human Endostatin
PPeking University Third Hospital
Preclinical
Conventional Chemotherapy
SShanghai Jiao Tong University School of Medicine
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Q4 2026
Phase 2/3Recruiting
Ovarian Cancer
NCT03458221
Phase 1/2Active, not recruiting
TNBC
NCT03090165
PreclinicalActive, not recruiting
Metastatic Breast Cancer (MBC)
NCT02605486
Phase 3Active, not recruiting
Prostate Adenocarcinoma
NCT05050084
Phase 2Active, not recruiting
Breast Cancer
NCT03650894
Phase 2Recruiting
Bladder Cancer
NCT05327647
Clinical
Trials by Indication[1]
Prostate Cancer80 trials
Show 77 more trials
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
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
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Completed·—·Phase 2·NCT00776594·102 enrolled
RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
Completed·—·Phase 2·NCT00630344·36 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
Cryoablation Therapy or Radiotherapy Therapy for Stage III Prostate Cancer
Unknown status·TTianjin Medical University Cancer Institute and Hospital·N/A·NCT02605226·240 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 Definitive Therapy to Treat Prostate Cancer
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02716974·26 enrolled
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Withdrawn·—·Phase 2·NCT00003517
Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer
Completed·—·Phase 2·NCT00658697·42 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
Metastatic Prostate Cancer13 trials
Show 10 more trials
Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases
Terminated·—·Phase 2·NCT02582749·16 enrolled
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
Active, not recruiting·—·Phase 2·NCT00544830·29 enrolled
Breast Cancer7 trials
Show 4 more trials
Prostate Adenocarcinoma4 trials
24 more indications
Fed3 trials
Androgen Deprivation Therapy2 trials
Fasting Conditions2 trials
TNBC2 trials
Trial2 trials
INTREPId (INTermediate Risk Erection PreservatIon Trial)
Active, not recruiting·—·Phase 2·NCT04025372·234 enrolled
Triple-Negative Breast Cancer2 trials
Polycystic Ovary Syndrome1 trial
Glioma1 trial
Bladder Cancer1 trial
A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
Recruiting·—·Phase 2·NCT05327647·160 enrolled
Pediatrics1 trial
Abiraterone Acetate1 trial
Metastatic Urothelial Cancer1 trial
A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer.
Withdrawn·—·Phase 2·NCT06018116
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
Fallopian Tube1 trial
Radiotherapy1 trial
Salivary Gland Cancer1 trial
Neoadjuvant Therapy1 trial
Non-Muscle Invasive Bladder Urothelial Carcinoma1 trial
Metastatic Breast Cancer (MBC)1 trial
Regulatory
FDA Approval Timeline[5]
Oct 4, 1995
CASODEX
NDA NDA020498
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Casodex drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Bicalutamide. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Androgen Receptor Antagonist[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- IIstituto Clinico Humanitas