NDAORALTABLETPriority Review
Approved
Dec 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
31
Data completeness
4/8 — Partial
Priority Review
CASODEX (bicalutamide) by AstraZeneca is 12. Approved for prostate cancer. First approved in 2008.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CASODEX (bicalutamide) is a non-steroidal androgen receptor inhibitor approved for prostate cancer treatment. It works by competitively blocking androgen receptor signaling in prostate tissue, often used in combination with LHRH analog therapy to suppress testosterone-driven cancer growth. The drug demonstrates the antiandrogen withdrawal phenomenon, where PSA reduction may occur after discontinuation in some patients.
LOE Approaching
As LOE approaches, CASODEX teams are transitioning toward lifecycle extension strategies and generics transition planning, with smaller support teams focused on retention and managed care.
Mechanism of Action
12.1. Mechanism of Action CASODEX is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the…
Indications (1)
Clinical Trials (31)
An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment
Started Jun 2026
800 enrolled
Non-metastatic Castration-resistant Prostate Cancer
Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
Started Apr 2024
53 enrolled
Triple Negative Breast Neoplasms
Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients
Started Apr 2019
30 enrolled
Breast Neoplasm FemaleBreast CancerBreast Carcinoma+1 more
Ribociclib and Bicalutamide in AR+ TNBC
Started May 2018
37 enrolled
Triple Negative Breast Cancer
Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)
Started Nov 2015
46 enrolled
Metastatic Breast Cancer (MBC)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.