NDAORALTABLET
Approved
Oct 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
CASODEX (bicalutamide) by ANI Pharmaceuticals is androgen receptor antagonists [moa]. First approved in 1995.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CASODEX (bicalutamide) is an oral androgen receptor antagonist approved in 1995 for advanced prostate cancer, working by blocking androgens that fuel tumor growth. It is a small-molecule hormone therapy used primarily in combination with luteinizing hormone-releasing hormone (LHRH) agonists or as monotherapy in early-stage disease.
$0.381MPart D
LOE ApproachingDeclining
Shrinking commercial footprint signals consolidation of brand team; roles focus on defending market share against generics rather than growth.
Mechanism of Action
Androgen Receptor Antagonists
Pharmacologic Class:
Androgen Receptor Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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.