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BICALUTAMIDE
BICALUTAMIDE is a Androgen Receptor Inhibitor [EPC] drug. It is currently FDA-approved (first approved 1995) for Stage D2 Metastatic Prostate Cancer.
Bicalutamide is a marketed drug primarily indicated for Stage D2 Metastatic Prostate Cancer, with a key composition patent expiring in 2028. Its primary strength lies in its established market presence and mechanism of action, which has demonstrated efficacy in managing advanced prostate cancer. The primary risk is the impending patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | BICALUTAMIDE |
|---|---|
| Drug class | Androgen Receptor Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1995 |
Approved indications
- Stage D2 Metastatic Prostate Cancer
Common side effects
- Hot Flashes
- Pain (General)
- Back Pain
- Asthenia
- Constipation
- Pelvic Pain
- Infection
- Nausea
- Dyspnea
- Peripheral Edema
- Diarrhea
- Nocturia
Serious adverse events
- Myocardial Infarct
- Congestive Heart Failure
- Angina Pectoris
- Heart Arrest
- Syncope
- Gastrointestinal Carcinoma
- Sepsis
- Pneumonia
- Pathological Fracture
- Coronary Artery Disorder
Drug interactions
- LHRH analogs (goserelin or leuprolide)
- CYP 3A4 substrates (e.g., midazolam)
- Coumarin anticoagulants
Key clinical trials
- Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer (PHASE2)
- An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS (PHASE3)
- Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer (PHASE1, PHASE2)
- Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer (PHASE3)
- Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer (PHASE3)
- Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT (PHASE2)
- Contributions to Hypertension With Androgen Deprivation Therapy (PHASE4)
- Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BICALUTAMIDE CI brief — competitive landscape report
- BICALUTAMIDE updates RSS · CI watch RSS
Frequently asked questions about BICALUTAMIDE
What is BICALUTAMIDE?
What is BICALUTAMIDE used for?
What drug class is BICALUTAMIDE in?
When was BICALUTAMIDE approved?
What development phase is BICALUTAMIDE in?
What are the side effects of BICALUTAMIDE?
Related
- Drug class: All Androgen Receptor Inhibitor [EPC] drugs
- Indication: Drugs for Stage D2 Metastatic Prostate Cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing