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Casodex (bicalutamide)
Casodex works by blocking the androgen receptor, a protein that helps prostate cancer cells grow.
Casodex (bicalutamide) is a small molecule androgen receptor inhibitor originally developed by AstraZeneca and currently owned by Ani Pharms. It was FDA-approved in 1995 for the treatment of metastatic prostate carcinoma. As an off-patent medication, Casodex is available as a generic from multiple manufacturers. This medication works by blocking the androgen receptor, which is a protein that helps prostate cancer cells grow. It is a key treatment option for patients with advanced prostate cancer.
At a glance
| Generic name | bicalutamide |
|---|---|
| Sponsor | ANI Pharmaceuticals |
| Drug class | Androgen Receptor Inhibitor [EPC] |
| Target | Androgen receptor |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1995 |
Mechanism of action
. Mechanism of Action. CASODEX is 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 effect of androgen and/or removes the source of androgen.When CASODEX is combined with luteinizing hormone releasing hormone (LHRH) analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with CASODEX as single agent for prostate cancer, rises in serum testosterone and estradiol have been noted.In subset of patients who have been treated with CASODEX and an LHRH agonist, and who discontinue CASODEX therapy due to progressive advanced prostate cancer, reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed.
Approved indications
- Metastatic Prostate Carcinoma
Common side effects
- Pain (General)
- Back Pain
- Asthenia
- Pelvic Pain
- Infection
- Abdominal Pain
- Chest Pain
- Headache
- Flu Syndrome
- Hot Flashes
- Hypertension
- Constipation
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:
- Casodex CI brief — competitive landscape report
- Casodex updates RSS · CI watch RSS
- ANI Pharmaceuticals portfolio CI