Bicalutamide: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Bicalutamide appears in the FDA drug-label database. Marketed as bicalutamide.
- Drug class
- Androgen Receptor Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Androgen Receptor Antagonists (as stated on the FDA label)
FDA-approved use
Bicalutamide tablets, USP 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets, USP 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies (14.2)]. • Bicalutamide tablet 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. (1) • Bicalutamide tablet 150 mg daily is not approved for use alone or with other treatments. (1)
Phase breakdown
Conditions being studied
Recruiting trials involving Bicalutamide
- Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
- Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
- Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery
- REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
- Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
- Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
Common questions
Is Bicalutamide FDA-approved?
Yes, marketed as bicalutamide.
How many recruiting trials involve Bicalutamide?
6 recruiting trials across 14 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.