Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bicalutamide · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Bicalutamide | EXPERIMENTAL | Bicalutamide 50 mg Tablet |
| Casodex® | ACTIVE_COMPARATOR | Casodex® 50 mg Tablet |
| Bicalutamide (test) | EXPERIMENTAL | Bicalutamide Tablet, 50 mg |
| Casodex® (reference) | ACTIVE_COMPARATOR | Casodex® Tablet, 50 mg |
| Name | Type | Description |
|---|---|---|
| Bicalutamide | DRUG | 50 mg Tablet |
| Casodex® | DRUG | 50 mg Tablet |
Inclusion Criteria: * Subjects will be males, non-smokers, 18 years of age and older. Exclusion Criteria: Subjects to whom any of the following applies will be excluded from the study: * Clinically significant illnesses within 4 weeks of the administration of study medication. * Clinically signi...
Bicalutamide is a small molecule drug developed by Teva Pharmaceutical Industries Limited. It is an androgen receptor antagonist that has been studied in Phase 1 clinical trials. The trials conducted so far have focused on healthy male volunteers under fasting and fed conditions.
Bicalutamide targets the androgen receptor (AR). It acts as an antagonist, meaning it blocks the action of androgens such as testosterone. This mechanism is relevant in conditions where androgen signaling plays a role.
Bicalutamide is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. Teva is a multinational pharmaceutical company headquartered in Israel.
Bicalutamide is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in healthy male volunteers. The drug is investigational and has not been approved by the FDA for any indication based on the available information.
Bicalutamide has been studied in two completed Phase 1 trials: NCT00973050, which evaluated a 50 mg tablet under fasting conditions, and NCT00972855, which evaluated the same tablet under fed conditions. Both trials enrolled 60 healthy male subjects in Canada.