Bicalutamide
As of the edition of 20 October 2026, Bicalutamide is a small molecule: marketed, first approved in 1995 (FR); acts on AR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Casodex
- First approved
- 5 May 1995 (FR)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- ACCORD FARMACĂUTICA LTDA; 6 holders in all
- Registered trials
- 159, 29 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Skin and connective tissue; Inherited and neonatal; Hormones; Nervous system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Bicalutamide.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| AR | Androgen receptor | P10275 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 3 | 1 | 0 |
| Phase 1 | 31 | 19 | 4 | 8 |
| Phase 2 | 77 | 38 | 19 | 15 |
| Phase 3 | 35 | 21 | 9 | 4 |
| Phase 4 | 6 | 3 | 0 | 2 |
| All trials | 159 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant and Lead sponsor of trials | 1994 to now |
| ANI Pharmaceuticals | Acquired holder | 2018 to now |