Testosterone cypionate
As of the edition of 20 October 2026, Testosterone cypionate is a small molecule: marketed, first approved in 1982 (US); acts on AR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Depo-Testadiol
- First approved
- 1 January 1982 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Azurity Pharmaceuticals; 2 holders in all
- Registered trials
- 31, 4 stopped early
- Disease areas
- Urinary and reproductive; Cancer; Hormones; Nervous system; Bones, joints and muscles; Injuries
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
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 Testosterone cypionate.
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 | 3 | 1 | 1 | 1 |
| Phase 1 | 5 | 2 | 2 | 1 |
| Phase 2 | 15 | 8 | 7 | 0 |
| Phase 3 | 3 | 0 | 1 | 1 |
| Phase 4 | 5 | 1 | 3 | 1 |
| All trials | 31 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Azurity Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2024 to now |