Testosterone undecanoate
As of the edition of 20 October 2026, Testosterone undecanoate is a small molecule: marketed, first approved in 2014 (US); acts on AR; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Aveed
- First approved
- 5 March 2014 (US)
- Approvals on record
- 9 in 1 region
- Holder of the most recent approval
- Marius Pharmaceuticals; 4 holders in all
- Registered trials
- 52, 3 stopped early
- Disease areas
- Hormones; Urinary and reproductive; Nervous system; Cancer; Digestive system; Mental health
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Tolmar holds a later exclusivity on its own new formulation or combination product, ending 2030; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Testosterone undecanoate.
See the 2 companies 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 | 8 | 5 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 22 | 14 | 5 | 2 |
| Phase 3 | 13 | 11 | 0 | 0 |
| Phase 4 | 8 | 6 | 1 | 1 |
| All trials | 52 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Endo | Originator, Applicant and Lead sponsor of trials | 2006 to now |
| Clarus Therapeutics | Later holder and Lead sponsor of trials | 2007 to now |
| Halozyme Therapeutics | Later holder | 2022 to now |
| Marius Pharmaceuticals | Later holder | 2022 to now |
| Tolmar | Acquired holder and Lead sponsor of trials | 2023 to now |
| Verity Pharmaceuticals | Acquired holder | 2024 to now |