Testosterone
As of the edition of 20 October 2026, Testosterone is a small molecule: marketed, first approved in 1953 (ES); acts on AR.
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
- Delatestryl
- First approved
- 1 June 1953 (ES)
- Approvals on record
- 38 in 6 regions
- Holder of the most recent approval
- CSL Behring; 19 holders in all
- Withdrawn from market
- 25 May 2012 (in some regions)
- Registered trials
- 218, 28 stopped early
- Disease areas
- Hormones; Urinary and reproductive; Nutrition and metabolism; Mental health; Cancer; 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
4 companies on route B because of this drug.
Companies on route B for this drug
In the product4 companies are on route B because of Testosterone.
See the 4 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 | 37 | 22 | 5 | 4 |
| Phase 1 | 40 | 33 | 1 | 6 |
| Phase 2 | 57 | 39 | 5 | 10 |
| Phase 3 | 44 | 35 | 1 | 3 |
| Phase 4 | 40 | 30 | 2 | 5 |
| All trials | 218 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sterimax | Applicant | 1992 to now |
| Johnson & Johnson | Later holder | 1993 to now |
| Actavis | Later holder and Lead sponsor of trials | 1995 to now |
| CSL Behring | Applicant | 2004 to now |
| ANI Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2006 to now |
| Abbott | Later holder and Lead sponsor of trials | 2007 to now |
| Endo | Acquired holder and Lead sponsor of trials | 2007 to now |
| Eli Lilly | Later holder and Lead sponsor of trials | 2007 to now |
| Acerus Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2008 to now |
| AbbVie | Acquired holder and Lead sponsor of trials | 2010 to now |
| Teva | Later holder | 2012 to now |
| Perrigo Israel Pharmaceuticals | Later holder | 2013 to now |
| Halozyme Therapeutics | Later holder and Lead sponsor of trials | 2013 to now |
| Upsher-Smith | Later holder and Lead sponsor of trials | 2014 to now |
| Auxilium Pharmaceuticals | Acquired holder | 2017 to now |
| Besins Healthcare | Acquired holder | 2023 to now |
| Azurity Pharmaceuticals | Acquired holder | 2024 to now |
| Bristol Myers Squibb | Earlier holder |