Oxandrolone
As of the edition of 20 October 2026, Oxandrolone 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
- Oxandrin
- First approved
- 1 January 1982 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Gemini Therapeutics
- Registered trials
- 17, 5 stopped early
- Disease areas
- Injuries; Inherited and neonatal; Heart and blood vessels; Nervous system; Nutrition and metabolism; Urinary and reproductive
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| AR | Androgen receptor | P10275 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 1 |
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 5 | 2 | 1 | 2 |
| Phase 3 | 3 | 1 | 0 | 2 |
| Phase 4 | 2 | 1 | 0 | 0 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gemini Therapeutics | Acquired holder | 2015 to now |
| Savient Pharmaceuticals | Earlier holder |