Methyltestosterone
As of the edition of 20 October 2026, Methyltestosterone 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
- Metandren
- First approved
- 1 January 1982 (US)
- Approvals on record
- 6 in 1 region
- Holder of the most recent approval
- Merck & Co.; 2 holders in all
- Registered trials
- 5, 2 stopped early
- Disease areas
- Cancer; Hormones; Pregnancy and women's health; 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 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 2 | 0 | 2 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant | |
| Novartis | Later holder |