Megestrol acetate
As of the edition of 20 October 2026, Megestrol acetate is a small molecule: marketed, first approved in 1982 (US); acts on PGR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1993
- Kind
- Small molecule
- Brand name
- Megace
- First approved
- 1 January 1982 (US)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Endo; 4 holders in all
- Registered trials
- 71, 13 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Immune system; Infections; Nutrition and metabolism
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 |
|---|---|---|
| PGR | Progesterone receptor | P06401 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 4 | 2 | 0 |
| Phase 1 | 7 | 3 | 1 | 2 |
| Phase 2 | 30 | 14 | 6 | 5 |
| Phase 3 | 21 | 9 | 7 | 5 |
| Phase 4 | 7 | 4 | 1 | 1 |
| All trials | 71 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Endo | Later holder and Lead sponsor of trials | 2004 to now |
| Bristol Myers Squibb | Applicant and Lead sponsor of trials |