Amifostine
As of the edition of 20 October 2026, Amifostine is a small molecule: marketed, first approved in 1995 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1995
- Kind
- Small molecule
- Brand name
- Ethyol
- First approved
- 8 December 1995 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Legacy Pharma Inc Sezc
- Registered trials
- 75, 14 stopped early
- Disease areas
- Cancer; Chemically induced; Blood and lymph; Urinary and reproductive; Lungs and airways; Pregnancy and women's health
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 14 | 9 | 0 | 3 |
| Phase 2 | 49 | 32 | 0 | 9 |
| Phase 3 | 8 | 7 | 0 | 1 |
| Phase 4 | 3 | 2 | 0 | 1 |
| All trials | 75 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Earlier holder | 1995 to now |
| Legacy Pharma Inc Sezc | Acquired holder | 2026 to now |