Stavudine
As of the edition of 20 October 2026, Stavudine is a small molecule: marketed, first approved in 1994 (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 1994
- Kind
- Small molecule
- Brand name
- Zerit
- First approved
- 24 June 1994 (US)
- Approvals on record
- 10 in 1 region
- Holder of the most recent approval
- Bristol Myers Squibb
- Registered trials
- 117, 5 stopped early
- Disease areas
- Immune system; Infections; Urinary and reproductive; Nutrition and metabolism; Nervous system; Skin and connective tissue
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 | 25 | 25 | 0 | 0 |
| Phase 1 | 13 | 12 | 0 | 1 |
| Phase 2 | 42 | 35 | 0 | 3 |
| Phase 3 | 24 | 20 | 0 | 1 |
| Phase 4 | 13 | 10 | 0 | 0 |
| All trials | 117 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator and Lead sponsor of trials | 1994 to now |