Nitazoxanide
As of the edition of 20 October 2026, Nitazoxanide is a small molecule: marketed, first approved in 2002 (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 2005
- Kind
- Small molecule
- Brand name
- Alinia
- First approved
- 22 November 2002 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- FARMOQUĂMICA S/A; 2 holders in all
- Registered trials
- 70, 10 stopped early
- Disease areas
- Infections; Digestive system; Lungs and airways; Immune system; Urinary and reproductive; 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 3 | 0 | 0 |
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 28 | 18 | 3 | 4 |
| Phase 3 | 27 | 9 | 5 | 5 |
| Phase 4 | 6 | 3 | 0 | 1 |
| All trials | 70 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Romark | Originator | 2002 to now |