Zinc sulfate
As of the edition of 20 October 2026, Zinc sulfate is a small molecule: marketed, first approved in 1987 (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 2025
- Kind
- Small molecule
- Brand name
- Tralement
- First approved
- 5 May 1987 (US)
- Approvals on record
- 10 in 3 regions
- Holder of the most recent approval
- Clinigen; 5 holders in all
- Registered trials
- 49, 2 stopped early
- Disease areas
- Infections; Lungs and airways; Blood and lymph; Inherited and neonatal; Mouth and teeth; 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 | 13 | 8 | 1 | 2 |
| Phase 1 | 3 | 2 | 0 | 0 |
| Phase 2 | 8 | 5 | 1 | 0 |
| Phase 3 | 16 | 14 | 0 | 0 |
| Phase 4 | 9 | 8 | 0 | 0 |
| All trials | 49 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant | 1996 to now |
| Abraxis Pharmaceutical | Acquired holder | 2006 to now |
| American Regent | Later holder | 2019 to now |
| Clinigen | Applicant | 2025 to now |
| Astellas | Originator | 1987 to 2006 |