Fosfomycin
As of the edition of 20 October 2026, Fosfomycin is a small molecule: marketed, first approved in 1972 (ES); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Monurol
- First approved
- 1 December 1972 (ES)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- Meitheal Pharmaceuticals; 5 holders in all
- Registered trials
- 37, 3 stopped early
- Disease areas
- Infections; Urinary and reproductive; Pregnancy and women's health; Cancer; Blood and lymph; Lungs and airways
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Meitheal Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, ending 2033; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 1 | 0 |
| Phase 1 | 7 | 5 | 0 | 0 |
| Phase 2 | 7 | 4 | 0 | 1 |
| Phase 3 | 8 | 5 | 1 | 1 |
| Phase 4 | 11 | 7 | 1 | 1 |
| All trials | 37 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Zambon | Applicant | 1996 to now |
| Meitheal Pharmaceuticals | Later holder and Lead sponsor of trials | 2025 to now |