Sulfamethoxazole
As of the edition of 20 October 2026, Sulfamethoxazole is a small molecule: marketed, first approved in 1968 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Bactrim
- First approved
- 1 February 1968 (ES)
- Approvals on record
- 32 in 5 regions
- Holder of the most recent approval
- ABLE LABORATORIES INC; 14 holders in all
- Registered trials
- 98, 13 stopped early
- Disease areas
- Infections; Urinary and reproductive; Immune system; Lungs and airways; Pregnancy and women's health; Cancer
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 11 | 2 | 4 |
| Phase 1 | 8 | 5 | 2 | 0 |
| Phase 2 | 26 | 14 | 4 | 5 |
| Phase 3 | 25 | 16 | 5 | 3 |
| Phase 4 | 20 | 10 | 8 | 1 |
| All trials | 98 |