Sulfasalazine
As of the edition of 20 October 2026, Sulfasalazine is a small molecule: marketed, first approved in 1950 (CH); acts on PTGS1 and PTGS2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1995
- Kind
- Small molecule
- Brand name
- Azulfidine
- First approved
- 4 May 1950 (CH)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- Pfizer; 2 holders in all
- Registered trials
- 41, 2 stopped early
- Disease areas
- Bones, joints and muscles; Skin and connective tissue; Immune system; Cancer; Digestive system; Nervous system
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 7 | 2 | 0 |
| Phase 1 | 7 | 6 | 1 | 0 |
| Phase 2 | 7 | 0 | 4 | 1 |
| Phase 3 | 9 | 6 | 0 | 0 |
| Phase 4 | 8 | 4 | 0 | 1 |
| All trials | 41 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 1950 to now |