Sulindac
As of the edition of 20 October 2026, Sulindac is a small molecule: marketed, first approved in 1982 (US); acts on PTGS1 and PTGS2; no US protection 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
- Clinoril
- First approved
- 1 January 1982 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- medac; 2 holders in all
- Registered trials
- 21, 5 stopped early
- Disease areas
- Cancer; Digestive system; Skin and connective tissue; Inherited and neonatal; Blood and lymph; Chemically induced
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 2 | 0 | 2 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 11 | 7 | 1 | 2 |
| Phase 3 | 4 | 2 | 1 | 1 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant |