Ketorolac
As of the edition of 20 October 2026, Ketorolac is a small molecule: marketed, first approved in 1989 (US); acts on PTGS1 and PTGS2; 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 2015
- Kind
- Small molecule
- Brand name
- Toradol
- First approved
- 30 November 1989 (US)
- Approvals on record
- 17 in 6 regions
- Holder of the most recent approval
- Rayner Surgical; 7 holders in all
- Withdrawn from market
- 1 January 1993 (in some regions)
- Registered trials
- 254, 42 stopped early
- Disease areas
- Nervous system; Urinary and reproductive; Eye; Bones, joints and muscles; Pregnancy and women's health; Injuries
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.
AbbVie holds a later exclusivity on its own new formulation or combination product, ending 2029; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
6 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product6 company-target rows are on route B because of Ketorolac.
See the 6 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 34 | 24 | 2 | 3 |
| Phase 1 | 36 | 25 | 3 | 4 |
| Phase 2 | 28 | 14 | 4 | 9 |
| Phase 3 | 50 | 33 | 9 | 3 |
| Phase 4 | 106 | 59 | 9 | 23 |
| All trials | 254 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Later holder and Lead sponsor of trials | 1992 to now |
| Roche | Acquired holder | 2003 to now |
| Rayner Surgical | Applicant | 2015 to now |
| Cosette Pharmaceuticals | Acquired holder | 2026 to now |