Ketoprofen
As of the edition of 20 October 2026, Ketoprofen is a small molecule: marketed, first approved in 1978 (ES); acts on PTGS1 and PTGS2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1986
- Kind
- Small molecule
- Brand name
- Orudis
- First approved
- 1 December 1978 (ES)
- Approvals on record
- 13 in 4 regions
- Holder of the most recent approval
- Novartis; 6 holders in all
- Registered trials
- 65, 9 stopped early
- Disease areas
- Nervous system; Bones, joints and muscles; Injuries; Blood and lymph; Mouth and teeth; Skin and connective tissue
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.
Companies that need a new molecule because of this drug
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Ketoprofen.
See the 5 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 | 8 | 5 | 0 | 1 |
| Phase 1 | 7 | 6 | 1 | 0 |
| Phase 2 | 10 | 6 | 2 | 1 |
| Phase 3 | 23 | 18 | 1 | 4 |
| Phase 4 | 17 | 10 | 2 | 3 |
| All trials | 65 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant | 1986 to now |
| Bayer | Later holder | 1995 to now |
| Hisamitsu Pharmaceutical | Applicant and Lead sponsor of trials | 2007 to now |
| Novartis | Later holder | 2009 to now |