Rofecoxib
As of the edition of 20 October 2026, Rofecoxib is a small molecule: withdrawn from the market in 2004; acts on PTGS2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Withdrawn from market, 2004
- Kind
- Small molecule
- Brand name
- Vioxx
- First approved
- 20 May 1999 (US)
- Approvals on record
- 6 in 1 region
- Holder of the most recent approval
- Merck & Co.
- Withdrawn from market
- 1 January 2004 (worldwide)
- Registered trials
- 26, 5 stopped early
- Disease areas
- Cancer; Bones, joints and muscles; Digestive system; Nervous system; Immune system; Inherited and neonatal
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PTGS2 | Prostaglandin G/H synthase 2 | P35354 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 17 | 13 | 0 | 2 |
| Phase 4 | 4 | 2 | 0 | 2 |
| All trials | 26 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Originator and Lead sponsor of trials | 1999 to now |