rofecoxib
Trade name: Vioxx
Small moleculewithdrawn
Approved
May 20, 1999
Rofecoxib is a nonsteroidal anti-inflammatory drug which selectively inhibits COX-2 and subsequent prostaglandin synthesis. The drug was developed by Merk and approved by FDA in 1999 for relief of signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles under the name Vioxx. Later on Merck voluntarily withdrawn Vioxx from the market due to safety concerns (high risk of heart attack and stroke). — NCATS
Clinical trial activity
32 trials · 19 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
19
Phase 3
20
Phase 4
6
Earliest trial started Oct 1, 1999 (NCT00568295)
Timeline
Indications
Approved for
Studied for
- Acute Pain · Phase 4
- Adenomatous Polyposis Coli · Phase 4
- Alzheimer Disease · Phase 2/Phase 3
- Analgesics · Phase 4
- Arthritis, Rheumatoid · Phase 4
- Arthropathy, Neurogenic · Phase 3
- Barrett Esophagus · Phase 4
- Brain Neoplasms · Phase 1
- Carcinoma, Non-Small-Cell Lung · Phase 2/Phase 3
- Colorectal Neoplasms · Phase 3
- Glioma · Phase 1
- Intestinal Polyposis · Phase 2/Phase 3
- Joint Diseases · Phase 2
- Neoplasms · Phase 1
- Osteoarthritis · Phase 3
- Osteoarthritis, Knee · Phase 3
- Pain · Phase 4
- Postoperative Pain · Phase 3
- Prostatic Neoplasms · Phase 3
- Stomach Neoplasms · Phase 3
- Tooth Extraction · Phase 2
Mechanism of action
- Cyclooxygenase-2INHIBITOR
PTGS2 inhibitor
Approval history
- withdrawnPriority reviewMay 20, 1999
Chemistry & pharmacology
Loading structure…
SMILES
CC(C)(N)CNC(=O)C[C@H]1CC[C@]2(CC1)OO[C@]1(O2)C2CC3CC(C2)CC1C3- Mol. weight
- 392.54 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL404431 ↗
- WikipediaRofecoxib ↗
- NCATS0QTW8Z7MCR ↗
- ChEMBLCHEMBL570680 ↗
- ChEMBLCHEMBL122 ↗
Also known as
- 4-(4-methylsulfonylphenyl)-3-phenyl-5h-furan-2-one
- cahill may roberts brand of rofecoxib
- ceeoxx
- merck brand of rofecoxib
- merck frosst brand of rofecoxib
- merck sharp & dhome brand of rofecoxib
- mk 0966
- mk-0966
- mk-0966
- mk-0966
- mk-1966
- mk 966
- mk-966
- mk-966
- mk-966
- msd brand of rofecoxib
- refecoxib
- rofecoxib
- rofecoxib
- rofecoxib
- rofecoxib
- rofecoxib
- rofecoxib
- rofecoxib
- rofecoxib
- rofecoxib
- rofecoxib
- rofecoxib
- vioxx
- vioxx
- vioxx
- vioxx
- vioxx
- vioxx dolor
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04684511 | Phase 3 | Oct 31, 2021 | Tremeau Pharmceuticals, Inc. |
| NCT02731742 | Phase 1 | Jun 22, 2016 | Merck |
| NCT00261586 | Phase 4 | Dec 2, 2005 | Johnson and Johnson, McNeil |
| NCT00165048 | Phase 3 | Oct 1, 2004 | Chinese University of Hong Kong |
| NCT00164892 | Phase 3 | Oct 1, 2004 | Chinese University of Hong Kong |
| NCT00263094 | N/A | Sep 1, 2004 | Tel Aviv University, University of Connecticut |
| NCT00140920 | Phase 4 | May 25, 2004 | Merck |
| NCT00157872 | Phase 4 | Jan 7, 2004 | Merck |
| NCT00844727 | Phase 2/Phase 3 (Phase 3) | Sep 1, 2003 | Osaka University |
| NCT00092378 | Phase 3 | Sep 1, 2003 | Merck |
| NCT00657449 | Phase 4 | Jun 1, 2003 | Pfizer |
| NCT00092352 | Phase 3 | Apr 29, 2003 | Merck |
| NCT00140933 | Phase 3 | Apr 1, 2003 | Merck |
| NCT00092365 | Phase 3 | Apr 1, 2003 | Merck |
| NCT01762891 | N/A | Mar 1, 2003 | Rio de Janeiro State University |
| NCT00140894 | Phase 4 | Mar 1, 2003 | Merck |
| NCT00060476 | Phase 3 | Jan 8, 2003 | Merck |
| NCT00385606 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2003 | Fondazione Giovanni Pascale, San Giuseppe Moscati Hospital |
| NCT00050362 | Phase 2 | Dec 1, 2002 | National Institute of Dental and Craniofacial Research (NIDCR) |
| NCT00092339 | Phase 3 | Aug 1, 2002 | Merck |
Showing 20 of 32 trials
Page 1 / 2
Organizations
Research & Development (19)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Merck | For profit | 15 | 15 | 3 | 1999 |
| Chinese University of Hong Kong | Academic/Hospital | 2 | 2 | 1 | 2004 |
| Johnson and Johnson | For profit | 2 | 2 | 2 | 1999 |
| McNeil | For profit | 2 | 0 | 2 | 1999 |
| National Institute of Dental and Craniofacial Research (NIDCR) | Government | 2 | 2 | 1 | 2001 |
| AstraZeneca | For profit | 1 | 1 | 1 | 2002 |
| Cancer Research Campaign | Academic/Hospital | 1 | 1 | 1 | 2001 |
| Fondazione Giovanni Pascale | Academic/Hospital | 1 | 1 | 1 | 2003 |
| National Institute on Aging (NIA) | Government | 1 | 1 | 1 | 2000 |
| Novartis | For profit | 1 | 1 | 1 | 2000 |
| Osaka University | Academic/Hospital | 1 | 1 | 1 | 2003 |
| Pfizer | For profit | 1 | 1 | 1 | 2003 |
| Rio de Janeiro State University | Academic/Hospital | 1 | 1 | 1 | 2003 |
| San Giuseppe Moscati Hospital | Academic/Hospital | 1 | 0 | 1 | 2003 |
| Tel Aviv University | Academic/Hospital | 1 | 1 | 1 | 2004 |
| Tremeau Pharmceuticals, Inc. | For profit | 1 | 1 | 1 | 2021 |
| University of Connecticut | Academic/Hospital | 1 | 0 | 1 | 2004 |
| University of Oxford | Academic/Hospital | 1 | 0 | 1 | 2001 |
| University of Texas at Houston | Academic/Hospital | 1 | 1 | 1 | 2002 |
19 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Merck | For profit | NDA | May 20, 1999 |