Rofecoxib
Vioxx (rofecoxib) is a small molecule pharmaceutical. Rofecoxib was first approved as Vioxx on 1999-05-20. It is used to treat dysmenorrhea and osteoarthritis in the USA. The pharmaceutical is active against prostaglandin G/H synthase 2.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| musculoskeletal diseases | D009140 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rofecoxib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VIOXX | Merck & Co | N-021042 DISCN | 1999-05-20 | 3 products |
| VIOXX | Merck & Co | N-021052 DISCN | 1999-05-20 | 2 products |
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| osteoarthritis | EFO_0002506 | D010003 | M15-M19 |
| dysmenorrhea | — | D004412 | N94.6 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
No data
Clinical
Clinical Trials
32 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | — | — | 6 | 1 | — | 7 |
| Pain | D010146 | EFO_0003843 | R52 | — | 2 | 2 | 1 | — | 5 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | 2 | 1 | — | 3 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | 1 | — | 2 |
| Nasopharyngeal neoplasms | D009303 | — | — | — | 1 | 1 | 1 | — | 2 |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | — | — | — | 1 | — | 1 |
| Analgesia | D000698 | — | — | — | — | — | 1 | — | 1 |
| Ankle injuries | D016512 | — | S93.4 | — | — | — | 1 | — | 1 |
| Acute pain | D059787 | — | R52 | — | — | — | 1 | — | 1 |
| Sprains and strains | D013180 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | 4 | — | — | 5 |
| Toothache | D014098 | — | K08.89 | — | — | 4 | — | — | 4 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | 2 | — | — | 2 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | 1 | — | — | 1 |
| Joint diseases | D007592 | — | M12.9 | — | — | 1 | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
| Adenoma | D000236 | — | — | — | — | 1 | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | — | — | 1 | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tooth extraction | D014081 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Antiphospholipid syndrome | D016736 | EFO_0002689 | D68.61 | — | — | — | — | 1 | 1 |
| Headache | D006261 | — | R51 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Rofecoxib |
| INN | rofecoxib |
| Description | Rofecoxib is a butenolide that is furan-2(5H)-one substituted by a phenyl group at position 3 and by a p-(methylsulfonyl)phenyl group at position 4. A selective cyclooxygenase 2 inhibitor, it was used from 1999 to 2004 for the treatment of ostoarthritis, but was withdrawn following concerns about an associated increased risk of heart attack and stroke. It has a role as a cyclooxygenase 2 inhibitor, a non-steroidal anti-inflammatory drug and an analgesic. It is a sulfone and a butenolide. |
| Classification | Small molecule |
| Drug class | cyclooxygenase-2 inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CS(=O)(=O)c1ccc(C2=C(c3ccccc3)C(=O)OC2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 162011-90-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL122 |
| ChEBI ID | 8887 |
| PubChem CID | 5090 |
| DrugBank | DB00533 |
| UNII ID | 0QTW8Z7MCR (ChemIDplus, GSRS) |
Target
Agency Approved
PTGS2
PTGS2
Organism
Homo sapiens
Gene name
PTGS2
Gene synonyms
COX2
NCBI Gene ID
Protein name
prostaglandin G/H synthase 2
Protein synonyms
COX-2, cyclooxygenase 2, cyclooxygenase 2b, Cyclooxygenase-2, PGH synthase 2, PGHS-2, PHS II, Prostaglandin H2 synthase 2, Prostaglandin-endoperoxide synthase 2, prostaglandin-endoperoxide synthase 2 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Mouse ortholog
Ptgs2 (19225)
prostaglandin G/H synthase 2 (Q543K3)
Alternate
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Variants
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Financial
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Estimated US medical usage
Rofecoxib
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,963 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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72,059 adverse events reported
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