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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 diseasesD009140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
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
VIOXXMerck KGaAN-021042 DISCN1999-05-20
3 products
VIOXXMerck KGaAN-021052 DISCN1999-05-20
2 products
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
dysmenorrheaHP_0100607D004412N94.6
osteoarthritisEFO_0002506D010003M15-M19
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AH: Coxibs
— M01AH02: Rofecoxib
HCPCS
No data
Clinical
Clinical Trials
31 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R52—221—5
Barrett esophagusD001471EFO_0000280K22.7———1—1
AnalgesiaD000698———1—1
Acute painD059787R52———1—1
Rheumatoid arthritisD001172EFO_0000685M06.9———1—1
Adenomatous polyposis coliD011125———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postoperative painD010149G89.18——5——5
OsteoarthritisD010003EFO_0002506M15-M19——3——3
Stomach neoplasmsD013274EFO_0003897C16——2——2
Knee osteoarthritisD020370EFO_0004616M17——1——1
Non-small-cell lung carcinomaD002289—11——1
Prostatic neoplasmsD011471C61——1——1
Colorectal neoplasmsD015179——1——1
Alzheimer diseaseD000544EFO_0000249F03—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tooth extractionD014081—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain neoplasmsD001932EFO_0003833C711————1
GliomaD005910EFO_00005201————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Antiphospholipid syndromeD016736EFO_0002689D68.61————11
HeadacheD006261HP_0002315R51————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameROFECOXIB
INNrofecoxib
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 classcyclooxygenase-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
PDB5KIR
CAS-ID162011-90-7
RxCUI232158
ChEMBL IDCHEMBL122
ChEBI ID8887
PubChem CID5090
DrugBankDB00533
UNII ID0QTW8Z7MCR (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
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,994 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5 adverse events reported
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