Celebrex, Onsenal(celecoxib)
Celebrex, Consensi, Onsenal, Seglentis (celecoxib) is a small molecule pharmaceutical. Celecoxib was first approved as Celebrex on 1998-12-31. It is used to treat adenomatous polyposis coli, ankylosing spondylitis, dysmenorrhea, osteoarthritis, and rheumatoid arthritis in the USA. It has been approved in Europe to treat adenomatous polyposis coli. The pharmaceutical is active against prostaglandin G/H synthase 2. In addition, it is known to target carbonic anhydrase 12, prostaglandin G/H synthase 1, and carbonic anhydrase 2.
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COVID-19
Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Celebrex (generic drugs available since 2014-05-30, discontinued: Elyxyb)
CombinationsSeglentis (discontinued: Consensi)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amlodipine besylate
+
Celecoxib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CONSENSI | Purple Biotech | N-210045 DISCN | 2018-05-31 | 3 products, RLD |
Hide discontinued
Celecoxib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CELEBREX | Upjohn | N-020998 RX | 1998-12-31 | 4 products, RLD |
Show 1 discontinued
Celecoxib
+
Tramadol hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SEGLENTIS | Kowa | N-213426 RX | 2021-10-15 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| celebrex | New Drug Application | 2022-02-08 |
| celecoxib | ANDA | 2023-06-07 |
| elyxyb - celecoxib | New Drug Application | 2021-10-01 |
| seglentis | New Drug Application | 2021-10-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| adenomatous polyposis coli | — | D011125 | — |
| ankylosing spondylitis | EFO_0003898 | D013167 | M45 |
| dysmenorrhea | HP_0100607 | D004412 | N94.6 |
| osteoarthritis | EFO_0002506 | D010003 | M15-M19 |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CELECOXIB / TRAMADOL HYDROCHLORIDE, SEGLENTIS, KOWA PHARMS | |||
| 2024-10-15 | NP | ||
CELECOXIB, ELYXYB, SCILEX HLDG | |||
| 2023-05-05 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Amlodipine Besylate / Celecoxib, Consensi, Purple Biotech | |||
| 10350171 | 2038-06-14 | DP | |
| 10925835 | 2038-06-14 | U-2410 | |
| 10945960 | 2038-06-14 | DP | |
| 9408837 | 2030-02-28 | U-2410 | |
| 9662315 | 2029-05-22 | DP | U-2410 |
| Celecoxib, Elyxyb, Scilex Hldg | |||
| 9572819 | 2036-05-27 | DP | U-2718 |
| 9795620 | 2036-05-27 | DP | U-2718 |
| 9949990 | 2036-05-27 | DP | U-2718 |
| 10376527 | 2036-05-27 | DP | U-2718 |
| 10722456 | 2036-05-27 | DP | U-2718 |
| 10799517 | 2036-05-27 | DP | U-2718 |
| Celecoxib / Tramadol Hydrochloride, Seglentis, Kowa Pharms | |||
| 8846744 | 2031-06-03 | DP | |
| 8598152 | 2030-04-19 | DS, DP | |
| 9012440 | 2030-04-19 | DS, DP | |
| 10238668 | 2030-04-19 | DS, DP | U-3244 |
| 10245276 | 2030-04-19 | DS, DP | |
| 10548909 | 2030-04-19 | U-3244 | |
| 11478488 | 2030-04-19 | U-3244 | |
ATC Codes
C: Cardiovascular system drugs
— C08: Calcium channel blockers
— C08C: Selective calcium channel blockers with mainly vascular effects
— C08CA: Dihydropyridine derivative selective calcium channel blockers with mainly vascular effects
— C08CA51: Amlodipine and celecoxib
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XX: Other antineoplastic agents in atc
— L01XX33: Celecoxib
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AH: Coxibs
— M01AH01: Celecoxib
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AJ: Opioids in combination with non-opioid analgesics
— N02AJ16: Tramadol and celecoxib
HCPCS
No data
Clinical
Clinical Trials
499 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 6 | 11 | 11 | 2 | 30 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | 16 | 9 | 3 | 29 |
| Colorectal neoplasms | D015179 | 6 | 15 | 6 | 1 | 2 | 28 | ||
| Healthy volunteers/patients | — | 21 | — | — | 3 | 3 | 27 | ||
| Postoperative pain | D010149 | G89.18 | 1 | 5 | 8 | 8 | 3 | 24 | |
| Pain | D010146 | EFO_0003843 | R52 | 2 | 3 | 3 | 6 | 3 | 17 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | 1 | 1 | 5 | — | 8 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | 2 | 5 | 1 | 8 |
| Colonic neoplasms | D003110 | C18 | 1 | 3 | 2 | 1 | 1 | 7 | |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | — | 3 | 3 | 1 | 7 |
Show 43 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 9 | 16 | 3 | — | 1 | 27 |
| Lung neoplasms | D008175 | C34.90 | 7 | 14 | 1 | — | 1 | 21 | |
| Prostatic neoplasms | D011471 | C61 | 1 | 9 | 2 | — | 1 | 11 | |
| Head and neck neoplasms | D006258 | 3 | 9 | 1 | — | — | 11 | ||
| Non-small-cell lung carcinoma | D002289 | 3 | 3 | 2 | — | — | 8 | ||
| Adenomatous polyposis coli | D011125 | — | 3 | 2 | — | 1 | 5 | ||
| Precancerous conditions | D011230 | 2 | 4 | 1 | — | — | 5 | ||
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | 1 | 2 | — | — | 4 |
| Rectal neoplasms | D012004 | — | 2 | 1 | — | — | 3 | ||
| Urinary bladder neoplasms | D001749 | C67 | 1 | 1 | 1 | — | 1 | 3 |
Show 20 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 7 | 8 | — | — | 1 | 14 | |
| Sarcoma | D012509 | 6 | 3 | — | — | 1 | 9 | ||
| Esophageal neoplasms | D004938 | C15 | 3 | 5 | — | — | — | 8 | |
| Melanoma | D008545 | 4 | 2 | — | — | 1 | 6 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 4 | — | — | 2 | 6 |
| Covid-19 | D000086382 | U07.1 | — | 4 | — | — | — | 4 | |
| Uterine cervical neoplasms | D002583 | 2 | 4 | — | — | — | 4 | ||
| Central nervous system neoplasms | D016543 | — | 4 | — | — | — | 4 | ||
| Glioblastoma | D005909 | EFO_0000515 | 1 | 3 | — | — | — | 3 | |
| Multiple myeloma | D009101 | C90.0 | 2 | 1 | — | — | — | 3 |
Show 54 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | 2 | — | — | — | — | 2 | ||
| Pharmacokinetics | D010599 | 2 | — | — | — | — | 2 | ||
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | — | — | — | — | 1 | |
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 |
Show 31 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heterotopic ossification | D009999 | — | — | — | — | 2 | 2 | ||
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | 1 | 1 | |
| Pulpitis | D011671 | EFO_1001139 | K04.0 | — | — | — | — | 1 | 1 |
| Treatment outcome | D016896 | — | — | — | — | 1 | 1 | ||
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 1 | 1 |
| Antiphospholipid syndrome | D016736 | EFO_0002689 | D68.61 | — | — | — | — | 1 | 1 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | — | — | 1 | 1 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 1 | 1 |
| Ovulation | D010060 | — | — | — | — | 1 | 1 | ||
| Squamous cell neoplasms | D018307 | — | — | — | — | 1 | 1 |
Show 2 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CELECOXIB |
| INN | celecoxib |
| Description | Celecoxib is a member of the class of pyrazoles that is 1H-pyrazole which is substituted at positions 1, 3 and 5 by 4-sulfamoylphenyl, trifluoromethyl and p-tolyl groups, respectively. A cyclooxygenase-2 inhibitor, it is used in the treatment of arthritis. It has a role as a cyclooxygenase 2 inhibitor, a geroprotector, a non-steroidal anti-inflammatory drug and a non-narcotic analgesic. It is a member of toluenes, a sulfonamide, a member of pyrazoles and an organofluorine compound. |
| Classification | Small molecule |
| Drug class | cyclooxygenase-2 inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1 |
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
CA12
CA12
PTGS1
PTGS1
CA2
CA2
Variants
Clinical Variant
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Financial
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Celebrex - Viatris
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Celebrex - Pfizer
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Tabular view
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Celebrex, Celecoxib
, Elyxyb - celecoxib, Seglentis
Adverse Events
Top Adverse Reactions
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20,955 adverse events reported
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