Celebrex, Onsenal(celecoxib)
Celebrex, Celecoxib, Consensi, Elyxyb, 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 and prostaglandin G/H synthase 1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Celebrex, Celecoxib, Elyxyb (discontinued: Celecoxib)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Celecoxib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ELYXYB | Scilex Pharmaceuticals | N-212157 RX | 2020-05-05 | 1 products, RLD, RS |
| CELEBREX | Upjohn | N-020998 RX | 1998-12-31 | 4 products, RLD |
Amlodipine besylate
+
Celecoxib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CONSENSI | Purple Biotech | N-210045 DISCN | 2018-05-31 | 3 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| celebrex | New Drug Application | 2024-11-22 |
| celecoxib | ANDA | 2025-09-22 |
| celecoxib 100 mg | ANDA | 2015-11-30 |
| celecoxib 200 mg | ANDA | 2019-11-01 |
| celecoxib 400 mg | ANDA | 2015-11-27 |
| celecoxib 50 mg | ANDA | 2015-11-28 |
| celecoxib celecoxib | ANDA | 2021-12-21 |
| elyxyb | New Drug Application | 2020-05-13 |
| elyxyb - celecoxib | New Drug Application | 2024-11-26 |
| generic drug | ANDA | 2022-01-17 |
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Indications
FDA
EMA
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
666 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | 4 | 28 | 14 | 12 | 58 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 2 | 9 | 21 | 14 | 7 | 51 |
| Postoperative pain | D010149 | — | G89.18 | 1 | 5 | 12 | 19 | 10 | 46 |
| Colorectal neoplasms | D015179 | — | — | 7 | 25 | 8 | 1 | 2 | 39 |
| Healthy volunteers/patients | — | — | — | 24 | — | — | 3 | 3 | 30 |
| Pain | D010146 | EFO_0003843 | R52 | 3 | 5 | 4 | 9 | 6 | 27 |
| Colonic neoplasms | D003110 | — | C18 | 4 | 6 | 7 | 1 | 1 | 18 |
| Acute pain | D059787 | — | R52 | 1 | 3 | 5 | 2 | 4 | 15 |
| Low back pain | D017116 | — | M54.5 | — | 1 | 5 | 5 | 4 | 15 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 10 | 2 | 1 | 2 | 14 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 10 | 18 | 3 | — | 6 | 34 |
| Neoplasms | D009369 | — | C80 | 16 | 12 | 2 | — | 2 | 28 |
| Non-small-cell lung carcinoma | D002289 | — | — | 8 | 16 | 3 | — | 1 | 26 |
| Lung neoplasms | D008175 | — | C34.90 | 9 | 14 | 1 | — | 1 | 23 |
| Head and neck neoplasms | D006258 | — | — | 4 | 12 | 1 | — | 1 | 15 |
| Rectal neoplasms | D012004 | — | — | 2 | 8 | 3 | — | 1 | 14 |
| Chronic pain | D059350 | — | — | — | 1 | 4 | — | 2 | 7 |
| Mouth neoplasms | D009062 | EFO_0003868 | C06.9 | 1 | 7 | 1 | — | — | 7 |
| Adenomatous polyposis coli | D011125 | — | D13.91 | 1 | 3 | 3 | — | 1 | 7 |
| Nasopharyngeal neoplasms | D009303 | — | — | 1 | 4 | 2 | — | — | 5 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | — | — | 7 | 4 | — | — | 1 | 11 |
| Carcinoma | D002277 | — | C80.0 | 2 | 6 | — | — | 1 | 8 |
| Esophageal neoplasms | D004938 | — | C15 | 3 | 5 | — | — | — | 8 |
| Recurrence | D012008 | — | — | 2 | 6 | — | — | — | 7 |
| Melanoma | D008545 | — | — | 5 | 3 | — | — | 1 | 7 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 4 | — | — | — | 6 |
| Central nervous system neoplasms | D016543 | — | — | — | 6 | — | — | — | 6 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 4 | — | — | 2 | 6 |
| Covid-19 | D000086382 | — | U07.1 | — | 4 | — | — | 1 | 5 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 5 | — | — | — | 5 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Germ cell and embryonal neoplasms | D009373 | — | — | 3 | — | — | — | — | 3 |
| Mesothelioma | D008654 | — | C45 | 3 | — | — | — | — | 3 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 2 | — | — | — | — | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | 1 | 2 |
| Primary myelofibrosis | D055728 | — | D47.4 | 2 | — | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | 1 | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | 1 | 2 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 2 | — | — | — | — | 2 |
| Hodgkin disease | D006689 | — | C81 | 1 | — | — | — | 1 | 2 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | 1 | — | — | — | 1 | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heterotopic ossification | D009999 | — | — | — | — | — | — | 2 | 2 |
| Cachexia | D002100 | — | R64 | — | — | — | — | 2 | 2 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | — | — | 2 | 2 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | — | — | 1 | 1 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | — | — | — | 1 | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | — | — | — | 1 | 1 |
| Papillomaviridae | D027383 | — | — | — | — | — | — | 1 | 1 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | — | 1 | 1 |
| Hemorrhoids | D006484 | EFO_0009552 | K64 | — | — | — | — | 1 | 1 |
| Shoulder injuries | D000070599 | — | — | — | — | — | — | 1 | 1 |
Show 64 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 |
Identifiers
| PDB | — |
| CAS-ID | 169590-42-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL118 |
| ChEBI ID | 41423 |
| PubChem CID | 2662 |
| DrugBank | DB00482 |
| UNII ID | JCX84Q7J1L (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CA2
CA2
Organism
Homo sapiens
Gene name
CA2
Gene synonyms
NCBI Gene ID
Protein name
carbonic anhydrase 2
Protein synonyms
CA-II, CAC, Carbonate dehydratase II, carbonic anhydrase B, Carbonic anhydrase C, Carbonic anhydrase II, carbonic dehydratase, Cyanamide hydratase CA2, epididymis luminal protein 76, epididymis secretory protein Li 282
Uniprot ID
Mouse ortholog
Car2 (12349)
carbonic anhydrase 2 (Q9DCY9)
Variants
No data
Financial
Revenue by drug
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Celebrex – Viatris
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Celebrex – Pfizer
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Elyxyb – Collegium Pharmaceutical
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Estimated US medical usage
Celecoxib
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Celebrex, Celecoxib, Celecoxib 100 mg, Celecoxib 200 mg, Celecoxib 400 mg, Celecoxib 50 mg, Celecoxib celecoxib, Elyxyb, Elyxyb - celecoxib, Generic drug, Vyscoxa
Adverse Events
Top Adverse Reactions
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68,759 adverse events reported
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