Celecoxib
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1998
- First approval year
- 1998
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Celecoxib
- Molecular weight
- 381.38
- Structure (SMILES)
- Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
- celebra
- Celebra
- celebrex
- Celebrex
- celecoxib
- Celecoxib
- celecoxib component of consensi
- Celecoxib component of consensi
- celecoxib component of seglentis
- Celecoxib component of seglentis
- elyxyb
- Elyxyb
- onsenal
- Onsenal
- "celecoxib", "Celebrex®"
- 200mg celecoxib 200mg qd po
- carbidopa levodopa and celecoxib
- celebrex
- Celebrex
- celebrex (celecoxib)
- Celebrex 200 mg
- Celebrex 200mg
- Celebrex 200Mg Capsule
- Celebrex capsule
- Celebrex Capsule
- Celebrex suspension
- CELEBREX®
- celecoxib
- Celecoxib
- CELECOXIB
- celecoxib (Celebrex)
- Celecoxib (Celebrex)
- Celecoxib (Celebrex®)
- Celecoxib (SC-58635)
- Celecoxib [EMA EPAR]
- Celecoxib [EP MONOGRAPH]
- Celecoxib [HSDB]
- Celecoxib [INN]
- Celecoxib [JAN]
And 63 more, listed on the interactive page.
- CAS registry numbers
- 169590-42-5
- ChEMBL ID
- CHEMBL118
- InChIKey
- RZEKVGVHFLEQIL-UHFFFAOYSA-N
- PubChem compound IDs
- 2662
- RxNorm IDs (RxCUI)
- 140587
- FDA ingredient codes (UNII)
- JCX84Q7J1L
- L01XX33
- M01AH01
Sources for recorded values
- Applicant
- UPJOHN
- Approval date
- 31 Dec 1998
- Application number
- NDA020998
- Status
- Withdrawn
- Status date
- 28 Nov 2008
- Authorisation date
- 17 Oct 2003
- Approved indications
- Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4). The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)
- Product number
- EMEA/H/C/000466
- Authorisation holder
- Pfizer Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- Yes
Therapeutic areas
- Adenomatous Polyposis Coli
European medicines record
- Patents
- 6
- Designations
- 2
- Earliest recorded loss of exclusivity
- 27 May 2036
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- celecoxib
- Type
- Synthetic organic
- Drug name stem
- -coxib
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- carbonic anhydrase 12
- Gene symbol
- CA12
- Protein identifier
- O43570
- Median affinity
- 7.74
- Affinity units
- pKi
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- COX-1
- Gene symbol
- PTGS1
- Protein identifier
- P23219
- Affinity units
- pIC50
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- COX-2
- Gene symbol
- PTGS2
- Protein identifier
- P35354
- Median affinity
- 8.7
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Cyclooxygenase-2 inhibitor
- Action type
- Inhibitor
- Target
- Prostaglandin G/H synthase 2
- Protein identifier
- P35354
Open Targets mechanisms
- Mechanism
- Cyclooxygenase-2 inhibitor
- Action type
- Inhibitor
- Target
- Prostaglandin G/H synthase 2
DrugCentral mechanisms
- Action type
- Inhibitor
- Gene symbol
- PTGS2
- Protein identifier
- P35354
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Squamous Cell Carcinoma of Head and Neck
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000199
- Subject identifier
- D000077195
- Condition
- Paraproteinemias
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000203
- Subject identifier
- D010265
- Condition
- Prostatic Hyperplasia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000284
- Subject identifier
- D011470
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Hypertension
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000537
- Subject identifier
- D006973
- Condition
- Wounds and Injuries
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000546
- Subject identifier
- D014947
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Neuroblastoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000621
- Subject identifier
- D009447
- Condition
- Pre-Eclampsia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000668
- Subject identifier
- D011225
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Stroke
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000712
- Subject identifier
- D020521
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Myositis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000783
- Subject identifier
- D009220
- Condition
- Memory Disorders
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001072
- Subject identifier
- D008569
- Condition
- Obesity
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
- Condition
- Ovarian Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001075
- Subject identifier
- D010051
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Uterine Cervical Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001416
- Subject identifier
- D002583
- Condition
- Keratosis, Actinic
- Highest recorded phase
- 1
- Condition identifier
- EFO:0002496
- Subject identifier
- D055623
And 94 more, listed on the interactive page.
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000196
- Condition identifier
- EFO_0000199
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000305
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000401
- Condition identifier
- EFO_0000537
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000546
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000658
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000668
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0000707
- Condition identifier
- EFO_0000712
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001072
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001073
- Condition identifier
- EFO_0001075
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001416
- Condition identifier
- EFO_0002496
- Highest recorded phase
- 1
- Condition identifier
- EFO_0002609
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003768
- Highest recorded phase
- 3
And 216 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Warning
- Black Box Warning
- Effect
- gastrointestinal toxicity
- Warning
- Black Box Warning
- Effect
- neurotoxicity
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- gastrointestinal toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- neurotoxicity
- Country
- United States
- Event
- abdominal discomfort
- Reports
- 375
- Reporting signal score
- 236.562
- Event
- anaphylactic reaction
- Reports
- 288
- Reporting signal score
- 201.443
- Event
- ankylosing spondylitis
- Reports
- 132
- Reporting signal score
- 259.954
- Event
- arthralgia
- Reports
- 913
- Reporting signal score
- 441.096
- Event
- arthritis
- Reports
- 281
- Reporting signal score
- 253.411
- Event
- arthropathy
- Reports
- 421
- Reporting signal score
- 559.768
- Event
- bedridden
- Reports
- 111
- Reporting signal score
- 202.822
- Event
- blood magnesium increased
- Reports
- 93
- Reporting signal score
- 322.076
- Event
- condition aggravated
- Reports
- 831
- Reporting signal score
- 473.318
- Event
- deafness neurosensory
- Reports
- 105
- Reporting signal score
- 228.537
- Event
- drug hypersensitivity
- Reports
- 2,908
- Reporting signal score
- 4,817.11
- Event
- drug intolerance
- Reports
- 642
- Reporting signal score
- 658.263
- Event
- epigastric discomfort
- Reports
- 104
- Reporting signal score
- 257.509
- Event
- fibromyalgia
- Reports
- 162
- Reporting signal score
- 248.702
- Event
- gastrointestinal haemorrhage
- Reports
- 384
- Reporting signal score
- 283.315
- Event
- hypersensitivity
- Reports
- 449
- Reporting signal score
- 214.683
- Event
- joint swelling
- Reports
- 421
- Reporting signal score
- 318.96
- Event
- loss of personal independence in daily activities
- Reports
- 401
- Reporting signal score
- 782.043
- Event
- mobility decreased
- Reports
- 259
- Reporting signal score
- 251.936
- Event
- musculoskeletal stiffness
- Reports
- 412
- Reporting signal score
- 388.039
- Event
- myocardial infarction
- Reports
- 384
- Reporting signal score
- 223.698
- Event
- osteoarthritis
- Reports
- 233
- Reporting signal score
- 255.773
- Event
- osteopenia
- Reports
- 134
- Reporting signal score
- 238.319
- Event
- pain
- Reports
- 1,004
- Reporting signal score
- 399.582
- Event
- pleural fibrosis
- Reports
- 103
- Reporting signal score
- 351.027
And 8 more, listed on the interactive page.
- NCT00001693
- NCT00188565
- NCT00001955
- NCT00005094
- NCT00159484
- NCT01729923
- NCT00931203
- NCT00005878
- NCT00066716
- NCT00137852
- NCT00183807
- NCT00520091
- NCT00006124
- NCT02343614
- NCT02885974
- NCT00006299
- NCT00006381
- NCT00045591
- NCT00056082
- NCT00070057
- NCT00075673
- NCT00088972
- NCT00101062
- NCT00135018
- NCT00201773
And 284 more, listed on the interactive page.
- Dose
- 200 mg
- Route
- Oral
- How often
- Once daily or twice daily
- Hydrogen bond acceptors
- 4
- Hydrogen bond donors
- 1
- Polar surface area
- 77.98
- Calculated partition coefficient (ALogP)
- 3.51
- Calculated partition coefficient (XLogP)
- 3.4
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 3
- Heavy atoms
- 26
- Molecular formula
- C17H14F3N3O2S
- Monoisotopic mass
- 381.07588236
- Natural product
- No
- 0591-3982
- 0591-3983
- 0591-3984
- 0615-8571
- 0615-8572
- 0904-7550
- 0904-7551
- 11788-112
- 11788-113
- 11788-114
- 11788-115
- 13668-307
- 13668-310
- 13668-441
- 13668-442
- 15370-501
- 16714-731
- 16714-732
- 16714-733
- 16714-734
- 23155-963
- 23155-964
- 23155-965
- 23155-966
- 27808-295
And 208 more, listed on the interactive page.
- Recorded assays
- 6,654
- Active assays
- 975
- Confirmatory
- Other
- Screening
- Summary
- Anti-Inflammatory Agents, Non-Steroidal
- Cyclooxygenase 2 Inhibitors
These details could not be displayed.
Related records
Trials (586)
- 6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients
- 99Tc-MDP Treatment for Knee Osteoarthritis
- A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis
- A Clinical Trial to Assess the Pharmacokinetics, Safety, and Food Effect of AD-230 in Healthy Adults
- A Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing soliD Tumours.
- A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
- A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers
- A Double-blind and Randomized Trial of Celecoxib Added to Risperidone in Treatment-naive First-episode Schizophrenia
- A First in Human Trial Evaluating THB335 in Healthy Participants
- A First-in-human Single Ascending Dose/Multiple Ascending Dose Study of ENN0403 in Healthy Subjects
- A Food Effect Study of SHR1459 on Healthy Chinese Adult Subjects
- A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis
- A Multicenter, Prospective, Randomized, Open-label Phase Ib/II Study of Celecoxib Plus Pembrolizumab and Gemcitabine/Cisplatin Versus Pembrolizumab and Gemcitabine/Cisplatin in Patients With CK5/6-High Unresectable Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma
- A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery
- A Multiple Dose Study of LY3023703 in Healthy Participants
- A Multiple-Dose PK Study to Evaluate the Comparative Bioavailability of PrimeC Tablets to Ciprofloxacin Tablets Co-administered With Celecoxib Capsules, in Healthy Adult Subject
- A Multiple-dose Study of LY3031207 in Healthy Participants
- A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement
- A Phase I Study of KLA318-2 Nanocrystal Injection
- A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
Approved for (15)
- Ankylosing spondylitis
- Cancer
- Classic familial adenomatous polyposis
- Colorectal neoplasm
- Dysmenorrhea
- Familial adenomatous polyposis 1
- Juvenile idiopathic arthritis
- Migraine disorder
- Neoplasm
- Osteoarthritis
- Peptic ulcer disease
- Rheumatic disorder
- Rheumatoid arthritis
- Spondylitis
- Stroke disorder
In development for (95)
- Actinic keratosis Phase 1
- Alzheimer disease Phase 3
- Amyotrophic lateral sclerosis Phase 2
- Anti-neutrophil antibody associated vasculitis Phase 1
- Benign prostatic hyperplasia Phase 2
- Bipolar disorder Phase 3
- Bone fracture Phase 1
- Brain cancer Phase 2
- Breast cancer Phase 3
- Breast carcinoma Phase 3
- Breast carcinoma in situ Phase 1
- Breast neoplasm Phase 3
- Central nervous system neoplasm Phase 2
- Cervical adenocarcinoma Phase 1
- Cervical cancer Phase 1
- Chronic hepatitis B virus infection Phase 2
- Colon carcinoma Phase 3
- Colonic neoplasm Phase 3
- Colorectal adenocarcinoma Phase 3
- Colorectal adenoma Phase 3
Other linked conditions (5)
- Diabetic kidney disease
- Metastatic prostate carcinoma
- Precancerous condition
- Pulpitis
- Squamous cell carcinoma
Targets (1)
- PTGS2 Cyclooxygenase-2 inhibitor