Diclofenac
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1988
- First approval year
- 1988
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Diclofenac
- Molecular weight
- 296.15
- Structure (SMILES)
- O=C(O)Cc1ccccc1Nc1c(Cl)cccc1Cl
- voltaren ophthalmic
- Voltaren ophthalmic
- voltaren xr
- Voltaren xr
- zorvolex
- Zorvolex
- zorvolex capsules
- Zorvolex capsules
- (O-(2,6-DICHLOROANILINO)PHENYL)ACETIC ACID
- ACECLOFENAC IMPURITY A [EP IMPURITY]
- aceclofenac impurity a ep impurity
- arthrotec
- Arthrotec
- diclofenac
- Diclofenac
- DICLOFENAC [HSDB]
- diclofenac [INN]
- DICLOFENAC [MART.]
- DICLOFENAC [MI]
- DICLOFENAC [ORANGE BOOK]
- DICLOFENAC [USAN]
- DICLOFENAC [VANDF]
- Diclofenac [WHO-DD]
- diclofenac acid
- Diclofenac acid
- diclofenac free acid
- Diclofenac free acid
- diclofenac hsdb
- diclofenac inn
- diclofenac mart
- diclofenac mi
- diclofenac orange book
- diclofenac usan
And 10 more, listed on the interactive page.
- CAS registry numbers
- 15307-86-5
- ChEMBL ID
- CHEMBL139
- InChIKey
- DCOPUUMXTXDBNB-UHFFFAOYSA-N
- PubChem compound IDs
- 3033
- RxNorm IDs (RxCUI)
- 3355
- FDA ingredient codes (UNII)
- 144O8QL0L1
- D11AX18
- M01AB05
- M01AB55
- M02AA15
- S01BC03
Sources for recorded values
- Applicant
- LUPIN PHARMS
- Approval date
- 21 Sept 2022
- Application number
- ANDA208021
- Patents
- 7
- Designations
- 0
- Earliest recorded loss of exclusivity
- 23 Apr 2030
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Over the counter
- Boxed warning
- Yes
- Pharmacology name
- diclofenac
- Type
- Synthetic organic
- Drug name stem
- -ac
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Parenteral
- topical
- Action
- Antagonist
- Action type
- Antagonist
- Target
- Peroxisome proliferator-activated receptor-γ
- Gene symbol
- PPARG
- Protein identifier
- P37231
- Median affinity
- 6.2
- Affinity units
- pKi
- Action
- Channel blocker
- Action type
- Channel blocker
- Target
- TRPM3
- Gene symbol
- TRPM3
- Protein identifier
- Q9HCF6
- Median affinity
- 5.2
- Affinity units
- pIC50
- Action
- Channel blocker
- Action type
- Channel blocker
- Target
- ASIC3
- Gene symbol
- ASIC3
- Protein identifier
- Q9UHC3
- Median affinity
- 4
- Affinity units
- pIC50
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- COX-1
- Gene symbol
- PTGS1
- Protein identifier
- P23219
- Median affinity
- 7.92
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- COX-2
- Gene symbol
- PTGS2
- Protein identifier
- P35354
- Median affinity
- 7.7
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- Proton-coupled Amino acid Transporter 1
- Gene symbol
- SLC36A1
- Protein identifier
- Q7Z2H8
- Median affinity
- 3.57
- Affinity units
- pIC50
- Mechanism
- Cyclooxygenase inhibitor
- Action type
- Inhibitor
- Target
- Cyclooxygenase
- Protein identifier
- P23219
- Mechanism
- Cyclooxygenase inhibitor
- Action type
- Inhibitor
- Target
- Cyclooxygenase
- Protein identifier
- P35354
Open Targets mechanisms
- Mechanism
- Cyclooxygenase inhibitor
- Action type
- Inhibitor
- Target
- Cyclooxygenase
- Action type
- Antagonist
- Gene symbol
- PPARG
- Protein identifier
- P37231
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Blocker
- Gene symbol
- TRPM3
- Protein identifier
- Q9HCF6
- Organism
- Homo sapiens
- Target development level
- Chemical evidence
- Action type
- Blocker
- Gene symbol
- ASIC3
- Protein identifier
- Q9UHC3
- Organism
- Homo sapiens
- Target development level
- Chemical evidence
- Action type
- Inhibitor
- Gene symbol
- PTGS1
- Protein identifier
- P23219
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- PTGS2
- Protein identifier
- P35354
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Pancreatitis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000278
- Subject identifier
- D010195
- Condition
- Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Infertility
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000545
- Subject identifier
- D007246
- Condition
- Wounds and Injuries
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000546
- Subject identifier
- D014947
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Periodontitis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000649
- Subject identifier
- D010518
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Keratosis, Actinic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0002496
- Subject identifier
- D055623
- Condition
- Pulmonary Embolism
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003827
- Subject identifier
- D011655
- Condition
- Acute Pain
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003843
- Subject identifier
- D059787
- Condition
- Spondylitis, Ankylosing
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003898
- Subject identifier
- D013167
- Condition
- Fractures, Bone
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003931
- Subject identifier
- D050723
- Condition
- Carcinoma, Basal Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004193
- Subject identifier
- D002280
- Condition
- Osteoarthritis, Knee
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004616
- Subject identifier
- D020370
- Condition
- Eye Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005752
- Subject identifier
- D005128
- Condition
- Rheumatic Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005755
- Subject identifier
- D012216
- Condition
- Stomach Ulcer
- Highest recorded phase
- 3
- Condition identifier
- EFO:0009454
- Subject identifier
- D013276
- Condition
- Sprains and Strains
- Highest recorded phase
- 4
- Condition identifier
- EFO:0009582
- Subject identifier
- D013180
- Condition
- Toothache
- Highest recorded phase
- 3
- Condition identifier
- EFO:0010072
- Subject identifier
- D014098
- Condition
- Aging
- Highest recorded phase
- 1
- Condition identifier
- EFO:0022597
- Subject identifier
- D000375
- Condition
- Keratosis, Actinic
- Highest recorded phase
- 4
- Condition identifier
- EFO:1000720
- Subject identifier
- D055623
- Condition
- Osteoarthritis, Hip
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000786
- Subject identifier
- D015207
- Condition
- Mastodynia
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001366
- Subject identifier
- D059373
- Condition
- Renal Colic
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001412
- Subject identifier
- D056844
- Condition
- Arthralgia
- Highest recorded phase
- 4
- Condition identifier
- HP:0002829
- Subject identifier
- D018771
And 9 more, listed on the interactive page.
- Condition identifier
- EFO_0000278
- Condition identifier
- EFO_0000313
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000545
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000546
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000649
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0002496
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003827
- Condition identifier
- EFO_0003898
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003931
- Highest recorded phase
- 1
- Condition identifier
- EFO_0004193
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004607
- Condition identifier
- EFO_0004616
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005752
- Condition identifier
- EFO_0005752
- Highest recorded phase
- 4
- Condition identifier
- EFO_0005755
- Condition identifier
- EFO_0005762
- Condition identifier
- EFO_0009259
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009260
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009582
- Condition identifier
- EFO_0009582
- Highest recorded phase
- 4
- Condition identifier
- EFO_0010072
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000720
- Condition identifier
- EFO_1000789
- Condition identifier
- EFO_1001366
And 49 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
- musculoskeletal toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- neurotoxicity
- Country
- United States
- Event
- abdominal discomfort
- Reports
- 1,831
- Reporting signal score
- 3,940.62
- Event
- abdominal pain upper
- Reports
- 454
- Reporting signal score
- 280.444
- Event
- acute kidney injury
- Reports
- 410
- Reporting signal score
- 177.263
- Event
- alopecia
- Reports
- 1,644
- Reporting signal score
- 3,334.61
- Event
- anaphylactic reaction
- Reports
- 353
- Reporting signal score
- 329.07
- Event
- angioedema
- Reports
- 341
- Reporting signal score
- 318.044
- Event
- ankylosing spondylitis
- Reports
- 113
- Reporting signal score
- 214.882
- Event
- anti-cyclic citrullinated peptide antibody positive
- Reports
- 950
- Reporting signal score
- 4,277.81
- Event
- arthralgia
- Reports
- 884
- Reporting signal score
- 460.093
- Event
- arthropathy
- Reports
- 1,426
- Reporting signal score
- 3,699.1
- Event
- blister
- Reports
- 513
- Reporting signal score
- 879.008
- Event
- blood cholesterol increased
- Reports
- 225
- Reporting signal score
- 276.681
- Event
- condition aggravated
- Reports
- 836
- Reporting signal score
- 533.446
- Event
- confusional state
- Reports
- 412
- Reporting signal score
- 204.837
- Event
- contusion
- Reports
- 281
- Reporting signal score
- 218.755
- Event
- deafness transitory
- Reports
- 78
- Reporting signal score
- 280.026
- Event
- discomfort
- Reports
- 1,248
- Reporting signal score
- 3,540.18
- Event
- drug hypersensitivity
- Reports
- 841
- Reporting signal score
- 511.618
- Event
- drug interaction
- Reports
- 481
- Reporting signal score
- 176.285
- Event
- drug intolerance
- Reports
- 1,268
- Reporting signal score
- 2,196.6
- Event
- ductus arteriosus stenosis foetal
- Reports
- 71
- Reporting signal score
- 283.991
- Event
- duodenal ulcer
- Reports
- 137
- Reporting signal score
- 241.136
- Event
- duodenal ulcer perforation
- Reports
- 625
- Reporting signal score
- 2,670.04
- Event
- embolia cutis medicamentosa
- Reports
- 226
- Reporting signal score
- 980.923
- Event
- fatigue
- Reports
- 1,949
- Reporting signal score
- 1,293.97
And 54 more, listed on the interactive page.
- NCT00108992
- NCT00484120
- NCT01456611
- NCT01967550
- NCT02286453
- NCT03304379
- NCT03949673
- NCT05050448
- NCT05254574
- NCT00139646
- NCT03199924
- NCT05653401
- NCT00141102
- NCT00171626
- NCT00171665
- NCT00171678
- NCT00171691
- NCT00242489
- NCT00371696
- NCT00447759
- NCT00864097
- NCT01461369
- NCT01510912
- NCT02088411
- NCT02183129
And 36 more, listed on the interactive page.
- Dose
- 50mg, 75mg, 100mg, 125mg
- How often
- Twice daily, three times a day, four times a day, at bedtime as needed
Conditions of use
- Use the lowest effective dose for the shortest duration
- Hydrogen bond acceptors
- 2
- Hydrogen bond donors
- 2
- Polar surface area
- 49.33
- Calculated partition coefficient (ALogP)
- 4.36
- Calculated partition coefficient (XLogP)
- 4.4
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 4
- Heavy atoms
- 19
- Molecular formula
- C14H11Cl2NO2
- Monoisotopic mass
- 295.0166840
- Natural product
- Yes
- 76420-332
- 83295-5500
- Recorded assays
- 6,467
- Active assays
- 143
- Confirmatory
- Other
- Summary
- Anti-Inflammatory Agents, Non-Steroidal
- Cyclooxygenase Inhibitors
These details could not be displayed.
Related records
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- Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
- Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
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Approved for (9)
- Actinic keratosis
- Cataract
- Dysmenorrhea
- Eye disorder
- Keratosis
- Migraine disorder
- Osteoarthritis
- Rheumatic disorder
- Rheumatoid arthritis
In development for (18)
- Alcohol dependence Early phase 1
- Ankylosing spondylitis Phase 3
- Basal cell carcinoma Phase 2
- Bile duct disorder Phase 2
- Bone fracture Phase 1
- Carcinoma Phase 2
- Depressive disorder Phase 1
- Gastric ulcer Phase 3
- Infertility disorder Phase 3
- Injury Phase 2
- Neoplasm Phase 1
- Osteoarthritis, hip Phase 3
- Osteoarthritis, knee Phase 3
- Pancreatitis Phase 1
- Periodontitis Phase 1
- Pulmonary embolism Phase 2
- Skin cancer Phase 2
- Skin carcinoma Phase 2
Other linked conditions (3)
- Breast cancer
- Duodenal ulcer
- Osteoarthritis, hand