Colchicine
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1961
- First approval year
- 1961
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Colchicine
- Molecular weight
- 399.44
- Structure (SMILES)
- COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
- colchicine component of col probenecid
- Colchicine component of col-probenecid
- colchicine component of colbenemid
- Colchicine component of colbenemid
- colchicine component of mitigare
- Colchicine component of mitigare
- colchicine component of proben c
- Colchicine component of proben-c
- colcrys
- Colcrys
- gloperba
- Gloperba
- lodoco
- Lodoco
- mitigare
- Mitigare
- (-)-colchicine
- 0 5mg oral colchicine
- acetamide n 5 6 7 9 tetrahydro 1 2 3 10 tetramethoxy 9 oxobenzo a heptalen 7 yl s
- ACETAMIDE, N-(5,6,7,9-TETRAHYDRO-1,2,3,10-TETRAMETHOXY-9-OXOBENZO(A)HEPTALEN-7-YL)-,(S)-
- col probenecid component colchicine
- COL-PROBENECID COMPONENT COLCHICINE
- colbenemid component colchicine
- COLBENEMID COMPONENT COLCHICINE
- colchcine
- Colchcine
- COLCHCINE [VANDF]
- colchcine vandf
- colchicine
- Colchicine
- Colchicine (Colcrys®)
- Colchicine (for 1 month)
- Colchicine (for 3 months)
- Colchicine (for 6 months)
- COLCHICINE [EP IMPURITY]
- COLCHICINE [EP MONOGRAPH]
- COLCHICINE [HSDB]
- COLCHICINE [JAN]
- COLCHICINE [MART.]
- COLCHICINE [MI]
- COLCHICINE [ORANGE BOOK]
And 55 more, listed on the interactive page.
- ATC classification codes
- M04AC01
Sources for recorded values
- CAS registry numbers
- 64-86-8
- ChEMBL ID
- CHEMBL107
- InChIKey
- IAKHMKGGTNLKSZ-INIZCTEOSA-N
- PubChem compound IDs
- 6167
- RxNorm IDs (RxCUI)
- 2683
- FDA ingredient codes (UNII)
- SML2Y3J35T
- Applicant
- HIKMA INTL PHARMS
- Approval date
- 26 Sept 2014
- Application number
- NDA204820
- Status
- opinion
- Status date
- 21 May 2026
- Approved indications
- Indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in patients with atherosclerotic disease or with multiple risk factors for cardiovascular disease.
- Product number
- EMEA/H/C/006653
- Authorisation holder
- Agepha Pharma s.r.o.
- 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
- No
Therapeutic areas
- Coronary Artery Disease
- Myocardial Infarction
- Stroke
European medicines record
- Patents
- 41
- Designations
- 2
- Earliest recorded loss of exclusivity
- 20 Dec 2037
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- colchicine
- Type
- Synthetic organic
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Agonist
- Action type
- Agonist
- Target
- TAS2R46
- Gene symbol
- TAS2R46
- Protein identifier
- P59540
- Median affinity
- 2.8
- Affinity units
- pEC50
- Action
- Agonist
- Action type
- Agonist
- Target
- TAS2R4
- Gene symbol
- TAS2R4
- Protein identifier
- Q9NYW5
- Median affinity
- 2.99
- Affinity units
- pEC50
- Action
- Antagonist
- Action type
- Antagonist
- Target
- glycine receptor α1 subunit
- Gene symbol
- GLRA1
- Protein identifier
- P23415
- Median affinity
- 3.5
- Affinity units
- pIC50
- Action
- Antagonist
- Action type
- Antagonist
- Target
- glycine receptor α2 subunit
- Gene symbol
- GLRA2
- Protein identifier
- P23416
- Median affinity
- 4.2
- Affinity units
- pIC50
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- bromodomain containing 4
- Gene symbol
- BRD4
- Protein identifier
- O60885
- Median affinity
- 4.7
- Affinity units
- pKd
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- tubulin beta class I
- Gene symbol
- TUBB
- Protein identifier
- P07437
- Median affinity
- 7.96
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P04350
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P07437
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P0DPH7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68363
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68366
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68371
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13509
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13885
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q3ZCM7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q6PEY2
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q71U36
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BQE3
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BUF5
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BVA1
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9H4B7
Open Targets mechanisms
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Action type
- Inhibitor
- Gene symbol
- BRD4
- Protein identifier
- O60885
- Organism
- Homo sapiens
- Target development level
- Chemical evidence
- Action type
- Inhibitor
- Gene symbol
- TUBB
- Protein identifier
- P07437
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Atrial Fibrillation
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000275
- Subject identifier
- D001281
- Condition
- Cardiovascular Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000319
- Subject identifier
- D002318
- Condition
- Diabetic Nephropathies
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000401
- Subject identifier
- D003928
- Condition
- Hypertension
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000537
- Subject identifier
- D006973
- Condition
- Intracranial Hemorrhages
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000551
- Subject identifier
- D020300
- Condition
- Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000612
- Subject identifier
- D009203
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Multiple Myeloma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Liver Cirrhosis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001422
- Subject identifier
- D008103
- Condition
- Coronary Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001645
- Subject identifier
- D003327
- Condition
- Reperfusion Injury
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002687
- Subject identifier
- D015427
- Condition
- Heart Failure
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Heart Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003777
- Subject identifier
- D006331
- Condition
- Behcet Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003780
- Subject identifier
- D001528
- Condition
- Lung Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003818
- Subject identifier
- D008171
- Condition
- Urogenital Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003863
- Subject identifier
- D014565
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Atherosclerosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003914
- Subject identifier
- D050197
- Condition
- Stomatitis, Aphthous
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003938
- Subject identifier
- D013281
- Condition
- Hepatitis C, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004220
- Subject identifier
- D019698
- Condition
- Vascular Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004264
- Subject identifier
- D014652
- Condition
- Peripheral Arterial Disease
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0004265
- Subject identifier
- D058729
- Condition
- Arrhythmias, Cardiac
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004269
- Subject identifier
- D001145
- Condition
- Gout
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004274
- Subject identifier
- D006073
And 17 more, listed on the interactive page.
- Condition identifier
- EFO_0000195
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000275
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000401
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000537
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000551
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000612
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000712
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001073
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001422
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001645
- Highest recorded phase
- 3
- Condition identifier
- EFO_0002687
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003144
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003780
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003818
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003863
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003884
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003907
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003914
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003938
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004220
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004264
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004265
- Condition identifier
- EFO_0004269
- Highest recorded phase
- 3
And 92 more, listed on the interactive page.
- Event
- abdominal pain
- Reports
- 113
- Reporting signal score
- 45.869
- Event
- acute kidney injury
- Reports
- 159
- Reporting signal score
- 146.754
- Event
- behcet's syndrome
- Reports
- 31
- Reporting signal score
- 113.952
- Event
- cholestasis
- Reports
- 35
- Reporting signal score
- 37.6137
- Event
- chondrocalcinosis
- Reports
- 10
- Reporting signal score
- 37.0392
- Event
- diarrhoea
- Reports
- 432
- Reporting signal score
- 337.279
- Event
- drug interaction
- Reports
- 176
- Reporting signal score
- 139.734
- Event
- drug intolerance
- Reports
- 105
- Reporting signal score
- 94.8121
- Event
- drug reaction with eosinophilia and systemic symptoms
- Reports
- 68
- Reporting signal score
- 96.4403
- Event
- drug resistance
- Reports
- 79
- Reporting signal score
- 136.904
- Event
- familial mediterranean fever
- Reports
- 15
- Reporting signal score
- 76.5925
- Event
- gout
- Reports
- 109
- Reporting signal score
- 297.262
- Event
- hypersensitivity vasculitis
- Reports
- 19
- Reporting signal score
- 38.1416
- Event
- leukopenia
- Reports
- 79
- Reporting signal score
- 81.334
- Event
- meningocele
- Reports
- 10
- Reporting signal score
- 43.4086
- Event
- metabolic acidosis
- Reports
- 44
- Reporting signal score
- 48.5261
- Event
- multiple organ dysfunction syndrome
- Reports
- 26
- Reporting signal score
- 55.2838
- Event
- myopathy
- Reports
- 68
- Reporting signal score
- 169.077
- Event
- neuromyopathy
- Reports
- 30
- Reporting signal score
- 118.205
- Event
- pancytopenia
- Reports
- 91
- Reporting signal score
- 108.274
- Event
- pericarditis
- Reports
- 39
- Reporting signal score
- 67.4958
- Event
- renal failure
- Reports
- 70
- Reporting signal score
- 44.7538
- Event
- renal failure acute
- Reports
- 71
- Reporting signal score
- 63.0982
- Event
- rhabdomyolysis
- Reports
- 125
- Reporting signal score
- 193.441
- Event
- sjogren's syndrome
- Reports
- 22
- Reporting signal score
- 49.3096
And 4 more, listed on the interactive page.
- NCT00000577
- NCT00004368
- NCT00004748
- NCT00128414
- NCT00128453
- NCT05737680
- NCT00128427
- NCT00370760
- NCT00506883
- NCT00819585
- NCT01399008
- NCT01994226
- NCT02060552
- NCT02063997
- NCT02139046
- NCT02330796
- NCT02500641
- NCT03131583
- NCT03933007
- NCT04130204
- NCT04875702
- NCT05324423
- NCT05698680
- NCT05936268
- NCT00700297
And 82 more, listed on the interactive page.
- Dose
- 0.6 mg
- Route
- Oral
- How often
- Once daily or twice daily
Conditions of use
- Administered without regard to meals
- Hydrogen bond acceptors
- 6
- Hydrogen bond donors
- 1
- Polar surface area
- 83.09
- Calculated partition coefficient (ALogP)
- 2.87
- Calculated partition coefficient (XLogP)
- 1
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 5
- Heavy atoms
- 29
- Molecular formula
- C22H25NO6
- Monoisotopic mass
- 399.16818752
- Natural product
- Yes
- 0143-3018
- 0254-0460
- 0378-1086
- 0591-5325
- 0904-6732
- 0904-7120
- 16571-832
- 31722-099
- 31722-899
- 33342-341
- 42571-341
- 43598-372
- 49884-171
- 50268-187
- 50742-263
- 51407-082
- 59467-318
- 59651-446
- 59651-455
- 60687-358
- 60687-727
- 60760-839
- 62135-789
- 63187-292
- 64380-796
And 29 more, listed on the interactive page.
- Recorded assays
- 13,666
- Active assays
- 3,379
- Confirmatory
- Other
- Screening
- Summary
- Gout Suppressants
- Tubulin Modulators
These details could not be displayed.
Related records
Trials (314)
- 1 or 6 Months of Dual Antiplatelet Therapy After Drug-coated Balloon Angioplasty for De-novo Small Coronary Artery Disease
- A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
- A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
- A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment
- A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.
- A Randomized Multicenter Study for Isolated Skin Vasculitis
- A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment
- A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.
- A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)
- A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)
- ACT-GLOBAL Adaptive Platform Trial for Stroke
- Adding Colchicine to Tocilizumab in Patients With Severe COVID-19 Pneumonia.
- Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection
- Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
- An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
- Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial
- Anti-Inflammatory and Anti-Fibrotic Drugs in Post COVID-19 Pulmonary Fibrosis
- Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
- Anti-inflammatory Effects of Colchicine in PCI
- Anti-inflammatory Therapy for Recurrent In-stent Restenosis
Approved for (2)
- Familial Mediterranean fever
- Gout
In development for (39)
- Acute coronary syndrome Phase 2
- Acute myocarditis Phase 3
- Amyotrophic lateral sclerosis Phase 2
- Asthma Phase 3
- Atherosclerosis Phase 2
- Atrial fibrillation Phase 3
- Behcet disease Phase 2
- Canker sore Phase 2
- Cardiac rhythm disease Phase 3
- Cardiovascular disorder Phase 3
- Cholangiocarcinoma Phase 2
- Chronic hepatitis C virus infection Phase 2
- Chronic kidney disease Phase 2
- Cirrhosis of liver Phase 1
- Coronary artery disorder Phase 3
- COVID-19 Phase 3
- Diabetic kidney disease Phase 2
- Heart disorder Phase 2
- Heart failure Phase 3
- Hypertensive disorder Phase 2
Other linked conditions (2)
Targets (15)
- TUBA1A Tubulin inhibitor
- TUBA1B Tubulin inhibitor
- TUBA1C Tubulin inhibitor
- TUBA3C Tubulin inhibitor
- TUBA3E Tubulin inhibitor
- TUBA4A Tubulin inhibitor
- TUBB Tubulin inhibitor
- TUBB1 Tubulin inhibitor
- TUBB2A Tubulin inhibitor
- TUBB2B Tubulin inhibitor
- TUBB3 Tubulin inhibitor
- TUBB4A Tubulin inhibitor
- TUBB4B Tubulin inhibitor
- TUBB6 Tubulin inhibitor
- TUBB8 Tubulin inhibitor