Colchicine

Generic Name: Colchicine

Brand Names: Colcrys, Gloperba, Lodoco, Mitigare

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₅NO_₆

CAS Number: 64-86-8

Unique Ingredient Identifier: SML2Y3J35T

Advanced Drug Monograph

Access comprehensive pharmacological analysis, clinical applications, and therapeutic considerations.

Background: Colchicine is an alkaloid drug derived from a plant belonging to the Lily family, known as Colchicum autumnale, or "autumn crocus." Its use was first approved by the FDA in 1961. Colchicine is used in the treatment of gout flares and Familial Mediterranean fever, and prevention of major cardiovascular events. It has also been investigated in other inflammatory and fibrotic conditions.

Indication: Colchicine is indicated for the prophylaxis and treatment of gout flares. It is also indicated in Familial Mediterranean fever (FMF) in children and adults of four years of age and older. It is also indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

Some off-label uses of colchicine include the treatment of the manifestations of Behcet's syndrome, pericarditis, and postpericardiotomy syndrome.

Associated Conditions: Behcet's Syndrome, Cardiovascular Mortality, Coronary Revascularization, Familial Mediterranean Fever (FMF ), Gout Flares, Myocardial Infarction, Pericarditis, Postpericardiotomy Syndrome, Stroke

Clinical Trials

Colchicine in Percutaneous Coronary Intervention

Phase 4

Completed

Conditions: Coronary Artery Disease
Acute Coronary Syndrome

Interventions: Drug: Colchicine vs Placebo

First Posted Date: 2015-11-01

Last Posted Date: 2023-02-21

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 714

Registration Number: NCT02594111

Locations: 🇺🇸
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY, New York, New York, United States

COlchicine for the Prevention of Post Electrical Cardioversion Recurrence of AF

Phase 3

Withdrawn

Conditions: Atrial Fibrillation

Interventions: Drug: Colchicine group

First Posted Date: 2015-10-21

Last Posted Date: 2018-01-25

Lead Sponsor: Elpen Pharmaceutical Co. Inc.

Registration Number: NCT02582190

Colchicine Cardiovascular Outcomes Trial (COLCOT)

Phase 3

Completed

Conditions: Coronary Artery Disease
Myocardial Infarction

Interventions: Drug: colchicine placebo
Drug: colchicine

First Posted Date: 2015-09-16

Last Posted Date: 2020-10-19

Lead Sponsor: Montreal Heart Institute

Target Recruit Count: 4745

Registration Number: NCT02551094

Locations: 🇨🇦
Montreal Heart Institute, Montreal, Quebec, Canada

Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout

Phase 4

Completed

Conditions: Gout

Interventions: Drug: Febuxostat 80/120mg/day
Drug: Allopurinol 100 up to 600mg/day
Drug: Colchicine
Drug: Naproxen
Drug: Omeprazole

First Posted Date: 2015-07-16

Last Posted Date: 2019-06-21

Lead Sponsor: Menarini International Operations Luxembourg SA

Target Recruit Count: 196

Registration Number: NCT02500641

Locations: 🇵🇱
Specjalistyczna Praktyka Lekarska Piotr Kubalski, Grudziądz, Poland
🇵🇱
Oddział Kardiologiczny, WSS im. W. Biegańskiego w Łodzi, Łódź, Poland
🇷🇴
S.C. Cardiomed S.R.L., Craiova, Romania

and more 23 locations

Colchicine for Diabetic Nephropathy Trial

Phase 1

Conditions: Diabetic Nephropathies

Interventions: Drug: Colchicine
Drug: Placebo

First Posted Date: 2015-05-13

Last Posted Date: 2017-05-09

Lead Sponsor: Sheba Medical Center

Target Recruit Count: 40

Registration Number: NCT02442921

Locations: 🇮🇱
Sheba Medical Center, Ramat Gan, Israel

Inflammation and Coronary Endothelial Function

Phase 2

Completed

Conditions: Coronary Artery Disease

Interventions: Drug: Methotrexate
Drug: Colchicine
Drug: Placebo

First Posted Date: 2015-02-19

Last Posted Date: 2021-10-21

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 111

Registration Number: NCT02366091

Locations: 🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States

Bucillamine for the Treatment of Acute Gout Flare in Subjects With Moderate to Severe Gout

Phase 2

Completed

Conditions: Gout

Interventions: Drug: Bucillamine
Drug: Colchicine

First Posted Date: 2015-01-05

Last Posted Date: 2016-10-05

Lead Sponsor: Revive Therapeutics, Ltd.

Target Recruit Count: 66

Registration Number: NCT02330796

Locations: 🇺🇸
Texas Physicians Research Medical Group, Arlington, Texas, United States
🇺🇸
West Coast Research, San Roman, California, United States
🇺🇸
Sun Research Institute, San Antonio, Texas, United States