How many clinical trials are studying Colchicine?

7 recruiting trials in our tracked data involve Colchicine.

What conditions is Colchicine being studied for?

In our tracked recruiting trials, Colchicine is being studied in trials for Atrial Fibrillation, Advanced Cancer, Cardiac Arrhythmia.

Colchicine: clinical trials recruiting now

Q: Is Colchicine FDA-approved?

Yes. According to the FDA drug label available through openFDA, Colchicine is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Colchicine appears in the FDA drug-label database. Marketed as colchicine.
Drug class: Alkaloid (FDA established pharmacologic class)

FDA-approved use

Colchicine tablets are an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults ( 1.1 ). • Familial Mediterranean fever (FMF) in adults and children 4 years or older ( Error! Hyperlink reference not valid. ). 1.1 Gout Flares Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. • Prophylaxis of Gout Flares: Colchicine tablets are indicated for prophylaxis of gout flares. • Treatment of Gout Flares: Colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. 1.2 Familial Mediterranean Fever (FMF) Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).

FDA recalls / enforcement

Reason (FDA)	Classification	Status	Initiated
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. — Granules Pharmaceuticals Inc.	Class II (FDA: may cause temporary or reversible harm)	Terminated	2024-12-18

FDA label via openFDA

Phase breakdown

Phase 2 2 Phase 3 5

Conditions being studied

Condition	Trials
Atrial Fibrillation	2
Advanced Cancer	1
Cardiac Arrhythmia	1
Cardiomyopathies	1
Cardiovascular Diseases	1
Chronic Kidney Diseases	1
Chronic kidney disease	1
Diabete Type 2	1
Epithelial Tumor	1
Heart Failure	1
Inflammatory Cardiomyopathy	1
Myocarditis	1
Osteoarthritis	1
Osteoarthritis, Hip	1
Osteoarthritis, Knee	1

Recruiting trials involving Colchicine

Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine
NCT04500665 · Phase: Phase 2 · Ages: 21 Years to 80 Years · Sex: All (male and female) · 1 location
CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
NCT06158698 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 10 locations
COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes
NCT05633810 · Phase: Phase 3 · Ages: 55 Years to 80 Years · Sex: All (male and female) · 39 locations
Colchicine After Electrocardioversion for Atrial Fibrillation
NCT05890664 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 8 locations
The COLchicine and Atrial FIBrillation Trial
NCT05928728 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
The Effect of ColcHicine on the Incidence of Knee or Hip Replacements
NCT06578182 · Phase: Phase 3 · Ages: 45 Years to 80 Years · Sex: All (male and female) · 1 location
Using Tumor Models to Determine Treatments
NCT06813079 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Colchicine FDA-approved?

Yes, marketed as colchicine.

How many recruiting trials involve Colchicine?

7 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.