Colchicine clinical trials
Colchicine is named as an intervention in 45 current clinical trials in our China, France, Italy, Netherlands, Canada, Denmark, Belgium, Australia, Switzerland, Egypt, USA, Spain, Portugal, Brazil, Taiwan, India, Sweden, Germany, Japan, South Korea and Singapore registers. 29 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Shanton Pharma Pte. Ltd (2). The most-studied condition is Cardiovascular Diseases.
Where Colchicine is approved
All regulators →Of the three regulators tracked here, the first to approve Colchicine was the US, on 29 Jul 2009. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Colchicine patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Colchicine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 24 listed patents; the last listed expires 20 Dec 2037 (US 10226423).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Colchicine
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Colchicine works
All drug targets →- Tubulin inhibitor InhibitorTarget: Tubulin✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- COVID-19–associated multisystem inflammatory syndrome in childrenPhase 3
- Orthomyxoviridae infectious diseasePhase 3
- Postpericardiotomy SyndromePhase 3
- ST Elevation Myocardial InfarctionPhase 3
- Ventricular arrhythmiaPhase 3
- Acute coronary syndromePhase 3
- Acute respiratory distress syndromePhase 3
- AmputationPhase 3
- Aortic stenosisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL107, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 2367, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Colchicine
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 4 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Colchicine Agepha PharmaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Colchicine
- ATC code
- M04AC01
- ChEMBL
- CHEMBL107
- DrugBank
- DB01394
- PubChem CID
- 6167
- CAS number
- 64-86-8
- FDA UNII
- SML2Y3J35T
- Wikidata
- Q326224
- Wikipedia
- Colchicine
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Colchicine
45 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Colchicine across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
4 single-substance products containing Colchicine on the HPRA medicines list.
- Colchicine 500 microgram TabletsRenata Pharmaceuticals (Ireland) Limited · PA22865/002/001 · Marketed
- Colchicine AGEPHA Pharma 0.5 mg tabletsAGEPHA Pharma s.r.o. · EU/1/26/2048/001
- Colchicine Halewood 500 microgram TabletsHalewood Chemicals (Ireland) Limited · PA22902/002/001 · Not marketed
- Colchicine Indoco 500 microgram tabletsIndoco Remedies Czech s.r.o. · PA23337/001/001 · Not marketed
Supply shortages
No entry for Colchicine in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- Colchicine Agepha PharmaEMA · 24 Jul 2026 · Agepha Pharma s.r.o.
Conditions studied with Colchicine
80 conditionsAll 80 conditions
| Condition (as registered) | Trials |
|---|---|
| Cardiovascular Diseases | 4 |
| Coronary Artery Disease | 3 |
| Colchicine | 3 |
| Gout | 2 |
| Acute Coronary Syndrome | 2 |
| Atherosclerotic Cardiovascular Disease (ASCVD) | 2 |
| CABG | 2 |
| Inflammation | 2 |
| Atherosclerosis | 2 |
| Heart Failure | 2 |
| Atrial Fibrillation | 2 |
| Hyperuricemia | 1 |
| Pneumonia | 1 |
| Unstable Angina | 1 |
| ST Elevation Myocardial Infarction | 1 |
| Non ST Segment Elevation Myocardial Infarction | 1 |
| Coronary Artery Disease (CAD) | 1 |
| Cerebral Amyloid Angiopathy | 1 |
| Intracerebral Hemorrhage Lobar | 1 |
| ACS - Acute Coronary Syndrome | 1 |
| Residual Inflammatory Risk | 1 |
| Intracerebral Hemorrhage | 1 |
| Spontaneous Intracerebral Hemorrhage | 1 |
| Supratentorial Intracerebral Haemorrhage | 1 |
| Acute Intracerebral Haemorrhage | 1 |
| Graft Failure | 1 |
| Inflammatory Response | 1 |
| Cardiac Disease | 1 |
| Transcatheter Aortic Valve Replacement | 1 |
| Transcatheter Heart Valve Thrombosis | 1 |
| Anti-inflammatory Therapy | 1 |
| CAD - Coronary Artery Disease | 1 |
| Coronary Heart Disease | 1 |
| Percutaneous Coronary Intervention | 1 |
| In-stent Restenosis | 1 |
| Peripheral Arterial Disease | 1 |
| Atherosclerosis of Extremities | 1 |
| Diabete Type 2 | 1 |
| Atrial Fibrillation (AF) | 1 |
| Acute Myocarditis | 1 |
| Stroke | 1 |
| Stroke, Ischemic | 1 |
| Myocardial Infarction | 1 |
| HIV Infection | 1 |
| Cardiovascular Diseases (CVD) | 1 |
| Cardiomyopathies | 1 |
| Myocarditis | 1 |
| Inflammatory Cardiomyopathy | 1 |
| Calcium Pyrophosphate Deposition Disease | 1 |
| Chondrocalcinosis | 1 |
| Amyotrophic Lateral Sclerosis | 1 |
| Post COVID Condition | 1 |
| Aortic Valve Disease | 1 |
| Aortic Valve Stenosis | 1 |
| Aortic Valve Calcification | 1 |
| Osteoarthritis, Knee | 1 |
| Osteoarthritis, Hip | 1 |
| Type 1 Diabetes | 1 |
| Chronic Inflammation | 1 |
| Hypertension | 1 |
| Cardiac Arrhythmia | 1 |
| Cardiovascular Complication | 1 |
| Perioperative Complication | 1 |
| Myocardial Injury | 1 |
| Pancreatic Ductal Carcinoma | 1 |
| Advanced Cancer | 1 |
| Epithelial Tumor | 1 |
| Primary Cutaneous Vasculitis | 1 |
| Cutaneous Polyarteritis Nodosa | 1 |
| IgA Vasculitis | 1 |
| Henoch-Schönlein Purpura | 1 |
| Atherothrombotic Diseases | 1 |
| Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG) | 1 |
| Chronic Limb-Threatening Ischemia | 1 |
| Type 2 Diabetes Mellitus (T2DM) | 1 |
| Non ST-Segment Elevation Myocardial Infarction | 1 |
| HFpEF - Heart Failure With Preserved Ejection Fraction | 1 |
| Hashimoto Thyroiditis | 1 |
| Subacute Thyroiditis | 1 |
| Thyroiditis | 1 |
Sponsors
lead sponsor per trial+ 26 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Colchicine trials
How many clinical trials are testing Colchicine?
45 current trials in our China, France, Italy, Netherlands, Canada, Denmark, Belgium, Australia, Switzerland, Egypt, USA, Spain, Portugal, Brazil, Taiwan, India, Sweden, Germany, Japan, South Korea and Singapore registers name Colchicine (also registered as SAP-001) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Colchicine trials recruiting patients?
Yes. 29 of the 45 trials are recruiting: 8 with sites in China, 4 with sites in France, 3 with sites in Italy, 3 with sites in Netherlands, 5 with sites in Canada, 2 with sites in Denmark, 3 with sites in Belgium, 3 with sites in Australia, 3 with sites in Switzerland, 2 with sites in Egypt, 2 with sites in Spain, 2 with sites in Portugal, 2 with sites in Brazil, 1 with sites in Taiwan, 1 with sites in India, 1 with sites in Sweden, 1 with sites in Germany, 1 with sites in Japan, 1 with sites in South Korea and 1 with sites in Singapore. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Colchicine clinical trials?
Shanton Pharma Pte. Ltd (2), Beijing Anzhen Hospital (2), Assistance Publique - Hôpitaux de Paris (2) and Herlev and Gentofte Hospital (2), among 41 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Colchicine licensed in Ireland?
Yes. The HPRA medicines list includes 4 single-substance products containing Colchicine, for example Colchicine 500 microgram Tablets (Renata Pharmaceuticals (Ireland) Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Colchicine shortage?
Not in the lists we track: Colchicine has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Colchicine works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Colchicine works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Colchicine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.