TheraRadar
Data updated: May 26, 2026

COL-PROBENECID (colchicine)

Metabolic Approved 1976-11-23

Colchicine is an alkaloid used to prevent and manage gout flares in adult patients. It also treats Familial Mediterranean fever in both adults and children four years of age and older. When used for gout, it helps patients by either preventing future attacks or addressing acute symptoms when taken at the first sign of a flare.

Source: FDA Label • WATSON LABS • Alkaloid
Jump to: Indications Approvals Trials Competitors Safety Patents

How COL-PROBENECID Works

This drug works by inhibiting β-tubulin polymerization, which disrupts the microtubules that allow neutrophils to move and release inflammatory triggers. It also appears to interfere with the assembly of the inflammasome complex, thereby reducing the activation of interleukin-1β in certain immune cells.

Source: FDA Label
1
Indication
--
Phase 3 Trials
49
Years on Market

Details

Status
Prescription
First Approved
1976-11-23
Routes
ORAL
Dosage Forms
TABLET

Companies

WATSON LABS
Active Ingredient: COLCHICINE , PROBENECID

COL-PROBENECID Approval History

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Original
New Indication
New Form
Label Update
18 FDA actions from 1976 to 2002
May 2002 SUPPL
Mfg · Manufacturing (CMC)
Apr 2001 SUPPL
Mfg · Manufacturing (CMC)
May 1991 SUPPL
Mfg · Manufacturing (CMC)

What COL-PROBENECID Treats

2 indications

COL-PROBENECID is approved for 2 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Gout flares (prevention and acute treatment)
  • Familial Mediterranean fever (FMF)
Source: FDA Label

COL-PROBENECID Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

ILARIS
Novartis
2009 10 indic.

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

107 trials
Trial Sponsor ID Phase Status Title
NCT05850091 PROACT 2 2023P000945 Ph 4 recruiting Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
NCT07571681 COLTHYR MU-THY-COL-2026-01 MD-MU-IRB-R.24.11.2879 Ph 2, Ph 3 not yet recruiting Colchicine for Autoimmune and Subacute Thyroiditis
NCT05637398 03-22 Ph 1, Ph 2 completed Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction
NCT05618353 POPCORN CARA-003-22S I01CX002358-01A2 Ph 4 recruiting The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial
NCT04381936 RECOVERY NDPHRECOVERY 2020-001113-21, ISRCTN50189673 Ph 3 recruiting Randomised Evaluation of COVID-19 Therapy
NCT06158698 CMP-MYTHiC CMP-MYTHiC PNRR-MAD-2022-12376225 Ph 3 recruiting CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
NCT07462325 PIC-CHD 2025-GSP-GG-13 Ph 4 not yet recruiting Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease
NCT05633810 COLCOT-T2D MHICC-2021-001 Ph 3 recruiting COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes
NCT05726019 COCAR SDC 5302/21/077 Ph 2 completed Colchicine in Patients Undergoing Coronary Artery Bypass Grafting After Acute Coronary Syndrome
NCT02939573 ARAMIS VCRC5562 U54AR057319 Ph 2 recruiting A Randomized Multicenter Study for Isolated Skin Vasculitis
NCT06802926 CoCAB-Pilot KY-2025-777 Ph 4 recruiting Pilot Trial of Colchicine for Graft Failure in CABG
NCT04916522 COHERENT COHERENT 2020-004492-40 Ph 2 active not recruiting The COlchicine HypERtENsion Trial
NCT07280572 RECLAIM EUCT 2024-511580-28 D-25-500086 Ph 3 enrolling by invitation RECLAIM Adaptive Platform Trial for PCC Treatments
NCT07145229 ABP-745-201 Ph 2 recruiting Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare
NCT04420624 COLD-MI RECHMPL18_0459 2020-000098-25 Ph 2, Ph 3 terminated COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction
NCT04500665 2020P002468 K23HL150311 Ph 2 recruiting Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine
NCT05162742 CHIANTI 112719 Ph 3 active not recruiting Colchicine and Inflammation in Aortic Stenosis
NCT05017571 10000235 000235-CH Ph 2 completed Colchicine to Suppress Inflammation and Improve Insulin Resistance in Adults and Adolescents With Obesity
NCT06090890 2023-GSP-GG-32 Ph 4 recruiting Anti-inflammatory Therapy for Recurrent In-stent Restenosis
NCT04382443 ORCA CECI-03 Ph 4 completed Oral Colchicine in Argentina to Prevent Restenosis
NCT04870424 Co-STAR Co-STAR Ph 3 completed Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
NCT05472337 210507002 Ph 2 recruiting Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome
NCT05890664 COLECTRO-AF 2023-00548, kt21sticherling Ph 3 recruiting Colchicine After Electrocardioversion for Atrial Fibrillation
NCT06279000 COLCAT CTU 22/025 Ph 3 recruiting Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery
NCT06280976 ARTCAP 23.0001 Ph 4 withdrawn Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
NCT02898610 CONVINCE 2015-004505-16 Ph 3 completed Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke
NCT06203977 REPAIR Ph 1 recruiting Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
NCT06578182 ECHO SMaartenskliniek 10140262210012, 2024-511359-16-00 Ph 3 recruiting The Effect of ColcHicine on the Incidence of Knee or Hip Replacements
NCT06813079 ADOPT 24-5059 Ph 2 not yet recruiting Using Tumor Models to Determine Treatments
NCT05936281 Gensci 048-202 GenSci 048-202 Ph 2 completed A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)
NCT05279690 STUDY-21-01175 Ph 1 completed Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors
NCT04322682 COVID-19 results posted MHIPS-2020-001 3R01HL146206-02S1 Ph 3 terminated Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
NCT06731595 PAPERS PAPERS Ph 2 completed Post-Ablation Pericarditis Reduction Study (PAPERS)
NCT05936268 Gensci 048-203 GenSci048-203 Ph 2 completed Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare
NCT03048825 CLEAR SYNERGY CLSYN.1702 OASIS-9 Ph 3 completed Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry
NCT05250596 COLOR-ACS ID 20426 2021-000637-13 Ph 2 completed COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)
NCT05439356 NCRC-2022-05 Ph 3 completed Colchicine in High-risk Patients With Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3)
NCT02260206 colchicine Ph 4 completed Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion
NCT05928728 COLFIB 2022-500850-40-01 Ph 3 recruiting The COLchicine and Atrial FIBrillation Trial
NCT06081049 COLHEART-PRESERVED Ph 2 recruiting The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)
NCT04324463 ACTCOVID19 PHRI.ACT.COVID19 Ph 3 completed Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial
NCT04848857 COLOCT CTACS202001 Ph 4 completed Colchicine for the Stability of Coronary Plaque in Acute Coronary Syndrome (COLOCT)
NCT03310125 COP-AF 2017-001-COPAF Ph 3 completed Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)
NCT03888846 P104375V04 Ph 2 completed Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers
NCT04857931 COLpEF MP-33-2021-2929 Ph 2 terminated Colchicine in HFpEF
NCT04218786 STMU2020 Ph 2 withdrawn Effect of Colchicine in Patients With Myocardial Infarction
NCT04492358 2020-002462-14 Ph 2, Ph 3 terminated Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center
NCT05130892 NLRP3-CRP Ph 4 completed Effect of Inflammasome Inhibitor on hsCRP in Patients After PCI
NCT04667780 ATH/IRB/Colchicine/25.11.2020 Ph 3 completed Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19
NCT04949516 MACT WKUH 2021-06-004 Ph 4 completed Mono Antiplatelet and Colchicine Therapy

Showing 50 of 107 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

COL-PROBENECID FDA Label Details

Indications & Usage

COL-PROBENECID is indicated for the treatment of Gout flares (prevention and acute treatment); Familial Mediterranean fever (FMF).

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Data Sources

FDA Approval: ANDA084279 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.