Colcrys

(Colchicine)

ApprovedSmall molecule

Colchicine is used to treat and prevent gout attacks, a painful condition caused by uric acid crystals in the joints. It is also used to treat familial Mediterranean fever, a rare inherited inflammatory condition.[2] Colcrys is currently approved and in use across 66 indications[4].[1]

Colcrys is one of 816 small molecule programs targeting Cerebral Amyloid Angiopathy. It is currently in Approved.

Indications

238

Total Trials

Active Trials

815

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cerebral Amyloid AngiopathyRecruiting

Coronary Artery DiseaseRecruiting

HIV InfectionRecruiting

Cirrhosis of LiverApproved

ArrhythmiaCompleted

Cardiovascular DiseaseRecruiting

Cardiac ArrhythmiaApproved

Essential HypertensionActive, not recruiting

Ischemia Reperfusion InjuryApproved

Venous ThromboembolismRecruiting

Cerebral Amyloid AngiopathyPhase 2

Recruiting

Coronary Artery DiseasePhase 3

Recruiting

HIV InfectionPhase 2

Recruiting

Cirrhosis of LiverApproved

Approved

ArrhythmiaApproved

Completed

Cardiovascular DiseasePhase 3

Recruiting

Cardiac ArrhythmiaApproved

Approved

Essential HypertensionPreclinical

Active, not recruiting

Ischemia Reperfusion InjuryApproved

Approved

Venous ThromboembolismApproved

Recruiting

Showing 10 of 64 indications

Competition

Competitive Landscape

332 competitors in Treatment

#DrugCompanyPhaseTrials

Colcrys

Jazz Pharmaceuticals

Approved

3 2

Biltricide

Bayer

Preclinical

3 3

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 4

Theo-Dur

Pfizer

Preclinical

1 5

Minipress

Pfizer

Preclinical

1 6

Niclocide

Bayer

Preclinical

1 7

Alfenta

Jazz Pharmaceuticals

Preclinical

1 8

Emtriva

Gilead

Preclinical

1 9

Lamprene

Novartis

Preclinical

1 10

Foscavir

CClinigen, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Cardiomyopathy

NCT04500665

Phase 3Recruiting

Injury

NCT06118034

Q1 2027

Phase 2Not yet recruiting

Baricitinib

NCT06768294

Phase 3Recruiting

Atrial Fibrillation

NCT05890664

Post-ApprovalNot yet recruiting

Heart Disease

NCT07462325

Q2 2027

Post-ApprovalRecruiting

Coronary Atherosclerosis

NCT05850091

Clinical

Trials by Indication[1]

COVID-1922 trials

Survival TRial Using CytoKines in COVID-19 (STRUCK Trial)

Completed·UUniversity of Sao Paulo·Phase 3·NCT04724629·60 enrolled

Impact of Colchicine and Low-dose Naltrexone on COVID-19

Completed·HHealthPartners Institute·Phase 2·NCT04756128·142 enrolled

Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center

Terminated·MMaria Joyera Rodríguez·Phase 2/3·NCT04492358·54 enrolled

Show 19 more trials

Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19

Completed·—·Phase 3·NCT04667780·102 enrolled

Colchicine in Moderate Symptomatic COVID-19 Patients

Completed·—·N/A·NCT04527562·299 enrolled

Randomised Evaluation of COVID-19 Therapy

Recruiting·UUniversity of Oxford·Phase 3·NCT04381936·70,000 enrolled

Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients

Completed·—·Phase 4·NCT05246072·135 enrolled

Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)

Terminated·BBaptist Health South Florida·Phase 1/2·NCT04762771·2 enrolled

COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19

Completed·LLomonosov Moscow State University Medical Research and Educational Center·Phase 2·NCT04403243·70 enrolled

Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial

Completed·PPopulation Health Research Institute·Phase 3·NCT04324463·6,667 enrolled

The ECLA PHRI COLCOVID Trial. Effects of Colchicine on Moderate/High-risk Hospitalized COVID-19 Patients.

Completed·EEstudios Clínicos Latino América·Phase 3·NCT04328480·1,279 enrolled

COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19

Terminated·MMaimonides Medical Center·Phase 2·NCT04363437·21 enrolled

Trial to Study the Benefit of Colchicine in Patients With COVID-19

Completed·FFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia·Phase 3·NCT04350320·102 enrolled

Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)

Completed·UUniversity of California, Los Angeles·Phase 2·NCT04355143·93 enrolled

Probiotic and Colchicine in COVID-19

Completed·—·N/A·NCT05911022·150 enrolled

Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19

Unknown status·SShanghai Public Health Clinical Center·N/A·NCT05038449·60 enrolled

Colchicine in COVID-19: a Pilot Study

Terminated·UUniversity Of Perugia·Phase 2·NCT04375202·227 enrolled

CorONa Virus edoxabaN ColchicinE (CONVINCE) COVID-19

Terminated·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT04516941·60 enrolled

Impact of Colchicine in Hospitalized Colombian Patients With COVID-19

Terminated·FFundación Universitaria de Ciencias de la Salud·Phase 3·NCT04539873·128 enrolled

Effectiveness of Colchicine Among Patients With COVID-19 Infection

Completed·HHawler Medical University·Phase 2·NCT04867226·100 enrolled

The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection

Completed·SShahid Beheshti University of Medical Sciences·Phase 2·NCT04360980·80 enrolled

Role of Ivermectin and Colchicine in Treatment of COVID-19: Randomized Controlled Clinical Trial

Completed·—·N/A·NCT05930002·120 enrolled

Colchicine21 trials

Anti-platelet Effects of Colchicine in Healthy Volunteers

Completed·NNYU Langone Health·Phase 4·NCT02140372·10 enrolled

Bioequivalence Study of Colchicine Tablets

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT01021020·28 enrolled

A Pharmacokinetic Study of Colchicine With an Oral Contraceptive

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT01040845·30 enrolled

Show 18 more trials

Colchicine's Efficacy in MI Patients: Comparing PCI and Non-Reperfusion Approaches

Completed·UUniversity of Brawijaya·Phase 1·NCT06426537·63 enrolled

Colchicine in HFpEF

Terminated·MMontreal Heart Institute·Phase 2·NCT04857931·14 enrolled

The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial

Recruiting·VVA Office of Research and Development·Phase 4·NCT05618353·700 enrolled

Study of Long-term Peg Intron vs. Colchicine in Non-responders.

Completed·—·Phase 4·NCT00179413·549 enrolled

Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

Unknown status·—·Phase 4·NCT06025071·800 enrolled

Effect of Low Dose ColchiciNe on the InciDence of POAF

Terminated·JJordan Collaborating Cardiology Group·Phase 3·NCT03015831·254 enrolled

Revisiting the Mechanism of the Anti-inflammatory Effect of Colchicine

Unknown status·—·Phase 1·NCT04355585·18 enrolled

Colchicine in Postoperative Fontan Patients

Terminated·UUniversity of Michigan·Phase 2/3·NCT03575572·11 enrolled

Colchicine in Acutely Decompensated HFREF

Recruiting·UUniversity of Virginia·Phase 4·NCT06286423·30 enrolled

Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI Pilot)

Completed·PPopulation Health Research Institute·Phase 3·NCT04160117·202 enrolled

Colchicine Has Anti-diabetic Effect

Completed·MMinistry of Health and Population, Egypt··NCT04377321·150 enrolled

Pharmacokinetic Study With Colchicine in Healthy Volunteers

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT01017003·14 enrolled

Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection

Completed·UUniversity of Baghdad·Phase 1·NCT05151614·160 enrolled

Different Doses of Colchicine on hsCRP

Completed·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 4·NCT06078904·200 enrolled

The Effect of ColcHicine on the Incidence of Knee or Hip Replacements

Recruiting·SSint Maartenskliniek·Phase 3·NCT06578182·1,410 enrolled

Apolipoprotein CIII Reduction Via Colchicine

Completed·SScripps Translational Science Institute·Phase 1·NCT02083510·5 enrolled

Anti-inflammatory Effects of Colchicine in PCI

Completed·NNYU Langone Health·Phase 4·NCT01709981·280 enrolled

Oral Colchicine in Argentina to Prevent Restenosis

Completed·CCentro de estudios en Cardiologia Intervencionista·Phase 4·NCT04382443·410 enrolled

Interaction11 trials

Drug-Drug Interaction Study Between Colchicine and Cyclosporine

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00983931·24 enrolled

Drug-Drug Interaction Between Colchicine and Verapamil ER

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00983242·24 enrolled

Drug-Food Interaction Study of Seville Orange Juice and Colchicine

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00960193·24 enrolled

Show 8 more trials

The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT03131583·15 enrolled

Drug-Drug Interaction Study of Colchicine and Theophylline

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00983905·30 enrolled

Drug-Drug Interaction Study of Colchicine and Clarithromycin

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00984061·24 enrolled

A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00984009·24 enrolled

Drug-Drug Interaction Study Between Colchicine and Diltiazem ER

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00983372·24 enrolled

Drug Interaction Study of Colchicine and Theophylline

Completed· Takeda logo

Takeda·Phase 4·NCT01601132·30 enrolled

Drug-Drug Interaction Study Between Colchicine and Ketoconazole

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00983216·24 enrolled

Drug-Drug Interaction Between Colchicine and Ritonavir

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00983515·24 enrolled

Atrial Fibrillation9 trials

Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels

Unknown status·HHillel Yaffe Medical Center·N/A·NCT04155879·300 enrolled

Colchicine in Atrial Fibrillation to Prevent Stroke

Completed·PPopulation Health Research Institute·Phase 3·NCT02282098·80 enrolled

Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients

Completed·JJordan Collaborating Cardiology Group·Phase 3·NCT03021343·360 enrolled

Show 6 more trials

Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation

Terminated·MMayo Clinic·Phase 3·NCT02177266·2 enrolled

Prophylaxis Against Postoperative Atrial Fibrillation in Patients Undergoing On-pump CABG

Unknown status·Ddoaa rashwan·Phase 2/3·NCT03905759·48 enrolled

Colchicine After Electrocardioversion for Atrial Fibrillation

Recruiting·UUniversity Hospital, Basel, Switzerland·Phase 3·NCT05890664·416 enrolled

Use of Colchicine to Decrease Atrial Fibrillation Recurrence After Ablation

Unknown status·SStony Brook University·Phase 3·NCT05459974·224 enrolled

Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study

Completed·PPopulation Health Research Institute·Phase 3·NCT01985425·100 enrolled

The COLchicine and Atrial FIBrillation Trial

Recruiting·HHerlev and Gentofte Hospital·Phase 3·NCT05928728·500 enrolled

Pericarditis6 trials

Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.

Completed·AAzienda Sanitaria Locale 3, Torino·Phase 4·NCT00235079·240 enrolled

Post-Ablation Pericarditis Reduction Study

Completed·—·Phase 2·NCT04906720·248 enrolled

Hydroxychloroquine in Colchicine-Resistant Glucocorticoid-Dependent Idiopathic Recurrent Pericarditis

Unknown status·HHippocration General Hospital·Phase 3·NCT05737680·30 enrolled

Show 3 more trials

Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

Completed·AAzienda Sanitaria Locale 3, Torino·Phase 3·NCT00128453·240 enrolled

Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)

Completed·AAzienda Sanitaria Locale 3, Torino·Phase 3·NCT00128414·120 enrolled

Post-Ablation Pericarditis Reduction Study (PAPERS)

Completed·—·Phase 2·NCT06731595·248 enrolled

84 more indications

Efficacy and Safety5 trials

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment

Completed· Takeda logo

Takeda·Phase 2·NCT02128490·189 enrolled

Efficacy and Safety of Thalidomide for Pediatric PFAPA Syndrome

Not yet recruiting·WWenjie Zheng·N/A·NCT07476625·106 enrolled

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout

Completed· Takeda logo

Takeda·Phase 3·NCT02139046·1,790 enrolled

Show 2 more trials

Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients

Completed· Gilead logo

Gilead·Phase 2·NCT02063997·248 enrolled

Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol

Completed· Regeneron logo

Regeneron·Phase 4·NCT01451645·82 enrolled

Acute Coronary Syndrome5 trials

Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome

Recruiting·PPontificia Universidad Catolica de Chile·Phase 2·NCT05472337·50 enrolled

Targeting Inflammation in Acute Coronary Syndrome Using Colchicine

Completed·HHamilton Health Sciences Corporation·Phase 2/3·NCT00754819·80 enrolled

Colchicine for Acute Coronary Syndromes

Unknown status·UUnknown Sponsor·Phase 4·NCT01906749·500 enrolled

Show 2 more trials

COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)

Completed·AAzienda USL Toscana Centro·Phase 2·NCT05250596·182 enrolled

Colchicine in Patients Undergoing Coronary Artery Bypass Grafting After Acute Coronary Syndrome

Completed·UUniversity of Sao Paulo General Hospital·Phase 2·NCT05726019·100 enrolled

Heart Failure5 trials

Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction

Unknown status·MMontreal Heart Institute·Phase 2/3·NCT06217120·60 enrolled

The COLchicine HEART Failure PRESERVED Trial (COLHEART-PRESERVED)

Recruiting·TTor Biering-Sørensen·Phase 2·NCT06081049·152 enrolled

Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction

Recruiting·II.M. Sechenov First Moscow State Medical University·Phase 1/2·NCT05637398·40 enrolled

Show 2 more trials

Randomized Double-blind Trial to Study the Benefit of Colchicine in Patients With Acutely Decompensated Heart Failure

Completed·FFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia·Phase 3·NCT04705987·279 enrolled

Colchicine in Patients with Heart Failure with Preserved Ejection Fraction and Inflammation

Not yet recruiting·DDongying Zhang·Phase 4·NCT06604611·200 enrolled

Coronary Artery Disease4 trials

Colchicine Use for Primary Prevention of Coronary Artery Disease

Not yet recruiting·QQingdao Central Hospital·Phase 3·NCT05175274·6,792 enrolled

Dose-finding Study of Colchicine in Type 2 Diabetic Patients With Coronary Artery Disease

Completed·—·Phase 2·NCT03376698·54 enrolled

Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention

Recruiting·AAZ Sint-Jan AV·Phase 3·NCT06095765·2,770 enrolled

Show 1 more trial

The Effect of Colchicine on Platelet Function Profiles in Patients With Stable Coronary Artery Disease

Completed·TThe University of The West Indies·Phase 1·NCT06567678·22 enrolled

Inflammation4 trials

An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.

Completed·UUniversity of South Florida·Phase 4·NCT01112982·74 enrolled

Post-MI PET Scan Imaging of Inflammation

Unknown status·GG.Gennimatas General Hospital·Phase 4·NCT02281305·20 enrolled

Canadian Study of Arterial Inflammation in Patients With Diabetes and Vascular Events: EvaluatioN of Colchicine

Recruiting·OOttawa Heart Institute Research Corporation·Phase 3·NCT04181996·115 enrolled

Show 1 more trial

The Effect of Colchicine on Inflammation in ACS Patients

Completed·—·Phase 3·NCT06054100·88 enrolled

Myocardial Infarction4 trials

Mechanistic Effects of Colchicine in Patients With Myocardial Infarction

Withdrawn·NNYU Langone Health·Phase 4·NCT02995512

Effect of Colchicine in Patients With Myocardial Infarction

Withdrawn·—·Phase 2·NCT04218786

Short-Term Outcomes of Early Administration of Colchicine in Non-ST Segment Elevation Myocardial Infarction Patients Treated With Drug-Eluting Stents.

Recruiting·—·Phase 1·NCT07143136·140 enrolled

Show 1 more trial

Effect of Colchicine On Left Ventricle Function After Anterior Myocardial Infarction Assessed By Speckle Tracking

Completed·—·Phase 4·NCT05200052·100 enrolled

Cardiomyopathy3 trials

Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine

Recruiting·—·Phase 2·NCT04500665·20 enrolled

CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine

Recruiting·NNiguarda Hospital·Phase 3·NCT06158698·80 enrolled

Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy

Not yet recruiting·—·Phase 1·NCT06304896·150 enrolled

Coronary Atherosclerosis3 trials

Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV

Completed·JJohns Hopkins University·Phase 2·NCT02624180·81 enrolled

Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine

Recruiting·MMassachusetts General Hospital·Phase 4·NCT05850091·200 enrolled

Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 4·NCT06342609·84 enrolled

Pneumonia3 trials

EFFICACY OF COLCHICINE IN IMPROVING CLINICAL OUTCOMES IN PATIENTS WITH MILD TO MODERATE COVID-19 PNEUMONIA IN LAHORE: A RANDOMIZED CONTROL TRIAL

Completed·ZZaeema Kanwal·Phase 1/2·NCT06847204·66 enrolled

Adding Colchicine to Tocilizumab in Patients With Severe COVID-19 Pneumonia.

Unknown status·HHamad Medical Corporation·Phase 1·NCT05118737·230 enrolled

Colchicine Counteracting Inflammation in COVID-19 Pneumonia

Completed·AAzienda Ospedaliero-Universitaria di Parma·Phase 2·NCT04322565·193 enrolled

Treatment3 trials

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

Completed·RRevive Therapeutics, Ltd.·Phase 2·NCT02330796·66 enrolled

RECLAIM Adaptive Platform Trial for PCC Treatments

Enrolling by invitation·JJanneke van de Wijgert·Phase 3·NCT07280572·1,250 enrolled

A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.

Unknown status·SSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.·Phase 2·NCT06270225·157 enrolled

Injury3 trials

The Role of Colchicine in Reducing The Rate of Myocardial Reperfusion Injury

Unknown status·IIndonesia University·Phase 3·NCT05734612·80 enrolled

Colchicine Prevents Myocardial Injury After Non-Cardiac Surgery Pilot Study

Withdrawn·UUniversity of British Columbia·N/A·NCT04139655

Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery

Recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 3·NCT06118034·768 enrolled

Anti-inflammatory Therapy3 trials

Anti-inflammatory Therapy for Recurrent In-stent Restenosis

Recruiting·FFu Wai Hospital, Beijing, China·Phase 4·NCT06090890·252 enrolled

Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients

Recruiting·SShanghai Tongji Hospital, Tongji University School of Medicine·N/A·NCT07064109·380 enrolled

Role of Colchicine as Anti-Inflammatory Therapy in HFpEF

Active, not recruiting·—·Phase 3·NCT06837623·75 enrolled

Cardiovascular2 trials

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

Completed·MMenarini International Operations Luxembourg SA·Phase 4·NCT02500641·196 enrolled

Colchicine Cardiovascular Outcomes Trial (COLCOT)

Completed·MMontreal Heart Institute·Phase 3·NCT02551094·4,745 enrolled

Vascular Inflammation2 trials

Colchicine in Vascular Inflammation Assessed With PET Imaging

Completed·MMontreal Heart Institute·Phase 2·NCT02162303·106 enrolled

Colchicine Effect on Perivascular Inflammation Index on Coronary CTA

Unknown status·UUniversity of Sao Paulo General Hospital·Phase 1·NCT05347316·40 enrolled

Diabetic Nephropathy2 trials

Colchicine for Diabetic Nephropathy Trial

Unknown status·SSheba Medical Center·Phase 1/2·NCT02442921·40 enrolled

Colchicine for Diabetic Nephropathy

Unknown status·PProf.Avi Livneh·Phase 2·NCT01005121·12 enrolled

Prednisolone2 trials

Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae

Unknown status·MMashhad University of Medical Sciences·Phase 2·NCT00723268·30 enrolled

Prednisolone Versus Colchicine for Acute Gout in Primary Care

Recruiting·UUniversity Medicine Greifswald·Phase 4·NCT05698680·314 enrolled

Coronavirus2 trials

Colchicine in Patients With Mild and Severe Coronavirus Disease

Terminated·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 2·NCT04367168·116 enrolled

Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

Terminated·MMontreal Heart Institute·Phase 3·NCT04322682·4,506 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare

Completed· Changchun GeneScience Pharmaceutical Co., Ltd. logo

Changchun GeneScience Pharmaceutical Co., Ltd.·Phase 2·NCT05936268·106 enrolled

A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment

Terminated·IIronwood Pharmaceuticals, Inc.·Phase 4·NCT03226899·242 enrolled

Osteoarthritis2 trials

Colchicine for Symptom and Inflammation in Knee Osteoarthritis

Completed·SSingapore General Hospital·Phase 2/3·NCT02176460·109 enrolled

Colchicine as Treatment for People With Hand Osteoarthritis

Completed·HHenning Bliddal·Phase 4·NCT04601883·100 enrolled

Ischemic stroke2 trials

Efficacy of Colchicine in Preventing Recurrent Stroke in the Patients With Acute Atherothrombotic Ischemic Stroke During Hospitalization

Unknown status·MMikhail Zykov·Phase 4·NCT06102720·200 enrolled

Colchicine for Secondary Prevention After Ischemic Stroke (CHANCE-3 EX)

Not yet recruiting·—·Phase 3·NCT07035405·7,500 enrolled

Antiplatelet2 trials

Mono Antiplatelet and Colchicine Therapy

Completed·WWonkwang University Hospital·Phase 4·NCT04949516·200 enrolled

MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study

Recruiting·—·Phase 4·NCT06543082·490 enrolled

Stroke2 trials

Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke

Completed·UUniversity College Dublin·Phase 3·NCT02898610·3,154 enrolled

COlchicine iN Circulating Inflammatory Markers After StrokE (CONCISE)

Unknown status·UUniversity College Dublin·Phase 2·NCT06062277·91 enrolled

Efficacy2 trials

Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients

Completed· Gilead logo

Gilead·Phase 2·NCT01399008·100 enrolled

Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS)

Completed·DDyve Biosciences, Inc.·Phase 2·NCT04130204·284 enrolled

Hypertension2 trials

Repurposing Colchicine to Improve Vascular Function in Hypertension

Completed·UUniversity of Copenhagen·N/A·NCT04303689·31 enrolled

The COlchicine HypERtENsion Trial

Active, not recruiting·HHerlev and Gentofte Hospital·Phase 2·NCT04916522·150 enrolled

Total Knee Replacement1 trial

Effect of Colchicine on Range of Motion After Manipulation Under Anesthesia for the Stiff Total Knee Replacement

Suspended·HHospital for Special Surgery, New York·Phase 4·NCT02926248·112 enrolled

Endothelial Function1 trial

Inflammation and Coronary Endothelial Function

Completed·JJohns Hopkins University·Phase 2·NCT02366091·111 enrolled

Cirrhosis1 trial

Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

Unknown status·NNational Center for Research Resources (NCRR)·Phase 1·NCT00004368·15 enrolled

Pulmonary Fibrosis1 trial

Colchicine and Post-COVID-19 Pulmonary Fibrosis

Unknown status·CClinAmygate·Phase 4·NCT04818489·260 enrolled

Inflammatory Cytokines1 trial

Immune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels

Completed·TTongji Hospital·Phase 4·NCT02060552·96 enrolled

Complication1 trial

The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention

Terminated·NNational and Kapodistrian University of Athens·Phase 2·NCT04326790·105 enrolled

Coronary Artery Bypass1 trial

Colchicine in Coronary Artery Bypass Graft (CABG)

Completed·GG.Gennimatas General Hospital·Phase 4·NCT02122484·60 enrolled

Other Solid Tumors1 trial

Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors

Completed·IIcahn School of Medicine at Mount Sinai·Phase 1·NCT05279690·16 enrolled

Recruiting·UUniversity of Pennsylvania·Phase 1·NCT06212271·24 enrolled

Asthma1 trial

Asthma Clinical Research Network (ACRN)

Withdrawn·MMilton S. Hershey Medical Center·Phase 3·NCT00000577

Spironolactone1 trial

Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry

Completed·PPopulation Health Research Institute·Phase 3·NCT03048825·7,264 enrolled

Post-Operative Atrial Fibrillation1 trial

COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)

Unknown status·UUnknown Sponsor·Phase 3·NCT01552187·360 enrolled

Prevention1 trial

A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)

Completed· Changchun GeneScience Pharmaceutical Co., Ltd. logo

Changchun GeneScience Pharmaceutical Co., Ltd.·Phase 2·NCT05936281·165 enrolled

Drug Interactions1 trial

To Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout

Unknown status·TThe Affiliated Hospital of Qingdao University·Phase 1·NCT05324423·20 enrolled

Atherosclerotic Plaque1 trial

Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)

Withdrawn·UUniversity of Louisville·Phase 4·NCT06280976

Prostate Cancer1 trial

Oral Colchicine in Men With Castrate Resistant Prostate Cancer

Withdrawn·MMilton S. Hershey Medical Center·Phase 2·NCT01481233

Multiple Myeloma1 trial

The Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients

Unknown status·—·Phase 3·NCT05802992·30 enrolled

Withdrawal1 trial

Withdrawal of Colchicine in Behçet Syndrome

Unknown status·IIstanbul University - Cerrahpasa··NCT06146192·130 enrolled

Vasculitis1 trial

Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04008316·264 enrolled

Primary Biliary Cirrhosis1 trial

Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004748·90 enrolled

Chronic Kidney Disease1 trial

A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.

Completed·SSeoul National University Hospital·Phase 4·NCT01173107·80 enrolled

Abdominal Aortic Aneurysm1 trial

Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial

Unknown status·GGuangdong Provincial People's Hospital·N/A·NCT05361772·230 enrolled

Arrhythmia1 trial

Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion

Completed·YYong Seog Oh·Phase 4·NCT02260206·20 enrolled

Chronic Hepatitis1 trial

Efficacy of Long-term Ribavirin in Non-responders With Chronic Hepatitis C and Advanced Fibrosis

Terminated·HHospital Universitario Ramon y Cajal·Phase 2·NCT00840489·50 enrolled

Aortic Stenosis1 trial

Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT04870424·120 enrolled

Insulin resistance1 trial

Colchicine to Suppress Inflammation and Improve Insulin Resistance in Adults and Adolescents With Obesity

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT05017571·152 enrolled

Shoulder pain1 trial

Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

Unknown status·—·N/A·NCT00983177·80 enrolled

Renal Impairment1 trial

Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)

Completed· Takeda logo

Takeda·Phase 4·NCT01084278·40 enrolled

Hyperuricemia1 trial

Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients

Completed· Gilead logo

Gilead·Phase 2·NCT01416402·27 enrolled

Oral ulcer1 trial

Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers

Completed·IIpekyolu Ilac Ltd. Sti·Phase 2·NCT03888846·41 enrolled

Fibrosis1 trial

Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR

Completed·ZZagazig University·N/A·NCT03659058·400 enrolled

Acute Myocardial Infarction1 trial

COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction

Terminated·UUniversity Hospital, Montpellier·Phase 2/3·NCT04420624·54 enrolled

Concentration1 trial

Relation Between Blood Concentration of Colchicine and Response to Colchicine Treatment in Gout Flare

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT03933007·26 enrolled

Behcet's Disease1 trial

Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's Disease

Completed·TTehran University of Medical Sciences·Phase 2·NCT00700297·169 enrolled

Heart Disease1 trial

Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease

Not yet recruiting·—·Phase 4·NCT07462325·176 enrolled

Rheumatoid Arthritis1 trial

Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity in Patients With Rheumatoid Arthritis.

Completed·HHospital Central "Dr. Ignacio Morones Prieto"·Phase 2·NCT04056039·60 enrolled

Cerebral Amyloid Angiopathy1 trial

Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage

Recruiting·HHuashan Hospital·Phase 2·NCT07026994·80 enrolled

Chronic Coronary Syndromes1 trial

ESCALATion of Medical Therapy Following Multimodality Plaque Evaluation in High-risk Chronic Coronary Syndromes

Not yet recruiting·KKing's College Hospital NHS Trust·Phase 3·NCT06469528·50 enrolled

Atherosclerosis1 trial

Evaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT05476991·2,800 enrolled

Postpericardiotomy Syndrome1 trial

Study of Colchicine to Prevent the Postpericardiotomy Syndrome

Completed·AAzienda Sanitaria Locale 3, Torino·Phase 3·NCT00128427·360 enrolled

Baricitinib1 trial

Baricitinib in CPPD - the BAPTIST Study

Not yet recruiting·II.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio·Phase 2·NCT06768294·32 enrolled

Percutaneous Coronary Intervention1 trial

Colchicine Protective Effect in Patients Undergoing Percutaneous Coronary Intervention (COLCHICINE-PROTECT)

Unknown status·HHelwan University·Phase 3·NCT05739929·400 enrolled

Amyotrophic Lateral Sclerosis1 trial

Colchicine for Amyotrophic Lateral Sclerosis

Completed·AAzienda Ospedaliero-Universitaria di Modena·Phase 2·NCT03693781·54 enrolled

ST Elevation Myocardial Infarction1 trial

Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)

Unknown status·NNational University of Malaysia·Phase 4·NCT06020300·64 enrolled

Aortic Valve Stenosis1 trial

Effect of Colchicine on the Progression of Aortic Valve Stenosis - a Pilot Study

Recruiting·OOttawa Heart Institute Research Corporation·Phase 2/3·NCT05253794·24 enrolled

Platelet Reactivity1 trial

Effect of Low Dose of Colchicine on Platelet Reactivity

Completed·UUniversity of Sao Paulo·N/A·NCT05956145·80 enrolled

Dialysis Patients1 trial

Colchicine and Inflammation in Hemodialysis Patients

Unknown status·—·Phase 2·NCT05677555·50 enrolled

Overweight1 trial

The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity

Completed·DDonders Centre for Cognitive Neuroimaging·N/A·NCT05785429·59 enrolled

Cardiovascular Disease1 trial

Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease

Recruiting·HHospital do Coracao·Phase 3·NCT06930885·7,713 enrolled

Acute1 trial

Pharmacokinetic Study of an Acute Gout Regimen

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT01017042·13 enrolled

Malignant Tumors1 trial

Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive Curative Treatment

Completed·KKaohsiung Medical University Chung-Ho Memorial Hospital·Phase 2·NCT04264260·42 enrolled

Gout1 trial

Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout

Recruiting·MMassachusetts General Hospital·Phase 4·NCT04875702·650 enrolled

Transient Ischemic Attack1 trial

Colchicine in High-risk Patients With Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3)

Completed·—·Phase 3·NCT05439356·8,343 enrolled

Azithromycin1 trial

Drug-Drug Interaction Study of Colchicine and Azithromycin

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00983294·24 enrolled

CAR1 trial

Pharmacokinetic and Exploratory Electrocardiogram (ECG) Study

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT01018420·18 enrolled

LAM1 trial

Effect of Inflammasome Inhibitor on hsCRP in Patients After PCI

Completed·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 4·NCT05130892·132 enrolled

Rhegmatogenous Retinal Detachment1 trial

Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment

Unknown status·SShahid Beheshti University of Medical Sciences·Phase 3·NCT00370201

Unspecified3 trials

Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT01130051·16 enrolled

Design and Rationale of the COLT Study

Not yet recruiting·AAzienda Sanitaria Locale ASL 6, Livorno·Phase 3·NCT07432529·940 enrolled

Bioavailability Study of Colcrys® in Apple Juice

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT01123395·16 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 29, 2009

COLCRYS

NDA NDA022352

Sep 26, 2014

MITIGARE

NDA NDA204820

Jan 30, 2019

GLOPERBA

NDA NDA210942

Jun 16, 2023

LODOCO

NDA NDA215727

Sources

References

[1]
ClinicalTrials.gov — 238 trial records for Colchicine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Colcrys drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Colchicine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Colchicine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215727). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Colcrys. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tubulin Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Jazz Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Oct 6, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8093297Oct 6, 2028

8415396Oct 6, 2028

7964648Oct 6, 2028

8093296Oct 6, 2028

8093298Oct 6, 2028

36 more patents

8415395Oct 6, 2028

7981938Oct 6, 2028

7964647Oct 6, 2028

8097655Oct 6, 2028

7935731Dec 3, 2028

7619004Dec 3, 2028

7601758Feb 10, 2029

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7906519Feb 17, 2029

9399036Aug 22, 2033

9675613Aug 22, 2033

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9555029Aug 22, 2033

8927607Aug 22, 2033

12280025Nov 1, 2033

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10130585May 9, 2034

12274751Nov 22, 2036

10383820Nov 22, 2036

10383821Nov 22, 2036

9907751Nov 22, 2036

12514819Nov 22, 2036

10226423Dec 20, 2037

Colcrys

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

COVID-1922 trials

Colchicine21 trials

Interaction11 trials

Atrial Fibrillation9 trials

Pericarditis6 trials

Efficacy and Safety5 trials

Acute Coronary Syndrome5 trials

Heart Failure5 trials

Coronary Artery Disease4 trials

Inflammation4 trials

Myocardial Infarction4 trials

Cardiomyopathy3 trials

Coronary Atherosclerosis3 trials

Pneumonia3 trials

Treatment3 trials

Injury3 trials

Anti-inflammatory Therapy3 trials

Cardiovascular2 trials

Vascular Inflammation2 trials

Diabetic Nephropathy2 trials

Prednisolone2 trials

Coronavirus2 trials

Safety and Efficacy2 trials

Osteoarthritis2 trials

Ischemic stroke2 trials

Antiplatelet2 trials

Stroke2 trials

Efficacy2 trials

Hypertension2 trials

Total Knee Replacement1 trial

Endothelial Function1 trial

Cirrhosis1 trial

Pulmonary Fibrosis1 trial

Inflammatory Cytokines1 trial

Complication1 trial

Coronary Artery Bypass1 trial

Other Solid Tumors1 trial

Hepatocellular Carcinoma1 trial

Pediatric Patients1 trial

Peripheral Artery Disease1 trial

Asthma1 trial

Spironolactone1 trial

Post-Operative Atrial Fibrillation1 trial

Prevention1 trial

Drug Interactions1 trial

Atherosclerotic Plaque1 trial

Prostate Cancer1 trial

Multiple Myeloma1 trial

Withdrawal1 trial

Vasculitis1 trial

Primary Biliary Cirrhosis1 trial

Chronic Kidney Disease1 trial

Abdominal Aortic Aneurysm1 trial

Arrhythmia1 trial

Chronic Hepatitis1 trial

Aortic Stenosis1 trial

Insulin resistance1 trial

Shoulder pain1 trial

Renal Impairment1 trial

Hyperuricemia1 trial

Oral ulcer1 trial

Fibrosis1 trial

Acute Myocardial Infarction1 trial

Concentration1 trial

Behcet's Disease1 trial

Heart Disease1 trial

Rheumatoid Arthritis1 trial

Cerebral Amyloid Angiopathy1 trial

Chronic Coronary Syndromes1 trial

Atherosclerosis1 trial

Postpericardiotomy Syndrome1 trial

Baricitinib1 trial