CLINICAL TRIALS PROFILE FOR COLCRYS

All Clinical Trials for COLCRYS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01001052 ↗	Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions	Completed	Mutual Pharmaceutical Company, Inc.	Phase 1	2009-10-01	The purpose of this study is to evaluate and compare the relative bioavailability of a single dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young , healthy subjects 18-30 years of age compared to a group of older, generally healthy subjects 60 years of age or older following an overnight fast.
NCT01084278 ↗	Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)	Completed	Takeda	Phase 4	2010-05-01	The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of colchicine in healthy adults with normal renal function, in patients with mild, moderate or severe renal impairment, and in patients with end-stage renal disease on hemodialysis. An additional objective of this study is to study the clearance of colchicine and its metabolites by hemodialysis. Secondary objectives include evaluation of the safety and tolerability of colchicine in the study population.
NCT01112982 ↗	An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.	Completed	Takeda Pharmaceuticals North America, Inc.	Phase 4	2010-05-01	The purpose of this study is to show that patients with gout suffer from chronic inflammation of their joints, observable by MRI, even in the absence of symptomatic gouty attacks. Secondary end-points of this study will include analyzing the effects of uric acid-lowering therapy (specifically with the FDA approved medication Febuxostat) in a subgroup of patients, checking for the presence of inflammatory markers to see if there is any correlation with the proposed chronic inflammation, and evaluating for other characteristic findings of gout on MRI.
NCT01112982 ↗	An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.	Completed	University of South Florida	Phase 4	2010-05-01	The purpose of this study is to show that patients with gout suffer from chronic inflammation of their joints, observable by MRI, even in the absence of symptomatic gouty attacks. Secondary end-points of this study will include analyzing the effects of uric acid-lowering therapy (specifically with the FDA approved medication Febuxostat) in a subgroup of patients, checking for the presence of inflammatory markers to see if there is any correlation with the proposed chronic inflammation, and evaluating for other characteristic findings of gout on MRI.
NCT01123395 ↗	Bioavailability Study of Colcrys® in Apple Juice	Completed	Mutual Pharmaceutical Company, Inc.	Phase 1	2010-05-01	The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast.
NCT01130051 ↗	Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce	Completed	Mutual Pharmaceutical Company, Inc.	Phase 1	2010-05-01	The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1 tablespoon) relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. A secondary objective is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the study period.

Clinical Trial Conditions for COLCRYS

Condition Name

Condition Name for COLCRYS
Intervention	Trials
Coronary Artery Disease	5
Healthy	4
Atrial Fibrillation	3
Gout	3

Condition MeSH

Condition MeSH for COLCRYS
Intervention	Trials
Coronary Artery Disease	5
Myocardial Ischemia	5
Coronary Disease	5
COVID-19	4

Clinical Trial Locations for COLCRYS

Trials by Country

Trials by Country for COLCRYS
Location	Trials
United States	28
Canada	2
Egypt	1
Japan	1
Qatar	1

Trials by US State

Trials by US State for COLCRYS
Location	Trials
New York	5
California	4
Florida	3
Ohio	2
Maryland	2

Clinical Trial Progress for COLCRYS

Clinical Trial Phase

Clinical Trial Phase for COLCRYS
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for COLCRYS
Clinical Trial Phase	Trials
Completed	13
Recruiting	3
Active, not recruiting	2

Clinical Trial Sponsors for COLCRYS

Sponsor Name

Sponsor Name for COLCRYS
Sponsor	Trials
Mutual Pharmaceutical Company, Inc.	3
Takeda	3
National Heart, Lung, and Blood Institute (NHLBI)	2

Sponsor Type

Sponsor Type for COLCRYS
Sponsor	Trials
Other	23
Industry	9
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Colcrys (Colchicine)

Last updated: October 30, 2025

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Introduction

Colcrys (colchicine) is a long-established medication primarily used for the treatment and prevention of gout flares and familial Mediterranean fever (FMF). Despite its age, colchicine continues to attract interest due to emerging therapeutic indications and ongoing clinical research. This article provides a comprehensive update on clinical trial activities, analyzes the current market landscape, and projects future growth prospects for Colcrys.

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Clinical Trials Update

Ongoing and Recent Trials

Colchicine remains at the forefront of multiple clinical trials driven by its anti-inflammatory properties and potential expansion into novel therapeutic areas. Recent updates include:

• CARDIOLOGY: A promising phase III trial, COLCOT (Colchicine Cardiovascular Outcomes Trial), demonstrated a significant reduction in ischemic cardiovascular events among post-myocardial infarction patients taking colchicine 0.5 mg daily. Published results from this study bolster colchicine's role in secondary cardiovascular prevention, prompting further studies exploring its efficacy in broader cardiovascular populations.

• GOUT and Hyperuricemia: As the gold standard for gout management, colchicine continues to be evaluated in combination therapies to enhance efficacy and reduce adverse events. Trials such as PRICS explore optimized dosing schedules and safety in elderly populations, given the risk of gastrointestinal and neuromuscular side effects.

• NEW INDICATIONS:

  • COVID-19: Multiple studies investigated colchicine’s anti-inflammatory role in preventing cytokine storm and reducing hospitalization rates for COVID-19. The COLCORONA trial indicated a potential benefit when colchicine was used early in the infection, although regulatory agencies have urged cautious interpretation of these findings pending further validation.
  • Pericarditis: Clinical trials like the CORP-2 study evaluate colchicine as a first-line agent for recurrent pericarditis, showing promising reductions in relapse rates.

• Autoimmune and Neurodegenerative Disorders: Investigations are underway into colchicine’s neuroprotective properties for diseases such as multiple sclerosis (MS) and its role in modulating inflammatory responses in autoimmune conditions.

Regulatory Status and Approvals

While Colcrys is FDA-approved specifically for gout and FMF, investigators are actively seeking supplemental indications. The expanding evidence base may influence future regulatory decisions, especially as trials demonstrate broader safety and efficacy profiles.

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Market Analysis

Current Market Landscape

Despite being a generic medication with established usage, Colcrys commands significant revenue through prescription volume, especially in gout management. The global gout therapeutics market was valued at approximately USD 1.6 billion in 2022, projected to grow at a CAGR of about 4% through 2030, driven by increasing prevalence and awareness.

Regulatory and Competitive Environment

• Patent and Brand Status: Since its patent expiration in 2009, Colcrys has faced competition from generic colchicine formulations, leading to a decline in brand-name sales but increased market penetration due to cost competitiveness.

• Emerging Competition: Novel anti-inflammatory agents and biologics targeting gout and cardiovascular inflammation are emerging, potentially impacting Colcrys's market share. However, colchicine’s low cost and established safety profile sustain its prevalence in clinical practice.

• Market Segments:

  • Gout: Largest segment, with high prescription rates particularly among elderly and comorbid populations.
  • Familial Mediterranean Fever: Niche but stable, mainly in specialized centers.
  • COVID-19 and Cardiology: Emerging segments that could substantially expand market size if ongoing trials yield positive results.

Market Drivers

• Rising prevalence of gout due to lifestyle and dietary factors.
• Growing recognition of colchicine’s cardiovascular benefits.
• Increased clinical research into novel indications.

Market Constraints

• Safety concerns, particularly gastrointestinal and neuromuscular adverse effects.
• Competition from newer, targeted biologics and urate-lowering therapies.
• Regulatory challenges regarding new indications and post-market safety.

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Market Projection

Growth Outlook (2023–2030)

• The global colchicine market is expected to stabilize with moderate growth, primarily fueled by expanding indications, especially in cardiovascular and inflammatory diseases.
• The integration of colchicine into COVID-19 management protocols, contingent upon rigorous validation, could add a new revenue stream.

Key Factors Influencing Growth

• Positive Clinical Trial Outcomes: Demonstrating efficacy in cardiovascular events or autoimmune conditions can significantly propel demand.
• Regulatory Approvals: Expanded labeling for new indications will open further market segments.
• Pricing and Reimbursement: Cost-effectiveness relative to biologics and targeted therapies will influence prescribing patterns.

Forecasted Revenue

Based on current trends, the colchicine market size could reach USD 2.5 billion by 2030, with key contributions from cardiology and autoimmune indications. The growth rate may accelerate if colchicine secures approvals for expanded indications with high unmet needs.

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Strategic Opportunities

• Development Pipeline Expansion: Investment in clinical trials targeting cardiovascular, pericarditis, and autoimmune indications could diversify revenue sources.
• Regulatory Engagement: Proactive dialogue with authorities to seek supplemental indications can facilitate faster market access.
• Combination Therapies: Exploring colchicine’s role in combination regimens may enhance therapeutic efficacy and adoption.

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Challenges and Risks

• Side effect profiles might hinder patient tolerability and adherence.
• Competition from specialized biologic therapies with superior targeting.
• Regulatory hurdles in expanding indications, requiring robust clinical data.
• Pricing pressures inherent with generic drugs.

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Key Takeaways

• Clinical research is expanding: Notably, colchicine’s emerging cardiovascular and anti-inflammatory indications warrant close monitoring, as successful trial outcomes could redefine its market scope.
• Market remains solid but competitive: While generic colchicine maintains a significant base, competition and safety considerations influence prescribing behaviors.
• Opportunities for growth: Strategic investments into supplementary indications, particularly in cardiovascular disease and pericarditis, are critical for future expansion.
• Regulatory engagement is pivotal: Securing approvals for new indications can accelerate market growth and improve patient access.
• Healthcare trends favor cost-effective therapies: As the demand for affordable yet effective treatments increases, colchicine’s role is positioned to remain influential, especially if safety and efficacy profiles are optimized.

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FAQs

1. What are the primary therapeutic indications for Colcrys?
   Colcrys is FDA-approved for gout management and familial Mediterranean fever. Ongoing research explores its utility in cardiovascular disease, pericarditis, and potentially other inflammatory conditions.

2. How does colchicine compare to newer anti-inflammatory agents?
   Colchicine remains a cost-effective option with a well-established safety profile, but newer biologics and targeted therapies may offer superior tolerability or efficacy in specific populations, influencing its future role.

3. What are the main safety concerns associated with colchicine?
   Adverse effects include gastrointestinal upset, neuromuscular toxicity, and potential drug interactions, especially in patients with renal or hepatic impairment.

4. Is colchicine’s market growth expected to accelerate?
   Yes, if ongoing clinical trials validate new indications, regulatory approvals follow, and the drug demonstrates efficacy in larger populations, growth prospects will improve.

5. What challenges does Colcrys face in expanding its indications?
   Major challenges involve demonstrating safety and efficacy in new indications through rigorous clinical trials, navigating regulatory pathways, and addressing safety concerns that could limit broader utilization.

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References

1. Tardif JC, et al. (2019). Efficacy of Low-Dose Colchicine After Myocardial Infarction. New England Journal of Medicine, 381(26), 2497-2505.
2. Nidorf SM, et al. (2020). Colchicine in Patients with Chronic Coronary Disease. New England Journal of Medicine, 383(19), 1838-1847.
3. European Medicines Agency. (2022). Colchicine: Summary of Product Characteristics.
4. MarketWatch. (2022). Global Gout Therapeutics Market Size, Share & Trends.
5. FDA. (2022). Summary Basis of Approval for Colcrys.

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In conclusion, Colcrys’s future hinges on ongoing clinical validation and regulatory pathways that may unlock expanded therapeutic roles. Its established market presence provides a strong platform for leveraging new indications, especially if safety profiles are maintained and efficacy convincingly demonstrated.