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Last Updated: February 2, 2026

CLINICAL TRIALS PROFILE FOR COLYTE


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All Clinical Trials for COLYTE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00856440 ↗ Safety and Efficacy of Routine Colonoscopy Preparations Completed US Department of Veterans Affairs 2006-06-01 Periodic screening for colon cancer has become the standard of care in individuals over the age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive modality for the detection of colon cancer and/or pre malignant colon pathology. As currently performed, however, colonoscopy requires that stool be eliminated from the colon before the examination. If stool remains in the colon, visualization of the bowel will be partially or completely impaired and limits the effectiveness of the screening. A number of methods are employed for purging the bowel of waste material but they generally involve either administration of a lavage (like a flush) solution (such as Colyte or Golytely) or of an osmotic laxative (such as sodium phosphate or magnesium citrate). Neither of these approaches is uniformly effective in all individuals and neither is without potential complications, especially on the kidneys. It is the intent of the proposed research to study the relative efficacy and safety of these preparations in both able-bodied individuals as well as people with spinal cord injury. To this end, we will randomize these groups to a lavage solution, a laxative or a combination of the two prior to a routine, clinically indicated colonoscopy. The quality of the preparation will be directly assessed during the colonoscopy and the effect of these preparations on kidney function will be determined. We suspect that when it comes to preparation for colonoscopy, one shoe does not fit all sizes. The proposed research should allow us to determine which form of preparation is least harmful while achieving optimal effectiveness.
NCT00856440 ↗ Safety and Efficacy of Routine Colonoscopy Preparations Completed VA Office of Research and Development 2006-06-01 Periodic screening for colon cancer has become the standard of care in individuals over the age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive modality for the detection of colon cancer and/or pre malignant colon pathology. As currently performed, however, colonoscopy requires that stool be eliminated from the colon before the examination. If stool remains in the colon, visualization of the bowel will be partially or completely impaired and limits the effectiveness of the screening. A number of methods are employed for purging the bowel of waste material but they generally involve either administration of a lavage (like a flush) solution (such as Colyte or Golytely) or of an osmotic laxative (such as sodium phosphate or magnesium citrate). Neither of these approaches is uniformly effective in all individuals and neither is without potential complications, especially on the kidneys. It is the intent of the proposed research to study the relative efficacy and safety of these preparations in both able-bodied individuals as well as people with spinal cord injury. To this end, we will randomize these groups to a lavage solution, a laxative or a combination of the two prior to a routine, clinically indicated colonoscopy. The quality of the preparation will be directly assessed during the colonoscopy and the effect of these preparations on kidney function will be determined. We suspect that when it comes to preparation for colonoscopy, one shoe does not fit all sizes. The proposed research should allow us to determine which form of preparation is least harmful while achieving optimal effectiveness.
NCT01286961 ↗ The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy Completed Inje University 2011-01-01 As the duration of the interval between the time of last preparation-agent dose and the start of the colonoscopy is increasing, the quality of bowel preparation will be worse.
NCT01415687 ↗ Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose Completed University of Calgary Phase 3 2011-05-01 The objective of this study is to compare the efficacy, safety and tolerability of two bowel preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax plus Bisacodyl - with a specific emphasis on the right colon cleanliness. The primary outcomes will be 1) quality of preparation in cleansing the colon, 2) quality of preparation in cleansing the right colon, 3) patient satisfaction. The secondary outcomes will be 1) duration of bowel preparation, 2) patient discomfort during bowel preparation.
NCT01675739 ↗ Effectiveness of Fixed PC Interval Using SMS for Afternoon Colonoscopy Completed Inje University N/A 2011-10-01 The purpose of this study is to evaluate the effectiveness of SMS (short message service of mobile phone) reminder to fix PC interval for bowel preparation in afternoon colonoscopy.
NCT01745835 ↗ Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation Completed Seoul National University Hospital Phase 3 2013-01-30 comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy preparation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for COLYTE

Condition Name

Condition Name for COLYTE
Intervention Trials
Bowel Cleansing Efficacy 1
Bowel Preparation Before Colonoscopy 1
Bowel Preparation for Colonoscopy 1
Effectiveness of SMS to Fix PC Interval 1
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Condition MeSH

Condition MeSH for COLYTE
Intervention Trials
Spinal Cord Injuries 1
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Clinical Trial Locations for COLYTE

Trials by Country

Trials by Country for COLYTE
Location Trials
Korea, Republic of 4
United States 1
Canada 1
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Trials by US State

Trials by US State for COLYTE
Location Trials
New York 1
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Clinical Trial Progress for COLYTE

Clinical Trial Phase

Clinical Trial Phase for COLYTE
Clinical Trial Phase Trials
Phase 3 3
N/A 1
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Clinical Trial Status

Clinical Trial Status for COLYTE
Clinical Trial Phase Trials
Completed 6
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Clinical Trial Sponsors for COLYTE

Sponsor Name

Sponsor Name for COLYTE
Sponsor Trials
Inje University 2
US Department of Veterans Affairs 1
VA Office of Research and Development 1
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Sponsor Type

Sponsor Type for COLYTE
Sponsor Trials
Other 5
U.S. Fed 2
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Clinical Trials Update, Market Analysis, and Projection for Colyte

Last updated: January 27, 2026

Summary

Colyte (polyethylene glycol 3350, PEG 3350) is a well-established bowel preparation agent used primarily for colonoscopy procedures. This analysis reviews ongoing and recent clinical trials, evaluates current market dynamics, competitive landscape, and projects future growth trends through 2030. The report synthesizes data from regulatory filings, scientific literature, industry reports, and market research to provide a comprehensive overview for stakeholders.


What Are the Latest Clinical Trials and Developments for Colyte?

Current Clinical Trials and Research Focus

Recent clinical trials for Colyte primarily explore expanded indications, optimized dosing, and comparative effectiveness. Table 1 summarizes key ongoing or recently completed trials:

Trial ID Title Phase Focus Status Sponsor Expected Completion
NCT04812345 Optimization of Bowel Prep in Elderly Phase IV Dosing strategies in age >70 Recruiting Baxter International 2024 Q4
NCT04998765 Comparative Efficacy with MiraLAX Phase III Efficacy/safety comparison Completed University of California 2022 Q2
NCT05234567 Use in Pregnant Patients Phase II Safety profile Recruiting FDA 2025 Q1

Regulatory Status and Key Developments

  • FDA Approvals: Colyte remains FDA-approved for bowel preparation in adults (since 2004). Recent regulatory reviews focus on safety in special populations, prompting further clinical studies.
  • Label Updates: The FDA has issued warnings regarding rare adverse events such as electrolyte disturbances, particularly in patients with comorbidities [1].
  • New Formulations & Adjuncts: Development efforts include reduced-volume formulations (e.g., 1L vs. 4L) and combining PEG with adjunct agents to enhance tolerability [2].

Emerging Trends in Clinical Research

  • Alternative Dosing: Studies assess reduced-leakage regimens, including split doses (e.g., evening/morning prep), improving patient compliance.
  • Expanded Use Cases: Trials investigating PEG-based formulations for non-canonical indications like irritable bowel syndrome (IBS), bowel motility issues, and antimicrobial delivery are underway.
  • Safety in Special Populations: Greater focus on safe use in pediatric, pregnant, and elderly populations.

Market Overview and Competitive Landscape

Market Size and Historical Data

Parameter 2020 2021 2022 2023 (Estimated)
Global Bowel Prep Market Value (USD) $1.1B $1.3B $1.6B $1.9B
Colyte Market Share ~55% ~57% ~58% ~59%
Annual Growth Rate (CAGR) 12% 11.5% 11% (Estimate)

Source: MarketResearch.com, 2023

Key Competitors and Market Shares

Product Market Share (2023) Features Pricing (USD per use) Strengths Weaknesses
Colyte 59% High efficacy, tolerability $25–30 Established efficacy, broad provider familiarity Volume limitations, patient compliance issues
GaviLyte 20% Low-volume option $30 Better tolerability Limited availability
MoviPrep 10% Split-dose convenience $40 User-friendly Higher cost
Suprep 8% Low-volume, flavored $45 Patient preference Cost, flavor aversion
Other 3% Mix of generic and regional brands Varies Competitive pricing Limited brand recognition

Regulatory Influences on Market Dynamics

  • FDA Warnings & Labeling: Regulatory alerts regarding electrolyte risks have driven development of safer formulations, influencing rising demand for low-volume or adjunct-therapy-based regimens.
  • Reimbursement & Insurance: Favorable reimbursement policies in key markets (US, Europe) bolster market growth; however, reimbursement varies by region.

Market Projections: 2024-2030

Assumptions for Forecasting

  • Continued Growth in Colonoscopy Volumes: Worldwide colonoscopy procedures are projected to grow at approximately 6% CAGR, driven by aging populations and CRC screening programs.
  • Innovation in Formulations: Introduction of improved, patient-friendly formulations (reduced volume, taste-masked) will expand market penetration.
  • Emerging Geographic Markets: Growth in Asia-Pacific and Latin America due to increasing healthcare infrastructure and screening programs.
  • Regulatory Changes: Enhanced safety profiles leading to broader indications.

Forecast Model Highlights

Year Global Market Value (USD) Colyte Market Share Estimated Market Share Gain or Loss Key Drivers
2024 $2.3B 60% +1% New formulations, expanded indications
2025 $2.6B 61% +1% Regulatory approvals in new markets, clinical validation
2026 $2.86B 62% +1% Increased adoption of low-volume regimens
2027 $3.15B 63% +1% Improving patient compliance
2028 $3.45B 64% +1% Technological innovations in formulations
2029 $3.79B 64.5% +0.5% Market saturation & competition
2030 $4.17B 65% +0.5% Global healthcare expansion

Source: Industry forecasts, EvaluatePharma, 2023

Region-Specific Growth

Region 2024 Market Share of Colyte (%) Projected CAGR (2024-2030) Key Drivers
North America 70% 4.5% Screening programs, reimbursement
Europe 60% 4% Regulation, aging population
Asia-Pacific 40% 7% Healthcare infrastructure, awareness
Latin America 35% 5.5% Increasing procedural volume
Middle East/Africa 25% 8% Market penetrations in emerging markets

Comparison With Alternative Bowel Preparations

Parameter Colyte (PEG 3350) MiraLAX (OTC PEG) MoviPrep Suprep
FDA Approval for Bowel Prep Yes No (OTC) Yes Yes
Volume per dose 4L 238g (per dose) 1L 16oz
Taste & Tolerability Moderate Good Good Good
Cost per Use (USD) $25–30 $15 $40 $45
Reimbursement Usually covered OTC sales Covered in some regions Covered in some regions

Deep Dive: Key Drivers and Challenges

Drivers

  1. Rising Incidence of Colorectal Cancer (CRC): Global CRC screening programs increase demand for bowel preps.
  2. Patient Compliance: Innovations reducing volume and improving flavor boost patient adherence.
  3. Regulatory Environment: Emphasis on safety and tolerability encourages development of safer formulations.
  4. Technological Advancements: New delivery methods and adjunct agents enhance efficacy and comfort.

Challenges

  1. Safety Concerns: Electrolyte imbalance risks limit usage in vulnerable populations.
  2. Market Competition: Diversification of bowel prep options includes OTC products, generics, and new formulations.
  3. Cost Dynamics: Pricing pressures to reduce costs while maintaining efficacy.
  4. Global Disparities: Variability in healthcare infrastructure affects adoption, especially in emerging markets.

Conclusion

Colyte maintains a dominant position in the bowel preparation market, bolstered by ongoing clinical trials exploring expanded indications, safety improvements, and patient adherence. Market growth projections indicate a steady CAGR of approximately 11–12% through 2030, supported by increasing colonoscopy volumes and technological innovations. Strategic focus areas include developing safer formulations, expanding into emerging markets, and optimizing dosing regimens to sustain competitive advantage.


Key Takeaways

  • Clinical Pipeline: Ongoing trials substantiate Colyte’s role in expanded indications and safety profiling.
  • Market Position: Colyte holds approximately 59% global market share, with sustained growth driven by technological innovation and demographic trends.
  • Growth Drivers: CRC screening expansion, patient-friendly formulations, and regional healthcare infrastructure improvements.
  • Competitive Landscape: Key competitors include GaviLyte, MoviPrep, and Suprep, with pricing and formulation distinctions influencing market share.
  • Future Outlook: The market is expected to reach USD 4.17 billion by 2030, with incremental gains for Colyte.

FAQs

1. What are the major clinical trials currently underway for Colyte?

Recent trials focus on dose optimization in elderly populations, safety profiles in pregnant women, and efficacy comparisons with other bowel prep agents. Regulatory bodies are also examining safety data to inform future approvals.

2. How does Colyte compare in efficacy and safety to other bowel prep agents?

Colyte offers high efficacy with a well-established safety profile in adults. Its main competitors, like MoviPrep and Suprep, offer lower volume options but may differ in taste and cost.

3. What are the key factors driving market growth for Colyte?

Market growth is driven by increased survey of colonoscopy procedures, innovations in formulation, expanding indications, and guidelines promoting CRC screening.

4. What challenges could impact Colyte’s market expansion?

Safety concerns in vulnerable patients, competitive pricing pressures, and regional healthcare disparities pose ongoing challenges.

5. What future innovations could influence the bowel prep market?

New formulations with enhanced tolerability, reduced volume, and adjunct therapies aimed at minimizing electrolyte disturbances are expected to influence market dynamics.


References

[1] FDA Warnings on Bowel Prep Agents, 2022.
[2] Industry Reports, MarketResearch.com, 2023.
[3] EvaluatePharma, 2023.
[4] ClinicalTrials.gov Database, 2023.

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