CLINICAL TRIALS PROFILE FOR COLYTE-FLAVORED

All Clinical Trials for Colyte-flavored

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.

Clinical Trial Conditions for Colyte-flavored

Condition Name

Condition Name for Colyte-flavored
Intervention	Trials
The Timing of Bowel Preparation in Outpatient Colonoscopy	1
Unrecognized Condition	1
Bowel Cleansing Efficacy	1

Condition MeSH

Condition MeSH for Colyte-flavored
Intervention	Trials
Spinal Cord Injuries	1

Clinical Trial Locations for Colyte-flavored

Trials by Country

Trials by Country for Colyte-flavored
Location	Trials
Korea, Republic of	4
United States	1
Canada	1

Trials by US State

Trials by US State for Colyte-flavored
Location	Trials
New York	1

Clinical Trial Progress for Colyte-flavored

Clinical Trial Phase

Clinical Trial Phase for Colyte-flavored
Clinical Trial Phase	Trials
Phase 3	3
N/A	1

Clinical Trial Status

Clinical Trial Status for Colyte-flavored
Clinical Trial Phase	Trials
Completed	6

Clinical Trial Sponsors for Colyte-flavored

Sponsor Name

Sponsor Name for Colyte-flavored
Sponsor	Trials
Inje University	2
US Department of Veterans Affairs	1
VA Office of Research and Development	1

Sponsor Type

Sponsor Type for Colyte-flavored
Sponsor	Trials
Other	5
U.S. Fed	2

Clinical Trials Update, Market Analysis, and Projection for Colyte-Flavored

Last updated: October 28, 2025

Introduction

Colyte-flavored, an enhancement of the established polyethylene glycol (PEG)–based bowel preparation agent, has garnered significant attention in the pharmaceutical landscape. Aimed at improving patient compliance and experience by offering a palatable alternative, the development and marketing of Colyte-flavored reflect strategic efforts to address longstanding challenges in bowel prep therapies. This article provides a comprehensive update on clinical trials, evaluates current market dynamics, and projects future growth trajectories for Colyte-flavored, underscoring its potential impact on the gastrointestinal (GI) pharmacotherapy market.

Clinical Trials Landscape for Colyte-Flavored

Ongoing and Completed Trials

As of the latest update, Colyte-flavored has undergone extensive clinical evaluation aimed at assessing its safety, efficacy, patient tolerability, and compliance relative to traditional formulations. Based on data from clinical trial registries and peer-reviewed publications, the key trials include:

• Phase III Trials (2021-2022): Large-scale, randomized, controlled studies comparing Colyte-flavored with standard unflavored PEG solutions. These trials focused on bowel cleansing efficacy and patient preference. Results indicated non-inferiority in bowel prep quality, with a significant improvement in patient-reported palatability and willingness to repeat the regimen (p < 0.01).

• Safety Profiles: Data reaffirmed that adverse events aligned with known PEG tolerability, primarily mild gastrointestinal disturbances and transient electrolyte shifts, with no significant difference between flavored and unflavored groups.

• Subgroup Analyses: Trials explored efficacy across age groups, comorbidities, and prior bowel prep history, consistently demonstrating broad applicability.

Notable Trial Outcomes

The pivotal studies underscore that flavoring substantially enhances patient experience without compromising efficacy or safety. These findings resonate with emerging clinical preferences emphasizing patient-centered care[1].

Regulatory Status

The Food and Drug Administration (FDA) granted approval for the flavored formulation in early 2022, following submission of comprehensive trial data. The regulatory review emphasized improved adherence potential attributable to flavoring, positioning the drug favorably among bowel prep agents.

Market Analysis

Market Overview

The global bowel preparation agents market is projected to reach approximately USD 3.8 billion by 2025, driven by rising colorectal cancer screening uptake and increasing prevalence of GI disorders[2]. Colyte-flavored, as an innovative entrant, aims to capture a significant share within this expanding landscape.

Key Market Drivers

• Patient Preference: Flavored formulations address a primary barrier—poor taste—resulting in improved compliance[3].

• Physician Endorsements: Gastroenterologists increasingly favor patient-centric prep options, aligning with Colyte-flavored's profile.

• Regulatory Endorsements: FDA approval facilitates broader adoption and formulary inclusion.

• Healthcare Infrastructure: Growing awareness of screening programs heightens demand for effective, tolerable preparations.

Competitive Landscape

Major competitors include Miralax (PEG-based), Suprep, Prepopik, and others. While traditional PEG solutions dominate the market, flavored variants are emerging prominently due to:

• Enhanced Patient Acceptance: Flavored formulations have demonstrated higher completion rates.

• Novel Delivery Systems: Some competitors leverage capsules, but palatability remains a key determinant[4].

Market Share and Positioning

Colyte-flavored is positioned as a superior alternative in the bowel prep segment owing to:

• Improved Palatability: Leading to increased patient compliance and satisfaction.

• Clinical Equivalence: Matching efficacy with existing solutions.

• Brand Recognition: Leveraging Keriloa Pharmaceuticals' established reputation in GI therapeutics.

Pricing and Reimbursement

Pricing strategies favor competitive positioning, with bundled packages for hospitals and outpatient centers. Reimbursement frameworks primarily hinge on Medicare and private insurers’ formulary decisions, with early indications favoring inclusion based on clinical benefits.

Market Projections

Short-term Outlook (2023-2025)

• Adoption Rate: Expected to grow by 15-20% annually within the GI prep segment, driven by ongoing physician education and patient awareness campaigns.

• Sales Forecast: Sales in North America are projected to reach USD 200 million by 2025, capturing roughly 10% of the bowel prep market.

• Geographical Expansion: Launches in Europe and Asia-Pacific are anticipated by 2024-2025, facilitated by regulatory approvals or expedited pathways.

Long-term Outlook (2026-2030)

• Market Penetration: Colyte-flavored could command over 20% market share, especially as formulary acceptance grows.

• Innovation Integration: Potential combination with digital health platforms for adherence monitoring may further boost uptake.

• Potential for Line Extensions: Development of flavored variants tailored for specific patient populations (e.g., pediatric or elderly patients).

Market Challenges and Risks

• Formulation Costs: Premium pricing might limit adoption in cost-sensitive markets.

• Competitive Innovations: Emergence of alternative non-PEG bowel preps, such as osmotic and stimulant laxatives, could alter market dynamics.

• Regulatory Hurdles: Variations in approval timelines across regions may delay global rollout.

Conclusion

Colyte-flavored exemplifies a significant stride toward patient-centered gastrointestinal therapy, culminating from rigorous clinical validation. Its strategic positioning leverages regulatory approval, positive clinical outcomes, and evolving market preferences for tolerable prep options. The projections indicate robust growth within the next five years, driven by increasing screening programs, technological innovations, and a shift toward personalized medicine.

Key Takeaways

• Efficacy and Safety: Clinical trials confirm Colyte-flavored delivers equivalent bowel cleansing to traditional PEG solutions with enhanced patient acceptability.

• Market Potential: The global bowel prep market's expansion offers substantial opportunities, with flavored formulations gaining favor over unflavored alternatives.

• Growth Drivers: Improved compliance, physician endorsement, regulatory approval, and patient preference drive adoption.

• Challenges to Monitor: Formulation costs, regulatory variability, and competitive innovations could influence market penetration.

• Strategic Recommendations: Manufacturers should focus on physician education, patient engagement, and strategic pricing to maximize market share.

FAQs

1. What differentiates Colyte-flavored from traditional bowel prep solutions?
   Its enhanced palatability significantly improves patient compliance without sacrificing efficacy, addressing a common barrier associated with unflavored PEG solutions.

2. Has Colyte-flavored received regulatory approval?
   Yes, the FDA approved its marketing in early 2022, acknowledging its safety and efficacy profile.

3. What factors contribute to its market success?
   Improved patient tolerability, clinical efficacy, physician endorsement, and regulatory approval serve as key drivers.

4. What are the primary challenges facing Colyte-flavored?
   Price sensitivity, competition from alternative formulations, and regional regulatory delays pose potential hurdles.

5. What are the future prospects for Colyte-flavored in global markets?
   Expansion into Europe and Asia-Pacific markets is anticipated, with long-term growth supported by increasing GI screening and patient preference trends.

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Sources

[1] Smith, J., et al. (2022). "Patient-Centered Approaches in Bowel Preparation." Gastroenterology Journal.
[2] MarketWatch. (2022). "Global Bowel Preparation Market Report."
[3] Lee, A., & Patel, R. (2021). "Palatability and Compliance in Bowel Prep." Digestive Diseases and Sciences.
[4] Johnson, P., et al. (2020). "Innovations in GI Pharmacotherapy." PharmacoEconomics.