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.
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.

Clinical Trial Conditions for COLYTE-FLAVORED

Condition Name

Condition Name for COLYTE-FLAVORED
Intervention	Trials
Bowel Preparation for Colonoscopy	1
Effectiveness of SMS to Fix PC Interval	1
Healthy Person	1
Spinal Cord Injury	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

Last updated: July 28, 2026

Colyte-flavored (Colyte) clinical trials update, market analysis, and exclusivity/patent-driven launch projections

Colyte-flavored is a flavor-branded variant name used for the polyethylene glycol 3350 (PEG 3350) plus electrolytes bowel-prep regimen marketed as a split-dose oral solution. As a non-prescription bowel cleansing product (OTC or Rx status depending on listing), its development footprint is dominated by formulation/labeling and manufacturing changes rather than new clinical development for new indications. A credible, data-backed “clinical trials update” and “market projection” requires itemized trial identifiers (NCT numbers), sponsor-level recruiting status, and FDA/Orange Book or NDA/ANDA/505(b)(2) linkage to the specific Colyte-flavored SKU. That information is not present in the prompt, and no complete, accurate update can be produced.

If “Colyte-flavored” instead refers to an investigational product or a different active ingredient combination under that label, the clinical-trials and IP landscape would change materially. Under the constraints here, no complete and accurate response is possible without the governing trial registry and regulatory identifiers.

What clinical trials exist for Colyte-flavored bowel prep, and what is the latest recruiting/status?

No NCT (ClinicalTrials.gov) or sponsor-specific trial mapping for “Colyte-flavored” is available in the prompt. A trials update must enumerate:

• NCT number, phase, sponsor, comparator
• endpoints (bowel cleansing scale, Boston Bowel Preparation Scale; adverse events)
• recruiting status and last update date
• geographic coverage and sample size

Without that mapping, any “update” would be speculative.

Which endpoints do Colyte PEG-electrolyte studies typically target?

For PEG plus electrolytes bowel preparation, studies generally target:

• adequacy of bowel cleansing (BBPS total score and segment scores)
• proportion with “excellent/good” cleansing
• tolerability (nausea, vomiting, abdominal pain)
• adherence to split-dose timing
• lab changes (electrolytes, renal function) in higher-risk cohorts

This is the standard set of endpoints, but it cannot be tied to “Colyte-flavored” specifically without trial records.

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What is the market size and growth outlook for Colyte-flavored (PEG-electrolyte bowel prep), by channel and geography?

A market analysis needs a defined product catalog (active ingredient, dosage form, branded vs generic status), and a source-backed market model (US vs ex-US, prescription vs OTC, GI clinic vs ambulatory surgery center channels). The prompt does not provide:

• country scope
• product identity (exact NDA/ANDA listing, strength, package size)
• competitive set (PEG-electrolyte brands and generics in that exact segment)
• whether “Colyte-flavored” is a distinct branded competitor or a flavor variant under an existing listing

Without those anchors, market numbers and projections cannot be produced accurately.

How do PEG-electrolyte bowel preps typically compete on price, substitutions, and formularies?

Competition usually clusters on:

• total volume and split-dose schedule adherence
• taste/flavor tolerance affecting patient completion
• packaging (split-dose kits, single-day vs two-day instructions)
• payer formulary positioning and pharmacy substitution
• pharmacy channel mix (mail order vs retail)

But “Colyte-flavored” positioning cannot be quantified without SKU and listing data.

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When does Colyte-flavored lose exclusivity, and what patents block generic or 505(b)(2) entry?

Exclusivity and blocking are determined by the controlling FDA marketing authorization:

• NDA/ANDA number for the PEG-electrolyte product
• Orange Book patent list (composition, formulation, method-of-use, packaging, manufacturing)
• FDA exclusivity periods (new chemical entity, new clinical investigations, pediatric, 505(b)(2 exclusivities)

The prompt provides no FDA application number or Orange Book listing for “Colyte-flavored,” so patent-expiration and launch timing cannot be computed.

What patent categories are most common for bowel-prep products?

For PEG-electrolyte bowel prep, patent activity (where present) tends to be in:

• flavor/taste masking compositions
• specific electrolyte concentrations or stabilization formulations
• manufacturing processes ensuring osmolarity, stability, or shelf-life
• instructions or patient-use devices (less common)

A “blocked vs unblocked” view requires the actual Orange Book record.

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What generic entry risks exist for Colyte-flavored, including Paragraph IV challenges?

Paragraph IV filing visibility requires:

• Orange Book patent list
• ANDA applicants referencing the exact patents
• litigation dockets and settlement dates (30-month stay, court rulings)

None of that linkage is provided.

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How strong is the patent estate for Colyte-flavored, and which companies hold the key filings?

Strength scoring (patent family breadth, remaining term, claim scope, litigation history) needs:

• patent numbers and assignees
• jurisdiction coverage
• maintenance status and terminal disclaimers
• enforcement and validity posture

No patent list is included.

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How does Colyte-flavored compare with Suprep, MoviPrep, or MiraLAX-based bowel regimens on clinical and commercial performance?

Comparative market modeling needs standardized inputs:

• dosing volume and tolerability metrics by regimen
• formulation and flavor differentiators
• brand vs generic price points
• payer and GI practice adoption rates

None of those inputs are present for Colyte-flavored.

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What is the FDA regulatory status of Colyte-flavored, and what is the likely development path for new formulations?

FDA status requires:

• NDA/ANDA type (NDA vs ANDA vs 505(b)(2))
• route (oral solution), dosage, labeling
• any recent supplements (CBE-30/changes to flavor, packaging, or manufacturing sites)
• FDA inspection history tied to manufacturing changes

Not provided.

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Commercial projection: base case, downside, and upside scenarios for Colyte-flavored

A projection model must specify:

• starting sales base (brand, flavor variant share, and volume)
• elasticity by channel
• generic substitution rates
• expected patent/exclusivity timeline and launch catalysts
• sensitivity to FDA enforcement actions or safety communications

No baseline, scope, or linkage to an exact product listing is provided, so no credible projection can be built.

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Key Takeaways

• A correct clinical-trials update and market projection for “Colyte-flavored” require binding to specific regulatory and trial identifiers (NCT numbers, FDA application and Orange Book listings).
• The prompt does not include those identifiers, so no complete, accurate update on trial status, exclusivity, patent blocking, or forecastable launch risk can be produced.

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FAQs

1. What PEG-electrolyte bowel prep trials use the Boston Bowel Preparation Scale (BBPS), and how do they differ from segment scoring?
2. How do flavor-masking formulation changes affect stability, tolerability, and FDA supplement pathways for PEG-electrolyte products?
3. What Orange Book patent categories most often show up for bowel prep drugs and impact generic substitution?
4. How do Paragraph IV ANDA challenges and 30-month stays typically work in the GI bowel preparation space?
5. What criteria do GI practices use to switch patients between PEG-electrolyte brands and generic alternatives?

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References

1. ClinicalTrials.gov. (n.d.). Database search results for bowel preparation and PEG-electrolyte trials. https://clinicaltrials.gov
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
3. U.S. Food and Drug Administration. (n.d.). Drug approvals and databases (NDA/ANDA/Supplements). https://www.fda.gov/drugs/drug-approvals-and-databases