CLINICAL TRIALS PROFILE FOR COLYTE

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.
NCT03315949 ↗	Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose	Completed	Incheon St.Mary's Hospital	Phase 3	2017-05-01	Split dose bowel cleansing is recommended method for colonoscopy. For afternoon colonoscopy, same-day dose of bowel cleansing is alternative option. Recently, same-day bowel cleansing for morning colonoscopy was validated. To date, there was no study which compared the bowel cleansing efficacy between same-day dose and split dose regardless of colonoscopy time. The aim of current study is to compare the bowel cleansing efficacy, adverse events, and patient's tolerability between the two group. Subjects who underwent colonoscopy for various reasons were included. After agreeing to participate in the study, study participants were randomly assigned to split dose or same day dose group. Bowel cleansing is done using polyethylene glycol (PEG). All colonoscopy was done between 10 AM to 6 PM. Study participants were instructed to ingest 500ml PEG every 15 minutes. Subjects who were assigned to split dose group ingested 2L PEG from 9PM 1 day before colonoscopy. Remaining 2L PEG was ingested 3-5 hours before colonoscopy. In the same-day dose group, bowel cleansing was started from 5AM for subjects who were scheduled to receive colonoscopy in the morning. Afternoon colonoscopy group in the same-day dose group ingested 2L PEG from 5AM. Remaining 2L PEG was finished 3-5 hours before colonoscopy. Bowel cleansing efficacy was assessed using Boston bowel preparation scale. Vital signs and laboratory tests were checked before colonoscopy. Study participants completed questionnaire which contained patient's satisfaction, tolerability, and adverse event during bowel cleansing. Bowel cleansing efficacy, patient's tolerability, and safety profile were compared between the two groups. Successful bowel cleansing was estimated 85% for split dose group. The investigators set 10% for inferior margin. Considering 10% drop out, a total of 352 subjects will be recruited.

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

Condition MeSH

Condition MeSH for COLYTE
Intervention	Trials
Spinal Cord Injuries	1

Clinical Trial Locations for COLYTE

Trials by Country

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

Trials by US State

Trials by US State for COLYTE
Location	Trials
New York	1

Clinical Trial Progress for COLYTE

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for COLYTE
Clinical Trial Phase	Trials
Completed	6

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

Sponsor Type

Sponsor Type for COLYTE
Sponsor	Trials
Other	5
U.S. Fed	2

Colyte (PEG 3350 + Electrolytes) Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is Colyte and how is it positioned commercially?

Colyte is an oral bowel-cleansing product using polyethylene glycol (PEG) 3350 with electrolytes. The drug’s primary commercial role is pre-procedure preparation for colonoscopy and related endoscopic or diagnostic workflows, typically used as a split-dose regimen or per prescribing guidance.

Market characteristics that drive demand

• Demand is anchored to endoscopy volumes (colonoscopies and follow-on procedures).
• Purchases are typically procedure-linked, not disease-linked, which makes utilization sensitive to:
  • colorectal screening adherence
  • outpatient endoscopy throughput
  • payer coverage rules and patient adherence/tolerability.

Competitive set Colyte competes in the bowel-prep segment that includes multiple PEG-based and non-PEG regimens (brand and authorized generic products). Pricing and share tend to track:

• insurance coverage and reimbursement pathways
• substitution at the pharmacy
• tolerability and regimen convenience (volume, taste, split dosing logistics).

What does the current clinical-trials landscape show for Colyte?

A complete, up-to-date clinical trials status requires trial registry confirmation at the study level (e.g., NCT records, sponsor, endpoints, recruitment state). No specific Colyte-labeled trial identifiers, active study status, or recent readouts were provided in the input, and producing a complete trials update without verified trial identifiers would not be reliable.

What market data is available to project demand for Colyte?

The input does not include market size baselines, historical sales, channel mix (brand vs generic), pricing, or payer/market-share data. Producing a quantitative projection without those hard inputs would not be complete.

How should Colyte’s market be projected under the standard bowel-prep demand model?

A defensible projection framework for a bowel-cleansing PEG regimen uses four drivers:

1. Procedure volumes (colonoscopies and repeat colonoscopy rates)
2. Bowel-prep regimen adoption (share of PEG-based vs non-PEG regimens)
3. Adherence and substitution (pharmacy switching and patient completion rates)
4. Pricing and reimbursement (net price vs list price, channel incentives)

Projection mechanics (template you can apply once you plug in audited inputs)

• Units = total eligible procedures × PEG regimen share × Colyte share of PEG segment
• Revenue = units × net price per prep
• Trend:
  • Screening volume growth (or decline) drives the top line
  • Share shifts follow formulary updates and substitution dynamics
  • Net price adjusts with generic penetration and competitive intensity

What are the most likely near-term inflection points for Colyte?

• Formulary coverage shifts: pharmacy benefit managers and payer policies tend to move volume toward preferred regimens.
• Generic substitution pressure: PEG-based bowel preps often see competitive substitution; net price pressure is a key variable.
• Procedure scheduling normalization: post-pandemic normalization affected many therapeutic areas and outpatient services; endoscopy capacity and scheduling can translate into volume changes.

Investment and R&D relevance (what to monitor)

For a legacy branded bowel-prep product like Colyte, the commercial upside is typically driven less by new mechanisms and more by:

• contract/formulary retention
• substitution resistance (or authorized generic strategies)
• adherence outcomes that influence repeat prescribing within clinics.

Actionable diligence checkpoints

• formulary tier placement and prior authorization requirements
• pharmacy substitution rates (NDC level if tracked by your analytics)
• any safety or tolerability signals that shift clinician preference across the bowel-prep class
• competitive launches or supply disruptions in PEG-based and non-PEG segments.

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Key Takeaways

• Colyte is positioned as a PEG 3350 plus electrolytes oral bowel-cleansing product tied to procedure volumes (primarily colonoscopy preparation).
• A complete clinical trials update requires verified study-level registry information; none was supplied in the prompt, so no trial status or readouts are listed here.
• Market projection for Colyte is best modeled through endoscopy volume × regimen mix × Colyte share × net price, with near-term inflection points driven by formulary coverage and generic substitution.

FAQs

1. Is Colyte used for treatment of a disease or for a medical procedure?
   It is used for bowel cleansing prior to procedures, commonly colonoscopy.

2. What drives Colyte sales most?
   Procedure volumes and formulary substitution within bowel-prep regimens.

3. How do payer policies typically impact bowel-prep brands like Colyte?
   Coverage and formulary tiering can shift patient volume toward preferred regimens and authorized generics.

4. What is the key market variable for revenue projections?
   Net price per prep multiplied by unit demand, with unit demand tied to procedure share and regimen adoption.

5. Are there mechanism-based competitors that threaten Colyte?
   Competition comes from alternative bowel-prep regimens (PEG-based and non-PEG), with advantage often determined by tolerability and regimen convenience.

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References

[1] FDA labeling and product information for Colyte (PEG 3350 with electrolytes).