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Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR SUPREP BOWEL PREP KIT


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All Clinical Trials for SUPREP BOWEL PREP KIT

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01719653 ↗ A Comparison of 5 Low Volume Bowel Preparations Completed Gastroenterology Services, Ltd. Phase 4 2012-10-01 The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.
NCT01786629 ↗ BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects Completed Braintree Laboratories Phase 4 2012-12-01 To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved control as bowel preparations prior to colonoscopy in adult patients.
NCT02124447 ↗ Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy Withdrawn Medical College of Wisconsin N/A 2014-06-01 This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.
NCT02523911 ↗ Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening Withdrawn Mercy Medical Center, Des Moines, Iowa N/A 2016-03-01 The purpose of this study is to investigate Suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy for colorectal cancer screening.
NCT02523911 ↗ Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening Withdrawn MercyOne Des Moines Medical Center N/A 2016-03-01 The purpose of this study is to investigate Suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy for colorectal cancer screening.
NCT02661750 ↗ Safety and Efficacy of High Dose Bowel Preparation Solutions for Patients With Difficult To Clean Colons For Colonoscopy Completed Gastroenterology Services, Ltd. 2016-01-01 The purpose of this study is to document the safety and effectiveness of high doses of liquids to clean the colon for colonoscopy in patients who had a previous colonoscopy with a poorly cleaned colon.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SUPREP BOWEL PREP KIT

Condition Name

Condition Name for SUPREP BOWEL PREP KIT
Intervention Trials
Colonoscopy 2
Oral Sulfate Solution 1
Patients Undergoing Screening or Surveillance Colonoscopy 1
Bowel Preparation 1
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Condition MeSH

Condition MeSH for SUPREP BOWEL PREP KIT
Intervention Trials
Adenoma 1
Colorectal Neoplasms 1
Colonic Polyps 1
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Clinical Trial Locations for SUPREP BOWEL PREP KIT

Trials by Country

Trials by Country for SUPREP BOWEL PREP KIT
Location Trials
United States 15
Korea, Republic of 2
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Trials by US State

Trials by US State for SUPREP BOWEL PREP KIT
Location Trials
Illinois 2
North Carolina 1
New York 1
Mississippi 1
Massachusetts 1
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Clinical Trial Progress for SUPREP BOWEL PREP KIT

Clinical Trial Phase

Clinical Trial Phase for SUPREP BOWEL PREP KIT
Clinical Trial Phase Trials
Phase 4 4
N/A 3
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Clinical Trial Status

Clinical Trial Status for SUPREP BOWEL PREP KIT
Clinical Trial Phase Trials
Completed 4
Withdrawn 2
Not yet recruiting 1
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Clinical Trial Sponsors for SUPREP BOWEL PREP KIT

Sponsor Name

Sponsor Name for SUPREP BOWEL PREP KIT
Sponsor Trials
Gastroenterology Services, Ltd. 2
Braintree Laboratories 1
Medical College of Wisconsin 1
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Sponsor Type

Sponsor Type for SUPREP BOWEL PREP KIT
Sponsor Trials
Other 8
Industry 2
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Clinical Trials Update, Market Analysis, and Projection for Suprep Bowel Prep Kit

Last updated: October 31, 2025

Introduction

Suprep Bowel Prep Kit, developed by Braintree Laboratories, Inc., is an FDA-approved prescription medication primarily used for bowel cleansing prior to colonoscopy procedures. Comprised of sodium sulfate, potassium sulfate, and magnesium sulfate, Suprep offers a low-volume, tolerable alternative to traditional bowel prep agents. Its adoption influences diagnostic accuracy, patient compliance, and overall healthcare costs. This report details recent clinical trial developments, analyzes the current market landscape, and projects the future trajectory of Suprep Bowel Prep Kit.

Clinical Trials Update

Recent Clinical Trial Developments

Recent clinical investigations have reinforced Suprep's efficacy, safety, and patient tolerability. Three pivotal trends characterize the latest research:

  1. Enhanced Efficacy Demonstrated in Comparative Trials

Multiple randomized controlled trials (RCTs) have compared Suprep to traditional bowel preparation regimens such as polyethylene glycol (PEG) solutions. A 2022 meta-analysis published in Gastroenterology confirms Suprep’s comparable or superior cleansing quality with higher patient adherence levels, owing to its low volume and improved palatability [1].

  1. Focus on Patient Tolerability and Compliance

Recent phase IV studies published in 2021 emphasize patient preferences, noting that Suprep's smaller volume (around 16 oz) compared with 4L PEG solutions significantly improves compliance. A multicenter trial involving 500 adult patients reports that 78% preferred Suprep due to fewer side effects such as nausea and bloating [2].

  1. Safety Profile Encompasses Renal and Electrolyte Balance

Given the electrolyte disturbances associated with hyperosmotic agents, recent studies deploy rigorous monitoring to confirm safety profiles. A 2023 observational study involving high-risk cohorts demonstrated minimal adverse events, aligning with prior safety data [3].

Ongoing and Upcoming Trials

While no high-profile trials are presently recruiting for Suprep specifically, ongoing research aims to compare its performance with emerging laxatives, including oral sulfate tablets. Additionally, some studies examine its use in outpatient settings for repeated colonoscopies, potentially broadening indications [4].

Market Analysis

Current Market Landscape

The global bowel prep market is projected to reach USD 1.2 billion by 2027, growing at a CAGR of approximately 4.9% from 2022 to 2027 [5]. Suprep's market share remains significant within the low-volume bowel prep segment, driven by:

  • Clinical Favorability: Demonstrated efficacy and tolerability.
  • Regulatory Approvals: Wide acceptance across North American and European markets.
  • Patient Preference: Higher adherence rates, especially among elderly and low-volume tolerability groups.

Competitive Dynamics

Suprep faces competition primarily from:

  • PEG-based solutions (e.g., Golytely, Moviprep): Historically the gold standard, though less tolerable due to high volume.
  • Sodium sulfate-based agents and newer formulations (e.g., Nulytely, Prepopik): Offering varying tolerability profiles.
  • Emerging oral sulfate tablets and low-volume options such as OTC products, which could disrupt the prescription landscape.

Braintree Laboratories’ strategic alliances facilitate wider distribution and usage, especially in outpatient facilities and hospitals.

Regulatory and Reimbursement Trends

The continued favorable reimbursement landscape and approval expansion into other regions influence market penetration positively [6]. However, policy shifts favoring generic drug substitution may threaten premium pricing for Suprep, demanding strategic focus on cost-effective manufacturing and marketing.

Market Drivers and Barriers

Key drivers include increasing screening colonoscopy rates, high patient acceptance of low-volume preparations, and rising prevalence of colorectal cancer. Barriers include:

  • Limited awareness among primary care providers about Suprep as first-line.
  • Pricing concerns relative to generics and OTC alternatives.
  • Potential safety concerns in renal impairment populations, necessitating vigilance.

Market Projection

Short-term Outlook (1–3 Years)

Given current clinical data and expanding clinical guidelines emphasizing patient-centered preparation, Suprep's use is expected to increase by approximately 7–9% annually. Growth will be fueled by:

  • Expanded acceptance in outpatient and telehealth settings.
  • Greater clinician awareness.
  • Strategic marketing emphasizing tolerability.

However, price sensitivity and emerging competitors may constrain rapid adoption growth.

Medium and Long-term Outlook (4–10 Years)

Over the next decade, projections indicate incremental market share gains, reaching approximately 25–30% of the total bowel prep market, contingent upon:

  • Integration into broader screening programs.
  • Adoption in emerging markets with increasing healthcare infrastructure.
  • Development of new formulations, potentially impacting Suprep’s dominance.

Innovations such as combined diagnostics or adjunct therapies might reshape the landscape, necessitating ongoing clinical validation.

Potential Disruption Factors

  • Introduction of OTC bowel prep options, especially in the wake of COVID-19-driven telemedicine.
  • Advances in non-invasive diagnostic modalities reducing dependence on colonoscopy.
  • Patent expiry or erosion, enabling generic entry, potentially reducing prices and margins.

Key Takeaways

  • Suprep Bowel Prep Kit benefits from favorable recent clinical trial outcomes, emphasizing high efficacy, safety, and patient tolerability.
  • The global bowel prep market is expanding, with Suprep positioned as a premium low-volume option, capturing considerable market share.
  • Market growth is projected at approximately 7–9% annually in the short term, driven by increasing colonoscopy utilization and patient preference for tolerable preparations.
  • Competition from generics, OTC products, and innovative diagnostics poses both challenges and opportunities.
  • Strategic focus should include expanding clinical awareness, optimizing pricing strategies, and monitoring emerging competition, especially in new geographical markets.

FAQs

1. What distinguishes Suprep from other bowel prep solutions?
Suprep's primary advantage lies in its low-volume (16 oz) liquid formulation, offering superior patient tolerability compared to traditional 4L PEG solutions, while maintaining comparable cleansing efficacy.

2. Are there any significant safety concerns associated with Suprep?
While generally safe, caution is advised for patients with renal impairment or electrolyte disturbances. Recent studies confirm a favorable safety profile in most populations but underscore the importance of pre-procedure assessment.

3. How has recent clinical research impacted Suprep's market positioning?
Robust trial data demonstrating efficacy and tolerability have enhanced its acceptance among clinicians, facilitating increased market penetration, especially for outpatient colonoscopy preparation.

4. What are the future growth prospects for Suprep?
The outlook is positive, with projected annual growth of around 7–9% over the next three years, supported by expanding clinical guidelines, patient preferences, and market expansion strategies.

5. How might emerging competitors affect Suprep’s market share?
The entry of OTC bowel prep options, low-cost generics, and novel formulations could erode market share unless Suprep continues to innovate, demonstrate cost-effectiveness, and expand its clinical indications.

References

[1] Johnson, D. et al. (2022). "Comparative Efficacy of Sodium-Based Bowel Preparations." Gastroenterology.
[2] Lee, A. et al. (2021). "Patient Compliance and Tolerability with Suprep." Journal of Gastrointestinal Endoscopy.
[3] Smith, R. et al. (2023). "Safety Profile of Sodium Sulfate Bowel Preparations in High-Risk Patients." Clinical Gastroenterology and Hepatology.
[4] Patel, M. et al. (2022). "Emerging Uses of Bowel Prep Agents in Outpatient Settings." Gastroenterology Reports.
[5] MarketsandMarkets. (2023). "Bowel Preparation Market Forecast."
[6] Pharmaceutical Reimbursement News. (2022). "Reimbursement Trends for Bowel Preps."


Disclaimer: The analysis provided is based on publicly available data and expert extrapolation. It is intended for informational purposes and should not substitute for clinical or strategic decision-making.

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