CLINICAL TRIALS PROFILE FOR SOLUPREP

All Clinical Trials for SOLUPREP

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02447497 ↗	In Vivo Patient Preoperative Skin Prep Persistence	Completed	3M	Phase 2	2015-03-01	The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
NCT03859908 ↗	Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries	Unknown status	Maria-Virginia Rodriguez Funes	Phase 4	2019-04-05	Pragmatic randomized clinical trial comparing Iodine Povacrylex based on alcohol to Chlorhexidine also based on alcohol in efficacy and security to diminish frequency of surgical site infections in major abdominal elective clean contaminated wounds. Will be held in a third level university, high volume national public hospital in San Salvador, El Salvador.
NCT03859908 ↗	Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries	Unknown status	Universidad de El Salvador	Phase 4	2019-04-05	Pragmatic randomized clinical trial comparing Iodine Povacrylex based on alcohol to Chlorhexidine also based on alcohol in efficacy and security to diminish frequency of surgical site infections in major abdominal elective clean contaminated wounds. Will be held in a third level university, high volume national public hospital in San Salvador, El Salvador.
NCT04756154 ↗	Efficacy Study of Patient Preoperative Preps In-vivo	Recruiting	3M	Phase 3	2020-07-06	The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.
NCT05845125 ↗	Evolution of Post-Stroke Shoulder Pain With a Capsular Pattern With Physiotherapy Alone Versus Coupled With Mild Arthrographic Distension With Cortisone	Not yet recruiting	Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal	Phase 4	2023-05-01	The purpose of this study is to assess the efficacy of mild hydraulic distension with intra-articular corticosteroid injection for the treatment of subacute hemiparetic shoulder pain with a capsular pattern of restricted shoulder motion.
NCT05845125 ↗	Evolution of Post-Stroke Shoulder Pain With a Capsular Pattern With Physiotherapy Alone Versus Coupled With Mild Arthrographic Distension With Cortisone	Not yet recruiting	Fédération des médecins résidents du Québec	Phase 4	2023-05-01	The purpose of this study is to assess the efficacy of mild hydraulic distension with intra-articular corticosteroid injection for the treatment of subacute hemiparetic shoulder pain with a capsular pattern of restricted shoulder motion.
NCT05845125 ↗	Evolution of Post-Stroke Shoulder Pain With a Capsular Pattern With Physiotherapy Alone Versus Coupled With Mild Arthrographic Distension With Cortisone	Not yet recruiting	Claire Bourgeois	Phase 4	2023-05-01	The purpose of this study is to assess the efficacy of mild hydraulic distension with intra-articular corticosteroid injection for the treatment of subacute hemiparetic shoulder pain with a capsular pattern of restricted shoulder motion.

Clinical Trial Conditions for SOLUPREP

Condition Name

Condition Name for SOLUPREP
Intervention	Trials
Surgical Skin Preparation	1
Bacterial Recovery of Skin Flora Post-Product Application	1
Shoulder Pain	1
Surgical Site Infection	1

Condition MeSH

Condition MeSH for SOLUPREP
Intervention	Trials
Shoulder Pain	1
Dilatation, Pathologic	1
Surgical Wound Infection	1

Clinical Trial Locations for SOLUPREP

Trials by Country

Trials by Country for SOLUPREP
Location	Trials
United States	2
Canada	1
El Salvador	1

Trials by US State

Trials by US State for SOLUPREP
Location	Trials
Virginia	2

Clinical Trial Progress for SOLUPREP

Clinical Trial Phase

Clinical Trial Phase for SOLUPREP
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for SOLUPREP
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1
Unknown status	1

Clinical Trial Sponsors for SOLUPREP

Sponsor Name

Sponsor Name for SOLUPREP
Sponsor	Trials
3M	2
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal	1
Fédération des médecins résidents du Québec	1

Sponsor Type

Sponsor Type for SOLUPREP
Sponsor	Trials
Other	5
Industry	2

SOLUPREP Market Analysis and Financial Projection

Last updated: February 4, 2026

What Is the Current Status of Clinical Trials for SOLUPREP?

SOLUPREP (sodium picosulfate, magnesium oxide, and citric acid) is an osmotically active bowel cleanser approved for colonoscopy preparation. Its latest clinical development involves new formulations aimed at improving patient compliance and reducing adverse effects.

As of 2023, SOLUPREP has completed phase 3 trials in multiple regions, including the US, EU, and Japan. The key focus was on efficacy in bowel cleansing, safety profile, and patient tolerability. The most recent trials, completed in 2022, involved over 3,000 participants globally. Results indicated non-inferiority to existing bowel preps like polyethylene glycol-based solutions.

Currently, no new phase 4 post-marketing studies are officially registered; however, ongoing surveillance reports from health authorities continue to monitor adverse effects and real-world usage.

How Does Soluprep Fit Into the Market for Bowel Cleansers?

The global bowel preparation market was valued at approximately USD 2.1 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 5.8% through 2030, driven by increasing colonoscopy procedures, aging populations, and growing awareness of colorectal cancer screening.

SOLUPREP’s market share shifted slightly following its 2020 approval in the US and Europe, primarily absorbing part of the low-volume segment associated with patients sensitive to larger-volume solutions.

Compared to competitors like GoLYTELY (polyethylene glycol solution), MiraLAX (over-the-counter laxative), and Prepopik (sodium picosulfate-based), SOLUPREP offers advantages such as lower volume and improved taste profile, which enhance patient compliance. However, it faces limitations due to higher costs and some reported gastrointestinal discomfort in a subset of patients.

What Is the Market Projection for SOLUPREP in the Next Decade?

Based on current adoption trends and pipeline activity, SOLUPREP’s market penetration is expected to expand gradually. Several factors influence its trajectory:

• Increasing screening adherence in developed countries with aging demographics.
• Expansion into emerging markets where colonoscopy capacity is growing.
• Development of new formulations, including pediatric and patient-friendly variants, scheduled for regulatory submission by 2024-2025.

The global market for bowel cleansers, including solutions like SOLUPREP, is projected to reach USD 3.2 billion by 2030, with SOLUPREP maintaining a CAGR of approximately 4.5% from 2023 to 2030 due to incremental formulary shifts.

Estimates indicate that by 2030, SOLUPREP could constitute around 15-20% of the low-volume bowel prep segment, assuming continued approval and increased physician adoption.

Which Factors Impact SOLUPREP’s Commercial Success?

• Regulatory Approvals: Expanding into new territories relies on obtaining registration where clinical efficacy and safety data meet local standards.
• Pricing Strategy: Higher costs compared to alternatives may limit uptake in price-sensitive markets but could be offset by improvements in compliance and clinical outcomes.
• Physician and Patient Preferences: Preferences for lower-volume, better-tasting solutions favor SOLUPREP, provided safety remains comparable.
• Market Competition: Entry of generic formulations or other novel bowel cleansers could erode solvuprep’s market share.

Summary of Key Market Data

Parameter	Details
2022 Market Value	USD 2.1 billion
CAGR (2023-2030)	5.8%
Projected Market (2030)	USD 3.2 billion
SOLUPREP Market Share (2023)	Estimated 8-10% of low-volume segment
Key Competitors	GoLYTELY, MiraLAX, Prepopik
Pricing Position	Premium, offset by tolerability benefits

Key Takeaways

• SOLUPREP remains in late-phase clinical evaluation, with impactful existing data supporting approval and use.
• The market for bowel preps is growing, driven by demographics and screening needs.
• It is positioned favorably against competitors due to patient tolerability, but cost and competition are barriers to further expansion.
• Longer-term growth depends on market expansion, formulary inclusions, and further product innovations.

FAQs

1. When is SOLUPREP expected to get regulatory approval in emerging markets?
   Regulatory submissions are ongoing or planned for 2023-2024, with approvals possibly within 12-24 months following submission.

2. Are there ongoing studies investigating new formulations of SOLUPREP?
   Yes, additional formulations aimed at pediatric use and improved taste are under clinical development, with regulatory submissions anticipated by 2024-2025.

3. What patient populations benefit most from SOLUPREP?
   Patients seeking lower-volume bowel preparations, those with prior intolerance to PEG-based solutions, and individuals with specific contraindications benefit most.

4. How does the safety profile of SOLUPREP compare to other bowel cleansers?
   It shows comparable safety, with minor gastrointestinal discomfort reported in some cases, and a lower incidence of electrolyte disturbances relative to older formulations.

5. What are the main barriers to SOLUPREP’s wider market adoption?
   Cost, physician familiarity, and competition from generics or alternative formulations are the primary barriers.

---

References

[1] Market data and projections from MarketsandMarkets, 2022.
[2] Clinical trial summaries from ClinicalTrials.gov, 2022-2023.
[3] Product information and regulatory updates from FDA and EMA, 2023.