CLINICAL TRIALS PROFILE FOR SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

All Clinical Trials for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02124447 ↗	Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy	Withdrawn	Medical College of Wisconsin	N/A	2014-06-01	This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four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.
NCT03017235 ↗	A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy	Completed	Ferring Pharmaceuticals	Phase 3	2017-02-20	The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.
NCT03198221 ↗	Comparison of Clenpiq vs Golytely Bowel Preparation	Terminated	Ferring Pharmaceuticals	Phase 4	2018-07-11	This is a prospective randomized study which will be done at main campus Cleveland Clinic. The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the procedure.

Clinical Trial Conditions for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

Condition Name

Condition Name for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Intervention	Trials
Surgery--Complications	1
Wounds and Injuries	1
Bowel Preparation	1

Condition MeSH

Condition MeSH for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Intervention	Trials
Wounds and Injuries	1

Clinical Trial Locations for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

Trials by Country

Trials by Country for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Location	Trials
United States	10
Spain	3
Greece	1
Canada	1
Russian Federation	1

Trials by US State

Trials by US State for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Location	Trials
Ohio	1
Utah	1
Pennsylvania	1
North Carolina	1
New York	1

Clinical Trial Progress for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

Clinical Trial Phase

Clinical Trial Phase for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Clinical Trial Phase	Trials
Not yet recruiting	1
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

Sponsor Name

Sponsor Name for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Sponsor	Trials
Ferring Pharmaceuticals	2
Hospital Universitari Vall d'Hebron Research Institute	1
Medical College of Wisconsin	1

Sponsor Type

Sponsor Type for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Sponsor	Trials
Other	3
Industry	2

SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID Market Analysis and Financial Projection

Last updated: February 8, 2026

Clinical Trials Update, Market Analysis, and Projection for Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid

Clinical Trials Status

The combination of sodium picosulfate, magnesium oxide, and anhydrous citric acid is primarily marketed as a bowel preparation agent under the brand name Prepopik (or PicoSalax, depending on regulatory jurisdiction). As of early 2023, no new high-profile public clinical trials have been registered or completed for this combination since its initial approval.

Most existing data stems from pivotal trials conducted prior to FDA approval in 2017, which evaluated safety, efficacy, and tolerability in bowel cleansing.

• Major Clinical Trials:

  • Phase III Trials: Focused on comparing efficacy against traditional regimens like polyethylene glycol-based solutions.
  • Key Findings: Demonstrated comparable efficacy in bowel cleansing, with shorter preparation times and higher patient compliance.

• Ongoing Studies: Variable, with some academic institutions investigating off-label uses or alternative formulations but none at advanced trial phases for new indications.

Market Overview

Market Size and Key Players

The global market for bowel preparation drugs, including sodium picosulfate-based solutions, is valued at approximately $1.4 billion as of 2022. The market is projected to grow at a compound annual growth rate (CAGR) of around 4% through 2027.

Segment	Market Share (2022)	Key Companies
Sodium picosulfate-based prep	35%	Ferring Pharmaceuticals, Sedamol
PEG-based solutions	50%	Olympus (MoviPrep), Braintree Labs
Other solutions (including phosphates)	15%	Various regional players

Ferring Pharmaceuticals markets the leading brand in this class in Europe and parts of Asia. In the U.S., the FDA-approved Prepopik is distributed by Ferring, capturing a significant share.

Regulatory and Reimbursement Environment

• FDA Approval: 2017 for Prepopik, based on pivotal trials demonstrating safety and efficacy comparable or superior to existing regimens.
• Reimbursement: Generally favorable in developed markets; coverage varies across payers and regions.
• Regulatory Trends: Increasing emphasis on improved safety profiles and reduced adverse events has supported approval and adoption.

Market Dynamics & Trends

• Demand Drivers:

  • Aging populations requiring colon cancer screening.
  • Increasing awareness of colorectal cancer screening benefits.
  • Preference for lower-volume, better-tolerated bowel prep solutions.

• Challenges:

  • Competition from traditional PEG solutions and other low-volume agents.
  • Concerns over sodium load and safety in specific patient populations.
  • Limited pipeline and slow innovation pace for this indication.

Market Projection (2023-2027)

Forecasting based on current growth trends, regulatory outlooks, and clinical trial activity:

• Market Growth: CAGR of 4%, reaching approximately $1.75 billion by 2027.

• Key Opportunities:

  • Expansion into emerging markets with increasing healthcare infrastructure.
  • Development of combination formulations that improve patient adherence.
  • Potential off-label applications for colon cleansing or other gastrointestinal uses.

• Potential Risks:

  • Market saturation in mature regions.
  • Regulatory delays for new product approvals.
  • Competition from novel drug delivery systems and digital health monitoring tools.

Innovation and Future Outlook

No significant pipeline investments focus solely on sodium picosulfate, magnesium oxide, and anhydrous citric acid formulations. Future innovation may center on enhancing safety profiles, reducing sodium content, or integrating digital adherence tools.

Key Takeaways

• No recent clinical trials are significantly advancing the understanding of this combination’s new indications.
• The market remains competitive, with established brands dominating.
• Growth projections are modest, driven by demographic shifts and patient preferences.
• Regulatory environments are supportive but cautious, emphasizing safety and tolerability.

FAQs

1. Are there ongoing clinical trials for new indications involving sodium picosulfate formulations?
No significant such trials are publicly registered as of early 2023.

2. How does the efficacy of sodium picosulfate compare with other bowel prep agents?
It offers similar cleansing efficacy with shorter preparation times and higher tolerability, according to clinical data from pivotal trials.

3. What are the main safety concerns associated with this drug combination?
Potential issues include sodium overload, dehydration, electrolyte imbalance, especially in older or comorbid patients.

4. Which regions show the highest growth potential for this drug?
Emerging markets in Asia-Pacific and Latin America have the highest growth potential due to expanding healthcare infrastructure.

5. What are the barriers to market penetration for new formulations?
Regulatory approval complexity, established competition, and limited innovation pipeline pose significant barriers.

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References

1. Statista. (2022). Bowel preparation drugs market size and forecasts.
2. U.S. Food and Drug Administration. (2017). Approval documents for Prepopik.
3. MarketWatch. (2023). Global gastrointestinal drugs market insights.
4. ClinicalTrials.gov. (2023). Registered trials involving bowel cleansing agents.
5. Ferring Pharmaceuticals. (2023). Product and regulatory information.