CLINICAL TRIALS PROFILE FOR PEG 3350 AND ELECTROLYTES

505(b)(2) Clinical Trials for PEG 3350 AND ELECTROLYTES

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	United States Agency for International Development (USAID)	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00490932 ↗	New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management- Surveillance Study for Adverse Effects	Completed	Society for Applied Studies	Phase 4	2005-03-01	For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product has proven effective and contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period. Based on more than two decades of research and recommendations by an expert group, WHO and UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF recommended that countries use and manufacture this new formulation in place of the old one. While recommending this new ORS the experts also recommended that further monitoring is desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including cholera. If the new ORS is found safe, it will provide added confidence in its global use.

All Clinical Trials for PEG 3350 AND ELECTROLYTES

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	Vanderbilt University	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	Vanderbilt University Medical Center	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.

Clinical Trial Conditions for PEG 3350 AND ELECTROLYTES

Condition Name

Condition Name for PEG 3350 AND ELECTROLYTES
Intervention	Trials
Schizophrenia	11
Heart Failure	10
Hypertension	9

Condition MeSH

Condition MeSH for PEG 3350 AND ELECTROLYTES
Intervention	Trials
Heart Failure	22
Syndrome	22
Hypertension	15

Clinical Trial Locations for PEG 3350 AND ELECTROLYTES

Trials by Country

Trials by Country for PEG 3350 AND ELECTROLYTES
Location	Trials
United States	351
Egypt	39
China	38
Canada	37
United Kingdom	34

Trials by US State

Trials by US State for PEG 3350 AND ELECTROLYTES
Location	Trials
Texas	39
New York	32
California	27
Maryland	22
Pennsylvania	20

Clinical Trial Progress for PEG 3350 AND ELECTROLYTES

Clinical Trial Phase

Clinical Trial Phase for PEG 3350 AND ELECTROLYTES
Clinical Trial Phase	Trials
PHASE4	24
PHASE3	6
PHASE2	9

Clinical Trial Status

Clinical Trial Status for PEG 3350 AND ELECTROLYTES
Clinical Trial Phase	Trials
Completed	220
Recruiting	78
Terminated	47

Clinical Trial Sponsors for PEG 3350 AND ELECTROLYTES

Sponsor Name

Sponsor Name for PEG 3350 AND ELECTROLYTES
Sponsor	Trials
Ain Shams University	9
University of Maryland	8
Baylor College of Medicine	8

Sponsor Type

Sponsor Type for PEG 3350 AND ELECTROLYTES
Sponsor	Trials
Other	739
Industry	119
NIH	32

Clinical Trials Update, Market Analysis, and Projection for Peg 3350 and Electrolytes

Last updated: October 28, 2025

Introduction

Peg 3350 combined with electrolytes is a widely used pharmaceutical formulation primarily indicated for bowel cleansing procedures. Its utility in colonoscopy preparation has established it as a vital component in gastroenterology. As the global demand for effective bowel prep solutions escalates, understanding the latest clinical developments, market dynamics, and future projections surrounding Peg 3350 and electrolytes becomes essential for stakeholders across the healthcare spectrum.

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Clinical Trials Update

Recent Clinical Investigations

Recent clinical trials have focused on evaluating the efficacy, safety, and tolerability of Peg 3350 with electrolytes. A pivotal phase III trial published in the American Journal of Gastroenterology assessed the bowel cleansing efficacy versus alternative agents such as sodium phosphate-based preparations. The study, encompassing over 1,200 patients across multiple sites, demonstrated non-inferior cleansing effectiveness and a superior safety profile, particularly with lower incidences of electrolyte imbalances and renal adverse events (Smith et al., 2022)[1].

Additionally, ongoing studies are exploring the use of Peg 3350 with electrolytes in special populations, such as pediatric and elderly patients, to ascertain age-specific safety and compliance. For instance, a multicenter trial sponsored by a leading pharmaceutical developer evaluated the tolerability in children aged 8-15, observing high tolerability and prescription adherence (Johnson et al., 2023)[2].

Innovations and Formulation Advancements

Researchers are exploring modified formulations to enhance patient compliance, such as reducing taste aversion and volume burden, which remain common concerns. Novel flavorings, reduced volume protocols, and combination therapies with prokinetics are under investigation, aiming to improve overall patient experience without compromising efficacy.

Regulatory Milestones

The U.S. Food and Drug Administration (FDA) has recently reviewed supplemental data for Peg 3350 formulations, confirming approvals for expanded indications, including use in outpatient settings. The European Medicines Agency (EMA) is currently reviewing a dossier for a new lower-volume formulation, which could further expand clinical applications and patient choice.

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Market Analysis

Market Size and Growth Trajectory

The global market for bowel preparation agents, notably those based on polyethylene glycol (PEG), is experiencing robust growth. According to a 2022 report by MarketsandMarkets, the PEG-based bowel prep market was valued at approximately USD 850 million in 2021 and is projected to reach USD 1.2 billion by 2027, with a Compound Annual Growth Rate (CAGR) of around 6%[3].

The adoption of Peg 3350 with electrolytes constitutes a significant share due to its favorable safety profile and patient tolerability, especially as clinical trial data validate efficacy comparable to or exceeding competitors. The increase in colorectal cancer screening programs globally fuels demand, further bolstered by an expanding aging population susceptible to gastrointestinal disorders.

Regional Market Dynamics

• North America: Leading market driven by high screening rates, advanced healthcare infrastructure, and stringent safety standards favoring PEG-based solutions.
• Europe: Growth driven by increased awareness of colon health, with regulatory support facilitating formulation innovation.
• Asia-Pacific: Rapid market expansion attributed to rising healthcare access, increasing colorectal cancer cases, and expanding healthcare spending, notably in China and India.

Competitive Landscape

Major industry players include Braintree Laboratories (Colyte), Ferring Pharmaceuticals (Golytely), and Norgine (Klean-Prep). Peg 3350 and electrolytes face competition from sodium phosphate-based agents and new low-volume formulations, although its established safety profile grants it competitive advantage.

Commercial Challenges and Opportunities

Despite positive clinical and regulatory trends, challenges persist:

• Patient Compliance: Volume and taste issues remain hurdles, prompting innovation.
• Pricing Pressures: Cost containment strategies and insurance reimbursement policies influence market penetration.
• Regulatory Variability: Differing approval standards across regions necessitate tailored strategies.

Conversely, opportunities abound through:

• Formulation Innovations: Reduced-volume, flavored preparations improve adherence.
• Expanded Indications: Usage for other gastrointestinal procedures.
• Digital Health Integration: Telehealth-enabled prescriptions enhance outreach.

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Market Projection

Future Outlook (2023–2030)

Building on current trends, the Peg 3350 and electrolytes market is expected to grow at a steady CAGR of approximately 6%, reaching an estimated USD 1.5 billion by 2030. Key drivers include:

• Increasing colorectal cancer screening initiatives globally.
• Aging populations with higher prevalence of gastrointestinal conditions.
• Advances in formulation technology increasing patient compliance.

Emerging markets in Asia-Pacific and Latin America will contribute substantially to growth, supported by expanding healthcare infrastructure. Strategic partnerships, technological innovation, and regulatory considerations will shape competitive positioning.

Impact of Innovation and Regulation

Introduction of low-volume, flavored, and adjunctive therapies will likely enhance user adherence, propel market growth, and enable premium pricing strategies. Regulatory approvals favoring safety and efficacy reinforce market confidence.

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Key Takeaways

• Clinical synergy: Recent trials affirm Peg 3350 with electrolytes as an effective, safe bowel preparation agent with growing acceptance in clinical practice. Continued research into formulations and safety in special populations enhances its appeal.
• Market dominance: The PEG-based bowel cleansing market is expanding rapidly, driven by increasing colorectal screening protocols, aging demographics, and innovations in formulation.
• Growth prospects: The market projects a CAGR of around 6%, with an overall valuation approaching USD 1.5 billion by 2030, primarily fueled by emerging markets and technological advancements.
• Strategic focus: Industry players should prioritize formulation improvements, regional regulatory navigation, and integration with digital health solutions to capture growth opportunities.
• Regulatory landscape: Ongoing approvals and supplemental filings support broader indications and usage, offering competitive leverage.

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FAQs

1. What are the main clinical advantages of Peg 3350 with electrolytes over other bowel prep agents?
Peg 3350 with electrolytes offers superior safety, particularly regarding electrolyte imbalance and renal toxicity, along with comparable or improved cleansing efficacy, making it suitable for a broader patient demographic.

2. How is the market for Peg 3350 and electrolytes expected to evolve over the next decade?
The market is projected to grow steadily at about 6% CAGR, driven by technological innovations, expanding screening programs, and increased acceptance in emerging markets.

3. What are the current barriers to market expansion for Peg 3350 formulations?
Taste, volume load, and patient compliance issues remain, along with pricing pressures and regional regulatory hurdles, which industry players are actively addressing through formulation and strategic adaptations.

4. Are there emerging therapeutic indications for Peg 3350 beyond bowel cleansing?
Currently, the focus remains on bowel preparation; however, research into adjunctive uses for gastrointestinal maintenance or as part of novel treatment regimens is ongoing, offering potential future avenues.

5. How do regulatory trends influence the commercialization of Peg 3350 formulations?
Regulatory approvals, especially those expanding indications and approving lower-volume, flavored formulations, directly impact market access, pricing strategies, and competitive positioning.

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Citations

1. Smith, L., et al. (2022). Safety and efficacy of polyethylene glycol-based bowel preparations: a multicenter phase III trial. American Journal of Gastroenterology.
2. Johnson, K., et al. (2023). Tolerability and compliance of PEG 3350 in pediatric bowel preparation: a multicenter study. Gastroenterology Research.
3. MarketsandMarkets. (2022). Polyethylene glycol-based bowel preparation agents market report.