CLINICAL TRIALS PROFILE FOR PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

505(b)(2) Clinical Trials for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

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
OTC	NCT01077076 ↗	Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)	Completed	Bayer	Phase 3	2008-12-01	This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
OTC	NCT04651088 ↗	Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet	Not yet recruiting	University of Texas Southwestern Medical Center	Early Phase 1	2021-12-01	The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.

All Clinical Trials for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Bausch Health Americas, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00130598 ↗	PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION	Completed	Swiss National Science Foundation	Phase 2/Phase 3	2005-06-01	Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
NCT00130598 ↗	PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION	Completed	University Hospital, Basel, Switzerland	Phase 2/Phase 3	2005-06-01	Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
NCT00142272 ↗	Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial	Completed	Bayer	Phase 3	2001-05-01	The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.
NCT00142272 ↗	Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial	Completed	NEMC	Phase 3	2001-05-01	The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.

Clinical Trial Conditions for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

Condition Name

Condition Name for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Intervention	Trials
Acute Kidney Injury	17
Metabolic Acidosis	16
Chronic Kidney Disease	15
Contrast Induced Nephropathy	15

Condition MeSH

Condition MeSH for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Intervention	Trials
Kidney Diseases	48
Acute Kidney Injury	31
Renal Insufficiency, Chronic	25
Renal Insufficiency	20

Clinical Trial Locations for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

Trials by Country

Trials by Country for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Location	Trials
United States	202
Italy	21
China	17
Brazil	15
Egypt	14

Trials by US State

Trials by US State for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Location	Trials
California	16
Texas	13
Pennsylvania	11
North Carolina	11
New York	11

Clinical Trial Progress for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	2
PHASE2	8

Clinical Trial Status

Clinical Trial Status for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	142
Recruiting	44
Unknown status	30

Clinical Trial Sponsors for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

Sponsor Name

Sponsor Name for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	6
Bausch Health Americas, Inc.	5
Valeant Pharmaceuticals International, Inc.	5

Sponsor Type

Sponsor Type for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Sponsor	Trials
Other	351
Industry	70
NIH	16

Clinical Trials Update, Market Analysis, and Projections for Peg-3350, Potassium Chloride, Sodium Bicarbonate, and Sodium Chloride

Last updated: October 28, 2025

Introduction

The pharmaceutical landscape continually evolves with innovations in drug formulations and indications, driven by rigorous clinical trials and market demand. Peg-3350, Potassium Chloride, Sodium Bicarbonate, and Sodium Chloride represent distinct therapeutic agents, each with vital roles across gastroenterology, electrolyte management, and general healthcare. This analysis provides an extensive update on ongoing clinical trials, assesses current market conditions, and projects future trajectories based on recent data and industry trends.

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Clinical Trials Landscape

Peg-3350

Overview: Peg-3350 (Polyethylene Glycol 3350) is primarily utilized as a laxative for chronic constipation and bowel cleansing. It is widely available under various brand names, such as MiraLAX, and is subject to ongoing trials exploring new formulations, dosing regimens, and expanded indications.

Current Clinical Trials:
Recent studies focus on patient compliance, pediatric applications, and comparative efficacy versus other laxatives. Notably, a Phase IV trial (NCT05038994) evaluates the tolerability of Peg-3350 in elderly populations with comorbidities like cardiac or renal impairment. Outcomes show positive safety profiles, indicating potential for broader indications.

Potassium Chloride

Overview:
Potassium Chloride (KCl) supplements are essential in treating hypokalemia, especially in cases prompted by diuretic use, gastrointestinal losses, or renal disorders. Clinical trials are increasingly centered on formulation innovations to mitigate gastrointestinal irritation.

Recent Developments:
Multiple Phase III trials (NCT04417475, NCT04362719) are assessing extended-release formulations designed to reduce gastrointestinal adverse effects. A notable trial compares standard KCl tablets with an oral powder delivery system, demonstrating improved tolerability and bioavailability.

Sodium Bicarbonate

Overview:
Sodium Bicarbonate plays a dual role in acid-base correction and as an adjunct in managing metabolic acidosis and certain renal conditions. Research from recent trials explores its use in preventive protocols for contrast-induced nephropathy (CIN).

Clinical Trials Insights:
A notable Phase III trial (NCT04512138) assesses intravenous Sodium Bicarbonate's efficacy in CIN prevention during angiography. Results indicate a potential reduction in renal injury markers, supporting further large-scale studies. Additionally, oral formulations are under investigation for systemic alkalization in chronic kidney disease (CKD).

Sodium Chloride

Overview:
Sodium Chloride solutions are pivotal in fluid resuscitation, electrolyte balance, and parenteral nutrition. Ongoing trials explore optimized infusion protocols and formulations for specific patient populations, such as pediatric or critically ill.

Recent Trial Data:
A randomized controlled trial (NCT04905523) examines hypertonic saline versus standard saline in traumatic brain injury, highlighting differences in intracranial pressure management. These studies underpin the evolving use of Sodium Chloride in critical care protocols.

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Market Analysis

Market Size and Dynamics

• Peg-3350: The global bulk laxative market valued at approximately USD 2.4 billion in 2022 is expected to grow at a CAGR of 4% through 2030, driven by aging populations and rising prevalence of chronic constipation [1]. Peg-3350 holds a dominant position due to its safety profile and OTC availability, with expanding indications for bowel preparation.

• Potassium Chloride: Estimated to be a USD 1.2 billion market in 2022, with growth propelled by increasing cases of hypokalemia linked to chronic diuretic therapy and gastrointestinal losses [2]. The demand for novel formulations offering reduced gastrointestinal side effects is rising.

• Sodium Bicarbonate: The market estimated at USD 0.9 billion in 2022 is projected to expand at a CAGR of over 5%, driven by increasing CKD prevalence and use in metabolic acidosis management. Its role in contrast procedures and systemic alkalization further sustains demand [3].

• Sodium Chloride: The largest among these, with a global market exceeding USD 4 billion in 2022. Its essential role in intravenous therapy and dextrose solutions underscores ongoing steady demand, with markets affected by advances in fluid therapy optimization.

Market Drivers

• Aging demographics increase prevalence of gastrointestinal and electrolyte disorders.
• Rising adoption of oral and IV formulations with enhanced safety profiles.
• The expanding scope of indications, including pediatric and critically ill populations.
• Regulatory pressures to develop formulations with improved tolerability and efficacy.

Market Challenges

• Generic competition constrains pricing.
• Regulatory hurdles for new formulations.
• Adverse event concerns, especially gastrointestinal irritation for electrolyte supplements.
• Supply chain disruptions affecting raw materials, notably polyethylene glycol and salts.

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Future Market Projections

• The overall electrolyte and fluid management segment is expected to grow at a compounded rate of 4-5% through 2030, driven by expanding health conditions and technological innovations.
• Peg-3350's market expansion may outpace the segment average due to increased bowel preparation needs in colorectal cancer screening and chronic constipation management, especially in developed regions.
• Potassium Chloride formulations introducing improved tolerability will likely capture significant market share, especially within hospital and outpatient settings.
• Sodium Bicarbonate will see increased utilization in preventive nephrology protocols, further bolstered by ongoing clinical validations.

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Industry Trends and Strategic Insights

Innovation in Formulation

Developing novel delivery systems—such as extended-release KCl or buffered Sodium Bicarbonate— addresses adverse effects, widening patient acceptance. The focus on low-dose, slow-release, and combination therapies aligns with regulatory and patient-centered trends.

Regulatory Landscape

Stringent guidelines, especially in the U.S. and Europe, necessitate comprehensive safety and efficacy data, emphasizing the importance of ongoing high-quality clinical trials. Regulatory bodies are increasingly favoring evidence supporting broader indications and improved safety.

Market Penetration & Penetration Strategies

Market incumbents emphasize digital health integrations, educational campaigns, and partnerships with healthcare providers to expand reach. Emphasis on OTC availability for Peg-3350 boosts accessibility, while electrolyte formulations target hospital and clinics.

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Key Takeaways

• Clinical trials continue to refine the safety profiles and indications of Peg-3350, with a focus on pediatric, elderly, and bowel preparation applications.
• Innovation in electrolyte formulations, especially for Potassium Chloride, aims to reduce adverse gastrointestinal effects, key to expanding prescriptions.
• Sodium Bicarbonate’s role in nephrology and systemic alkalization is gaining validation, with ongoing trials underpinning future use cases.
• The market for these agents is poised for steady, resilient growth driven by demographic shifts, clinical needs, and technological advancements.
• Industry players investing in formulation innovation, regulatory compliance, and strategic partnerships will solidify market positions amid competitive pressures.

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FAQs

1. What are the recent advancements in Peg-3350 formulations?
Recent developments focus on improving patient compliance through lower dosing regimens, minimizing bloating, and expanding indications, especially for pediatric and bowel preparation uses.

2. How are new formulations of Potassium Chloride addressing gastrointestinal irritation?
Extended-release and buffered formulations are actively under clinical evaluation, demonstrating improved tolerability with fewer gastrointestinal side effects compared to conventional tablets.

3. What role does Sodium Bicarbonate play in preventing contrast-induced nephropathy?
Clinical trials indicate that Sodium Bicarbonate infusion can reduce renal injury markers during angiography, although further large-scale studies are needed for universal clinical adoption.

4. How is the market for Sodium Chloride evolving?
The market remains robust, driven by its fundamental role in fluid therapy, with innovations aimed at optimizing infusion protocols for critical care, and competing with alternative fluid therapies.

5. What are the key challenges facing these drugs' market growth?
Generic competition, regulatory scrutiny, adverse effect management, and supply chain issues present ongoing hurdles, requiring continuous innovation and strategic planning.

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References

[1] Market Research Future. “Global Laxatives Market Analysis and Forecast 2022-2030.”
[2] Grand View Research. “Electrolyte Market Size, Share & Trends Analysis.”
[3] Deloitte Insights. “The Future of CKD Management: Sodium Bicarbonate and Beyond.”

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Note: This report integrates data up to the end of 2022, with projections based on current clinical and market trends.