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.

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
Florida	11
Pennsylvania	11
North Carolina	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	3
PHASE2	9

Clinical Trial Status

Clinical Trial Status for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	143
Recruiting	45
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
University of Colorado, Denver	5
Bausch Health Americas, Inc.	5

Sponsor Type

Sponsor Type for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Sponsor	Trials
Other	359
Industry	72
NIH	16

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE Market Analysis and Financial Projection

Last updated: April 28, 2026

Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride: Clinical Trials Update and Market Outlook

What is the product profile and how is it used?

Peg-3350 (polyethylene glycol 3350) plus electrolytes is a prescription gastrointestinal (GI) bowel cleansing regimen. The fixed-dose combination typically pairs:

• Peg-3350: osmotic laxative for bowel preparation
• Potassium chloride (KCl): electrolyte replacement
• Sodium bicarbonate: buffering agent to help maintain acid-base balance
• Sodium chloride (NaCl): electrolyte replacement

In market terms, this category sits in bowel preparation prior to colonoscopy and related GI endoscopy indications. The presence of both PEG and electrolyte components targets dehydration and electrolyte imbalance risk versus PEG-only regimens (standard rationale in product labeling).

How is the clinical evidence landscape structured?

Clinical development for this class is dominated by:

1. Bioequivalence and bridging work for reformulations or salts composition changes (typical for generic entrants once reference products are established).
2. Comparative bowel cleanliness endpoints (for example, adequate cleansing rates and scales like BBPS or equivalent).
3. Safety endpoints focusing on electrolyte shifts, dehydration events, and tolerability.

Because “Peg-3350, potassium chloride, sodium bicarbonate, sodium chloride” is an ingredient-level description rather than a single named proprietary product in all jurisdictions, clinical-trial indexing can fragment across branded references and generic variants. That means trial counts and sponsors vary by how registries label the regimen.

What is the current clinical trials update?

No complete, registry-level update can be produced from the information provided. A clinical trials update requires a uniquely identified regimen (brand, sponsor, or NDC/EMA/UK dossier name) and a time-bounded search of registries (ClinicalTrials.gov, EU CTR, WHO ICTRP). The prompt provides only ingredient names, which does not meet the minimum information needed to produce an accurate “update” with trial identifiers, dates, phase, status, and endpoints.

What is the addressable market and buyer demand?

Even without registry-level granularity, the commercial demand mechanics for PEG + electrolyte bowel prep are stable:

• Primary buyers: hospitals, ambulatory surgery centers, GI clinics, and pharmacies distributing bowel prep kits
• Primary utilization driver: outpatient colonoscopy volume and scheduling
• Decision drivers: bowel cleanliness performance, safety/tolerability, patient compliance, package format, and formulary placement

This category typically competes on:

• Efficacy (proportion with “adequate” cleansing)
• Safety (clinically meaningful electrolyte abnormalities, dehydration, and adverse event rates)
• Compliance (tolerability of volume and taste, adherence to split dosing)

How does the competitive set look?

For PEG-based bowel cleansing, competitive positioning usually includes:

• Other PEG + electrolyte kits with differing volumes, dosing schedules, and flavoring/excipients
• Non-PEG regimens (commonly sodium picosulfate with magnesium citrate, and other low-volume options)

Competitive outcomes are typically measured in trials comparing cleansing adequacy, but formulary decisions in practice also depend on price and contracting.

Market sizing and projection framework

A rigorous market projection requires:

• Current annual unit demand (bowel prep kits)
• Average selling price (ASP) and channel mix
• Forecasts of colonoscopy volumes, guideline adherence, and outpatient migration
• Patent and exclusivity timelines by geography for the reference product and major generics
• Tender/contract pricing dynamics (especially for hospital formularies)

The prompt does not provide geographic scope (US vs EU vs ex-US), channel, or brand reference. Without this, any specific numeric market projection would be fabricated.

What projection can be stated without inventing numbers?

A usable projection can be provided only at the level of directional market forces for this class:

• Demand is steady because colonoscopy preparation is recurring and guideline-driven.
• Generic penetration increases volume elasticity and price competition over time.
• Regimen compliance improvements (split dosing instructions, patient-friendly formulations) protect share in formularies.
• Regulatory scrutiny of safety keeps electrolyte monitoring and labeling important, but does not typically eliminate established PEG electrolyte products.

No quantified forecast is deliverable from the provided inputs.

Commercial guidance for R&D and investment

Given the ingredient-level identification, the highest-probability commercialization pathways in this category are:

• Generic entry through bioequivalence and stability packages
• Formulation optimization that improves tolerability and adherence while maintaining cleansing efficacy
• Labeling and patient-instructions strategy (evidence packages that support split dosing compliance)

However, producing actionable, audit-grade decisions (timelines, probability of approval, and expected unit economics) requires a unique target product dossier.

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Key Takeaways

• Peg-3350 with potassium chloride, sodium bicarbonate, and sodium chloride is a bowel cleansing regimen used primarily before colonoscopy, with efficacy and electrolyte safety driving adoption.
• A registry-grade clinical trials update and a numeric market projection cannot be produced accurately from ingredient-only input.
• Commercial outcomes for this drug class are shaped by generic penetration, formulary contracting, compliance characteristics, and bowel cleanliness performance.

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FAQs

1. Is this regimen typically used for colonoscopy preparation only?
   It is primarily marketed for bowel cleansing prior to colonoscopy and related GI endoscopic exams requiring colonic visualization.

2. What are the key efficacy endpoints used in bowel prep trials?
   Trials commonly use bowel cleansing scales that categorize adequacy of cleansing (BBPS or comparable scoring systems).

3. What safety signals matter most for PEG plus electrolytes?
   Electrolyte disturbances, dehydration, and tolerability (nausea, abdominal discomfort, adherence to dosing).

4. How do generics compete in this segment?
   Through bioequivalence, stability, and cost advantages, while maintaining comparable bowel cleansing performance and safety.

5. What factors most influence formulary inclusion?
   Cleansing adequacy performance, adverse event profile, patient compliance, and price through hospital and outpatient contracting.

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References

[1] No sources were cited because the prompt did not provide a uniquely identifiable product, geography, or time window needed to compile registry-level clinical-trial and market data.