CLINICAL TRIALS PROFILE FOR POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

All Clinical Trials for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00603681 ↗	Comparison of PEG Solutions With and Without Electrolytes in the Treatment of Constipation	Completed	Orion Corporation, Orion Pharma	Phase 4	2008-01-01	The aim of the study is to show that new polyethylene glycol (PEG) solution without electrolytes is as effective in the treatment of constipation as PEG solution with electrolytes in the elderly institutionalized people. Also, the tolerability and the safety of the study drug will be examined.
NCT01170754 ↗	Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy	Completed	Temple University	Phase 4	2010-04-01	A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets Phosphosoda) are now used on a limited basis because of their known association with renal injury. Polyethylene glycol (PEG) mixed with a balanced electrolyte solution (e.g. Golytely) has been used for over two decades for colon cleansing. The mixture is not very palatable due to the electrolyte additives which include sodium sulfate. To overcome the limitation of existing preps, gastroenterologists and colorectal surgeons worldwide have been using PEG powder alone (same quantity as found in Golytely prep) not mixed with electrolytes (Glycolax or Miralax) and dissolving this into 64 ounces of Gatorade. Conservatively, we estimate that 25% of colonoscopies in the US are being done with this prep. Anecdotally there have been reports (case series) that it is far more palatable and the prep is equally efficacious. The active ingredient, PEG, is not changed and therefore this is not surprising. The issue at present is that there has never been a blinded study to confirm these claims. This study will compare the efficacy of the two preps. There is no funding. The investigators will charge insurance companies for the prep - this is our current practice. The procedures will be done on healthy individuals referred for colon cancer screening and the exam will be billed to their insurance. There will be no patient honorarium. The investigators will check electrolytes to be sure patients do not develop hypokalemia with the Gatorade prep.
NCT01212445 ↗	Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)	Completed	Bayer	Phase 2	2010-10-01	The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping. In addition, the proportion of subjects with a BM (without straining and without hard and/or lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E was evaluated for the time to first BM.
NCT01251822 ↗	Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation	Completed	Norgine	Phase 3	2010-11-01	This study is to compare the efficacy and safety of polyethylene glycol (PEG) 3350 with that of prucalopride in the treatment of chronic constipation in females. A total of 240 patients will be randomly allocated to treatment with one or the other agent. The study consists of a 14-day run-in period, with treatment subsequently administered for 28 days on a daily basis. During the study, patients will fill in a stool diary, samples of faeces will be collected, and colonic transit time will be measured prior to therapy, and from days 22 to 28 of treatment. The proportion of patients with normalised bowel movements (three or more spontaneous movements) during the last week of the study (days 22 to 28 of treatment) will be compared between treatments.

Clinical Trial Conditions for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

Condition Name

Condition Name for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
Intervention	Trials
Bowel Preparation	3
Constipation	3
Constipation - Functional	1
Pediatric Functional Constipation	1

Condition MeSH

Condition MeSH for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
Intervention	Trials
Constipation	3
Digestive System Diseases	1
Colitis	1
Diabetes Mellitus, Type 2	1

Clinical Trial Locations for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

Trials by Country

Trials by Country for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
Location	Trials
United States	3
China	2
Ireland	1
France	1
Netherlands	1

Trials by US State

Trials by US State for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
Location	Trials
Wisconsin	1
Michigan	1
Pennsylvania	1

Clinical Trial Progress for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

Clinical Trial Phase

Clinical Trial Phase for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	4
Phase 3	2

Clinical Trial Status

Clinical Trial Status for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
Clinical Trial Phase	Trials
Completed	7
NOT_YET_RECRUITING	3
Unknown status	2

Clinical Trial Sponsors for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

Sponsor Name

Sponsor Name for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
Sponsor	Trials
Ascension Genesys Hospital	1
General Hospital of Shenyang Military Region	1
Genesys Regional Medical Center	1

Sponsor Type

Sponsor Type for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
Sponsor	Trials
Other	11
Industry	5

Polyethylene Glycol 3350 and Electrolytes Clinical Trials Update, Market Analysis, and Exclusivity Timeline (US)

Last updated: July 28, 2026

What is polyethylene glycol 3350 and electrolytes used for, and how is it positioned commercially?

Polyethylene glycol 3350 plus electrolytes is an oral osmotic laxative indicated to treat constipation. In the US, the clinical and commercial category is led by branded prescription products and switchable OTC constipation brands depending on formulation and labeling. The active ingredients are the polyethylene glycol (PEG) component plus added electrolytes (commonly sodium salts and potassium salts depending on brand), designed to maintain intravascular volume during high-volume bowel-prep or constipation regimens.

What patient segments drive demand?

• Adult constipation management (chronic idiopathic constipation, episodic constipation).
• Bowel preparation workflows where PEG-electrolyte regimens are used as pre-procedure cathartics in some labels (brand- and formulation-dependent).
• Retail self-care channel (OTC where applicable), and pharmacy channel (prescription where labeled accordingly).

What makes this category “formulation heavy”?

• Dose volume and electrolyte composition impact tolerability (nausea, bloating), adherence, and resumption of normal bowel habits.
• Palatability, administration device (sachets, bottles), and taste-masking drive switch behavior in OTC and payer-facilitated settings.

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What clinical trials are active or recently updated for polyethylene glycol 3350 and electrolytes?

No complete and source-verifiable update set is available here for active/recent interventional trials specific to “polyethylene glycol 3350 and electrolytes” as a single pooled entity (the ingredient often maps to multiple formulations and brands). With only the drug class name provided, an accurate trial registry pull across ClinicalTrials.gov, EU CTR, and company pipelines cannot be produced without risking fabricated trial identifiers, endpoints, or timelines.

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What patents protect polyethylene glycol 3350 and electrolytes formulations in the US?

A patent estate cannot be stated accurately from the drug class label alone because PEG-electrolyte products vary by electrolyte salt system, concentration, dosing regimen, excipients, and manufacturing method. Patents also often expire broadly at the ingredient level while later-life formulation and process patents may survive. Without a specific branded product name (and its Orange Book listing), a correct, litigation-ready inventory of US patent numbers and expiration dates cannot be produced.

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When do polyethylene glycol 3350 and electrolytes lose exclusivity in the US?

Exclusivity depends on the specific FDA approval (NDA/ANDA) and the exact listed drug. “Polyethylene glycol 3350 and electrolytes” spans multiple NDA/ANDA products and strengths. Without the referenced product(s) and approval identifiers, any statement about exclusivity end dates would be non-actionable and risk being wrong.

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What is the Orange Book status of polyethylene glycol 3350 and electrolytes?

Orange Book status is listing-level and product-specific. The class name does not uniquely map to an FDA “listed drug” record, so Orange Book patent counts, listed patent numbers, and approval dates cannot be provided reliably without a specific reference product.

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What generic entry risks exist for polyethylene glycol 3350 and electrolytes?

Generic risks are largely driven by:

• Whether a product is still under enforceable patents or unexpired exclusivity (listing-dependent).
• Formulation barriers such as electrolyte composition equivalence and manufacturing controls.
• Labeling barriers tied to specific regimen instructions.

A generic-entry risk assessment with Paragraph IV mechanics requires the exact branded or RLD product and its Orange Book patent list. Those inputs are not available in the prompt.

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How strong is the patent estate for polyethylene glycol 3350 and electrolytes?

PEG-electrolyte laxatives typically face rapid patent erosion for core compositions, shifting enforceability toward:

• Process and manufacturing patents.
• Specific electrolyte ratios and dose forms.
• Palatability and excipient systems.

A strength rating with defensible legal detail requires identification of the controlling US patents and jurisdictions.

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How does polyethylene glycol 3350 and electrolytes compare with alternative constipation therapies by clinical performance and access?

In practice, PEG-electrolyte laxatives compete with:

• Stimulant laxatives (bisacodyl, senna).
• Lactulose.
• Magnesium-based products.
• Prescription agents for chronic constipation (e.g., secretagogues, prokinetics) depending on payer and indication.
• Bulk-forming agents.

PEG-electrolyte regimens generally have a favorable tolerability profile versus stimulants, with efficacy driven by osmotic water retention and bowel motility support. Commercially, payer position and channel mix tend to favor low-cost, high-availability products once generics are established.

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What manufacturing and IP barriers affect supply for polyethylene glycol 3350 and electrolytes?

Key operational constraints that can affect availability:

• Multi-dose sachet/bottle packaging supply chains.
• Consistent electrolyte composition across lots.
• Quality control for osmotic balance and dissolution characteristics.
• Scale-up of powder blending and moisture control.

These barriers are process-driven more than composition-driven, so IP risk is usually secondary to supply quality and regulatory compliance.

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Market analysis: sales drivers, pricing pressure, and forecast direction for polyethylene glycol 3350 and electrolytes

Executive view: For PEG-electrolyte laxatives, market trajectory is usually anchored by broad generic penetration, routine retail replenishment, and low willingness-to-pay upside. Forecast growth typically comes from:

• Population aging and constipation prevalence.
• Increased retail adoption for episodic constipation.
• Periodic procedural demand where applicable under labeling and local practice.
• Channel expansion (retail chains, pharmacy private label in some geographies).

What governs price and margin?

• Competitive generic pricing and PBM/contract pharmacy dynamics where prescription labeling applies.
• OTC switching driven by package size, unit dose cost, and perceived tolerability.
• Substitution across PEG brands and between PEG-based and non-PEG laxatives.

What is the realistic near-term outlook?

Without product-specific sales baselines and specific country scope, a quantified projection cannot be stated in a way that supports investment or litigation decisions. A “class-level” forecast would not map to measurable revenue because:

• Different brands have different strengths, pack sizes, and regulatory labeling.
• OTC and prescription channels overlap but are not interchangeable in reported market data.
• Geographic coverage changes the competitive set materially.

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Key commercial scenarios for the next 3–7 years

Scenario 1: Stable volume, continued pricing compression

• Most consistent outcome in mature laxative classes after generic saturation.
• Limited differentiation beyond packaging and tolerability improvements.

Scenario 2: Brand differentiation via formulation and adherence

• New dosing formats or taste-masking can protect some share, but patent/market protection depends on whether “new” changes map to enforceable exclusivity or only incremental product lifecycle management.

Scenario 3: Periodic supply shocks

• Short-term availability impacts can shift share to substitutes.
• These shocks are supply-regulatory driven rather than IP driven.

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Key takeaways

• “Polyethylene glycol 3350 and electrolytes” is a formulation-dependent constipation product class, and clinical trial, patent, Orange Book, and exclusivity answers are listing- and product-specific.
• A defensible clinical trials update and patent/exclusivity timeline cannot be completed from the ingredient-level prompt without identifying the exact FDA listed drug(s).
• Market direction for PEG-electrolyte laxatives is typically volume-led with pricing compression once generics dominate; investment-level projections require product-specific revenue baselines and geography.

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FAQs

1. Which FDA-listed drug is the reference for polyethylene glycol 3350 and electrolytes in the Orange Book?
2. Are there any Paragraph IV filings for polyethylene glycol 3350 and electrolytes, and which companies are defendants?
3. What reformulations (electrolyte ratios, dose forms, excipients) can support new patents for PEG-electrolyte laxatives?
4. How do PEG-electrolyte bowel-prep regimens differ from PEG-only constipation products in dosing and tolerability?
5. What supply-chain risks most often disrupt availability of PEG-electrolyte laxatives?

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed 2026-07-28).
2. ClinicalTrials.gov. (accessed 2026-07-28).