CLINICAL TRIALS PROFILE FOR POLYETHYLENE GLYCOL 3350

505(b)(2) Clinical Trials for POLYETHYLENE GLYCOL 3350

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	NCT00681265 ↗	Tear Film Break-up Time After Instillation of Artificial Tears	Completed	Eyeon Therapeutics, Inc.	N/A	2008-06-01	This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye.
OTC	NCT01044212 ↗	Bowel Function After Minimally Invasive Urogynecologic Surgery	Completed	University of Rochester	N/A	2009-11-01	The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.
New Formulation	NCT01325896 ↗	Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON)	Unknown status	Haematology Service,	Phase 2	2002-09-01	- Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic malignancies. Between 50 and 70% of symptomatic patients presented response to induction chemotherapy. The rate of complete responses (CR) achieved with standard induction of these treatments is less than 5% of cases and the median event-free survival between 2 and 3 years although most of the patients died from the disease. - High dose chemotherapy with autologous stem cell transplant has improved the response rate and survival of patient with MM. However eventually all patients relapse with a median EFS between 40-50 months post-transplant. - To improve these results and sustain remission, various maintenance treatment have been proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits in a meta-analysis. - Intron A s.c. need administration of 3 days per week and is not well tolerated - Recently a new formulation of Interpheron alpha2b is available. Conjugated with polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in MM. - The purpose of this study is to evaluate the role of Pegintron as maintenance after autologous transplant in MM
New Formulation	NCT01325896 ↗	Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON)	Unknown status	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 2	2002-09-01	- Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic malignancies. Between 50 and 70% of symptomatic patients presented response to induction chemotherapy. The rate of complete responses (CR) achieved with standard induction of these treatments is less than 5% of cases and the median event-free survival between 2 and 3 years although most of the patients died from the disease. - High dose chemotherapy with autologous stem cell transplant has improved the response rate and survival of patient with MM. However eventually all patients relapse with a median EFS between 40-50 months post-transplant. - To improve these results and sustain remission, various maintenance treatment have been proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits in a meta-analysis. - Intron A s.c. need administration of 3 days per week and is not well tolerated - Recently a new formulation of Interpheron alpha2b is available. Conjugated with polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in MM. - The purpose of this study is to evaluate the role of Pegintron as maintenance after autologous transplant in MM
New Dosage	NCT01533090 ↗	Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy	Completed	Catholic University of the Sacred Heart	N/A	2010-04-01	The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.

All Clinical Trials for POLYETHYLENE GLYCOL 3350

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001410 ↗	PEG-Glucocerebrosidase for the Treatment of Gaucher Disease	Completed	National Institute of Mental Health (NIMH)	Phase 1	1993-10-01	Gaucher disease is a lysosomal storage disease resulting from glucocerebroside accumulation in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in patients of all ages. The condition is marked by enlargement of the liver and spleen (hepatosplenomegaly), low blood and platelet counts, and bone abnormalities. The condition is passed from generation to generation on via autosomal recessive inheritance. There are actually three types of Gaucher disease. Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease does not affect the nervous system. The symptoms of type I can appear at any age. Type 2 Gaucher disease presents prenatally or in infancy and usually results in death for the patient. Type 2 is an acute neuronopathic form and can affect the brain stem. It is the most severe form of the disease. Type 3 Gaucher disease is also neuronopathic, however it is subacute in nature. This means the course of the illness lies somewhere between long-term (chronic) and short-term (acute). Currently there is not a cure for Gaucher disease. Treatment for the disease has traditionally been supportive. In some severely affected patients, bone-marrow transplants have corrected the enzyme deficiency, but it is considered a high-risk procedure and recovery can be very slow. Enzyme replacement therapy is another therapy option and has been approved by the Food and Drug Administration (FDA) for use in type 1 patients. PEG-glucocerbrosidase is a drug designed to clear out the accumulation of lipid (glucocerebroside) from the blood stream. The drug is actually an enzyme attached to large molecules called polyethylene glycol (PEG). The large molecules of PEG allow the enzyme to remain in the blood stream for long periods of time. By modifying glucocerebrosidase with PEG, it is believed that smaller doses will be required, meaning a reduction in cost for the patient and more convenient administration of the drug. The purpose of this study is to evaluate the effects and safety of enzyme replacement therapy using PEG- glucocerebrosidase for the treatment of Gaucher disease.
NCT00004695 ↗	Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency	Completed	Icahn School of Medicine at Mount Sinai	N/A	1997-09-01	OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency. II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.
NCT00018031 ↗	Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2001-06-01	This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b. This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher blood concentration and thus maintaining activity against the hepatitis C virus. HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is not available. The liver biopsy is done to determine the severity of liver disease. For this test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is injected into an arm vein, the skin in the area over the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray, electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening tests, candidates who appear eligible for the study will have a physical examination, medical history and repeat blood tests. Women who can become pregnant will have serial pregnancy tests throughout the study. Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth. In addition, patients will continue to take all other medications prescribed by their doctor. Clinic visits will be scheduled as follows: - Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV. - Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection. - Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients will return to the clinic for a routine test.
NCT00029900 ↗	ADI-PEG in Patients With Metastatic Melanoma	Completed	FDA Office of Orphan Products Development	Phase 1	2001-09-01	This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.
NCT00056992 ↗	Testing of ADI-PEG in Hepatocellular Carcinoma	Completed	FDA Office of Orphan Products Development	Phase 2	2002-09-01	Amino acid deprivation therapy is an effective means for the treatment of some forms of cancer. Recently it has been found that human hepatocellular carcinomas (HCC) cell lines appear to require arginine for growth. Arginine is not an essential amino acid for human adults or infants as it can be synthesized from citrulline (for review see Rogers 1994). Therefore, selective elimination of arginine from the circulation may be a means of treating patients with metastatic melanoma or non resectable HCC. The enzyme arginine deiminase (ADI) metabolizes arginine into citrulline (Cunin 1986). However, ADI is only found in microbes and not in humans. ADI is therefore, highly immunogenic and has a short serum half-life following injection. These potential drawbacks (microbial source and thus viewed as foreign by the human immune system, and a short serum half-life) can be overcome by covalent attachment of polyethylene glycol (PEG) to argininedeiminase and termed this drug ADI-PEG 20. ADI-PEG 20 appears to be an effective anti-cancer treatment for human HCC. Pharmacokinetic and pharmacodynamic data indicates a once a week injection of 160 IU/m2 of ADI-PEG 20 eliminates all detectable arginine from the circulation for at least 7 days. This treatment appears to be well tolerated. The purpose of this study is to determine the efficacy of this treatment in patients with HCC. Efficacy is a primary end point of this study. No patients will recieve placebo.
NCT00085917 ↗	Peginterferon Alpha-2a and Ribavirin to Treat Hepatitis C in HIV-infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2004-06-01	This study will evaluate the safety and effectiveness of combination therapy with peginterferon alpha-2a and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. Peginterferon alpha with ribavirin is the therapy of choice for people with HCV alone. Peginterferon alpha-2a is a compound that results from attaching a polyethylene glycol molecule to interferon alpha-2a. This compound stays in the blood longer than unmodified interferon alpha-2a, causing a higher blood concentration and thus maintaining greater activity against the hepatitis C virus. HIV-infected patients 18 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2-1/2 year study. Candidates are screened with a medical history and physical examination, blood and urine tests, eye examination, chest x-ray, electrocardiogram (EKG), liver ultrasound, and pregnancy test in women who are able to become pregnant. If a recent liver biopsy is not available, this test is done to determine the type and severity of liver disease. The patient is given a sedative before the procedure. Then, the skin in the area over the biopsy site is numbed with a local anesthetic and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. Participants begin treatment with injections under the skin of peginterferon alpha-2a and ribavirin pills by mouth on study day 0. Peginterferon is given either once or twice a week for 4 weeks and then once a week for 44 weeks. Ribavirin is given daily. In addition, patients continue to take all other medications prescribed by their doctor. Clinic visits are scheduled for the following procedures: - Days 1, 3, 4, 7, 10 and weeks 2, 3, and 4 - Blood tests for safety measures and to measure blood levels of HIV and HCV. - Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 - Blood and urine tests to determine the side effects of treatment and its effect on the HCV infection. In addition, eye examinations are done every 3 months, and pregnancy and thyroid function tests are done several times during the treatment period. - Week 48 or end of treatment - Treatment stops after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients return to the clinic for a chest x-ray, EKG, blood tests, and abdominal ultrasound. Patients are hospitalized for a repeat liver biopsy. - Weeks 52, 56, 64 and 72 - Blood and urine tests to determine the side effects of treatment and its effect on the HCV infection, and a urine pregnancy test in women.

Clinical Trial Conditions for POLYETHYLENE GLYCOL 3350

Condition Name

Condition Name for POLYETHYLENE GLYCOL 3350
Intervention	Trials
Constipation	30
Colonoscopy	24
Bowel Preparation	22
Anemia	21

Condition MeSH

Condition MeSH for POLYETHYLENE GLYCOL 3350
Intervention	Trials
Constipation	40
Anemia	22
Renal Insufficiency, Chronic	16
Kidney Diseases	15

Clinical Trial Locations for POLYETHYLENE GLYCOL 3350

Trials by Country

Trials by Country for POLYETHYLENE GLYCOL 3350
Location	Trials
United States	285
China	102
Italy	48
Canada	30
Spain	28

Trials by US State

Trials by US State for POLYETHYLENE GLYCOL 3350
Location	Trials
New York	18
Texas	17
California	15
Maryland	15
Pennsylvania	14

Clinical Trial Progress for POLYETHYLENE GLYCOL 3350

Clinical Trial Phase

Clinical Trial Phase for POLYETHYLENE GLYCOL 3350
Clinical Trial Phase	Trials
PHASE4	9
PHASE3	3
PHASE2	6

Clinical Trial Status

Clinical Trial Status for POLYETHYLENE GLYCOL 3350
Clinical Trial Phase	Trials
Completed	187
Recruiting	44
Unknown status	39

Clinical Trial Sponsors for POLYETHYLENE GLYCOL 3350

Sponsor Name

Sponsor Name for POLYETHYLENE GLYCOL 3350
Sponsor	Trials
Hoffmann-La Roche	30
Jiangsu Hansoh Pharmaceutical Co., Ltd.	6
National Cancer Institute (NCI)	6

Sponsor Type

Sponsor Type for POLYETHYLENE GLYCOL 3350
Sponsor	Trials
Other	376
Industry	132
NIH	12

Clinical Trials Update, Market Analysis and Projection for Polyethylene Glycol 3350 (PEG 3350)

Last updated: April 28, 2026

What is polyethylene glycol 3350 and how is it used in clinical development?

Polyethylene glycol 3350 (PEG 3350) is an osmotic laxative used to treat constipation and, in some regimens, bowel cleansing prior to colorectal procedures. Commercially, PEG 3350 is widely marketed as an active ingredient in multiple formulations (commonly for chronic constipation and pediatric constipation). Most “clinical development” activity in this category is formulation, dosing, palatability, and device-adjunct work rather than new-molecule discovery.

For business planning, the key point is that PEG 3350 is not a single patented drug product with a unified clinical pipeline. It is an established active pharmaceutical ingredient with broad market penetration and overlapping product families that compete through formulation and labeling rather than through new molecular IP.

What does the current clinical trials landscape look like for PEG 3350?

PEG 3350 clinical activity is typically dominated by:

• Pediatric constipation trials (dose optimization, adherence, palatability, long-term tolerability)
• Bowel preparation studies (comparative regimens, split dosing, efficacy endpoints like bowel cleansing scores)
• Formulation and delivery studies (including comparator trials against other osmotic laxatives or bowel prep regimens)

Current-state interpretation for decision-making

Because PEG 3350 is widely available and off-patent in many markets, the pragmatic clinical question is not “new drug approval prospects” but “incremental differentiation that can support a durable product claim.” Trial outcomes that typically drive product momentum are:

• Higher caregiver and patient adherence (taste, volume, dosing schedule)
• Comparable or improved bowel cleansing quality (if marketed for prep indications)
• Safety consistency (GI events, dehydration-related events, electrolyte abnormalities when relevant)

Market impact linkage: products that win on adherence and labeling expand prescription and repeat use, which matters more than modest efficacy changes in a mature active ingredient category.

Where do the competitive benchmarks sit for PEG 3350 products?

PEG 3350 competes within osmotic laxatives and against stimulant and secretagogue classes depending on indication and geography. The competitive benchmark is usually not “PEG vs another molecule” in a head-to-head sense across all endpoints; it is:

• For chronic constipation: ease of use, tolerability, and pediatric acceptance
• For bowel prep: bowel cleanliness quality and patient compliance with diet and split dosing

Practical differentiation levers used by manufacturers

Most active-ingredient incumbents and new entrants attempt to differentiate through:

• Dosing volume reduction or regimen simplification
• Palatability improvements
• Packaging, administration devices, and clear pediatric protocols
• Labeling breadth (pediatric age range, specific constipation duration definitions)
• Safety monitoring approach and patient counseling materials that support adherence

What is the PEG 3350 market structure and pricing logic?

PEG 3350 functions as a mature active ingredient. That shapes market economics:

• High availability and multiple generic equivalents compress price at the active level
• Value migrates to branded formats, specific pediatric claims, and physician familiarity
• Tender and formulary dynamics matter more than R&D intensity
• Distribution and contracting often outrank pipeline novelty

Market segmentation commonly used for PEG 3350

PEG 3350 is typically segmented by indication:

• Chronic constipation (including pediatric constipation)
• Bowel cleansing / bowel preparation regimens

For investors and commercial teams, the most relevant demand drivers are:

• Chronic constipation prevalence and the intensity of constipation management programs
• Pediatric constipation treatment patterns (primary care and pediatric GI referral)
• Endoscopy procedure volumes that drive bowel prep use

How should investors and R&D teams project demand and revenue in a mature PEG 3350 category?

Projection must reflect competitive pressure from generics and the reality that PEG 3350 is not a single-trajectory “pipeline story.” A defensible projection model for PEG 3350 products usually uses a three-layer approach:

1) Indication-level volume growth

• Population growth and procedure growth
• Constipation management guideline adherence and prescribing patterns
• Pediatric prescribing capture driven by dosing convenience

2) Market share dynamics

• Share shifts from branded to generics, and from less convenient products to better-adhered formats
• Formulary inclusion and payer coverage
• Pack size and dosing schedule fit for outpatient use

3) Price and net revenue rate

• Net price drift downward in off-patent active ingredient categories
• Residual premium for specific labeled formats and branded patient support programs
• Pharmacy contracting and channel mix (retail versus institutional)

Scenario projection framework (revenue, not drug-level “growth story”)

Use product-level forecasting rather than “PEG 3350 market growth” alone:

• Base case: volume grows; net revenue per unit declines at a moderated rate due to mix shifts
• Downside: accelerated generic erosion in the strongest payor segments
• Upside: successful label breadth expansion or formulation superiority supports share gains and reduces price erosion

What are the core risks to PEG 3350 market growth?

Key risks typically include:

• Rapid generic substitution and payer-driven switching
• Competitive reformulations that neutralize differentiated dosing advantages
• Labeling constraints and pediatrics-specific evidence burden
• Regulatory and quality system shocks (batch consistency, complaint handling, recalls), which can be acute in widely used OTC-adjacent and Rx products

What product and trial signals should be treated as “go/no-go” for PEG 3350 differentiation?

For a mature active ingredient, differentiation must show measurable commercial impact. High-signal trial endpoints and evidence packages include:

• Adherence and completion rates (for both constipation therapy and prep regimens)
• Bowel cleansing quality scores (for endoscopy preparation) using standardized scoring methods
• Safety consistency across pediatric and adult populations
• Clinically meaningful differences on patient-reported outcomes, especially caregiver-administered pediatric measures

What is the investment takeaway from PEG 3350 given typical pipeline economics?

PEG 3350 is more “execution and differentiation” than “disruptive R&D.” The strongest commercial strategies tend to be:

• Make administration easier and improve completion
• Win formulary inclusion with a strong evidence package
• Target pediatric segments where dosing convenience and tolerability drive repeat use
• For bowel prep, focus on regimen design that improves compliance with diet and split dosing

Key Takeaways

• PEG 3350 is a mature, widely used osmotic laxative; clinical “innovation” is mostly formulation, dosing, and regimen differentiation rather than new molecular development.
• Market economics are dominated by generic competition at the active level; value accrues to specific labeled formats, pediatric usability, and bowel preparation regimen performance.
• Projection should be product-level and scenario-based: demand growth plus share gains can offset net price pressure, but generic erosion is the primary downside driver.
• High-signal clinical evidence for differentiated products centers on adherence, patient completion, bowel cleansing quality, and safety consistency.

FAQs

1) Is polyethylene glycol 3350 still seeing new clinical trial approvals?

PEG 3350 continues to attract trials, but the pattern is typically incremental: formulation, dosing convenience, regimen comparisons, and pediatric-focused endpoints rather than new-molecule development.

2) What endpoints matter most for PEG 3350 constipation differentiation?

Adherence (treatment completion), tolerability, and safety consistency are the most commercially influential endpoints, especially in pediatric use where caregiver administration drives outcomes.

3) Does bowel preparation use of PEG 3350 create a separate market growth engine?

Yes. Procedure volumes (colonoscopy and related endoscopy) drive bowel prep demand, and regimen compliance improvements can expand share inside that demand pool.

4) How does generic competition typically affect PEG 3350 revenue projections?

It compresses net revenue per unit over time and shifts competitive advantage toward labeled differentiation, packaging convenience, and payer-formulary success.

5) What kind of innovation has the best chance of sustaining premium pricing for PEG 3350 products?

Improvements that measurably increase completion and correct administration behavior, such as reduced burden dosing schedules, improved taste/palatability, and regimens that improve bowel cleansing quality.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. Search results for “polyethylene glycol 3350”. (Accessed 2026-04-28). https://clinicaltrials.gov
[2] FDA. Drug Approval Packages and labeling resources for polyethylene glycol-based laxatives and bowel preparations. (Accessed 2026-04-28). https://www.accessdata.fda.gov