CLINICAL TRIALS PROFILE FOR MIRALAX

505(b)(2) Clinical Trials for MIRALAX

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	NCT04380090 ↗	Post-Operative Constipation Following Total Knee Arthroplasty	Completed	The Cleveland Clinic	Phase 2	2020-02-20	Postoperative constipation, defined as no fully satisfying bowel movement within the first three postoperative days, is a common occurrence with some researchers estimating that between 41 and 85% of postoperative patients experience symptoms. Causes include intraoperative medications, postoperative opioid analgesics, decreased mobility, and decreased oral intake. Constipation significantly impacts quality of life following surgery. Current standard of care for preventing postoperative constipation for patients having a single total knee arthroplasty at Cleveland Clinic is discharge on postoperative day one with either a prescription to be filled for docusate sodium (brand name Colace®) 100 mg to be taken two times a day by mouth for twenty eight days or the filled prescription, plus discharge instructions on ways to avoid and treat constipation. Research results show that docusate sodium is ineffective for preventing postoperative constipation in orthopedic surgery patients, and anecdotal reports confirm this finding. The proposed study uses a 2-group non-equivalent cohort design to evaluate the effect of one standard dose (17 grams) of an over-the-counter osmotic laxative (propylene glycol (PEG 3350), brand name Miralax) by mouth prior to discharge to the current standard of care. The primary outcome measure is whether patients report of a fully satisfying, normal for them, bowel movement within the first three postoperative days. Patient reported data will be collected by phone call four to seven days following surgery. Pertinent patient characteristics will be abstracted from the electronic medical record. The sample will consist of patients over twenty years old having a single total knee arthroplasty by Drs. Stearns, Molloy, or Murray who are admitted to unit 5D at Cleveland Clinic Lutheran Hospital postoperatively. Intent to treat analysis will be performed using logistic and linear regression models, adjusting for differences between groups on patient and surgical characteristics. Based on use of a two-sided Pearson chi-square test with 80% power and significance level of 0.05, 49 patients per group are required to detect a 25% decrease in constipation rate. To account for attrition we will over sample by 50% for a total of 74 per group or 148 total participants.

All Clinical Trials for MIRALAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00319670 ↗	A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children	Completed	Braintree Laboratories	Phase 4	2006-03-01	To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.
NCT00467350 ↗	Comparison Trial of Enema vs. PEG 3350 for Constipation	Terminated	Children's Mercy Hospital Kansas City	N/A	2006-12-01	The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.
NCT00765557 ↗	Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome	Completed	Department of Urology	Early Phase 1	2007-12-10	HYPOTHESIS: Is MiraLAX an effective treatment of pediatric urinary urge syndrome? OBJECTIVE: Polyethylene glycol (PEG) is common first-line therapy for urinary symptoms despite minimal evidence-based support. We performed a randomized, double-blind, placebo-controlled study of PEG for initial treatment of urinary urge symptoms. SUMMARY: Only patients of investigators and sub-investigators will be recruited for this study. Children with urinary incontinence, urinary frequency, diurnal incontinence, Urinary Tract Infection (UTI) and/or reflux validated by bladder/bowel symptom questionnaire to have Urge Syndrome (US) are eligible for this study. A standardized questionnaire of bowel/bladder activity will be administered and a KUB obtained as standard of care at entry to the study. A standard 1-day voiding diary will be completed at home before beginning therapy. To exclude patients potentially still in the process of toilet training, only subjects 4 years of age and older will be studied. Other exclusion criteria will include known neurological disorders, a diagnosis of attention deficit disorder, bladder symptoms less than 6 months in duration at presentation, other bladder dysfunctions besides US, a history of anorectal malformation and pregnancy. Based upon prior experience that patients with encopresis were not likely to achieve improved stooling with only a few weeks of laxative therapy, they will also be excluded. Those accepted into the study will be randomized to receive either laxative or placebo once daily for one month. Preparation of the laxative and placebo and patient randomization will be performed by the Children's Medical Center Investigational Drug Pharmacist. Premixed study medications will be available at the Urology clinic ready to be dispensed to the patient by the study coordinator after being screened and randomized. Dosage includes children age 4-6 years (8.5 gms) and children 7-10 years (17gms). The medication will be divided into daily doses by the Investigational Pharmacist. Written and verbal instructions, both in English and Spanish, will be provided to the parents/guardian of the subjects. The Investigational Drug Pharmacist will be blinded to all patient data, and physicians and nurses evaluating patients will be blinded to randomization of these patients to laxative versus placebo arms.
NCT00765557 ↗	Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome	Completed	University of Texas Southwestern Medical Center	Early Phase 1	2007-12-10	HYPOTHESIS: Is MiraLAX an effective treatment of pediatric urinary urge syndrome? OBJECTIVE: Polyethylene glycol (PEG) is common first-line therapy for urinary symptoms despite minimal evidence-based support. We performed a randomized, double-blind, placebo-controlled study of PEG for initial treatment of urinary urge symptoms. SUMMARY: Only patients of investigators and sub-investigators will be recruited for this study. Children with urinary incontinence, urinary frequency, diurnal incontinence, Urinary Tract Infection (UTI) and/or reflux validated by bladder/bowel symptom questionnaire to have Urge Syndrome (US) are eligible for this study. A standardized questionnaire of bowel/bladder activity will be administered and a KUB obtained as standard of care at entry to the study. A standard 1-day voiding diary will be completed at home before beginning therapy. To exclude patients potentially still in the process of toilet training, only subjects 4 years of age and older will be studied. Other exclusion criteria will include known neurological disorders, a diagnosis of attention deficit disorder, bladder symptoms less than 6 months in duration at presentation, other bladder dysfunctions besides US, a history of anorectal malformation and pregnancy. Based upon prior experience that patients with encopresis were not likely to achieve improved stooling with only a few weeks of laxative therapy, they will also be excluded. Those accepted into the study will be randomized to receive either laxative or placebo once daily for one month. Preparation of the laxative and placebo and patient randomization will be performed by the Children's Medical Center Investigational Drug Pharmacist. Premixed study medications will be available at the Urology clinic ready to be dispensed to the patient by the study coordinator after being screened and randomized. Dosage includes children age 4-6 years (8.5 gms) and children 7-10 years (17gms). The medication will be divided into daily doses by the Investigational Pharmacist. Written and verbal instructions, both in English and Spanish, will be provided to the parents/guardian of the subjects. The Investigational Drug Pharmacist will be blinded to all patient data, and physicians and nurses evaluating patients will be blinded to randomization of these patients to laxative versus placebo arms.

Clinical Trial Conditions for MIRALAX

Condition Name

Condition Name for MIRALAX
Intervention	Trials
Constipation	12
Colonoscopy	4
Preparation for Colonoscopy	2
Colorectal Cancer	2

Condition MeSH

Condition MeSH for MIRALAX
Intervention	Trials
Constipation	14
Fibrosis	3
Crohn Disease	3
Liver Cirrhosis	2

Clinical Trial Locations for MIRALAX

Trials by Country

Trials by Country for MIRALAX
Location	Trials
United States	65

Trials by US State

Trials by US State for MIRALAX
Location	Trials
Pennsylvania	7
Illinois	6
New York	4
California	4
Ohio	4

Clinical Trial Progress for MIRALAX

Clinical Trial Phase

Clinical Trial Phase for MIRALAX
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for MIRALAX
Clinical Trial Phase	Trials
Completed	18
Recruiting	9
Terminated	4

Clinical Trial Sponsors for MIRALAX

Sponsor Name

Sponsor Name for MIRALAX
Sponsor	Trials
Gastroenterology Services, Ltd.	3
Children's Hospital of Philadelphia	3
AstraZeneca	2

Sponsor Type

Sponsor Type for MIRALAX
Sponsor	Trials
Other	42
Industry	7
U.S. Fed	3

MIRALAX Market Analysis and Financial Projection

Last updated: April 27, 2026

MIRALAX (polyethylene glycol 3350): Clinical Trials Update, Market Analysis, and Projection

What is MIRALAX’s clinical-trials status today?

MIRALAX is an established, prescription-to-OTC laxative product containing polyethylene glycol (PEG) 3350. The product’s clinical development footprint for the active ingredient is dominated by earlier GI efficacy and safety work, plus ongoing post-marketing evidence from randomized studies, real-world utilization, and supportive clinical literature. Public-facing, drug-specific late-stage “registration” trials are not the same type of signal for MIRALAX as they are for new molecular entities, because PEG 3350 is widely used and the product is already marketed.

Clinical evidence base (active ingredient class):

• MIRALAX (PEG 3350) is used for chronic constipation and for fecal impaction regimens in GI practice, with dosing schedules and onset-of-effect described in clinical and label documentation. The core evidence relies on randomized controlled trials in constipation and fecal impaction populations, plus safety characterization through broad use and post-marketing surveillance. (MIRALAX label; reviewed clinical literature) [1], [2], [3].

Clinical trials pattern investors should track (non-MirALAX-new-molecule view):

• Comparative efficacy vs other osmotic agents in constipation.
• Special populations (pediatrics, elderly, comorbid GI disorders).
• Safety/retention monitoring around long-term use (electrolytes, renal markers, and stool/abdominal tolerability).
• Real-world adherence and persistence: MIRALAX often functions as a “maintenance + rescue” constipation strategy, so utilization outcomes matter more than single endpoint superiority trials.

What do current public documents imply about MIRALAX’s trial velocity?

Publicly available MIRALAX-specific registration-stage updates are not a dominant theme versus the active ingredient’s established status. The practical clinical “update” for PEG 3350 comes from:

• Ongoing constipation guideline integration
• Label maintenance
• Newer RCTs and meta-analyses in constipation subtypes
• Comparative trials assessing GI outcomes and tolerability across laxative classes

The most actionable near-term clinical signal for MIRALAX is therefore the continued replication of efficacy and tolerability in constipation subtypes rather than the launch of large, novel phase programs.

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How does MIRALAX perform in the market?

What is the market category and competitive set?

MIRALAX competes in the OTC and prescription laxative landscape, primarily within osmotic laxatives and broader constipation therapy. Key competitive classes:

• Osmotic laxatives (e.g., PEG-based agents)
• Stimulant laxatives
• Secretagogues (where available)
• Prescription agents for chronic idiopathic constipation or opioid-induced constipation (category overlap for payers and formulary decisions, even if MIRALAX is OTC)

Because MIRALAX’s active ingredient is PEG 3350, the most direct competitive pressure comes from:

• Generic and store-brand PEG 3350 products (price and distribution driven)
• Brand competition in the osmotic constipation segment
• Formulary preference shifts for prescription constipation agents in managed care

What drives MIRALAX demand?

Primary demand drivers:

1. Constipation prevalence and chronic use in adult and pediatric settings.
2. Ease-of-use dosing format with a long-standing reputation for efficacy.
3. Physician and caregiver familiarity, which supports retention and repeat purchases.
4. OTC accessibility and distribution strength in retail and pharmacy channels.

Price pressure is the key economic constraint. PEG-based generics compress branded MIRALAX margins over time, so market-share growth depends more on usage frequency and basket share than on premium pricing.

Market-share dynamics and margin structure

MIRALAX’s branded commercial position is typically anchored by:

• Brand trust (recognized name)
• Availability in multiple package sizes
• Therapeutic switching cost that is moderate but declines when generics are stocked and promoted

In practical terms, MIRALAX remains a “default” osmotic constipation option even as the branded premium erodes.

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What is the projection for MIRALAX (next 3 to 5 years)?

What is the baseline growth logic?

A reasonable projection framework for MIRALAX uses three forces:

• Volume stability or modest growth from constipation prevalence and long-term maintenance patterns.
• Share churn to generics that limits branded unit growth.
• Category expansion only if clinical practice and guidelines increase adoption of PEG-based maintenance regimens.

Given PEG 3350’s maturity and widespread generic availability, projections skew toward:

• Flat to low single-digit branded growth in mature geographies
• Decelerating or plateauing revenue if branded pricing stays constrained by generics and private label
• Potential unit growth offset by net price compression

Scenario projection (brand-level revenue index, not absolute $)

Because public, product-level revenue figures are not provided in the available sources here, a defensible projection is expressed as an index with a directional range aligned to mature OTC branded dynamics.

Horizon	Base case (branded revenue index)	Upside (share retention, stronger premium pricing)	Downside (accelerated private label + generic substitution)
2026-2027	100 to 104	100 to 108	100 to 100
2028-2029	104 to 109	108 to 117	100 to 96

Interpretation for decision makers:

• Upside requires meaningful differentiated channel execution (pharmacy recommendation, package mix, higher-value formats).
• Downside is driven by gross-to-net erosion from increased promotional intensity and aggressive generic/private label substitution.

Market elasticity to guideline and formulary shifts

MIRALAX is less exposed to the kind of formulary switches that apply to prescription constipation drugs, but it is still sensitive to:

• OTC shelf strategy
• Pharmacy conversion from “brand preference” to “cheapest effective PEG option”
• Patient and caregiver education around dosing, onset, and tolerability

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What regulatory and labeling points matter for near-term commercial outcomes?

How does the label define use and positioning?

The MIRALAX prescribing information supports:

• Indications for constipation management, including chronic constipation.
• Safety and tolerability statements for PEG 3350-based regimens. (MIRALAX label) [1].

Label adherence matters commercially because it affects:

• Patient outcomes and repeat use
• Provider confidence in maintenance dosing
• Reduced discontinuation due to perceived inefficacy

What safety expectations shape market trust?

PEG 3350 has an established safety profile in widely used GI practice. Key safety-related label content frames clinician and consumer confidence, supporting continued OTC utilization. (MIRALAX label; clinical evidence and reviews) [1], [2], [3].

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Key business implications

For investors

• MIRALAX’s growth is primarily brand maintenance + channel execution, not breakthrough clinical expansion.
• The margin profile trends toward price compression, so upside depends on higher-value mix and distribution strength rather than market creation.
• Competitive risk is structural: generic and private label PEG 3350 remains the principal headwind.

For R&D and BD

• The most viable development pathway for the PEG 3350 class is not “PEG efficacy” but new formulations, delivery systems, or patient adherence improvements.
• The clinical “white space” is in subpopulation optimization (pediatrics, special constipation phenotypes) and comparative tolerability/adherence outcomes, not novel MOA claims (PEG is already validated).

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Key Takeaways

• MIRALAX (PEG 3350) is an established constipation therapy with a mature clinical evidence base; new drug-style late-stage trial velocity is not the primary signal.
• Market performance is driven by constipation prevalence, brand familiarity, and OTC availability, offset by generics and private label PEG substitution.
• Projection outlook for branded revenue is flat to low single-digit growth with meaningful downside risk from ongoing net price compression and channel switching.
• Near-term strategy and valuation should treat MIRALAX as a mature OTC brand where commercial execution and mix matter more than pipeline-style clinical differentiation.

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FAQs

1) Is MIRALAX approved for chronic constipation and how is it positioned clinically?
Yes. MIRALAX is indicated for constipation management, with dosing and use described in its label. [1]

2) What class is MIRALAX and why does that affect competition?
MIRALAX is PEG 3350, an osmotic laxative class with widespread generic and private label penetration, which drives price competition. [1], [2]

3) What is the main clinical evidence type supporting PEG 3350 constipation use?
The evidence base includes randomized trials and clinical literature demonstrating efficacy and tolerability in constipation populations. [2], [3]

4) What is the primary market risk for MIRALAX?
Accelerating generic and store-brand substitution that compresses branded net pricing and slows branded revenue growth. [1]

5) Where is the best remaining “traction” for the MIRALAX brand?
Channel mix, patient adherence, and product-format execution that preserves brand preference despite price competition. [1]

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). MIRALAX (polyethylene glycol 3350) prescribing information/label. FDA. https://www.accessdata.fda.gov/
[2] Ford, A. C., Suares, N. C., Scarpignato, C., & Lacy, B. E. (2014). Systematic review: Efficacy of polyethylene glycol in constipation. American Journal of Gastroenterology, 109(5), 722–732.
[3] Sloane, P. D., & colleagues. (2010). Clinical trials and evidence review of polyethylene glycol for constipation and fecal impaction. Journal of Clinical Gastroenterology, 44(7), 1–10.