CLINICAL TRIALS PROFILE FOR MUCINEX DM

505(b)(2) Clinical Trials for MUCINEX DM

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	NCT00902707 ↗	Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung	Completed	Reckitt Benckiser Inc.	Phase 1	2009-05-01	The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
OTC	NCT00902707 ↗	Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung	Completed	Reckitt Benckiser LLC	Phase 1	2009-05-01	The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
OTC	NCT00902707 ↗	Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung	Completed	University of North Carolina, Chapel Hill	Phase 1	2009-05-01	The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
OTC	NCT01114581 ↗	Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection	Completed	Reckitt Benckiser LLC	Phase 2	2010-04-01	The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.

All Clinical Trials for MUCINEX DM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00441246 ↗	Phase 4 Study - Mucinex D as Adjunct Therapy	Completed	Adams Respiratory Therapeutics	Phase 4	2007-02-01	The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.
NCT00902707 ↗	Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung	Completed	Reckitt Benckiser Inc.	Phase 1	2009-05-01	The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
NCT00902707 ↗	Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung	Completed	Reckitt Benckiser LLC	Phase 1	2009-05-01	The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
NCT00902707 ↗	Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung	Completed	University of North Carolina, Chapel Hill	Phase 1	2009-05-01	The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
NCT01046136 ↗	Mucinex Exploratory Cold Study	Completed	Reckitt Benckiser Inc.	Phase 2	2009-12-01	This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.
NCT01046136 ↗	Mucinex Exploratory Cold Study	Completed	Reckitt Benckiser LLC	Phase 2	2009-12-01	This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.

Clinical Trial Conditions for MUCINEX DM

Condition Name

Condition Name for MUCINEX DM
Intervention	Trials
Healthy Subjects	7
Acute Respiratory Infection	2
Acute Upper Respiratory Track Infection	1
Acute Upper Respiratory Tract Infection	1

Condition MeSH

Condition MeSH for MUCINEX DM
Intervention	Trials
Respiratory Tract Infections	4
Infections	4
Infection	3
Bronchitis	2

Clinical Trial Locations for MUCINEX DM

Trials by Country

Trials by Country for MUCINEX DM
Location	Trials
United States	63
India	1

Trials by US State

Trials by US State for MUCINEX DM
Location	Trials
North Carolina	6
California	3
South Carolina	3
Texas	3
Ohio	3

Clinical Trial Progress for MUCINEX DM

Clinical Trial Phase

Clinical Trial Phase for MUCINEX DM
Clinical Trial Phase	Trials
Phase 4	4
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for MUCINEX DM
Clinical Trial Phase	Trials
Completed	15
Not yet recruiting	1

Clinical Trial Sponsors for MUCINEX DM

Sponsor Name

Sponsor Name for MUCINEX DM
Sponsor	Trials
Reckitt Benckiser LLC	9
Reckitt Benckiser Inc.	6
Adams Respiratory Therapeutics	1

Sponsor Type

Sponsor Type for MUCINEX DM
Sponsor	Trials
Industry	18
Other	3

MUCINEX DM Market Analysis and Financial Projection

Last updated: May 4, 2026

Clinical Trials Update, Market Analysis, and Projection for MUCINEX DM

MUCINEX DM is an over-the-counter (OTC) fixed-dose combination of dextromethorphan hydrobromide (for cough) and guaifenesin (for mucus). It is marketed in multiple formulations, with product-level and brand-level manufacturing/distribution by major OTC players. No consolidated, drug-development-style “clinical trial pipeline” exists in the typical investigational sense because MUCINEX DM is an established OTC product with well-characterized active ingredients and ongoing post-market work that is not typically tracked as phase-based registration.

What is the clinical evidence base behind MUCINEX DM?

Is there a current phase-based clinical pipeline for MUCINEX DM?

There is no standardized, publicly tracked phase 1 to phase 3 program for “MUCINEX DM” as a single product in registries in the way it would exist for a novel prescription drug. The active ingredients are long-standing:

• Dextromethorphan: antitussive with extensive historical clinical use.
• Guaifenesin: expectorant with extensive historical clinical use.

For OTC combinations, clinical updates tend to be product-specific (bioequivalence, formulation changes, stability, and post-marketing safety surveillance) rather than novel efficacy claims under new indications.

What types of studies show up in practice for OTC cough/cold combinations?

Across OTC cough and cold products, the clinical work that is commonly public and relevant falls into these buckets:

• Bioequivalence / comparative pharmacokinetic studies when formulation or dosage form changes occur.
• Human factor studies or palatability/tolerability studies for specific dosage forms.
• Stability and formulation work that is often not labeled as “clinical trials” but supports continued supply and regulatory compliance.
• Post-marketing safety signals and adverse-event monitoring via FDA MedWatch and related surveillance.

These updates do not usually translate into new market exclusivity eras the way branded prescription assets do.

What does the evidence imply for near-term product strategy?

Because the active ingredients are not new and the label is not expanding into new therapeutic categories via phase trials, the commercial competitive set is typically shaped by:

• price and promotional intensity
• packaging formats (liquid, tablets, extended release, max strength variants)
• channel access (mass, club, pharmacy chains, e-commerce)
• supply continuity and retailer planogram placement

What is happening in the market for OTC cough and cold products like MUCINEX DM?

Core demand drivers

The OTC cough and cold segment moves with seasonal respiratory virus pressure and consumer symptom management behavior. Mucinex DM sits in a large category that includes:

• cough suppressant products (dextromethorphan-based)
• expectorants (guaifenesin-based)
• combination products (mucus + cough)

Key demand factors:

• winter seasonality (respiratory infection incidence)
• consumer preference for “one-bottle” combination symptom relief
• retailer merchandising and trade spend
• substitution dynamics between branded and private label OTC cough products

Competitive landscape

MUCINEX DM competes primarily against:

• other OTC combo products using dextromethorphan and guaifenesin
• cough suppressant only products (e.g., dextromethorphan single-ingredient)
• expectorant only products (e.g., guaifenesin single-ingredient)
• store-brand equivalents

Commercially, brand equity and distribution scale tend to matter more than clinical differentiation for these ingredients.

Regulatory and label constraints

OTC cough and cold product positioning is constrained by:

• existing monograph frameworks and/or OTC regulatory pathways for cough/cold uses
• label language requirements for dosing, age limitations, and warnings

For fixed-dose combinations, the product must stay within recognized OTC use constraints; these are not usually the basis for “pipeline-like” market expansions.

What is the market outlook and how should you project MUCINEX DM volume and revenue?

Projection framework for an OTC combination

A practical projection for an established OTC product usually uses:

1. Category seasonal baseline (winter peak and off-season trough)
2. Share-of-category stability (or modest shift tied to promotion, distribution, and price)
3. Price and mix (size pack, formulation versions, “max strength” variants)
4. Channel mix changes (e-commerce vs stores)
5. Regulatory or supply shocks (rare, but can move share temporarily)

Because MUCINEX DM is not a prescription R&D asset, projections are less about clinical milestones and more about retail economics and category health.

Scenario structure (base, upside, downside)

Use three scenarios anchored to category demand and brand share behavior:

• Base case

  • Category demand follows typical respiratory-season variability
  • Brand share is stable
  • Price/mix reflects modest increases tied to inflation and pack upgrades

• Upside case

  • Stronger-than-normal respiratory season in key geographies
  • Higher promotional effectiveness and retailer inventory stability
  • Mix shifts toward premium variants or larger packs

• Downside case

  • Weaker seasonality
  • Higher private label penetration or stronger competitive promotional pressure
  • Retail inventory constraints reduce sell-through

What a credible projection needs to be anchored to

For investment-grade projection, you must anchor to:

• historical annual sales trend for the specific brand and dosage form
• OTC cough/cold category dollar and unit movement
• retailer and channel-specific distribution counts
• SKU-level performance (liquid vs tablet; dosing frequency; pack size)

Without those datasets in the prompt, the only accurate “projection” you can produce would be non-quantified scenario logic, which does not meet high-stakes decision standards.

What clinical trial-related milestones should be monitored now?

Product-level updates that can still matter commercially

Even without phase trials, monitor:

• formulation changes that trigger new stability packages and may shift SKU pricing
• pack-size changes that affect shelf velocity
• any public comparative studies that confirm OTC performance claims within regulatory constraints
• adverse-event trends connected to cough suppressant use (notably dextromethorphan safety in misuse contexts)

Signals that could change market positioning

The strongest “clinical” signals for an OTC combination come from:

• label updates (age restrictions, dosing limits, warnings)
• safety communications in relation to dextromethorphan-containing products
• regulator action tied to OTC cough/cold product compliance

Key Takeaways

• MUCINEX DM does not function like a phase-based clinical asset; it is an established OTC combination of dextromethorphan and guaifenesin, with ongoing post-market and product-maintenance activity rather than a visible phase pipeline.
• Market performance is driven primarily by seasonal respiratory demand, retailer execution, price/mix, and brand-versus-private-label substitution.
• High-quality projections require historical brand/SKU unit and revenue data plus category movement. A scenario framework is appropriate, but a quantified projection cannot be produced from the information provided.

FAQs

1) Does MUCINEX DM have active phase 3 trials registered under that product name?

No publicly trackable phase-by-phase investigational program typically exists for “MUCINEX DM” as an OTC brand product in the way it does for prescription pipeline drugs.

2) What are the two active ingredients in MUCINEX DM?

MUCINEX DM combines dextromethorphan hydrobromide (antitussive) and guaifenesin (expectorant).

3) What drives seasonal demand for products like MUCINEX DM?

Respiratory virus incidence and winter seasonality drive OTC cough and mucus management demand.

4) What kind of studies are most likely to appear for OTC cough/cold products?

Bioequivalence, formulation comparatives, stability work, and post-marketing safety surveillance are the most common study types.

5) How should you model MUCINEX DM market growth?

Use a base-category baseline with share stability assumptions, then adjust for promotional intensity, price/mix, and channel mix shifts via scenarios.

References

[1] U.S. Food and Drug Administration (FDA). Orange Book (search for OTC-related entries is limited for OTC products; use for active ingredient regulatory context). https://www.accessdata.fda.gov/scripts/cder/ob/
[2] U.S. Food and Drug Administration (FDA). MedWatch: The FDA Safety Information and Adverse Event Reporting Program. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
[3] U.S. Food and Drug Administration (FDA). FDA OTC drug monograph framework resources (cough and cold context). https://www.fda.gov/drugs/over-counter-otc-drugs/over-counter-otc-drug-monograph-system
[4] National Library of Medicine. ClinicalTrials.gov (query for dextromethorphan and guaifenesin; product-name-level visibility varies for OTC). https://clinicaltrials.gov/