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.
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.

Clinical Trial Conditions for Mucinex Dm

Condition Name

Condition Name for Mucinex Dm
Intervention	Trials
Healthy Subjects	7
Acute Respiratory Infection	2
Healthy	1
Mucociliary Clearance	1

Condition MeSH

Condition MeSH for Mucinex Dm
Intervention	Trials
Infections	4
Respiratory Tract 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
Nebraska	3
Massachusetts	3
Kentucky	3
Illinois	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
Vitaccess Ltd	1

Sponsor Type

Sponsor Type for Mucinex Dm
Sponsor	Trials
Industry	18
Other	3

Mucinex DM: Clinical Trials, Market Analysis, and Projections

Last updated: January 7, 2025

Introduction to Mucinex DM

Mucinex DM is a widely used over-the-counter (OTC) medication designed to provide relief from chest congestion and coughing associated with colds, flu, and other respiratory infections. It combines two active ingredients: guaifenesin, an expectorant, and dextromethorphan, a cough suppressant.

Clinical Trials and Efficacy

Historical Clinical Trials

A significant clinical trial that highlighted the efficacy of guaifenesin, the primary component of Mucinex DM, was conducted in 2002. This double-blind trial demonstrated that guaifenesin effectively loosens mucus, making it easier to cough up[4].

Another notable study, although not exclusively on Mucinex DM, involved evaluating the safety and efficacy of Mucinex D (guaifenesin and pseudoephedrine) as an adjunct therapy to antibiotics in patients with acute respiratory infections. This Phase 4 study, completed in 2007, was sponsored by Adams Respiratory Therapeutics and aimed to assess symptom relief in such patients[1].

Mechanism of Action

Mucinex DM works through a dual mechanism:

• Guaifenesin: Acts as an expectorant, thinning and loosening mucus in the airways, making it easier to expel.
• Dextromethorphan: Acts as a cough suppressant, reducing the urge to cough by affecting the brain's cough reflex centers[4].

Market Analysis

Global Guaifenesin Market

The global guaifenesin market, which includes Mucinex DM, is projected to grow significantly. Here are some key points:

• Market Size: The global guaifenesin market is forecasted to reach USD 95 million by 2027, growing at a CAGR of around 3.1% from 2022 to 2027[2].
• Segmentation: The market is segmented by product (tablets, dissolving granules, syrup, extended-release tablets), purity, application (cough treatment drugs, chest congestion medication), and end-use industry (multispecialty hospitals, clinics)[2].
• Geography: North America is the fastest-growing region, driven by developing medical infrastructure, increasing cases of respiratory complications, and rising health expenditure. The region is expected to grow with a CAGR of around 4.5% during the forecast period[2].

Sales and Revenue

Mucinex DM and its variants have shown strong sales performance:

• Mucinex DM Maximum Strength: Sales for the last twelve months were $104 million.
• Mucinex DM Regular Strength: Sales for the last twelve months were $67 million[3].

FDA Approvals and Market Presence

In 2015, Allergan and Perrigo received FDA approval for three Mucinex equivalent products, including Mucinex DM Regular and Maximum Strength. These products are marketed as store brands, providing consumers with high-quality, affordable alternatives[3].

Market Projections

Growing Demand in Healthcare

The demand for guaifenesin, particularly in cough treatment drugs, is expected to rise due to several factors:

• Increasing Respiratory Complications: Rising cases of respiratory infections, such as pertussis (estimated at 24.1 million cases globally), drive the demand for effective treatments like Mucinex DM[2].
• Hospital Sector Growth: The growth in the hospital sector, especially in regions like India where the hospital sector is expected to rise to USD 132.84 billion by 2022, further boosts the demand for guaifenesin-based medications[2].

Challenges and Opportunities

Despite the growth prospects, the guaifenesin market faces challenges:

• Availability of Substitutes: The presence of substitute medications can impact market share.
• Potential Side Effects: While guaifenesin has a relatively safe profile, potential side effects and interactions need to be managed[2].

However, the increasing application of guaifenesin in various forms (tablets, syrups, granules) and its use across different age groups (pediatric and geriatric) offer significant growth opportunities.

Key Takeaways

• Market Growth: The global guaifenesin market is expected to grow at a CAGR of around 3.1% from 2022 to 2027.
• Regional Dominance: North America is the fastest-growing region due to its developing medical infrastructure and rising health expenditure.
• Dual Mechanism: Mucinex DM's combination of guaifenesin and dextromethorphan provides relief from both chest congestion and coughing.
• Clinical Efficacy: Clinical trials have demonstrated the efficacy of guaifenesin in loosening mucus and the additional benefit of dextromethorphan in suppressing coughs.
• Market Presence: Strong sales performance and FDA approvals for equivalent products ensure a robust market presence.

FAQs

What is the primary mechanism of action of Mucinex DM?

Mucinex DM works through a dual mechanism: guaifenesin thins and loosens mucus, while dextromethorphan suppresses the cough reflex.

What are the approved uses of Mucinex DM?

Mucinex DM is approved for treating chest congestion and thick, stubborn mucus, as well as dry cough caused by minor throat and bronchial irritation[4].

How does Mucinex DM differ from regular Mucinex?

Mucinex DM includes dextromethorphan, a cough suppressant, in addition to guaifenesin, making it more effective for treating both mucus-related symptoms and persistent coughing[4].

What is the projected market size of the global guaifenesin market by 2027?

The global guaifenesin market is forecasted to reach USD 95 million by 2027[2].

Which region is expected to be the fastest-growing in the global guaifenesin market?

North America is the fastest-growing region, driven by developing medical infrastructure and rising health expenditure[2].

Sources

1. Lake Clinical Trial Phase 4 Study - Mucinex D as Adjunct Therapy. Mental Health Network of Care.
2. Guaifenesin Market Size Report, 2022-2027 - IndustryARC. IndustryARC.
3. Allergan And Perrigo Receive FDA Approval Of Three Extended-Release Products Equivalent To Mucinex And Mucinex DM. PR Newswire.
4. Mucinex vs Mucinex Dm. WithPower.