CLINICAL TRIALS PROFILE FOR MUCINEX D

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

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	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.
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.

All Clinical Trials for MUCINEX D

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.

Clinical Trial Conditions for MUCINEX D

Condition Name

Condition Name for MUCINEX D
Intervention	Trials
Healthy Subjects	7
Acute Respiratory Infection	2
Filamentary Keratitis	1
Healthy	1

Condition MeSH

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

Clinical Trial Locations for MUCINEX D

Trials by Country

+

−

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

Trials by US State

+

−

Trials by US State for MUCINEX D
Location	Trials
North Carolina	6
Texas	3
Ohio	3
Nebraska	3
Massachusetts	3

Clinical Trial Progress for MUCINEX D

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for MUCINEX D

Sponsor Name

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

Sponsor Type

Sponsor Type for MUCINEX D
Sponsor	Trials
Industry	18
Other	3

Mucinex D: Clinical Trials, Market Analysis, and Projections

Introduction to Mucinex D

Mucinex D is a widely used over-the-counter (OTC) medication designed to alleviate symptoms associated with colds, allergies, and respiratory infections. It contains two active ingredients: guaifenesin, an expectorant, and pseudoephedrine, a decongestant. Here’s a comprehensive look at the clinical trials, market analysis, and future projections for Mucinex D.

Clinical Trials and Efficacy

Purpose and Design

A notable clinical trial aimed to determine if treatment with Mucinex D could lower the use of antibiotics in the treatment of upper respiratory infections compared to a placebo. This study involved 1,179 participants divided into two patient groups, including a placebo group. The primary purpose was to assess the safety and efficacy of Mucinex D in reducing antibiotic usage[1].

Effectiveness

Mucinex D has been shown to be effective in relieving nasal congestion and sinus pressure. The combination of guaifenesin and pseudoephedrine works by thinning and loosening mucus in the airways and reducing swelling in the nasal passages, respectively. Studies have indicated that both Mucinex D and its variant, Mucinex DM (which includes a cough suppressant), provide significant relief from congestion and cough symptoms, with effects noticeable within hours of administration[4].

Market Analysis

Market Size and Growth

The expectorant drugs market, which includes Mucinex D, is projected to experience steady growth. By 2025, the market is expected to reach USD 104.5 million and is anticipated to grow at a CAGR of 4.5% to reach USD 130.23 million by 2030[2].

Regional Dominance

North America is expected to dominate the expectorant drugs market, driven by the high prevalence of respiratory diseases, the presence of key players, rising R&D expenditure, and an aging population. The Asia Pacific region is estimated to be the fastest-growing market due to increasing healthcare infrastructure and rising demand for effective treatments for respiratory conditions[2].

Key Players

Major companies operating in the expectorant drugs market include Merck KGaA, Perrigo Company plc, Sun Pharmaceutical Industries Ltd, Johnson & Johnson Private Limited, and Sanofi. These companies are driving innovation and growth in the market through continuous research and development[2].

Market Projections

Global Expectorant Drugs Market

The global expectorant drugs market is projected to reach significant milestones. By 2033, the market is expected to grow to US$ 27.8 billion from US$ 16.8 billion in 2023, at a CAGR of 5.2%[3].

Segment Analysis

• Drug Type: Guaifenesin, the active ingredient in Mucinex D, led the drug type segment in 2023, holding over 47.9% of the market share[3].
• Formulation: Tablets dominated the formulation segment, capturing more than 40.5% of the market share[3].
• Route of Administration: Oral administration led the route of administration segment, accounting for over 68.5% of the market share[3].
• Indications: Chronic Obstructive Pulmonary Disease (COPD) was the leading indication for expectorant drugs in 2023, with a 35.4% market share[3].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the global guaifenesin market, including disruptions in production and supply chains. However, the surging demand for cough and cold medications during the recovery phase led to major growth opportunities. The pandemic highlighted the importance of effective treatments for respiratory conditions, further driving the demand for expectorants like guaifenesin[5].

Regional Growth

North America

North America remains the largest market for expectorant drugs, driven by the high prevalence of respiratory diseases and a well-developed pharmaceutical sector. The region is expected to continue its dominance due to factors such as rising health expenditure and an aging population[2][5].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing market, driven by increasing healthcare infrastructure and a growing demand for effective treatments for respiratory conditions. This region offers significant growth opportunities for companies operating in the expectorant drugs market[2][5].

Challenges and Opportunities

Availability of Substitutes and Side Effects

The global guaifenesin market faces challenges such as the availability of substitute products and potential side effects. However, the growing application of guaifenesin in cough treatment drugs and its increasing usage in hospitals and clinics are expected to drive market growth despite these challenges[5].

Growing Demand in Hospitals

The demand for guaifenesin is flourishing in hospitals for various applications, including cough treatment drugs and chest congestion relief. The advancement in pharmaceutical technology and the growth in hospital infrastructure are expected to boost the demand for guaifenesin, offering major growth opportunities in the market[5].

Key Takeaways

• Clinical Efficacy: Mucinex D has been shown to be effective in reducing nasal congestion and sinus pressure, and it may help lower the use of antibiotics in treating upper respiratory infections.
• Market Growth: The expectorant drugs market, including Mucinex D, is projected to grow at a CAGR of 4.5% to reach USD 130.23 million by 2030.
• Regional Dominance: North America dominates the market, while the Asia Pacific region is the fastest-growing.
• COVID-19 Impact: The pandemic has driven growth in the demand for cough and cold medications, benefiting the guaifenesin market.
• Challenges and Opportunities: Despite challenges like substitute products and side effects, the growing demand in hospitals and advancements in pharmaceutical technology are expected to drive market growth.

FAQs

What are the active ingredients in Mucinex D?

Mucinex D contains guaifenesin, an expectorant, and pseudoephedrine, a decongestant[4].

How does Mucinex D work?

Mucinex D works by thinning and loosening mucus in the airways (guaifenesin) and reducing swelling in the nasal passages (pseudoephedrine), making it easier to breathe and relieving congestion[4].

What is the projected market size for expectorant drugs by 2030?

The expectorant drugs market is expected to reach USD 130.23 million by 2030, growing at a CAGR of 4.5% from 2025 to 2030[2].

Which region is expected to be the fastest-growing market for expectorant drugs?

The Asia Pacific region is estimated to be the fastest-growing market for expectorant drugs[2].

How has the COVID-19 pandemic impacted the guaifenesin market?

The COVID-19 pandemic disrupted production and supply chains but also led to a surge in demand for cough and cold medications, driving growth in the guaifenesin market during the recovery phase[5].

Sources

1. Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute Upper Respiratory Infection - ClinicalTrials.gov
2. Expectorant Drugs Market Size & Share Analysis - Mordor Intelligence
3. Expectorant Drugs Market Size, Share | CAGR Of 5.2% - Market.US
4. Mucinex D vs Mucinex Dm - WithPower
5. Guaifenesin Market Size Report, 2022-2027 - IndustryARC