CLINICAL TRIALS PROFILE FOR MUCINEX

505(b)(2) Clinical Trials for Mucinex

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

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.

Clinical Trial Conditions for Mucinex

Condition Name

Condition Name for Mucinex
Intervention	Trials
Healthy Subjects	7
Acute Respiratory Infection	2
Common Cold	1
Filamentary Keratitis	1

Condition MeSH

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

Clinical Trial Locations for Mucinex

Trials by Country

Trials by Country for Mucinex
Location	Trials
United States	63
India	1

Trials by US State

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

Clinical Trial Progress for Mucinex

Clinical Trial Phase

Clinical Trial Phase for Mucinex
Clinical Trial Phase	Trials
Phase 4	4
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

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

Clinical Trial Sponsors for Mucinex

Sponsor Name

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

Sponsor Type

Sponsor Type for Mucinex
Sponsor	Trials
Industry	18
Other	3

The Comprehensive Guide to Mucinex: Clinical Trials, Market Analysis, and Projections

Introduction to Mucinex

Mucinex, a brand name for the drug guaifenesin, is a widely used expectorant that helps in the clearance of mucus from the airways, providing relief to patients with respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, and acute respiratory infections.

Clinical Trials and Approval Process

Before any drug, including guaifenesin, can be approved for market use, it must undergo a rigorous clinical trial process.

Phases of Clinical Trials

• Phase 1: Focuses on safety and dosage in a small group of healthy volunteers, typically 20 to 100 people, over one to two years. The goal is to identify frequent side effects and determine if the drug is safe[1].
• Phase 2: Evaluates efficacy and safety in a larger group, usually 100 to 300 people, also over one to two years. This phase determines if the drug works as intended[1].
• Phase 3: Involves a larger population, typically 1,000 to 3,000 people, and takes two to three years. This phase further assesses efficacy, safety, and side effects, often including different study groups to account for various genetic backgrounds[1].
• Phase 4 (Post-Marketing): After the drug is approved and enters the market, post-marketing studies gather additional data on safety, efficacy, and optimal use in a real-world setting, involving hundreds of thousands to millions of people[1].

Guaifenesin, the active ingredient in Mucinex, has undergone these phases and has been approved by the FDA for use as an expectorant.

Market Analysis

Market Size and Growth

The global guaifenesin market is expected to experience significant growth. By 2033, the market is projected to reach $2.7 billion, up from $1.3 billion in 2023, growing at a Compound Annual Growth Rate (CAGR) of 7.4% during the forecast period from 2024 to 2033[2].

Key Drivers of the Market

• Increasing Demand for Respiratory Health Products: The COVID-19 pandemic has highlighted the importance of respiratory health, leading to an increased demand for expectorant drugs like guaifenesin[3].
• Pharmaceutical and Biotech Advancements: New drug formulations and the approval of over-the-counter (OTC) equivalents, such as Mucinex DM Maximum Strength, have boosted the market[3].
• Geographical Growth: North America is the fastest-growing region, driven by developing medical infrastructure, rising health expenditure, and an increase in respiratory and cough-related complications[3].

Product Segmentation

The guaifenesin market is segmented by product type, application, and distribution channel.

• Product Type: Tablets, granules, syrups, and others. Tablets led the market in 2023 with a 42.7% market share[2].
• Application: Mucolytic agent, cough suppressant, and others. Cough suppressant held a significant share of 48.3% in 2023[2].
• Distribution Channel: Retail pharmacies, hospital pharmacies, and online pharmacies. Hospital pharmacies dominated with a 46.5% revenue share in 2023[2].

Regional Analysis

North America, particularly the US and Canada, leads the market, followed by Europe and the Asia Pacific region. The growth in these regions is driven by increasing cases of respiratory conditions and advancements in medical infrastructure[2][5].

Trends in the Guaifenesin Market

Shift Toward Combination Therapies

There is a growing preference for combination therapies that offer multi-symptom relief. Consumers are opting for medications that combine guaifenesin with other active ingredients like dextromethorphan and pseudoephedrine. This trend is reflected in the significant sales of combination cough and cold medications, which accounted for approximately 60% of OTC respiratory product sales in the US in 2023[2].

Impact of COVID-19

The COVID-19 pandemic has accelerated the growth of the pharmaceutical sector, including the demand for cough and cold medications. This trend is expected to continue post-pandemic, contributing to the growth of the guaifenesin market[3].

Safety and Efficacy

Clinical Evidence

While early studies on guaifenesin showed some clinical benefit, they were limited by small cohorts and lack of robust statistical analyses. However, post-marketing surveillance over more than 50 years has supported a favorable safety profile for guaifenesin, with no associated fatalities reported during extensive surveillance periods[4].

Real-World Use

The real-world use of guaifenesin, as observed in post-marketing studies, has provided valuable insights into its safety and efficacy in a broader population. This ongoing monitoring ensures that the drug continues to meet safety and efficacy standards in diverse patient groups[1].

Key Takeaways

• The global guaifenesin market is expected to reach $2.7 billion by 2033, growing at a CAGR of 7.4% from 2024 to 2033.
• North America is the fastest-growing region due to its developing medical infrastructure and rising health expenditure.
• The demand for guaifenesin is driven by its use in treating respiratory issues, including cough and nasal congestion.
• Combination therapies and the COVID-19 pandemic have significantly impacted market growth.
• Post-marketing studies continue to support the safety and efficacy of guaifenesin.

FAQs

What is the primary use of guaifenesin in Mucinex?

Guaifenesin in Mucinex is used as an expectorant to help clear mucus from the airways, providing relief for patients with respiratory conditions.

How does the clinical trial process for drugs like guaifenesin work?

The clinical trial process involves four phases: Phase 1 (safety and dosage), Phase 2 (efficacy and safety), Phase 3 (large-scale efficacy and safety), and Phase 4 (post-marketing studies).

What are the key drivers of the guaifenesin market growth?

Key drivers include increasing demand for respiratory health products, pharmaceutical and biotech advancements, and geographical growth, particularly in North America.

What is the trend towards combination therapies in the guaifenesin market?

There is a growing preference for combination therapies that offer multi-symptom relief, combining guaifenesin with other active ingredients to address various symptoms simultaneously.

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

The COVID-19 pandemic has accelerated the growth of the pharmaceutical sector, including the demand for cough and cold medications, and this trend is expected to continue post-pandemic.

Sources

1. ACS Pressroom: "The rise and fall of a fake decongestant: What phenylephrine tells us about the FDA’s evolving standards for safety and efficacy"[1].
2. Market.US: "Global Guaifenesin Market Size, Share | CAGR Of 7.4%"[2].
3. DrugPatentWatch: "Pharmaceutical drug prices and trends for SM GUAIFENESIN-PSE ER"[3].
4. Journal of COPD Foundation: "Guaifenesin & CMH in Stable Chronic Bronchitis - A Comprehensive Review"[4].
5. IndustryARC: "Guaifenesin Market Size Report, 2022-2027"[5].

Last updated: 2025-01-02