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.
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

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
Texas	3
Ohio	3
Nebraska	3
Massachusetts	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
Dr. Reddy's Laboratories Limited	1

Sponsor Type

Sponsor Type for MUCINEX
Sponsor	Trials
Industry	18
Other	3

Clinical Trials Update, Market Analysis, and Projection for Mucinex (Guaifenesin)

Last updated: October 30, 2025

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Introduction

Mucinex, marketed primarily as an expectorant, is a well-established over-the-counter (OTC) medication containing guaifenesin. Recognized for relieving chest congestion by thinning and loosening mucus, Mucinex is a flagship product within the respiratory therapeutics landscape. Although initially developed decades ago, ongoing clinical trials, evolving consumer preferences, regulatory updates, and emerging competitor strategies influence Mucinex's market trajectory. This report synthesizes recent developments in clinical research, assesses current market dynamics, and provides projections for Mucinex's future performance.

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Clinical Trials Landscape for Guaifenesin and Mucinex

Current Clinical Trials and Research Directions

While Mucinex itself is marketed OTC and not subject to extensive ongoing clinical trials, research continues into guaifenesin’s broader therapeutic applications and formulations. As of 2023, a limited number of registered clinical trials explore:

• Enhanced formulations: New delivery methods, including extended-release tablets, nebulized forms, and combinations with other agents such as dextromethorphan, are under clinical evaluation to improve efficacy and patient compliance [1].

• Off-label uses: Studies assessing guaifenesin's efficacy in managing conditions like chronic cough, bronchitis, and as an adjunct in respiratory therapy aim to expand its therapeutic scope.

• Safety and pharmacokinetics: Research continues focusing on the safety profile, especially in populations such as pediatrics and pregnant women, and on understanding pharmacokinetics of novel formulations.

Most of these trials are sponsored by pharmaceutical companies aiming to develop new formulations or combination products, rather than testing the efficacy of existing Mucinex products per se.

Regulatory Environment and Formulation Innovations

The Food and Drug Administration (FDA) maintains a generally favorable stance toward guaifenesin as an OTC expectorant [2], but there is increasing scrutiny around combination products. Recent regulatory updates favor transparency, especially regarding claims related to efficacy beyond expectorant action.

In response, manufacturers are investing in reformulations such as sustained-release formulations, which can reduce dosing frequency and improve convenience—crucial factors in consumer preference.

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Market Analysis of Mucinex

Market Size and Revenue Streams

The global expectorants market, predominantly led by guaifenesin-based products like Mucinex, is valued at approximately USD 1.2 billion in 2022 [3]. North America accounts for the lion's share owing to high OTC medication penetration and consumer awareness. Mucinex’s parent company, Reckitt Benckiser, holds a significant portion, driven by effective branding and product line diversification.

Competitive Landscape

Mucinex's primary competitors include:

• Robitussin (Johnson & Johnson): Offers expectorant formulations with guaifenesin.
• Duetact: A combination cough syrup.
• Natural and herbal alternatives: Such as herbal expectorants, which appeal to holistic health consumers.

Emerging competitors are focusing on bi-layer tablets, multi-symptom relief formulations, and digital health integrations—all aimed at capturing consumer attention.

Consumer Preferences and Trends

Key trends influencing Mucinex's market include:

• Preference for multi-symptom relief: Consumers favor formulations that address multiple symptoms simultaneously (e.g., cough, congestion, sore throat).
• Shift towards natural remedies: A segment of consumers is shifting towards herbal or natural expectorants, challenging traditional OTC sales.
• Efficacy perception and safety: Trust built over decades supports Mucinex’s brand; however, misinformation and safety concerns regarding combination products influence purchasing behavior.

Regulatory and Economic Factors

Regulatory policies, including the FDA’s oversight of combination OTC products, impact product formulation and marketing. Economically, the COVID-19 pandemic increased demand for respiratory-related OTCs, temporarily boosting Mucinex sales. Post-pandemic recovery indicates a stabilization but emphasizes the importance of innovation and diversification.

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Future Market Projections

Market Growth Trajectory

The expectorant market is projected to grow at a CAGR of 3.5% from 2023 to 2030 [4]. Key drivers include:

• Aging populations: Increased prevalence of chronic respiratory conditions.
• Influenza and respiratory infections: Seasonal and pandemic-related surges sustain demand.
• Product diversification: Innovation in sustained-release and combination drugs will expand market share.

Innovations Driving Growth

• Extended-release formulations: Promising higher patient adherence.
• Combination OTC products: Addressing multi-symptom relief with convenience.
• Digital integration: Telehealth and digital symptom trackers may enhance consumer engagement and product recommendations.

Potential Challenges

• Regulatory hurdles: Stricter oversight on combination claims.
• Market saturation: Competitive pressure from generic manufacturers.
• Natural alternatives: Eroding market share among consumers seeking non-pharmacologic remedies.

In summary, Mucinex is poised for moderate growth, sustained by ongoing innovation, favorable regulatory environment, and broad consumer acceptance. However, success hinges on adaptive marketing strategies and continuous product innovation.

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Key Takeaways

• Clinical research continues to explore unmet needs and enhances formulation strategies for guaifenesin-based expectorants, indirectly influencing Mucinex's product development pipeline.
• Market dynamics favor Mucinex due to strong brand recognition, product diversification, and rising respiratory health awareness.
• Growth prospects depend on innovative formulations, expanded indications, and consumer preference shifts towards multi-symptom and natural remedies.
• Regulatory landscapes demand transparency and efficacy validation, shaping future product claims and marketing.
• Digital health integration offers opportunities for personalized medicine and improved consumer engagement.

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FAQs

1. Is Mucinex undergoing any new clinical trials for expanded indications?
No recent clinical trials focus on Mucinex itself. However, ongoing research into guaifenesin formulations and combination products may influence future indications.

2. What are the main competitors to Mucinex in the expectorant market?
Robitussin and various generic brands represent significant competitors. Additionally, natural expectorants are gaining traction among consumers seeking alternative remedies.

3. How has the COVID-19 pandemic affected Mucinex sales?
The pandemic temporarily boosted OTC respiratory medication sales, including Mucinex, due to heightened respiratory health concerns. Post-pandemic, growth has stabilized, with innovation remaining key.

4. What are the regulatory considerations impacting Mucinex’s future?
Regulatory focus on combination product claims and safety profiles influences formulation development. Transparency and clinical efficacy evidence remain critical.

5. What innovations are likely to influence Mucinex’s market share moving forward?
Extended-release formulations, multi-symptom combination products, and digital health integration are anticipated to be pivotal in maintaining competitive edge.

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References

[1] ClinicalTrials.gov. Guaifenesin Studies. (2023).
[2] FDA. Over-the-Counter Monograph for Guaifenesin. (2021).
[3] MarketWatch. Expect Respiratory Drugs Market Size & Share, 2022.
[4] Grand View Research. Respiratory Therapeutics Market Forecast, 2023-2030.

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Disclaimer: This report reflects current data and projections based on available sources up to early 2023. Market dynamics and clinical research developments are subject to change, requiring ongoing monitoring.