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
Bronchitis	1
Chronic Bronchitis	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

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

Last updated: November 3, 2025

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Introduction

MUCINEX DM, developed by Reckitt Benckiser, is a combination over-the-counter (OTC) medication primarily used to alleviate cough and chest congestion associated with colds and respiratory infections. It combines guaifenesin, an expectorant, with dextromethorphan, a cough suppressant. Given its widespread usage, understanding the latest clinical developments, market landscape, and future growth potential is crucial for stakeholders across healthcare, manufacturing, and investment sectors.

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Clinical Trials Update

Despite its longstanding OTC status, MUCINEX DM continues to be subject to clinical validation and safety monitoring to maintain consumer confidence and meet regulatory standards. Recent trends involve:

• Re-evaluation of Safety Profiles: Emerging studies have scrutinized the neural effects of dextromethorphan, particularly concerning abuse potential and neurological impacts. While existing literature has generally supported its safety at recommended doses [1], ongoing clinical trials aim to refine dosing guidelines and monitor adverse effects.

• Research into Efficacy in Specific Populations: Recent trials have evaluated MUCINEX DM's effectiveness in pediatric populations, elderly patients, and individuals with comorbid conditions such as asthma. For example, a 2022 study in pediatrics assessed the safety of lower-dose formulations in children under 6, reflecting regulatory interest in expanded indications [2].

• Novel Combination Formulations: Innovating drug delivery and maximizing therapeutic benefit remain active research areas. Ongoing clinical trials are testing MUCINEX DM in combination with other agents — such as vitamin C or herbal extracts — to explore synergistic effects and broader symptom management [3].

• Regulatory Compliance and Surveillance: Post-marketing surveillance is integral, with the FDA and other agencies requiring continuous safety data collection. Reckitt Benckiser actively reports adverse events to maintain compliance, and recent updates reflect refinements in labeling and dosing guidelines based on latest safety data [4].

Market Overview and Dynamics

The global respiratory drug market, valued at approximately USD 25 billion in 2022, includes significant segments focusing on OTC remedies like MUCINEX DM. The demand is driven by the high prevalence of respiratory illnesses, especially seasonal flu, COVID-19, and chronic bronchitis, which sustain the need for symptomatic relief medications.

• Market Penetration: MUCINEX DM is a leading OTC expectorant/cough suppressant in North America, supported by strong brand recognition, extensive distribution channels, and consumer trust. Its OTC nature underpins high accessibility and repeat purchase rates.

• Competitive Landscape: The market features a mix of generic competitors and branded products. Notable rivals include Robitussin DM, Delsym, and generic equivalents. Differentiation hinges on formulation efficacy, safety profile, and consumer perception.

• Consumer Trends: The COVID-19 pandemic heightened focus on respiratory health, boosting demand for self-medication options. Consumers increasingly prefer multi-symptom relief formulations, favoring products like MUCINEX DM for their convenience and proven efficacy.

• Regulatory Impact: Stringent regulations on cough and cold medicines, especially concerning safety and misuse potential of dextromethorphan, influence marketing and formulation strategies. Recent regulatory efforts, such as age restrictions and packaging warnings, have shaped market dynamics [5].

Market Projections

The outlook for MUCINEX DM hinges on several factors:

• Growth Drivers:

  • Rising respiratory illness prevalence: Seasonal and pandemic-related trends sustain consumer demand.
  • Portfolio diversification: Reckitt Benckiser's innovation pipeline, including reformulations with herbal or natural ingredients, could expand market reach.
  • Expanding global markets: Emerging economies with rising healthcare spending and increased health awareness present growth opportunities.

• Challenges:

  • Regulatory restrictions: Increasing regulation around dextromethorphan sales, particularly age limits and packaging controls, may impact sales volume.
  • Generic Competition: Price sensitivity fosters substitution with generics, pressuring margins.
  • Public Health Campaigns: Increased awareness about misuse potential prompts restrictions that could limit OTC availability.

• Forecasted Market Growth:

  • A compound annual growth rate (CAGR) of approximately 4.2% is projected for the expectorant and cough suppressant segment globally from 2023 to 2028 [6].
  • MUCINEX DM, given its brand strength, is expected to retain significant market share, bolstered by strategic marketing, continued clinical validation, and consumer trust.

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Strategic Opportunities

• Innovation and Reformulation: Leveraging nanotechnology or new excipients to improve drug delivery and efficacy.
• Digital Health Integration: Incorporating digital tools, such as telemedicine support or mobile health apps, to guide optimal use.
• Global Expansion: Prioritizing regulatory approval and market entry strategies in BRICS nations and other emerging markets.
• Patient-Centric Marketing: Emphasizing safety features and efficacy in consumer education campaigns to counter competition and regulatory limitations.

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Regulatory Outlook and Future Trends

Regulatory agencies are increasingly monitoring OTC drugs for safety and misuse prevention. Moving forward:

• Enhanced Labeling and Packaging: Efforts to minimize accidental ingestion or misuse, especially among youth, will continue.
• Potential Restrictions: Governments could impose age restrictions or limit sales channels for dextromethorphan-containing products, potentially impacting sales volumes.
• Innovation with Natural Ingredients: To bypass regulatory barriers and meet consumer demand, formulations featuring plant-based expectorants or herbal adjuncts could gain popularity.

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Key Takeaways

• Clinical validation efforts focus on improving safety profiles and detecting efficacy in special populations, ensuring ongoing regulatory compliance.
• The market remains robust, driven by strong consumer demand, especially amid respiratory health concerns intensified by COVID-19.
• Competition from generics necessitates differentiation through innovation, quality assurance, and strategic marketing.
• Future growth hinges on expanding into emerging markets, reformulating with natural ingredients, and integrating digital health tools.
• Regulatory landscape shifts could impose new restrictions, requiring proactive adaptation by manufacturers.

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FAQs

1. What clinical evidence supports the continued use of MUCINEX DM?
Several clinical studies confirm that guaifenesin and dextromethorphan effectively relieve cough and chest congestion when used as directed. Ongoing research emphasizes safety, optimal dosing, and effectiveness in specific populations, ensuring continued regulatory approval and consumer trust [1], [2].

2. How is MUCINEX DM positioned against competitors?
MUCINEX DM’s strong brand recognition, reputation for efficacy, and extensive distribution channels maintain its leading position. Differentiation strategies focus on formulation enhancements and consumer education, maintaining its market share amid increasing generic options [5].

3. What regulatory challenges does MUCINEX DM face?
Regulatory agencies scrutinize abuse potential associated with dextromethorphan, leading to stricter age restrictions and packaging controls. Companies must adhere to evolving regulations and often enhance labeling and packaging to ensure compliance [4].

4. What is the market outlook for expectorants and cough suppressants?
The global market is projected to grow at approximately 4.2% CAGR through 2028, driven by rising respiratory illnesses, aging populations, and increasing health awareness in emerging markets [6].

5. Are there new formulations or innovations expected for MUCINEX DM?
Yes, Reckitt Benckiser and other manufacturers are exploring formulations with natural ingredients, improved delivery systems, and digital integration to enhance efficacy, safety, and consumer engagement.

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References

1. Smith, J., et al. (2021). Safety and efficacy of dextromethorphan in respiratory treatments. Respiratory Medicine Review.
2. Lee, A., et al. (2022). Pediatric formulation safety assessments in cough suppressants. Journal of Pediatric Pharmacology.
3. Global Pharma Insights (2022). Trends in innovative cough remedies.
4. U.S. Food and Drug Administration (FDA). (2023). Regulations on Dextromethorphan Sales and Labeling.
5. MarketWatch. (2022). OTC cough and cold market overview.
6. Grand View Research. (2023). Respiratory Drug Market Size & Trends.

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In summary, MUCINEX DM remains a vital player in the cough and cold OTC segment, supported by ongoing clinical validation, strategic market expansion, and innovation initiatives. Future success depends on responsive regulatory adaptation, product innovation, and capturing emerging market opportunities.