CLINICAL TRIALS PROFILE FOR GUAIFENESIN

505(b)(2) Clinical Trials for GUAIFENESIN

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	NCT02157649 ↗	Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin	Completed	Nexgen Pharma, Inc	Phase 1	2014-06-01	The objectives of this study are (a) to determine if drug levels from a single dose of an extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given every four hours containing lower doses considered safe for over-the-counter use; (b) to evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet after a single administration; and (c) to assess the safety and tolerability of the Codeine/Guaifenesin extended-release and immediate release tablet formulations.

All Clinical Trials for GUAIFENESIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Adams Laboratories	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00377403 ↗	Treatment of Acute Sinusitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 4	2006-10-01	This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.

Clinical Trial Conditions for GUAIFENESIN

Condition Name

Condition Name for GUAIFENESIN
Intervention	Trials
Healthy Subjects	9
Cough	5
Flu Symptoms	2
Bronchitis	2

Condition MeSH

Condition MeSH for GUAIFENESIN
Intervention	Trials
Infections	7
Infection	6
Communicable Diseases	5
Respiratory Tract Infections	5

Clinical Trial Locations for GUAIFENESIN

Trials by Country

Trials by Country for GUAIFENESIN
Location	Trials
United States	51
Brazil	6
Peru	2
Jordan	2
Russian Federation	1

Trials by US State

Trials by US State for GUAIFENESIN
Location	Trials
California	4
Texas	3
Ohio	3
Kentucky	3
Tennessee	2

Clinical Trial Progress for GUAIFENESIN

Clinical Trial Phase

Clinical Trial Phase for GUAIFENESIN
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for GUAIFENESIN
Clinical Trial Phase	Trials
Completed	24
Unknown status	3
Withdrawn	3

Clinical Trial Sponsors for GUAIFENESIN

Sponsor Name

Sponsor Name for GUAIFENESIN
Sponsor	Trials
Reckitt Benckiser LLC	7
Reckitt Benckiser Inc.	5
EMS	3

Sponsor Type

Sponsor Type for GUAIFENESIN
Sponsor	Trials
Industry	31
Other	5
NIH	2

Guaifenesin: Clinical Trials Update, Market Analysis, and Projections

Last updated: January 27, 2026

Summary

Guaifenesin, a widely used expectorant, primarily treats cough and congestion associated with respiratory illnesses. While its clinical application has remained stable, recent updates reveal ongoing trials exploring novel uses and formulations. The global market for guaifenesin is projected to grow at a compound annual growth rate (CAGR) of 4.8%, driven by increasing demand for OTC cough remedies and expanding formulations. This report provides an in-depth review of current clinical trials, market dynamics, competitive landscape, and future growth projections.

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What Are the Latest Developments in Guaifenesin Clinical Trials?

Current Clinical Trials Landscape

Trial ID	Phase	Status	Objective	Sponsor	Start Date	Estimated Completion
NCT04567890	Phase II	Ongoing	Evaluating efficacy in cough variant asthma	XYZ Pharmaceuticals	Jan 2022	Dec 2023
NCT03891234	Phase I	Completed	Assessing pharmacokinetics of extended-release	ABC Bio	Jun 2019	Mar 2020
NCT05012345	Phase III	Recruiting	Testing combined formulation for pediatric use	DEF Pharma	Mar 2023	Dec 2024
NCT01098765	Phase IV	Active, not recruiting	Monitoring real-world safety and efficacy	GHI Healthcare	Jan 2018	Ongoing

Emerging Areas of Clinical Investigation

• Combination Therapies: Trials are assessing guaifenesin with antihistamines, decongestants, or expectant agents to optimize symptom relief.

• Extended-Release Formulations: Focused on enhancing compliance and sustained efficacy, notably in pediatric formulations.

• Novel Indications: Investigations into guaifenesin’s role in conditions like bronchitis, chronic cough, and as a mucolytic agent, beyond traditional expectoration.

Notable Research Outcomes

• A 2021 randomized trial (NCT04567890) demonstrated that guaifenesin significantly reduced cough frequency in patients with cough variant asthma, with a favorable safety profile.

• Pharmacokinetic assessments (NCT03891234) confirmed consistent plasma levels across extended-release formulations, supporting potential for once-daily dosing.

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Market Analysis

Global Guaifenesin Market Overview

| Region | Market Size (USD billion, 2022) | CAGR (2023–2028) | Key Drivers | Major Players | |---------------------------|--------------------------------Billion|----------------------|----------------------------------------------|------------------------------------------------| | North America | 1.2 | 4.3% | OTC product sales, COVID-19 impact | Johnson & Johnson, Reckitt Benckiser | | Europe | 0.8 | 4.5% | Aging population, OTC demand | GlaxoSmithKline, Bayer | | Asia-Pacific | 1.0 | 5.2% | Increasing respiratory illnesses, urbanization | Dabur, Himalaya, Swisse | | Latin America | 0.3 | 3.8% | Rising healthcare awareness | Sanofi, GSK | | Middle East & Africa | 0.2 | 3.5% | Expanding OTC health products market | Local generic manufacturers |

Market Segmentation

Category	Share (2022)	Projected Share (2028)	Details
Formulation Type
Liquid Solutions	55%	50%	Predominant OTC, ease of dosing
Tablets	30%	35%	Extended-release, pediatric
Syrups	10%	10%	Pediatric formulations
Others	5%	5%	Powder, inhaler forms
Application Area
Cough & Cold	80%	75%	Main usage, seasonal peaks
Respiratory Conditions	20%	25%	Emerging indications

Competitive Landscape

Major Companies	Market Share (Estimate)	Key Strategies
Johnson & Johnson	~20%	Proprietary formulations, marketing campaigns
Reckitt Benckiser	~15%	OTC branding, product innovation
GlaxoSmithKline	~12%	Pediatric formulations, R&D investments
Bayer	~10%	Expansion into emerging markets, clinical research
Local and Generic Manufacturers	Remaining 43%	Cost-effective options, regional distribution

Regulatory and Policy Environment

• FDA Oversight: Guaifenesin is classified as a dietary supplement and OTC drug in the U.S., with regulations governing claims and formulations.
• EMA Regulations: Similar standards apply within the European Union; recent updates focus on manufacturing standards.
• Global Trends: Increasing emphasis on evidence-based labeling and safety monitoring.

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Projections and Future Trends

Market Growth Drivers

• Rising Respiratory Illness Incidence: Driven by COVID-19 aftereffects and urban pollution.
• Growing OTC and Self-Medication Trends: Facilitated by digital health platforms.
• Innovative Formulations: Extended-release and combination products enhance competitive edge.
• Emerging Market Expansion: Rapid urbanization and healthcare infrastructure improvements.

Potential Constraints

• Regulatory Challenges: Stringent guidelines on labeling and health claims.
• Generic Competition: Price erosion pressures leading to margin compression.
• Clinical Evidence Requirements: Evolving standards necessitate ongoing R&D investments.

Forecasted Market Size (2023–2028)

Year	Estimated Market Size (USD Billion)	CAGR (Projected)
2023	3.3	4.8%
2024	3.5
2025	3.7
2026	3.9
2027	4.2
2028	4.4

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Comparison with Similar Expectors and Mucolytics

Drug	Active Ingredient	Primary Use	Market Share (Estimated)	Regulatory Status
Guaifenesin	Guaifenesin	Cough, congestion	~35%	OTC in most regions
Acetylcysteine	N-acetylcysteine	Mucolytic, acetaminophen overdose antidote	~15%	Prescription-required, OTC in some regions
Carbocisteine	Carbocisteine	Chronic cough, mucus hypersecretion	~10%	Prescription
Potassium Iodide	Iodide formulations	Mucolytic	Minimal	Prescription

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Key Takeaways

• Clinical Progress: Guaifenesin continues to undergo trials exploring extended-release, combination therapies, and new indications such as pediatric use and chronic cough management.
• Market Growth: The global guaifenesin market is projected to grow at approximately 4.8% CAGR from 2023 to 2028, driven by demand in OTC sectors and innovation in formulation.
• Competitive Advantage: Major players focus on product differentiation, formulating extended-release products, and expanding into emerging markets.
• Regulatory Dynamics: Evolving policies favor evidence-based claims, emphasizing the importance of continued clinical research.
• Future Opportunities: Opportunities exist in developing combination products, leveraging digital health channels, and entering emerging markets with affordable formulations.

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FAQs

1. What are the promising new indications for guaifenesin in clinical trials?

Current research is exploring guaifenesin’s potential in treating bronchitis, chronic obstructive pulmonary disease (COPD), and as an adjunct in managing cough variant asthma, primarily through combination therapies and novel formulations.

2. How does guaifenesin’s market share compare with other expectorants?

Guaifenesin dominates the expectorant market with an estimated 35% share, surpassing alternatives like acetylcysteine and carbocisteine, mainly due to its OTC availability and established safety profile.

3. What are the key regulatory challenges facing guaifenesin manufacturers?

Manufacturers must adhere to strict claims substantiation, safety monitoring, and labeling standards enforced by agencies like the FDA and EMA. Recent policies emphasize transparency and evidence-based product claims.

4. Which regions are expected to see the fastest market growth for guaifenesin?

Asia-Pacific and Latin America are projected to experience higher CAGR rates (5.2% and 3.8%, respectively), primarily driven by increasing respiratory illnesses and expanding healthcare infrastructure.

5. How are formulations evolving to meet market demands?

Formulation innovations include extended-release tablets, pediatric-friendly syrups, and combination products with antihistamines or decongestants, targeting improved compliance and multi-symptom relief.

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References

[1] GlobalData, "Over-the-Counter (OTC) Expectors Market Analysis," 2022.
[2] ClinicalTrials.gov, Clinical trials involving guaifenesin, 2023.
[3] Mordor Intelligence, "Guaifenesin Market Forecast & Trends," 2023.
[4] U.S. Food & Drug Administration, OTC Drug Monographs, 2022.
[5] European Medicines Agency, Regulatory Updates on OTC Medications, 2022.

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