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NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Adams Laboratories	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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
Common Cold	2
Flu Symptoms	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
India	1

Trials by US State

Trials by US State for guaifenesin
Location	Trials
California	4
Texas	3
Ohio	3
Kentucky	3
Massachusetts	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
Withdrawn	3
Unknown status	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 Future Projections

Last updated: October 28, 2025

Introduction

Guaifenesin, a longstanding expectorant used primarily for symptomatic relief of coughs associated with respiratory conditions, continues to hold a significant position within the OTC pharmacopoeia. As respiratory ailments see persistent prevalence globally, especially amidst ongoing respiratory illnesses like COVID-19, understanding the latest developments—clinical trials, market dynamics, and future growth projections—becomes pivotal for stakeholders across pharmaceutical and healthcare sectors.

Clinical Trials Update on Guaifenesin

Overview of Current Clinical Research

Historically, guaifenesin has been evaluated extensively for its safety and efficacy, primarily through observational and comparative studies. Its traditional role as an over-the-counter (OTC) expectorant has limited extensive clinical trial requirements; however, recent research efforts have focused on additional therapeutic applications, combination formulations, and optimizing dosing paradigms.

In 2022 and 2023, a growing number of clinical trials explored novel uses of guaifenesin. Notably, these include:

• Subjective Symptom Relief in Respiratory Conditions: Several randomized controlled trials (RCTs) assessed guaifenesin's efficacy in alleviating cough frequency and sputum viscosity. Results consistently support its role in improving expectoration and patient comfort, though some studies highlight modest benefits over placebo.

• Combination Formulations in Respiratory Infections: Trials evaluating combinations of guaifenesin with antihistamines, decongestants, and other expectorants seek to enhance symptomatic relief. For instance, a 2021 study examined guaifenesin combined with pseudoephedrine, demonstrating improved symptom scores in acute bronchitis.

• Potential Use in Chronic Respiratory Diseases: Limited but emerging trials investigated guaifenesin's adjunctive role in managing chronic obstructive pulmonary disease (COPD) and bronchiectasis. Outcomes suggest potential benefits in reducing mucus plugging and improving lung function when used alongside standard therapy.

Safety and Pharmacovigilance

Ongoing pharmacovigilance data affirms guaifenesin's excellent safety profile, with adverse events being rare and predominantly mild gastrointestinal or allergic reactions. No significant new safety signals emerged from recent trials, supporting its continued OTC status.

Innovative Formulation Research

Recent clinical research also emphasizes improved delivery systems:

• Extended-release formulations: A 2020 trial demonstrated that extended-release guaifenesin maintains sustained expectorant activity, improving adherence and symptom control.

• Combination drugs: Trials on combination products, such as guaifenesin with dextromethorphan, aim to balance expectoration with cough suppression, with preliminary data confirming synergistic effects.

Market Analysis of Guaifenesin

Market Size and Trends

Guaifenesin commands a substantial share of the global expectorant market, estimated at over $500 million in 2022[1]. The compound’s widespread OTC availability, low-cost manufacturing, and extensive consumer familiarity underpin its solid market presence.

Key market drivers include:

• Rising respiratory illnesses: The COVID-19 pandemic elevated healthcare focus on respiratory symptom management, propelling demand for OTC expectorants like guaifenesin.

• Growing aging population: Age-related respiratory conditions, such as COPD and bronchiectasis, bolster demand for expectorant therapies.

• Consumer preference for OTC products: The shift toward self-medication, especially in emerging markets, sustains positive sales trajectories.

Regional Market Dynamics

• North America: Dominates with a market size exceeding $200 million, driven by high healthcare awareness and OTC sales channels.

• Europe: Showing steady growth, accounting for approximately $150 million, with regulatory variations influencing brand availability.

• Asia-Pacific: Fastest-growing segment, projected to expand at a CAGR of approximately 6% through 2028[2]. Rising urbanization, increased healthcare spending, and broadening OTC access underpin this trend.

• Latin America and Middle East: Emerging markets with expanding distribution networks and improved healthcare infrastructure fuel future growth.

Competitive Landscape

Guaifenesin faces competition from multi-ingredient cough and cold formulations, although its standalone presence remains strong. Major players include Johnson & Johnson, Reckitt Benckiser, and GlaxoSmithKline, which market branded formulations and generic equivalents. The market is characterized by:

• Brand loyalty: Established products maintain dominance but face competition from generics.

• Product diversification: Development of new formulations (e.g., extended-release, combination drugs) is a key competitive strategy.

• Regulatory considerations: Stringent approval pathways for novel formulations demand significant investment but can offer market differentiation.

Regulatory Environment

OTC regulatory regimes vary globally, influencing market entry strategies:

• United States: Guaifenesin is Generally Recognized As Safe (GRAS). FDA regulates combination products and labeling.

• Europe: Regulated by EMA, with some formulations requiring parental or clinician oversight.

• Emerging markets: Regulatory pathways often less stringent but increasingly harmonized to international standards.

Market Projections and Future Outlook

Growth Forecasts

Analysts project the global guaifenesin market will grow at a CAGR of approximately 4.5% to 6% through 2030, reaching an estimated $850 million to $1 billion. Drivers include:

• Increased respiratory disease prevalence in aging populations.

• Innovation-driven formulation strategies, including sustained-release and combination products.

• Expansion into emerging markets, fueled by rising healthcare awareness and OTC channels.

Potential Factors Influencing Future Growth

• Innovative Therapeutic Applications: As clinical trials uncover potential roles in managing conditions like chronic cough, bronchiectasis, and mucus hypersecretion, market opportunities will expand.

• Regulatory Scrutiny and Safety Profile: Maintaining its safety and efficacy will be pivotal, with regulatory authorities emphasizing evidence-based claims.

• Consumer Preferences: Demand for natural, fast-acting, and minimally side-effect formulations will shape product development.

• E-commerce and Direct-to-Consumer Sales: Digital sales channels will sustain market penetration, especially in countries with growing OTC markets.

• Impact of New Delivery Systems: Advanced formulations offering convenience and improved efficacy will define competitive advantages.

Key Takeaways

• The clinical research landscape for guaifenesin is predominantly characterized by validation of its expectorant properties; recent trials are exploring expanded therapeutic indications and formulations aimed at improving efficacy and patient adherence.

• Globally, the market remains robust, driven by respiratory illness prevalence, aging demographics, and consumer-driven OTC healthcare regimes.

• Regional variations, regulatory nuances, and ongoing innovation strategies will influence market expansion trajectories.

• Projections indicate sustained growth through 2030, with emerging markets poised for significant contributions.

• Stakeholders should monitor clinical developments, formulation innovations, and regulatory trends to capitalize on upcoming opportunities.

FAQs

1. What new clinical applications are being explored for guaifenesin?
   Recent trials investigate its potential in managing mucus hypersecretion in chronic respiratory conditions like COPD and bronchiectasis, as well as combination therapies aiming to optimize symptom relief.

2. How does guaifenesin compare to other expectorants in efficacy?
   While generally effective for symptomatic relief, comparative studies suggest that guaifenesin offers modest benefits over placebo, with its main advantage being a favorable safety profile and ease of OTC access.

3. Are there safety concerns associated with long-term use of guaifenesin?
   Current data affirms guaifenesin’s safety for short- and long-term use within recommended doses. Rare adverse events include gastrointestinal discomfort and allergic reactions.

4. What are the main market challenges for guaifenesin?
   Challenges include regulatory scrutiny over claims, competition from combination products, and the need for continuous innovation to meet consumer expectations.

5. How might emerging delivery technologies impact the guaifenesin market?
   Innovations like sustained-release formulations and innovative delivery systems can enhance efficacy and adherence, offering competitive advantages and opening new market segments.

Sources

[1] IBISWorld, “Expectorants Market Size & Industry Trends,” 2022.
[2] Grand View Research, “Global Cough and Cold Remedies Market,” 2022–2028 Outlook.