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NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Adams Laboratories	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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.
NCT00377403 ↗	Treatment of Acute Sinusitis	Completed	Washington University School of Medicine	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.
NCT00857987 ↗	Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections.	Unknown status	Azidus Brasil	Phase 3	2010-04-01	Evaluate the improvement of the common cold with the use of medication

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
India	1

Trials by US State

Trials by US State for Guaifenesin
Location	Trials
California	4
Kentucky	3
Texas	3
Ohio	3
North Carolina	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, Market Analysis, and Projections

Introduction

Guaifenesin, an expectorant commonly used to treat cough and chest congestion, has been a staple in over-the-counter (OTC) and prescription medications for decades. This article delves into the recent clinical trials, market analysis, and future projections for guaifenesin, providing a comprehensive overview of its efficacy, market trends, and growth opportunities.

Clinical Trials and Efficacy

Recent Studies

Several clinical trials have been conducted to assess the efficacy of guaifenesin in managing cough and respiratory symptoms.

• A multi-center clinical trial published in 2013 involved 378 subjects with acute respiratory tract infections (RTIs). The study found that symptoms in both the guaifenesin and placebo groups improved to a similar degree over time, with no significant differences in sputum volume, percent solids, interfacial tension, elasticity, viscosity, or mechanical impedance[1].
• Another study from 2015 evaluated the effect of guaifenesin on mucociliary clearance and cough clearance. It concluded that guaifenesin did not result in significant improvements in any of the objective outcome measures compared to placebo, although there was a statistically significant difference in the subjective assessment of mucus thickness at one evaluation time point[4].

Mixed Results

Clinical trials have yielded mixed results regarding guaifenesin's efficacy. Some studies suggest that guaifenesin can inhibit cough reflex sensitivity and reduce sputum thickness subjectively, but these findings are not consistently supported by objective measures[4].

Safety Profile

Despite the limited evidence of its efficacy, guaifenesin is generally well-tolerated, with the most common adverse effects being nausea, vomiting, and gastrointestinal discomfort[4].

Market Analysis

Global Market Size and Growth

The global guaifenesin market is projected to experience significant growth over the next few years.

• By 2027, the market is forecasted to reach USD 95 million, growing at a CAGR of around 3.1% from 2022 to 2027[2].
• A more aggressive projection suggests the market will reach US$ 2.7 billion by 2033, growing at a CAGR of 7.4% from 2023 to 2033[3].

Regional Trends

• North America: This region is the fastest-growing in the global guaifenesin market, driven by developing medical infrastructure, growing cases of respiratory and cough-related complications, and rising health expenditure. It is expected to grow with a CAGR of around 4.5% during the forecast period[2].
• Asia-Pacific: This region accounts for approximately 45% of the global market share, with key markets like India and China reporting significant annual production growth and export increases[5].

Distribution Channels

• Hospital pharmacies dominate the distribution channel segment, holding the largest revenue share of 46.5% in the guaifenesin market[3].

Product Forms

• The market is segmented into tablets, granules, syrups, and others, with tablets leading the market share in 2023 with 42.7%[3].

Market Drivers and Opportunities

Growing Prevalence of Respiratory Conditions

The increasing prevalence of respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, and acute respiratory infections drives the demand for guaifenesin. For instance, COPD affected approximately 251 million individuals globally in 2022, and asthma prevalence in the United States remains significant, affecting about 25 million people[3].

COVID-19 Impact

The COVID-19 pandemic has created both challenges and opportunities for the guaifenesin market. While the initial phase saw disruptions in production and supply chains, the recovery phase led to a surge in demand for cough and cold medications, contributing to market growth[2].

Expansion into Emerging Markets

Emerging economies such as Brazil, South Africa, and Indonesia present significant growth opportunities due to increasing healthcare awareness and rising incidences of respiratory conditions. The Indian pharmaceutical sector, for example, is projected to grow at a CAGR of 10%, indicating robust market potential for OTC medications[3][5].

Challenges and Limitations

Availability of Substitutes and Side Effects

The global guaifenesin market faces challenges from the availability of substitute products and potential side effects. Despite its widespread use, guaifenesin's efficacy is sometimes questioned, and the presence of alternative expectorants and cough suppressants can impact market growth[2].

Key Players and Strategic Initiatives

Major Players

Key players in the guaifenesin market include Perrigo Company plc, Lupin, Johnson & Johnson, Hikma Pharmaceuticals PLC, and others. These companies are engaged in developing innovative products, expanding product lines, and forming strategic partnerships to enhance market penetration and streamline supply chains[3].

Research and Development

Companies are investing in research and development to improve drug formulations, ensuring better efficacy and patient compliance. This includes developing combination therapies that address multiple respiratory symptoms, which is a significant growth strategy in the market[3].

Key Takeaways

• Efficacy: Clinical trials show mixed results regarding guaifenesin's efficacy, but it remains a widely used expectorant due to its safety profile.
• Market Growth: The global guaifenesin market is projected to grow significantly, driven by increasing prevalence of respiratory conditions and expanding healthcare infrastructure.
• Regional Trends: North America and the Asia-Pacific region are key growth areas, with emerging markets offering significant opportunities.
• Distribution Channels: Hospital pharmacies dominate the distribution segment, and tablets are the leading product form.
• Challenges: The market faces challenges from substitute products and potential side effects.

FAQs

What is the current market size of the global guaifenesin market?

The global guaifenesin market size is forecasted to reach USD 95 million by 2027 and US$ 2.7 billion by 2033, depending on the source and projection period[2][3].

What are the primary drivers of the guaifenesin market?

The primary drivers include the growing prevalence of respiratory conditions, expanding healthcare infrastructure, and increasing demand for OTC cold and cough medications[2][3].

Which region is the fastest-growing in the guaifenesin market?

North America is the fastest-growing region in the global guaifenesin market, driven by developing medical infrastructure and rising health expenditure[2].

What are the common side effects of guaifenesin?

The most common adverse effects of guaifenesin are nausea, vomiting, and gastrointestinal discomfort[4].

Which companies are major players in the guaifenesin market?

Major players include Perrigo Company plc, Lupin, Johnson & Johnson, Hikma Pharmaceuticals PLC, and others[3].

References

1. Respiratory Care: "Guaifenesin has no effect on sputum volume or properties in adolescents and adults with productive cough from an acute respiratory tract infection."
2. IndustryARC: "Guaifenesin Market Size Report, 2022-2027."
3. Market.us: "Guaifenesin Market Size, Share | CAGR Of 7.4%."
4. Drug Topics: "Reevaluating the Use of Guaifenesin in the Management of Acute Cough Associated with the Common Cold."
5. Global Growth Insights: "Guaifenesin (API) Market Size, Share & Trends Analysis, 2025-2033."

Last updated: 2024-12-31