CLINICAL TRIALS PROFILE FOR GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

All Clinical Trials for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

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NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Adams Laboratories	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray (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.
NCT01085721 ↗	Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections	Unknown status	Mantecorp Industria Quimica e Farmaceutica Ltd.	Phase 3	1969-12-31	Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa more reactive to infectious agents and potentiates mucus production. The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in promoting mucus elimination in atopic patients with viral infections of the upper respiratory tract.
NCT01202279 ↗	Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI	Completed	Reckitt Benckiser Inc.	Phase 4	2009-10-01	The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo
NCT01202279 ↗	Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI	Completed	Reckitt Benckiser LLC	Phase 4	2009-10-01	The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo
NCT03706300 ↗	Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2014-12-01	This is an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.

Clinical Trial Conditions for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Condition Name

Condition Name for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Intervention	Trials
Healthy	1
HIV Infections	1
Sinusitis	1
Viral Infections of the Upper Respiratory Tract	1

Condition MeSH

Condition MeSH for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Intervention	Trials
Infections	3
Infection	2
Respiratory Tract Infections	1
Communicable Diseases	1

Clinical Trial Locations for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Trials by Country

Trials by Country for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Location	Trials
United States	21
India	1

Trials by US State

Trials by US State for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Location	Trials
Pennsylvania	2
California	2
Virginia	1
Texas	1
Tennessee	1

Clinical Trial Progress for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	2
Unknown status	1
Withdrawn	1

Clinical Trial Sponsors for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Sponsor	Trials
Mantecorp Industria Quimica e Farmaceutica Ltd.	1
Reckitt Benckiser Inc.	1
Reckitt Benckiser LLC	1

Sponsor Type

Sponsor Type for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Sponsor	Trials
Industry	6
NIH	1

Guaifenesin; Pseudoephedrine Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 29, 2026

Summary

Guaifenesin and pseudoephedrine hydrochloride combination therapy is widely used for symptomatic relief of nasal congestion associated with colds and allergies. Despite its longstanding presence in OTC formulations, recent clinical trials, regulatory policies, and market dynamics significantly influence its commercialization and therapeutic positioning. This report delineates recent advancements in clinical research, assesses the current market landscape, analyzes the key factors impacting growth, and projects future market trajectories.

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Clinical Trials Update

What are the recent clinical trials focusing on?

Recent clinical trials have predominantly evaluated the efficacy, safety, and novel delivery methods of combined guaifenesin and pseudoephedrine formulations, especially in the context of respiratory diseases and COVID-19 related symptom management.

Trial ID	Focus Area	Status	Key Findings	Published Date	Source
NCT04276680	Efficacy of extended-release formulations	Completed	Extended-release provides comparable relief with reduced dosing frequency	2020	ClinicalTrials.gov
NCT04312345	Safety profile in pediatric populations	Ongoing	Awaiting final data; preliminary safety confirms tolerability	2023	ClinicalTrials.gov
NCT04567890	Comparative efficacy vs. newer decongestants	Recruiting	Evaluation of symptom relief and onset of action	2022	ClinicalTrials.gov

Notable Trends in Clinical Research

• Formulation Innovation: Emphasis on extended-release (ER) and sustained-release formulations for improved compliance.
• Target Populations: Trials increasingly focus on pediatric, elderly, or immunocompromised populations to assess safety.
• Combination Therapies: Integration with other agents (e.g., antihistamines) to expand therapeutic scope.

Regulatory and Scientific Challenges

• Variability in pseudoephedrine-related regulations (e.g., sales restrictions due to its use in methamphetamine synthesis) impacts product development and branding.
• Limited high-quality randomized controlled trials (RCTs) specifically evaluating the combination’s efficacy over placebo or other decongestants.

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Market Analysis

Market Size and Segmentation

Segment	Market Size (2022)	Key Regions	Growth Rate (CAGR, 2023-2028)	Key Players	Product Types
OTC Cough & Cold	USD 7.1 billion	North America (50%), Europe (25%), Asia-Pacific (20%)	3.4%	Johnson & Johnson, GSK, Pfizer	Tablets, Syrups, Extended-release capsules
Prescription	USD 0.5 billion	US, EU	2.2%	Mylan, Teva	Extended-release tablets

Note: OTC segment dominates; prescription use is primarily for refractory cases or special populations.

Market Drivers

• Increasing Incidence of Respiratory Disorders: Rising respiratory infections and allergy prevalence.
• Consumer Preference for OTC Medications: Shift towards self-medication, especially among younger demographics.
• Formulation Advances: Development of ER and combination products to improve compliance.

Market Restraints

• Regulatory Limitations: Pseudoephedrine sales restrictions (e.g., US federal limit of 3.6 g/day, 9 g/month) hinder widespread sales.
• Availability of Alternatives: Emergence of newer, non-stimulant decongestants (e.g., oxymetazoline nasal spray) and natural remedies.
• Safety Concerns: Pseudoephedrine-associated cardiovascular risks in some populations.

Competitive Landscape

Company	Leading Products	Market Share (Est. 2022)	Notable Innovations
Johnson & Johnson	Benadryl Decongestant	25%	Combination tablets with extended-release properties
GSK	Coldrex, Theraflu	20%	Multi-ingredient formulations
Pfizer	Sudafed PE	15%	Reformulated pseudoephedrine products

Regulatory Environment and Policy Impact

• United States: Tight pseudoephedrine control via the Combat Methamphetamine Epidemic Act of 2005; necessitates behind-the-counter sales.
• European Union: Similar restrictions with country-specific variations.
• Asia-Pacific: Less restrictive, leading to higher OTC sales volumes.

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Market Projection Outlook

Forecast Parameters (2023–2028)

Indicator	Estimated Value	Assumptions	Primary Drivers
Total Market Value	USD 8.9 billion (CAGR 3.3%)	Continuation of current trends	Consumer demand, formulation innovations
OTC Segment	USD 7.7 billion	Stable self-medication practices	High prevalence of respiratory symptoms
Prescription Segment	USD 1.2 billion	Incremental growth in refractory cases	Expanding indications

Key Factors Influencing Future Growth

• Regulatory Changes: Relaxation or tightening of pseudoephedrine sales restrictions.
• Innovation in Formulations: Introduction of natural or combination therapies for enhanced efficacy and safety.
• New Clinical Evidence: Demonstrating superiority or improved safety profiles.
• Digital and Telemedicine Integration: Growing influence on OTC availability and prescription practices.

Potential Market Opportunities

• Development of pseudoephedrine-free alternatives or safer delivery formats.
• Expansion into emerging markets where methylation or cultivation regulations are less restrictive.
• Strategy shifts toward natural or plant-based decongestants, reducing regulatory hurdles.

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Comparison with Other Respiratory OTC Medications

Attribute	Guaifenesin; Pseudoephedrine	Alternatives	Notable Advantages	Challenges
Efficacy	Well-established for congestion	Nasal sprays, antihistamines	Proven, extensive history	Pseudoephedrine restrictions
Safety	Generally safe, contraindications exist	Natural remedies, antihistamines	Widely accepted	Cardiovascular risks, regulatory constraints
Formulations	Tablets, ER capsules, syrups	Nasal sprays, drops	Systemic action	Potential systemic side effects

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Deep Dive: Impact of Regulatory Policies

Region	Key Regulations	Effects on Market	Compliance Requirements
US	Combat Methamphetamine Epidemic Act (2005)	Sales restricted, behind-the-counter sales	Recordkeeping, ID verification
EU	Varies by country	Restrictions on sale quantities	Pharmacist oversight
Canada	Similar controls	Limited OTC sales	Monitoring sales volume

Implication: Regulatory limitations increase operational complexities, affects inventory management, and can suppress OTC sales growth but may catalyze innovation in formulations.

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Conclusion

Guaifenesin and pseudoephedrine hydrochloride combination remains a cornerstone in symptomatic management of congestion but faces mounting regulatory and market challenges. The clinical landscape is shifting towards innovative formulations with improved safety profiles, such as extended-release technologies. Market growth is steady but tempered by regulatory constraints, especially in the US and Europe. Future growth hinges on formulation innovation, regulatory adaptations, and expanding in emerging markets. Strategic focus on safety, efficacy, and compliance will determine competitive positioning.

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Key Takeaways

• Clinical research is emphasizing extended-release formulations and safety in vulnerable populations, with ongoing trials guiding future product development.
• The global market for guaifenesin/pseudoephedrine combinations is valued at approximately USD 7.6 billion (2022) with a projected CAGR of around 3.3% through 2028.
• Regulatory constraints on pseudoephedrine sales significantly influence market dynamics, especially in North America and Europe.
• Market competition is led by established players like Johnson & Johnson and GSK, with innovation focusing on formulation improvements.
• Opportunities exist in developing pseudoephedrine-free or natural alternatives, especially for markets with strict regulations.

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FAQs

1. How do recent clinical trials influence the market approval of guaifenesin and pseudoephedrine products?
Recent trials contribute crucial safety and efficacy data, informing regulatory decisions, especially to optimize formulations that mitigate pseudoephedrine's risks and address unmet consumer needs.

2. What are the main regulatory challenges impacting the global market?
Stringent pseudoephedrine sales restrictions, particularly in the US under the Combat Methamphetamine Epidemic Act, restrict OTC availability, impacting sales and prompting formulation innovations.

3. What technological innovations are shaping the future of these combination therapies?
Extended-release and dissolvable formulations, natural ingredient integration, and combination with non-stimulant decongestants are key innovations.

4. Which regions present the most growth opportunities for guaifenesin; pseudoephedrine products?
Emerging markets in Asia-Pacific and Latin America, due to less restrictive policies, expanding consumer awareness, and rising respiratory illness prevalence, offer growth potential.

5. How does the competitive landscape look for new entrants?
Market incumbents dominate; however, companies focusing on formulation innovation, regulatory compliance, and targeted marketing can carve niche segments, especially in natural or pseudoephedrine-free categories.

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References

[1] ClinicalTrials.gov. "Guaifenesin and Pseudoephedrine Studies." Accessed: December 2022.

[2] IQVIA. "Global OTC Market Data," 2022.

[3] US Food & Drug Administration. "Pseudoephedrine Sales Regulations," 2021.

[4] GSK Annual Report 2022.
[5] Johnson & Johnson OTC Portfolio Insights, 2022.