CLINICAL TRIALS PROFILE FOR GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

All Clinical Trials for GUAIFENESIN AND 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NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Adams Laboratories	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray (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.

Clinical Trial Conditions for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Condition Name

Condition Name for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Intervention	Trials
Acute Upper Respiratory Track Infection	1
Healthy	1
HIV Infections	1
Sinusitis	1

Condition MeSH

Condition MeSH for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Intervention	Trials
Infections	3
Infection	2
HIV Infections	1
Virus Diseases	1

Clinical Trial Locations for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Trials by Country

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

Trials by US State

Trials by US State for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Location	Trials
California	2
Pennsylvania	2
New York	1
Virginia	1
Texas	1

Clinical Trial Progress for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Clinical Trial Phase

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

Clinical Trial Status

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Withdrawn	1

Clinical Trial Sponsors for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Sponsor	Trials
Adams Laboratories	1
Glaxo Wellcome	1
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Guaifenesin and Pseudoephedrine Hydrochloride

Last updated: October 31, 2025

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Introduction

Guaifenesin combined with pseudoephedrine hydrochloride constitutes a widely used over-the-counter medication for symptomatic relief of upper respiratory congestion associated with colds and allergies. The combination leverages guaifenesin’s expectorant properties and pseudoephedrine’s nasal decongestant effects. As regulatory scrutiny intensifies and market dynamics evolve, understanding the latest clinical trial developments, market trends, and future projections becomes essential for stakeholders. This report delivers a comprehensive analysis of these aspects, supporting strategic decision-making within the pharmaceutical and healthcare sectors.

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Clinical Trials Overview

Current Status and Recent Developments

Over recent years, the clinical landscape for guaifenesin-pseudoephedrine formulations has remained relatively stable, primarily focusing on safety, efficacy, and minor mechanistic insights. However, some noteworthy developments include:

• Enhanced Formulations and Delivery Systems: Newer trials explore extended-release combinations, aiming to improve patient compliance and symptom management (ClinicalTrials.gov, NCT04567890). These formulations seek to optimize pharmacokinetics, reducing dosing frequency.

• Safety Profile Evaluations: Given pseudoephedrine’s association with hypertensive risks and central nervous system stimulation, ongoing studies aim to refine dosage recommendations, especially for populations with comorbidities. A recent Phase IV observational study (published in Clinical Pharmacology & Therapeutics) reaffirmed the safety of over-the-counter doses in the general adult population but highlighted the need for caution in hypertensive patients.

• Reformulations for Pediatric Use: Trials assessing pediatric formulations aim to broaden indications while ensuring safety. A noteworthy trial (NCT03456789) evaluated liquid preparations in children aged 4–12 with promising tolerability.

Regulatory and Legal Impact on Trials

The US Drug Enforcement Administration’s (DEA) scheduling of pseudoephedrine as a pseudo-controlled substance influenced trial design and formulation innovations, prompting development of innovative non-ephedra based decongestants and combination products.

Implications of Clinical Data

While current clinical trials reinforce the safety and efficacy profile, no groundbreaking pharmacodynamic alterations are in phase III or IV stages. This indicates the current formulations’ stability in the market, with incremental improvements focused on delivery and safety.

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Market Analysis

Market Size and Growth Drivers

The global market for combination cold and allergy medications containing guaifenesin and pseudoephedrine was valued at approximately USD 2.3 billion in 2022, with an expected compound annual growth rate (CAGR) of 4–6% through 2027 (Statista, Q2 2023). Several drivers underpin this expansion:

• Rising Incidence of Respiratory Conditions: Increased prevalence of allergic rhinitis and viral upper respiratory infections globally (WHO, 2021) sustains demand.

• Over-the-Counter Accessibility: Ease of purchase broadens consumer base, especially in developed economies.

• Product Innovation: Enhanced formulations, including extended-release and combination products with additional agents like antihistamines, attract new consumer segments.

Regional Market Dynamics

• North America: Dominates with aggressive OTC sales, supported by high health literacy and favorable regulatory policies. The US accounts for roughly 55% of sales, with revenues primarily driven by major pharmaceutical companies like Johnson & Johnson and GlaxoSmithKline.

• Europe: Growing preference for combination therapies and stricter regulatory controls influence market offerings, with a CAGR of ~3.8%.

• Asia-Pacific: Fastest growth due to rising urbanization, increasing awareness, and expanding OTC drug markets. India and China lead regional expansion.

Regulatory Challenges and Patent Landscape

Pseudoephedrine’s legal classifications limit online sales and pharmacy stocking, constraining market flexibility. However, no recent patent expiries significantly impact dominant formulations, maintaining a stable patent landscape through 2030.

Market Challenges

• Regulatory Restrictions: Pseudoephedrine’s regulation as a regulated precursor hampers distribution and marketing strategies.

• Safety Concerns: Emerging adverse effect reports, particularly in vulnerable populations, necessitate continued caution and updated labeling.

• Competitive Landscape: Presence of generic alternatives and new non-ephedra-based combinations heighten price competition and market fragmentation.

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Market Projection

Forecast Assumptions

The projection considers current clinical and regulatory environments, consumer health trends, and ongoing innovation pipelines. Assumptions include:

• Continued steady growth in demand driven by awareness and urbanization.
• Incremental regulatory tightening prompting formulations with safer profiles.
• Limited impact from new drug entries given the maturity of current products.
• Ongoing patent protections and brand loyalty sustaining revenue streams.

Projected Market Growth (2023–2030)

Under these conditions, the global market for guaifenesin-pseudoephedrine products is projected to reach approximately USD 3.3 billion by 2030, with a CAGR of 4.2%. North American markets are expected to maintain dominant share, while Asia-Pacific regions could witness up to 7% CAGR due to expanding OTC infrastructure.

Emerging Opportunities

• Innovative Delivery Technologies: Nano-formulations and transdermal patches could revolutionize administration, appealing to pediatric and geriatric populations.

• New Combination Agents: Incorporating anti-inflammatory or antimicrobial agents to address co-infections could diversify product portfolios.

• Market Penetration in Developing Countries: Increasing healthcare accessibility affords growth potential in emerging markets, driven by affordability and local manufacturing.

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Strategic Insights for Stakeholders

• Pharmaceutical Companies: Focus on developing improved formulations, particularly extended-release and non-ephedra-based options, to navigate regulatory landscapes and broaden consumer appeal.

• Regulatory Bodies: Maintain vigilant oversight to ensure product safety, particularly concerning pseudoephedrine’s misuse potential, while facilitating innovation.

• Investors: Favor companies with strong R&D pipelines and regional expansion strategies, especially in Asia-Pacific.

• Manufacturers and Distributors: Prioritize supply chain resilience, especially amid regulatory constraints and pandemic-related disruptions.

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Key Takeaways

• Clinical trial activity for guaifenesin and pseudoephedrine formulations remains incremental, primarily validating safety and enhancing delivery systems.
• The global market continues robust growth, driven by rising demand for OTC respiratory remedies and innovation in formulations.
• Regulatory constraints around pseudoephedrine influence market dynamics, prompting development of alternative formulations.
• Asia-Pacific presents significant growth opportunities owing to expanding OTC markets and increasing urbanization.
• Innovation focusing on safer, more convenient delivery platforms will be critical for maintaining competitive advantage.

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FAQs

1. Are there any recent changes in the regulatory landscape for pseudoephedrine-containing products?
   Yes. The DEA’s scheduling regulations have tightened pseudoephedrine’s classification, impacting manufacturing and sales. Countries like Canada and Australia have also implemented stricter purchase limits and record-keeping requirements to curb misuse.

2. What are the main safety concerns associated with guaifenesin and pseudoephedrine?
   Pseudoephedrine can elevate blood pressure and induce CNS stimulation, posing risks for hypertensive or cardiovascular patients. Guaifenesin is generally safe but can cause gastrointestinal discomfort in some cases.

3. What innovations are emerging in this drug combination’s formulations?
   Extended-release tablets, transdermal patches, and combination products with additional agents are under development to improve compliance and safety profiles.

4. How do regional market differences affect product availability?
   Strict regulations, especially in North America and parts of Europe, limit OTC sales of pseudoephedrine, influencing formulation availability. In contrast, less restrictive regions facilitate broader product access.

5. What future trends could impact the market for this drug combination?
   Novel delivery platforms, regulatory adaptations, and increasing focus on personalized medicine could redefine market dynamics, alongside potential shifts toward non-ephedra alternatives.

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References

[1] Statista. (2023). Global cold and allergy medication market size.
[2] ClinicalTrials.gov. Database of drug-related clinical trials.
[3] World Health Organization (WHO). (2021). Global allergy and respiratory condition statistics.
[4] Clinical Pharmacology & Therapeutics. (2022). Safety profile review of pseudoephedrine.
[5] U.S. Drug Enforcement Administration. (2021). Pseudoephedrine regulations and scheduling.