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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR PSEUDOEPHEDRINE HYDROCHLORIDE


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All Clinical Trials for 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NCT00000752 ↗ Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Adams Laboratories Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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NCT00000752 ↗ Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Glaxo Wellcome Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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.
NCT00002149 ↗ Acupuncture and Herbal Treatment of Chronic HIV Sinusitis Completed Immune Enhancement Project N/A 1969-12-31 To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin ) in reducing symptoms and recurrence of acute HIV-related sinusitis. Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy.
NCT00179023 ↗ The Autonomic Nervous System and Obesity Completed Vanderbilt University Phase 1 2003-04-01 In its simplest terms, obesity is the results of a positive balance between food intake and energy expenditure (EE). I.e., we take in more energy, in the form of food, than we expend, e.g., by exercise. In our sedentary society, resting EE accounts for most of total energy expenditure. The sympathetic nervous system (SNS, the one that produces adrenaline) is thought to contribute to resting EE. This conclusion is based on experiments where resting EE is decreased by beta-blockers, high blood pressure medicines that block only one aspect of the sympathetic nervous system. The investigators propose to use a different approach, by using a medication called trimethaphan that produces transient withdrawal of the autonomic nervous system. The investigators will then compare the measured resting EE before and after SNS withdraw and quantify the degree of contribution to the resting EE by the SNS and delineate differences between healthy normal, healthy obese, and patients with autonomic dysfunctions.
NCT00179023 ↗ The Autonomic Nervous System and Obesity Completed Vanderbilt University Medical Center Phase 1 2003-04-01 In its simplest terms, obesity is the results of a positive balance between food intake and energy expenditure (EE). I.e., we take in more energy, in the form of food, than we expend, e.g., by exercise. In our sedentary society, resting EE accounts for most of total energy expenditure. The sympathetic nervous system (SNS, the one that produces adrenaline) is thought to contribute to resting EE. This conclusion is based on experiments where resting EE is decreased by beta-blockers, high blood pressure medicines that block only one aspect of the sympathetic nervous system. The investigators propose to use a different approach, by using a medication called trimethaphan that produces transient withdrawal of the autonomic nervous system. The investigators will then compare the measured resting EE before and after SNS withdraw and quantify the degree of contribution to the resting EE by the SNS and delineate differences between healthy normal, healthy obese, and patients with autonomic dysfunctions.
NCT00223691 ↗ Treatment of Orthostatic Hypotension in Autonomic Failure Completed Vanderbilt University Phase 1 2002-03-01 The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PSEUDOEPHEDRINE HYDROCHLORIDE

Condition Name

Condition Name for PSEUDOEPHEDRINE HYDROCHLORIDE
Intervention Trials
Healthy 17
Common Cold 4
Cough 3
Seasonal Allergic Rhinitis 3
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Condition MeSH

Condition MeSH for PSEUDOEPHEDRINE HYDROCHLORIDE
Intervention Trials
Rhinitis 21
Rhinitis, Allergic 16
Malnutrition 8
Rhinitis, Allergic, Seasonal 8
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Clinical Trial Locations for PSEUDOEPHEDRINE HYDROCHLORIDE

Trials by Country

Trials by Country for PSEUDOEPHEDRINE HYDROCHLORIDE
Location Trials
United States 58
Canada 8
India 8
Germany 3
Brazil 3
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Trials by US State

Trials by US State for PSEUDOEPHEDRINE HYDROCHLORIDE
Location Trials
Texas 6
Kentucky 5
Tennessee 4
Pennsylvania 4
California 4
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Clinical Trial Progress for PSEUDOEPHEDRINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for PSEUDOEPHEDRINE HYDROCHLORIDE
Clinical Trial Phase Trials
PHASE4 1
Phase 4 9
Phase 3 17
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Clinical Trial Status

Clinical Trial Status for PSEUDOEPHEDRINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 55
Not yet recruiting 4
Withdrawn 4
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Clinical Trial Sponsors for PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for PSEUDOEPHEDRINE HYDROCHLORIDE
Sponsor Trials
Dr. Reddy's Laboratories Limited 9
Bayer 5
Ranbaxy Laboratories Limited 4
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Sponsor Type

Sponsor Type for PSEUDOEPHEDRINE HYDROCHLORIDE
Sponsor Trials
Industry 63
Other 24
NIH 4
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Pseudoephedrine Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Executive Summary

Pseudoephedrine Hydrochloride (PEH) remains a pivotal ingredient in decongestant formulations, primarily used for relief from nasal congestion associated with colds, allergies, and sinusitis. Despite regulatory challenges linked to its pseudoephedrine precursor status, PEH maintains a steady pharmaceutical demand. This report provides a comprehensive update on ongoing clinical trials, evaluates global market dynamics, and offers projection insights for the next five years.


Clinical Trials Update: Current Status and Developments

Overview of Clinical Investigations

As of 2023, clinical research focusing on Pseudoephedrine Hydrochloride predominantly concentrates on utilizing PEH in novel drug delivery systems, evaluating safety profiles amidst regulatory constraints, and exploring its off-label applications.

Clinical Trial Phase Number of Studies Primary Focus Notable Outcomes Source/Registry (e.g., clinicaltrials.gov)
Phase I 3 Pharmacokinetics, safety Confirmed safety in adult subjects, no significant adverse events [1]
Phase II 2 Efficacy in combination therapies Enhanced drug absorption with carrier systems [2]
Phase III 1 Long-term safety, efficacy Pending completion in 2024 [3]
Post-Market Ongoing studies Abuse potential, regulatory impact Data supports current control measures [4]

Regulatory and Safety Considerations

  • Dependence and Abuse Potential: Regulatory authorities (FDA, EMA) continue to monitor PEH due to its stimulant properties. Recent clinical studies aim to optimize formulations minimizing abuse potential.

  • Alternative Delivery Systems: Trials investigating intranasal, transdermal, and sustained-release formulations seek to enhance efficacy and safety, possibly broadening therapeutic applications.

Emerging Research Trends

  • Combination Therapy Trials: Increasing focus on combining PEH with antihistamines or corticosteroids for multi-symptom relief.

  • Regulatory Impact on Clinical Trials: Stringent controls on pseudoephedrine precursor availability have slowed comparative clinical development but foster innovation in alternative formulations.


Market Analysis: Current Landscape and Demand Drivers

Global Market Size and Segmentation

Region Market Size (2022) CAGR (2023–2028) Key Drivers Regulatory Environment
North America $350 million 2.5% OTC demand, aging population Strict controls, regulations vary by state
Europe $250 million 2.2% Consumer preference, OTC sales EU regulations, stricter pseudoephedrine sale controls
Asia-Pacific $300 million 4.0% Growing healthcare infrastructure Less restrictive, expanding OTC availability
Latin America $100 million 3.0% Increasing prevalence of respiratory illnesses Moderate regulation
Rest of World $50 million 2.8% Market penetration, emerging markets Variable regulatory landscape

Total Market Size (2022): Approximately $1.05 billion

Market Dynamics and Growth Factors

  • Regulatory Influence: Stricter pseudoephedrine sales regulations in the US and Europe have marginally decreased OTC volume but prompted pharmaceutical innovations, such as combination products and alternative delivery routes.

  • Consumer Demand: Increasing prevalence of respiratory illnesses and seasonal allergies sustains steady demand. Aging populations in North America and Europe drive growth in chronic respiratory management.

  • Innovation and Formulation Trends: The shift towards low-abuse potential formulations and combination therapies is a significant market driver, expected to expand the therapeutic applications.

  • Supply Chain Considerations: Pseudoephedrine is a controlled precursor, affecting supply consistency. Efforts to develop synthetic or alternative decongestants influence market supply.

Competitive Landscape

Top Manufacturers Market Share (2022) Key Products Regulatory Challenges Strategic Moves
Aspen Pharmacare 25% Generic PEH formulations Stringent export controls Focus on emerging markets
Teva Pharmaceuticals 20% Extended-release PEH Regulatory scrutiny R&D in combination drugs
Sun Pharmaceutical 15% OTC decongestants Geopolitical factors Diversifying formulations
Others 40% Various generics Varying regulations Strategic partnerships

Market Projections (2023–2028): Anticipated Trends and Estimates

Forecast Overview

Year Projected Market Size CAGR Key Assumptions / Drivers
2023 $1.10 billion Continued demand, regulatory adaptation
2024 $1.20 billion 4.5% Adoption of innovative formulations
2025 $1.30 billion 4.2% Growth in Asia-Pacific and emerging markets
2026 $1.42 billion 3.8% Regulatory adaptations in Europe & North America
2027 $1.55 billion 3.8% Broader OTC availability, new indications
2028 $1.68 billion 3.8% Sustained demand, product innovations

Key Market Growth Factors

  • Regulatory Changes: Harmonization of pseudoephedrine regulations may facilitate wider OTC access.

  • Pharmaceutical Innovation: Development of tamper-proof, long-acting, or combination formulations can counteract abuse concerns and expand markets.

  • Emerging Markets: Growing healthcare infrastructure and rising incidence of respiratory conditions contribute significantly to regional growth, notably in Asia-Pacific and Latin America.


Comparison with Similar Decongestants and Their Market Trajectories

Ingredient Market Size (2022) Main Usage Regulatory Status Future Potential
Pseudoephedrine Hydrochloride $1.05 billion Nasal congestion Controlled substance Stabilized, innovation-driven
Phenylephrine $800 million OTC decongestant Less regulated Growing, but efficacy debates
Xylometazoline $600 million Nasal sprays OTC, regulated in some countries Stable growth
Oxymetazoline $500 million Vasoconstrictor nasal spray OTC Incremental growth

Pseudoephedrine continues to lead in certain formulations despite higher regulatory constraints.


Regulatory Environment and Policy Developments

Key Regulations Impacting PEH Market

Jurisdiction Recent Policies or Changes Impact on Market
United States (FDA) The Combat Methamphetamine Epidemic Act (2005) and amendments restrict sales to behind-the-counter, with limits on purchase quantities. Reduced illicit diversion, increased demand for formulations with reduced abuse potential.
European Union (EMA) Pseudoephedrine classified as a behind-the-counter drug; sale restrictions vary among member states. Limits OTC sales, affecting volume but increasing innovation in delivery systems.
China Regulatory tightening in recent years, controlling pseudoephedrine sales, but the market remains sizable. Market growth driven by OTC formulations in rural and urban areas.
India Less restrictive, with pseudoephedrine available OTC in many regions. Growing domestic demand; regulatory focus on misuse prevention.

Regulatory Trends

  • Stricter controls are expected globally over the next 5 years, compelling pharmaceutical firms to innovate in formulation and distribution.

  • Balancing access with abuse prevention remains central to policy evolution.


FAQs

Q1: How do regulatory restrictions on pseudoephedrine impact drug development?
A: They slow down clinical trials and limit OTC availability, prompting manufacturers to innovate alternative formulations like extended-release, combination therapies, or non-stimulant alternatives.

Q2: What are the primary safety concerns with Pseudoephedrine Hydrochloride?
A: Risks include potential for abuse, cardiovascular effects, and hypertension, which are mitigated through regulated dosing, formulation controls, and patient screening.

Q3: Which markets show the highest growth potential for PEH?
A: Asia-Pacific and Latin America are projected to exhibit the highest CAGR due to expanding healthcare infrastructure and increased demand for respiratory treatments.

Q4: Are there effective synthetic alternatives to PEH?
A: Yes, phenylephrine is one such alternative, though debates exist regarding its efficacy relative to PEH. Research continues into non-phenethylamine decongestants to circumvent regulatory constraints.

Q5: What is the outlook for clinical trials involving PEH?
A: Future trials are likely to focus on reformulation for safety, abuse deterrence, and expanded therapeutic indications, with increased emphasis on controlled-release and combination products.


Key Takeaways

  • Market Stability with Growth Potential: Despite regulatory constraints, the global PEH market is expected to grow at approximately 3.8% CAGR through 2028, driven by innovation and emerging markets.

  • Regulatory Navigation: Evolving laws necessitate adaptive strategies, including reformulation and enhanced control measures, to maintain market share.

  • Innovation Drive: Focus on abuse-resistant formulations and combination therapies will shape future product pipelines and clinical research.

  • Regional Diversification: Asia-Pacific and Latin America represent crucial growth corridors, with increasing demand and less restrictive regulations.

  • Clinical Development Focus: Ongoing trials predominantly aim to improve safety, efficacy, and delivery systems, addressing current regulatory and safety concerns.


References

  1. ClinicalTrials.gov. "Safety and Pharmacokinetics of PEH," accessed January 2023.
  2. EMA Reports on Pseudoephedrine Formulations, 2022.
  3. U.S. FDA Drug Trials Database, 2023.
  4. Global Regulatory Updates on CNS Stimulants, International Journal of Drug Policy, 2022.

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