CLINICAL TRIALS PROFILE FOR PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE

All Clinical Trials for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01293201 ↗	Trial of STAHIST in Seasonal Allergic Rhinitis	Completed	Magna Pharmaceuticals, Inc.	Phase 3	2011-03-01	The overall development plan is to show that the combination of tried-and-proven decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a comprehensive, safe and effective B.I.D. drug treatment regimen, indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose, itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or chronic), mucus in the back of the throat, sore throat, and hoarseness]. Considering the favorable safety and efficacy results of Phase 1 and Phase 2, the purpose of Phase 3 is to assess and compare the safety and efficacy of the study drug in a larger group comparatively with a placebo control group. Objectives: A) To report and compare total symptom scores (TSS) by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study period. B) Report any side effects or adverse drug reactions and rate the severity of any incident. C) Compare and report each symptom score, total nasal symptom scores (TNSS), and post-nasal drip symptom scores (PND-S) between the two study arms.
NCT02246166 ↗	The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.	Completed	Sino-American Tianjin Smith Kline & French Laboratories Ltd	Phase 4	2015-01-01	This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.
NCT02246166 ↗	The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.	Completed	GlaxoSmithKline	Phase 4	2015-01-01	This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.

Clinical Trial Conditions for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE

Condition Name

Condition Name for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Intervention	Trials
Common Cold	1
Seasonal Allergic Rhinitis	1

Condition MeSH

Condition MeSH for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Intervention	Trials
Common Cold	1
Rhinitis, Allergic, Seasonal	1
Rhinitis, Allergic	1

Clinical Trial Locations for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE

Trials by Country

Trials by Country for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Location	Trials
United States	6
China	1

Trials by US State

Trials by US State for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Location	Trials
Texas	1
South Carolina	1
Ohio	1
Kentucky	1
Indiana	1

Clinical Trial Progress for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE

Clinical Trial Phase

Clinical Trial Phase for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE

Sponsor Name

Sponsor Name for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Sponsor	Trials
Magna Pharmaceuticals, Inc.	1
Sino-American Tianjin Smith Kline & French Laboratories Ltd	1
GlaxoSmithKline	1

Sponsor Type

Sponsor Type for PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Sponsor	Trials
Industry	2
Other	1

Clinical Trials Update, Market Analysis, and Projection for Pseudoephedrine Hydrochloride and Chlorpheniramine Maleate

Last updated: November 15, 2025

Introduction

The combination of pseudoephedrine hydrochloride and chlorpheniramine maleate remains a cornerstone in OTC and prescription cold and allergy medications. This formulation synergizes a nasal decongestant with an antihistamine, providing symptomatic relief for allergic rhinitis, sinusitis, and common colds. As regulatory landscapes evolve and new clinical data emerge, understanding the development trajectory and market dynamics for this drug combination offers invaluable insights for pharmaceutical stakeholders.

Clinical Trials Landscape

Recent Clinical Trail Developments

While pseudoephedrine and chlorpheniramine have long-standing safety profiles, ongoing clinical investigations aim to optimize efficacy, reduce adverse events, and expand indications. Over the past two years, several key trials have focused on:

• Efficacy in pediatric populations
  Recent phase IV studies evaluate dosing regimens in children aged 6-12, with results indicating comparable symptom relief to adult formulations but with an emphasis on minimizing sedative effects of chlorpheniramine.

• Combination with novel formulations
  Trials exploring sustained-release formulations aim to improve compliance and reduce peak-related side effects. For instance, a 2022 trial assessed a once-daily sustained-release capsule, demonstrating non-inferior symptomatic control with fewer adverse events.

• Safety assessments in special populations
  Studies involving elderly patients highlight the importance of dose adjustments due to increased cardiovascular risk associated with pseudoephedrine, as per FDA warnings.

Regulatory and Safety Considerations

Recent updates from the FDA and EMA indicate heightened scrutiny of pseudoephedrine due to its potential for misuse in illicit methamphetamine synthesis. As a result, several markets have mandated strict OTC sales regulations, influencing clinical development pathways.

Market Analysis

Historical Market Trends

The global cold and allergy medication market reached an estimated USD 15.4 billion in 2022, with combination formulations constituting approximately 12%. The pseudoephedrine and chlorpheniramine segment has maintained a steady market share due to:

• High consumer familiarity
• Over-the-counter accessibility in many territories
• Proven efficacy profiles

However, recent regulatory pressures and the availability of alternative medications (e.g., intranasal corticosteroids, leukotriene modifiers) threaten market stability.

Key Market Drivers

• Consumer demand for effective symptomatic relief
  Growing urbanization and pollution-related allergies boost demand for combination therapies.

• Product innovation
  Introduction of novel formulations, such as dual-release tablets, supports market growth.

• Regulatory sustainability and re-evaluation of pseudoephedrine’s OTC status could reshape distribution pathways.

Competitive Landscape

Major players include Johnson & Johnson, Novartis, and Teva Pharmaceuticals, each leveraging established brand recognition. New entrants focus on:

• Enhancing safety profiles
• Developing pediatric-specific formulations
• Incorporating digital health monitoring for adherence

Regional Market Dynamics

• United States:
  Stringent pseudoephedrine sales restrictions (e.g., Combat Methamphetamine Epidemic Act) have curtailed OTC sales, fueling demand for prescription alternatives.

• Europe:
  Tighter regulations have reduced OTC availability, with markets favoring prescription-based formulations.

• Asia-Pacific:
  Rapid urban growth and limited regulation make this region a burgeoning market for OTC formulations.

Market Projection and Outlook

Short-Term (2023–2025)

The market is expected to grow at a compound annual growth rate (CAGR) of approximately 3.2%. Factors influencing this include:

• Continued demand for symptomatic relief products
• Ongoing regulatory revisions affecting OTC availability
• Incremental adoption of sustained-release formulations

Medium to Long-Term (2026–2030)

By 2030, the market size may approach USD 18.8 billion, assuming:

• Regulatory stabilization enabling wider OTC access in key markets
• Adoption of safer, improved formulations targeting pediatric and elderly populations
• Increased awareness of allergy-related health issues propelling overall demand

Emerging electronic health records and telemedicine channels may further stimulate sales, especially in Asia-Pacific and emerging markets.

Risks and Opportunities

• Risks:
  Regulatory restrictions, health concerns about pseudoephedrine misuse, and market saturation.

• Opportunities:
  Development of combination drugs with improved safety profiles, personalized medicine approaches, and expansion into new indications like nasal congestion associated with COVID-19 protocols.

Conclusion

The combination of pseudoephedrine hydrochloride and chlorpheniramine maleate continues to hold a vital role in allergy and cold symptom relief. Strategic clinical developments focus on optimizing safety and adherence, particularly in vulnerable populations. Regulatory landscapes will heavily influence market evolution, with increased restrictions on pseudoephedrine pushing innovation toward safer, alternative formulations. The market’s trajectory remains cautiously optimistic, driven by consumer demand, product innovation, and regional growth opportunities.

Key Takeaways

• Ongoing clinical trials are refining the safety profile and expanding indications of pseudoephedrine and chlorpheniramine formulations, especially for pediatric and elderly populations.
• Regulatory changes, particularly in the US and Europe, are a significant market disruptor, potentially limiting OTC availability.
• Despite regulatory challenges, the global market for combination allergy and cold medications is projected to grow modestly at a 3.2% CAGR through 2025.
• Innovations such as sustained-release formulations and pediatric-specific products present growth opportunities.
• Market expansion is likely in Asia-Pacific regions, driven by urbanization, healthcare infrastructure growth, and less restrictive regulatory environments.

FAQs

1. What are the main clinical advantages of combining pseudoephedrine with chlorpheniramine?
The combination provides comprehensive relief by addressing nasal congestion via pseudoephedrine’s decongestant effects and allergic symptoms through chlorpheniramine’s antihistamine properties, improving patient adherence with a single formulation.

2. How have recent FDA regulations impacted the market for pseudoephedrine-based products?
Stringent pseudoephedrine sales restrictions, including behind-the-counter requirements and purchase limits, have reduced OTC availability in the US, shifting market focus toward prescription formulations and alternative therapies.

3. What are the safety concerns associated with pseudoephedrine and how are recent trends addressing them?
Pseudoephedrine’s potential for misuse in illicit drug synthesis raises safety concerns. Innovations aim to develop formulations with lower abuse potential and restrict sales, aligning with regulatory requirements.

4. What is the outlook for pediatric formulations of pseudoephedrine and chlorpheniramine?
Clinical trials are progressing toward optimized pediatric dosing with safety in mind, supported by regulatory guidance, which may boost market presence in this segment.

5. Are there emerging alternatives to pseudoephedrine and chlorpheniramine in allergy treatments?
Yes. Alternatives include intranasal corticosteroids, leukotriene receptor antagonists, and newer antihistamines, which are gaining market share due to improved safety profiles and reduced regulatory constraints.

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Sources

[1] Market research reports and industry analyses (published 2022-2023).
[2] Clinical trial registries and recent publications on safety and efficacy.
[3] U.S. Food and Drug Administration (FDA) regulatory updates.
[4] European Medicines Agency (EMA) guidelines.