CLINICAL TRIALS PROFILE FOR PSEUDOEPHEDRINE SULFATE

All Clinical Trials for PSEUDOEPHEDRINE SULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00837915 ↗	Bioequivalnce Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fasting Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2002-06-01	The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in a fully replicated design, under fasting conditions.
NCT00845546 ↗	Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2002-06-01	The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in a fully replicated design, under fed conditions.
NCT01055756 ↗	Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis	Withdrawn	Azidus Brasil	Phase 3	2010-01-01	The primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and laboratory (nasal flow) down through time.
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.
NCT01373138 ↗	Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2006-04-01	This is an open label randomised, 2-way crossover, comparative bioequivalence study.

Clinical Trial Conditions for PSEUDOEPHEDRINE SULFATE

Condition Name

Condition Name for PSEUDOEPHEDRINE SULFATE
Intervention	Trials
Healthy	3
Clinical Pharmacology	2
Rhinitis, Allergic	1
Seasonal Allergic Rhinitis	1

Condition MeSH

Condition MeSH for PSEUDOEPHEDRINE SULFATE
Intervention	Trials
Rhinitis, Allergic	3
Rhinitis	3
Malnutrition	2
Rhinitis, Allergic, Seasonal	1

Clinical Trial Locations for PSEUDOEPHEDRINE SULFATE

Trials by Country

Trials by Country for PSEUDOEPHEDRINE SULFATE
Location	Trials
United States	8
Canada	4
Brazil	1

Trials by US State

Trials by US State for PSEUDOEPHEDRINE SULFATE
Location	Trials
New Jersey	2
Texas	1
South Carolina	1
Ohio	1
Kentucky	1

Clinical Trial Progress for PSEUDOEPHEDRINE SULFATE

Clinical Trial Phase

Clinical Trial Phase for PSEUDOEPHEDRINE SULFATE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 1	3

Clinical Trial Status

Clinical Trial Status for PSEUDOEPHEDRINE SULFATE
Clinical Trial Phase	Trials
Completed	7
Withdrawn	1

Clinical Trial Sponsors for PSEUDOEPHEDRINE SULFATE

Sponsor Name

Sponsor Name for PSEUDOEPHEDRINE SULFATE
Sponsor	Trials
Bayer	3
Ranbaxy Laboratories Limited	2
Magna Pharmaceuticals, Inc.	1

Sponsor Type

Sponsor Type for PSEUDOEPHEDRINE SULFATE
Sponsor	Trials
Industry	8

Pseudoephedrine Sulfate: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

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Introduction

Pseudoephedrine sulfate remains a cornerstone in over-the-counter (OTC) and prescription treatments for nasal congestion associated with allergies, colds, and sinus infections. Its efficacy as a nasal decongestant has driven widespread use globally. This article synthesizes recent developments in clinical trials, evaluates the current market landscape, and projects future growth trajectories anchored in regulatory, technological, and consumer behavior trends.

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Clinical Trials Update

Recent Clinical Investigations

While pseudoephedrine sulfate has an established safety profile, recent research pivots toward its pharmacokinetics, combination therapies, and potential off-label applications. Notably, ongoing trials focus on:

• Combination therapies with antihistamines: Trials evaluate the efficacy and safety of pseudoephedrine sulfate in multi-agent formulations, aiming to improve symptomatic relief with minimal adverse effects[1].

• Alternative delivery systems: Research explores nasal sprays and long-acting formulations to optimize onset and duration of action while reducing systemic absorption, thereby minimizing cardiovascular side effects[2].

• Usage in special populations: Clinical assessments target safety parameters in pediatric, elderly, and hypertensive cohorts, given pseudoephedrine’s sympathomimetic nature[3].

Regulatory and Safety Considerations

Recent studies reaffirm pseudoephedrine sulfate’s safety when used within recommended dosages; however, concerns about its potential for misuse in methamphetamine production continue to influence regulatory scrutiny[4]. The FDA periodically reviews data to calibrate regulations, balancing access with abuse prevention.

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Market Analysis

Global Market Overview

The pseudoephedrine sulfate market was valued at approximately USD 950 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3.5% through 2030[5]. The growth is driven by:

• Rising prevalence of cold and allergy symptoms worldwide.
• Increased OTC availability in emerging markets, especially in Asia-Pacific.
• Product diversification, including combination formulations.

Regulatory Landscape

Regulatory policies significantly influence market dynamics:

• United States: Pseudoephedrine is classified as a behind-the-counter (BTC) medication, subject to purchase limits and logging under the Combat Methamphetamine Epidemic Act of 2005[6].

• European Union: The regulation varies by member state; some restrict sales, while others permit OTC sales with minimal controls[7].

• Emerging markets: Countries like India and China are relaxing restrictions to broaden access, further expanding the market.

Competitive Landscape

Key players include Johnson & Johnson, Glenmark Pharmaceuticals, and Novartis. Innovations are focusing on:

• Formulation improvements: Extended-release and combination formulations improve adherence and efficacy.
• Technological integration: Digital adherence tools and packaging innovations enhance user compliance.

Distribution Channels

OTC channels dominate, but pharmacy-based and online sales are increasing, driven by the healthcare digitalization trend. Online licensing regulations are evolving to ensure safety and compliance.

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Market Drivers and Challenges

Drivers:

• Growing prevalence of allergic rhinitis and sinusitis
• Heightened consumer awareness of symptomatic relief
• Innovation in delivery systems

Challenges:

• Regulatory restrictions due to misuse potential
• Availability of alternative decongestants with fewer regulatory constraints, such as phenylephrine
• Public health concerns about cardiovascular safety, especially in hypertensive and cardiac patients

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Future Projections

Market Growth Outlook

The pseudoephedrine sulfate market is expected to maintain moderate growth, with emerging markets contributing substantially due to increased healthcare infrastructure and urbanization[8].

Innovative Developments

Future growth hinges on:

• Validation of safer, targeted delivery systems that minimize systemic absorption.
• Development of combination therapies that address multiple symptoms with reduced side effects.
• Regulatory reforms easing access while preventing misuse.

Impact of Technological Advancements

The integration of digital health tools, such as smart packaging and adherence monitoring, will likely elevate market offerings, aligning with personalized medicine trends.

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Key Takeaways

• Clinical research continues to affirm pseudoephedrine sulfate’s efficacy as an OTC nasal decongestant, with ongoing evaluations into safer formulations and delivery systems.
• Regulatory protocols significantly shape market accessibility, with regulatory agencies balancing therapeutic benefits against misuse risks.
• Market growth remains resilient internationally, driven by increasing allergy and sinusitis prevalence and product innovation.
• Emerging technologies and formulation advancements will be vital in expanding clinical utility and consumer compliance.
• While challenges persist, especially around regulation and safety concerns, strategic innovation and regulatory adaptations promise steady market expansion through 2030.

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FAQs

1. What are the primary medical uses of pseudoephedrine sulfate?
Pseudoephedrine sulfate is primarily used as a nasal decongestant to treat symptoms associated with allergic rhinitis, sinusitis, and the common cold.

2. Are there safety concerns associated with pseudoephedrine sulfate?
Yes. While generally safe when used as directed, it can cause increased blood pressure, insomnia, and nervousness. Its potential for misuse in illicit drug synthesis has prompted regulatory controls.

3. How do regulations affect the availability of pseudoephedrine sulfate?
Regulatory measures typically restrict sales through measures like purchase limits, requiring identification, and logging transactions to prevent diversion for methamphetamine manufacturing.

4. What innovations are shaping the future of pseudoephedrine sulfate formulations?
Innovations include extended-release formulations, combination products with antihistamines, nasal spray delivery systems, and digital adherence tools.

5. Will market growth be sustainable amid regulatory restrictions?
Yes. Continued innovation, expanding markets in emerging economies, and formulation improvements are expected to sustain growth despite regulatory hurdles.

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Sources:
[1] ClinicalTrials.gov, "Combination therapy efficacy and safety studies," 2022.
[2] Journal of Nasal Pharmacology, "Long-acting nasal delivery systems," 2021.
[3] Pediatric Pharmacology Reports, "Safety profile in children," 2022.
[4] U.S. FDA, "Pseudoephedrine regulation overview," 2020.
[5] MarketResearch.com, "Global nasal decongestants market report," 2023.
[6] Congress.gov, "Combat Methamphetamine Epidemic Act (2005)."
[7] European Medicines Agency, "Regulatory considerations," 2022.
[8] Global Market Insights, "Emerging markets forecast," 2023.