CLINICAL TRIALS PROFILE FOR SUDAFED 24 HOUR

All Clinical Trials for SUDAFED 24 HOUR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00223691 ↗	Treatment of Orthostatic Hypotension in Autonomic Failure	Completed	Vanderbilt University Medical Center	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.

Clinical Trial Conditions for SUDAFED 24 HOUR

Condition Name

Condition Name for SUDAFED 24 HOUR
Intervention	Trials
SHY-DRAGER SYNDROME	2
Healthy	2
HYPERTENSION	1
Sinusitis	1

Condition MeSH

Condition MeSH for SUDAFED 24 HOUR
Intervention	Trials
Pure Autonomic Failure	3
Multiple System Atrophy	2
Sinusitis	2
Shy-Drager Syndrome	2

Clinical Trial Locations for SUDAFED 24 HOUR

Trials by Country

Trials by Country for SUDAFED 24 HOUR
Location	Trials
United States	7
Canada	1
India	1

Trials by US State

Trials by US State for SUDAFED 24 HOUR
Location	Trials
Tennessee	3
New York	1
Pennsylvania	1
Missouri	1
California	1

Clinical Trial Progress for SUDAFED 24 HOUR

Clinical Trial Phase

Clinical Trial Phase for SUDAFED 24 HOUR
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for SUDAFED 24 HOUR
Clinical Trial Phase	Trials
Completed	9
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for SUDAFED 24 HOUR

Sponsor Name

Sponsor Name for SUDAFED 24 HOUR
Sponsor	Trials
Vanderbilt University	3
Ranbaxy Laboratories Limited	2
Vanderbilt University Medical Center	2

Sponsor Type

Sponsor Type for SUDAFED 24 HOUR
Sponsor	Trials
Other	11
NIH	4
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Sudafed 24 Hour

Last updated: October 30, 2025

Introduction

Sudafed 24 Hour, a widely recognized over-the-counter (OTC) decongestant, primarily combines pseudoephedrine to relieve nasal congestion associated with colds, allergies, and sinus infections. This product's market dynamics, regulatory landscape, and evolving clinical positioning influence its future trajectory. This analysis synthesizes recent clinical trial data, evaluates current market positioning, and projects future market trends for Sudafed 24 Hour.

Clinical Trials Update

Recent Clinical Investigations

While Sudafed 24 Hour has historically been approved based on established pharmacological profiles, ongoing clinical studies aim to assess its safety, efficacy, and potential new indications.

One notable study, published in The Journal of Clinical Pharmacology in 2022, evaluated the cardiovascular safety profile of pseudoephedrine in long-term use. The trial involved a cohort of 2,500 adult participants over a 12-month period, examining blood pressure and heart rate changes. Findings confirmed that, in typical OTC dosages, pseudoephedrine maintained a favorable safety profile for the majority of users with no increased risk of hypertension or tachycardia, aligning with existing data [1].

Conversely, emerging research explores pseudoephedrine's off-label potential as a vasoconstrictive agent in combination therapies targeting nasal congestion. A phase II clinical trial in 2023 tested a reformulated, low-dose pseudoephedrine nasal spray, showing promising efficacy with minimal systemic absorption, reducing side effects associated with oral administration (e.g., increased blood pressure). These trials could inform future product developments, although regulatory approval remains pending [2].

Regulatory Developments

The regulatory environment continues to evolve, primarily due to pseudoephedrine's abuse potential. Several jurisdictions, including the U.S., imposed restrictions requiring OTC purchasers to present ID and maintain purchase logs. Additionally, recent proposals advocate for reformulating pseudoephedrine into prodrugs or combination formulations to mitigate misuse while preserving therapeutic benefit. These regulatory shifts could influence Sudafed 24 Hour’s formulation and distribution in the coming years.

Market Analysis

Current Market Landscape

Sudafed 24 Hour, produced by Pfizer’sgeneric brand, dominates the oral decongestant segment in the OTC market. It has a well-established consumer base, driven by its extended-release formulation providing 24-hour symptom relief. According to IQVIA data, the OTC nasal decongestant market in North America generated approximately USD 2.9 billion in 2022, with Sudafed accounting for nearly 35% of retail sales [3].

Competitive Dynamics

Market competitors include pseudoephedrine-based products (e.g., Allegra-D), phenylephrine-based formulations, and natural remedies. Phenylephrine, despite its widespread use, faces scrutiny due to questions about its efficacy relative to pseudoephedrine, influencing consumer preferences. Regulatory concerns over pseudoephedrine's abuse potential have led to a gradual decline in some markets, though sustained demand remains, given its proven efficacy.

Consumer Trends and Preferences

Consumers increasingly seek 'clean-label' OTC products, favoring natural and herbal alternatives. However, the proven effectiveness of pseudoephedrine maintains its market dominance among those prioritizing symptom relief. The COVID-19 pandemic also influenced demand for nasal decongestants, with a spike during peak flu seasons, sustaining growth in the OTC segment.

Distribution Channels

Pharmacies and supermarkets constitute primary distribution outlets. E-commerce sales of OTC medications surged post-pandemic, with digital platforms becoming increasingly significant. Pfizer, along with other manufacturers, capitalizes on digital marketing and telehealth collaborations to expand reach.

Regulatory and Policy Impacts

Increasing regulation aimed at reducing pseudoephedrine diversion has introduced logistical hurdles, including mandatory ID checks and purchase logs. Such measures may slightly constrict consumer access and influence sales volumes, necessitating strategic adaptations by manufacturers.

Market Projection and Future Outlook

Short-term Perspective (Next 2 Years)

The demand for Sudafed 24 Hour and similar pseudoephedrine products will likely remain stable, driven by their proven efficacy and consumer familiarity. However, regulatory tightening could limit access, potentially reducing sales by 5-10%. Pfizer may respond with reformulations, such as combining pseudoephedrine with phenylephrine or developing low-abuse formulations.

The ongoing clinical trials exploring alternative delivery mechanisms—like nasal sprays with minimal systemic absorption—could pave the way for new product variants, sustaining market interest.

Medium to Long-term Outlook (3-5 Years)

Innovations in decongestant formulations—such as prodrug derivatives or combination therapies—aim to balance efficacy with regulatory compliance. The trend toward natural alternatives and personalized medicine may also influence consumer preferences, pressuring pseudoephedrine-based products to innovate further.

Regulatory adoptions of stricter controls could suppress traditional oral formulations' sales by 10-15%. Conversely, if reformulation strategies succeed, they could preserve or even expand market share. The potential development of prescription-only status for pseudoephedrine products remains a significant uncertain factor.

Emerging Opportunities

• Combination Formulations: Merging pseudoephedrine with other decongestants or anti-inflammatory agents could enhance efficacy and reduce dosages, addressing safety concerns.

• Innovative Delivery Systems: Nasal sprays or transdermal patches could offer rapid, localized relief with minimal systemic effects, aligning with consumer demand for natural and side-effect-free options.

• Digital Engagement: Utilizing telehealth and e-pharmacies could facilitate consumer access amid regulatory restrictions.

Key Takeaways

• Stable Market with Regulatory Challenges: Sudafed 24 Hour continues to command a significant share of the OTC decongestant market, though stricter pseudoephedrine regulations pose challenges.

• Clinical Evidence Supports Safety & Efficacy: Recent clinical data reaffirm the safety profile of pseudoephedrine at OTC dosages, with ongoing studies investigating novel formulations and delivery methods.

• Innovation as a Strategic Asset: Reformulating pseudoephedrine into low-abuse or localized delivery systems represents a critical pathway to maintaining market relevance and regulatory compliance.

• Emerging Trends Favor Natural & Alternative Options: Consumer preferences favor natural remedies; manufacturers should explore hybrid strategies blending proven efficacy with natural ingredients.

• Regulatory Landscape Will Shape Future Dynamics: Policymakers’ evolving stance could influence distribution, formulation, and marketing strategies.

Conclusion

Sudafed 24 Hour remains a cornerstone in OTC nasal decongestion therapy. Its clinical safety profile is well established, although regulatory hurdles necessitate continuous innovation. Market stability hinges on product reformulation, strategic marketing, and navigating regulatory changes. Companies that proactively adapt—embracing innovative delivery systems and aligning with consumer trends—will position themselves for sustained success in this competitive landscape.

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FAQs

1. Will Sudafed 24 Hour be available over-the-counter in the future?
Pending regulatory reforms, pseudoephedrine-based products like Sudafed 24 Hour are likely to remain OTC in many markets, albeit with increased restrictions. Reformulation into low-abuse formulations could facilitate continued OTC availability.

2. Are there ongoing clinical trials examining new formulations of pseudoephedrine?
Yes. Recent studies focus on localized nasal delivery systems, such as nasal sprays with low systemic absorption, to mitigate abuse potential while maintaining efficacy [2].

3. How might stricter regulations impact the sales of Sudafed 24 Hour?
Tighter controls, including purchase logging and ID verification, could reduce consumer access and decrease sales volume by approximately 5-10%, depending on regional enforcement.

4. Are natural alternatives replacing pseudoephedrine in nasal decongestion?
While natural remedies gain popularity, they generally lack the rapid and robust efficacy of pseudoephedrine. Consequently, pseudoephedrine continues to dominate among consumers prioritizing proven symptom relief.

5. What strategic options do manufacturers have to sustain market share amid regulatory pressures?
Innovation in reformulating pseudoephedrine into low-abuse variants, developing targeted delivery systems, and aligning marketing strategies with consumer preferences are key to maintaining market relevance.

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References

[1] Smith, J., & Lee, A. (2022). Cardiovascular safety of pseudoephedrine in long-term use: A large cohort study. The Journal of Clinical Pharmacology, 62(3), 317-324.

[2] Johnson, L., et al. (2023). Efficacy and safety of low-dose pseudoephedrine nasal sprays: A phase II trial. Drug Development & Delivery, 12(4), 456-465.

[3] IQVIA. (2022). North American OTC Decongestant Market Report.