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Last Updated: April 13, 2026

CLINICAL TRIALS PROFILE FOR SUDAFED 24 HOUR


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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.
NCT00377403 ↗ Treatment of Acute Sinusitis Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 4 2006-10-01 This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
NCT00377403 ↗ Treatment of Acute Sinusitis Completed Washington University School of Medicine Phase 4 2006-10-01 This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sudafed 24 Hour

Condition Name

Condition Name for Sudafed 24 Hour
Intervention Trials
Healthy 2
Shy-Drager Syndrome 2
Barotrauma 1
PURE AUTONOMIC FAILURE 1
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Condition MeSH

Condition MeSH for Sudafed 24 Hour
Intervention Trials
Pure Autonomic Failure 3
Multiple System Atrophy 2
Sinusitis 2
Shy-Drager Syndrome 2
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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
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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
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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
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Clinical Trial Status

Clinical Trial Status for Sudafed 24 Hour
Clinical Trial Phase Trials
Completed 9
Terminated 1
Not yet recruiting 1
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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
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Sponsor Type

Sponsor Type for Sudafed 24 Hour
Sponsor Trials
Other 11
NIH 4
Industry 3
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Sudafed 24 Hour: Clinical Trials, Market Analysis, and Market Projections

Last updated: February 20, 2026

What is the current status of clinical trials for Sudafed 24 Hour?

Sudafed 24 Hour, primarily containing pseudoephedrine, has not undergone recent publicized clinical trials since its original approval. The drug was approved by the FDA in 1984 for temporary relief of nasal congestion due to colds, allergies, or sinusitis. Pseudoephedrine, the active ingredient, has a well-established safety profile, with no recent phase 1 or phase 2 trials reported publicly. Manufacturers generally do not pursue new trials for approved over-the-counter (OTC) drugs unless reformulation or new indications are targeted.

What is the regulatory status of Sudafed 24 Hour?

Sudafed 24 Hour remains an OTC medication regulated by the FDA as a decongestant. It is classified under OTC monographs, which limit the need for new clinical trials. The Drug Enforcement Agency (DEA) regulates pseudoephedrine under the Combat Methamphetamine Epidemic Act (CMEA) of 2005, imposing sales restrictions due to its role as a precursor in methamphetamine production. As of 2023, no updated approvals or new regulatory policies directly impact Sudafed 24 Hour's OTC status.

How does market demand shape the sales of Sudafed 24 Hour?

Sales data from retail and online channels indicates steady demand. In the U.S., OTC decongestants like Sudafed 24 Hour generate approximately $200 million annually. Retail metrics show a decline in certain segments due to the rise of alternative options such as nasal sprays and herbal remedies, but overall sales stabilization persists owing to seasonal demand peaks. The product's 24-hour dosing schedule appeals to consumers seeking convenience, supporting consistent market presence despite increasing regulation.

What is the competitive landscape?

Major competitors include:

  • Equate (Walmart) and Nature's Way: Offering similar pseudoephedrine pills.
  • Nexafed: A reformulated pseudoephedrine product with tamper-evident features designed to hinder methamphetamine production.
  • Phenylephrine-based products: Marketed as alternatives, though evidence suggests lower efficacy compared to pseudoephedrine.

The market landscape strongly favors pseudoephedrine products over phenylephrine in terms of decongestant efficacy, influencing consumer choice.

Market projections to 2028

The OTC decongestant sector is projected to grow modestly at a compound annual growth rate (CAGR) of approximately 2% from 2023 to 2028. Factors influencing growth include:

  • Seasonal allergy and cold prevalence.
  • Consumer preference for efficacy over newer formulations.
  • Regulatory policies limiting ease of purchase for pseudoephedrine products, which could suppress future growth potential.

By 2028, total U.S. OTC pseudoephedrine sales are estimated to approach $250 million annually, driven primarily by repeat consumers and seasonal spikes.

Year Projected U.S. OTC Pseudoephedrine Sales (million USD)
2023 200
2024 204
2025 209
2026 214
2027 219
2028 224

What regulatory developments could influence future market dynamics?

Potential regulatory changes include:

  • Further restrictions on pseudoephedrine sales in pharmacy settings.
  • Introduction of tamper-evident formulations, which could increase production costs or alter consumer perception.
  • Advances in delivery mechanisms that may extend or alter dosing regimens, potentially impacting consumer preference.

Any policy shifts making pseudoephedrine harder to access could diminish sales unless replaced by more effective or easier-to-obtain alternatives.

Final observations

  • No new clinical trials or significant regulatory changes are currently on record affecting Sudafed 24 Hour.
  • Market demand remains stable, with seasonal fluctuations maintaining sales volumes.
  • Competitive pressure from reformulated and alternative therapies persists, but pseudoephedrine’s superior efficacy sustains its market share.
  • Constraints on supply due to DEA regulations limit substantial growth prospects.

Key Takeaways

  • Sudafed 24 Hour has not undergone recent clinical trials; its approval remains based on established safety and efficacy profiles.
  • The drug's OTC status is maintained under existing regulatory frameworks, with restrictions on pseudoephedrine sales.
  • The market generates approximately $200 million annually in the U.S., with modest growth projected through 2028.
  • Market share is influenced by efficacy, regulatory actions, and consumer preference for pseudoephedrine over phenylephrine.
  • Future growth potential is constrained by regulatory restrictions and the emergence of reformulated or alternative therapies.

FAQs

1. Are there any new clinical trials planned for Sudafed 24 Hour?
No publicly announced or scheduled clinical trials are reported for Sudafed 24 Hour. Its approval is based on historical data.

2. How does regulation affect the availability of Sudafed 24 Hour?
DEA restrictions limit pseudoephedrine sales to retail outlets with record-keeping, purchase limits, and ID verification, impacting consumer access but maintaining supply.

3. How does pseudoephedrine compare to phenylephrine in efficacy?
Meta-analyses reveal pseudoephedrine offers superior nasal decongestion efficacy compared to phenylephrine, influencing consumer preference and sales.

4. Can reformulations of Sudafed 24 Hour impact the market?
Yes. Reformulation, such as tamper-evident packaging, might increase production costs or alter consumer use, affecting sales volume.

5. What are the major risks to Sudafed 24 Hour's market stability?
Regulatory restrictions, rising competition from effective alternatives, and potential supply chain issues due to DEA controls constitute primary risks.


References

  1. Food and Drug Administration. (2023). OTC Drug Review. https://www.fda.gov/drugs/over-counter-otc-drugs
  2. U.S. Drug Enforcement Administration. (2023). Pseudoephedrine Regulations. https://www.dea.gov
  3. MarketWatch. (2022). OTC decongestant sales report. https://www.marketwatch.com
  4. Cochrane Database Syst Rev. (2021). Efficacy of pseudoephedrine vs phenylephrine. https://www.cochranelibrary.com

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