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Last Updated: February 12, 2025

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NCT00000752 ↗ Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Adams Laboratories Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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NCT00000752 ↗ Preventing Frequent Sinus Infections in HIV-Infected Patients Withdrawn Glaxo Wellcome Phase 2 1969-12-31 To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad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.
>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
Rhinitis, Allergic, Seasonal 3
Cough 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
India 8
Canada 8
Brazil 3
Germany 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
Phase 4 9
Phase 3 17
Phase 2 5
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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
[disabled in preview] 6
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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 23
NIH 4
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Pseudoephedrine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Pseudoephedrine Hydrochloride

Pseudoephedrine hydrochloride is a small molecule drug that acts as an α-adrenergic receptor agonist, primarily used as a decongestant to alleviate nasal congestion caused by the common cold, allergies, or sinusitis. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Mechanism and Therapeutic Use

Pseudoephedrine hydrochloride works by stimulating α-adrenergic receptors in the smooth muscle of the blood vessels in the nasal passages, leading to vasoconstriction and reduced nasal mucosa swelling. This results in increased airflow through the nasal passages, providing relief from congestion[1][4].

Clinical Trials Update

As of the latest data, pseudoephedrine hydrochloride is involved in various clinical trials, although specific details on ongoing trials are limited. For instance, a clinical trial identified by the ID NCT05720455 is associated with pseudoephedrine hydrochloride, but the details of this trial are not publicly available at this time[1].

Market Analysis

Global Market Trends

The global pseudoephedrine hydrochloride market is projected to experience significant growth over the next few years. According to market insights, the global market is expected to grow from its current value in 2024 to a higher value by 2030, at a Compound Annual Growth Rate (CAGR) during the forecast period[2].

Regional Market Breakdown

  • North America: The market in the US and Canada is estimated to increase from its current value in 2024 to a higher value by 2030, at a CAGR during the forecast period.
  • Europe: The European market is also expected to grow, with estimates indicating an increase from its current value in 2024 to a higher value by 2030.
  • Asia Pacific: Countries like China, Japan, and South Korea will see significant growth, with the Chinese market in particular expected to expand substantially[2].

Key Manufacturers

The global market for pseudoephedrine hydrochloride is dominated by several key manufacturers, including Malladi, Selectchemie AG, Sun Pharmaceutical, Nortec Química, Embio, Dephis Pharma, Apeloa Pharmaceutical, and Chifeng Arker Pharmaceutical. These companies collectively hold a significant share of the market revenue[2].

Market Segmentation

By Type

The pseudoephedrine hydrochloride market is segmented based on the purity of the drug, with categories including purity ≥98% and purity ≥99%. This segmentation helps in understanding the different quality standards and their market demand[2].

By Application

Pseudoephedrine hydrochloride is used in various formulations, including capsules and tablets. The drug is often combined with other agents such as acetaminophen, antihistamines, and expectorants to relieve symptoms associated with seasonal or perennial allergic rhinitis, nonallergic rhinitis, and the common cold[4].

Market Projections

Growth Drivers

The growth of the pseudoephedrine hydrochloride market is driven by several factors, including the increasing prevalence of respiratory conditions, the rising demand for over-the-counter (OTC) medications, and advancements in pharmaceutical technology. The market is also influenced by regulatory changes and the need for effective decongestants[2][5].

Challenges and Limitations

Despite its effectiveness, pseudoephedrine hydrochloride faces challenges due to its potential for abuse and the production of illegal drugs. This has led to strict regulations, requiring prescriptions in many countries to prevent misuse. Additionally, the FDA's scrutiny of OTC drugs, as seen in the case of phenylephrine, could impact the market dynamics of pseudoephedrine hydrochloride[1][3].

Supply Chain and Regulatory Considerations

The supply chain for pseudoephedrine hydrochloride could be affected by regulatory changes. For example, if the FDA were to pull oral phenylephrine from the market due to its lack of effectiveness, it could lead to supply-chain disturbances and increased demand for pseudoephedrine-based products. However, this would also necessitate the development of more pseudoephedrine-based alternatives to meet the market demand[3].

Conclusion

Pseudoephedrine hydrochloride remains a crucial drug in the management of nasal congestion, with a growing market driven by its efficacy and the increasing prevalence of respiratory conditions. However, it faces regulatory and supply chain challenges that need to be addressed to ensure its continued availability and safe use.

Key Takeaways

  • Mechanism of Action: Pseudoephedrine hydrochloride acts as an α-adrenergic receptor agonist to relieve nasal congestion.
  • Market Growth: The global market is projected to grow significantly from 2024 to 2030.
  • Regional Markets: North America, Europe, and Asia Pacific are key regions with significant growth potential.
  • Key Manufacturers: Companies like Malladi, Selectchemie AG, and Sun Pharmaceutical dominate the market.
  • Regulatory Challenges: Strict regulations due to potential abuse and FDA scrutiny of OTC drugs.

FAQs

What is the primary use of pseudoephedrine hydrochloride?

Pseudoephedrine hydrochloride is primarily used as a decongestant to alleviate nasal congestion caused by the common cold, allergies, or sinusitis.

Which regions are expected to see significant growth in the pseudoephedrine hydrochloride market?

North America, Europe, and the Asia Pacific region are expected to see significant growth in the pseudoephedrine hydrochloride market.

What are the key challenges facing the pseudoephedrine hydrochloride market?

The market faces challenges due to the potential for abuse, strict regulations, and the need for effective alternatives in case other OTC decongestants are pulled from the market.

Who are the major manufacturers of pseudoephedrine hydrochloride?

Major manufacturers include Malladi, Selectchemie AG, Sun Pharmaceutical, Nortec Química, Embio, Dephis Pharma, Apeloa Pharmaceutical, and Chifeng Arker Pharmaceutical.

What is the expected CAGR for the global pseudoephedrine hydrochloride market from 2024 to 2030?

The exact CAGR is not specified in the sources, but the market is projected to grow significantly during this period.

Sources

  1. Pseudoephedrine Hydrochloride - Drug Targets, Indications, Patents. Synapse.
  2. Global Pseudoephedrine Hydrochloride Market Insights, Forecast to 2030. QYResearch.
  3. New Study Points to Supply Chain Disruptions. UPMC.
  4. Pseudoephedrine Monograph for Professionals. Drugs.com.
  5. Pseudoephedrine Market Industry Report 2024: Size, Share, and Key Growth Opportunities. News Channel Nebraska.

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