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Last Updated: January 3, 2025

CLINICAL TRIALS PROFILE FOR PYRIDOSTIGMINE BROMIDE


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All Clinical Trials for pyridostigmine bromide

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00953914 ↗ Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients Completed Hospital de Clinicas de Porto Alegre N/A 2005-03-01 The purpose of the study is to determine if pyridostigmine bromide improves heart rate variability of type 2 diabetes mellitus subjects with cardiovascular autonomic neuropathy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for pyridostigmine bromide

Condition Name

Condition Name for pyridostigmine bromide
Intervention Trials
Orthostatic Hypotension 3
Dyspnea 1
Immuno-senescence 1
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Condition MeSH

Condition MeSH for pyridostigmine bromide
Intervention Trials
Hypotension 6
Hypotension, Orthostatic 5
Acquired Immunodeficiency Syndrome 2
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Clinical Trial Locations for pyridostigmine bromide

Trials by Country

Trials by Country for pyridostigmine bromide
Location Trials
United States 15
Mexico 3
Netherlands 1
Korea, Republic of 1
Brazil 1
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Trials by US State

Trials by US State for pyridostigmine bromide
Location Trials
New York 3
New Jersey 2
North Carolina 2
Tennessee 2
Vermont 1
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Clinical Trial Progress for pyridostigmine bromide

Clinical Trial Phase

Clinical Trial Phase for pyridostigmine bromide
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for pyridostigmine bromide
Clinical Trial Phase Trials
Completed 9
Recruiting 4
Unknown status 2
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Clinical Trial Sponsors for pyridostigmine bromide

Sponsor Name

Sponsor Name for pyridostigmine bromide
Sponsor Trials
Vanderbilt University Medical Center 2
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran 2
James J. Peters Veterans Affairs Medical Center 2
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Sponsor Type

Sponsor Type for pyridostigmine bromide
Sponsor Trials
Other 25
NIH 4
U.S. Fed 4
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Pyridostigmine bromide Market Analysis and Financial Projection

Pyridostigmine Bromide: Clinical Trials, Market Analysis, and Projections

Introduction to Pyridostigmine Bromide

Pyridostigmine bromide is a medication widely used in the symptomatic treatment of myasthenia gravis (MG), a chronic autoimmune disorder characterized by muscle weakness and fatigue. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Current Use in Myasthenia Gravis

Pyridostigmine bromide is the most commonly used drug for the symptomatic treatment of MG. A study involving the Dutch-Belgian myasthenia patient registry assessed its effectiveness and side effects. Out of 642 invited patients, 410 completed the questionnaire, with 61% reporting current use of pyridostigmine. The median effectiveness reported was 60 on a Visual Analog Scale (VAS) ranging from 0 to 100, and the net benefit was 65[1].

Clinical Trials in HIV

Apart from its use in MG, pyridostigmine has been investigated in clinical trials for its potential in treating HIV-related conditions. For instance, a Phase 2 study (NCT00518154) found that adding pyridostigmine to antiretroviral therapy (ART) led to a significant increase in circulating CD4 cells in individuals with incomplete immune reconstitution despite viral suppression on ART[4].

Another ongoing Phase 1/2 study (NCT04353778) is evaluating whether pyridostigmine can reduce bacterial overgrowth in the small intestines and signs of inflammation in adults with HIV[4].

Side Effects and Net Benefit

Patient-Reported Side Effects

The study from the Dutch-Belgian myasthenia patient registry also assessed the prevalence and characteristics of side effects associated with pyridostigmine. While the drug provided a significant net benefit, patients reported various side effects, which led to discontinuation in some cases. Male patients were more likely to discontinue pyridostigmine than female patients (44% vs. 30%)[1].

Predictors of Discontinuation

The same study aimed to identify predictors of pyridostigmine discontinuation. Understanding these predictors can help clinicians manage patient expectations and side effects more effectively, thereby improving treatment adherence.

Market Analysis

Global Market Size and Projections

The global Pyridostigmine Bromide API market has been growing steadily. As of 2023, the market was valued at a significant amount, and it is anticipated to reach even higher values by 2030, with a notable Compound Annual Growth Rate (CAGR) during the period from 2023 to 2030[2][5].

Regional Market Segmentation

The market is segmented by region, with detailed analyses provided for North America, Europe, and the Asia Pacific. Key countries such as the United States, Canada, Germany, France, the UK, Italy, and China are highlighted for their consumption growth rates and market sizes[5].

Key Manufacturers

The global Pyridostigmine Bromide API market is dominated by several key manufacturers, including Bausch Health, Patheon Austria, PCI Synthesis, Procos SpA, Maithri Laboratories, Shanghai Zhongxi Sunve Pharmaceutical, and Hainan Healthcare Pharma. These top players ensure a significant supply of the API worldwide[5].

Technological Trends and New Developments

Competitive Landscape

The market report provides profiles of the competitive landscape, highlighting key competitors and their market ranks. This information is crucial for businesses looking to develop growth strategies and assess their position in the current marketplace[2].

New Product Developments

The report also discusses technological trends and new product developments in the Pyridostigmine Bromide API market. These trends are essential for understanding the future direction of the market and identifying potential opportunities for innovation and expansion[2].

Impact of External Factors

Economic and Pandemic Influences

The global Pyridostigmine Bromide API market has faced significant fluctuations due to economic environments, the COVID-19 pandemic, and the Russia-Ukraine War. These factors have been comprehensively considered in market research to provide a realistic outlook for the future[5].

Future Projections

Market Growth

The market is expected to continue growing, driven by increasing demand for pyridostigmine bromide in the treatment of MG and potential new indications. The projected growth is supported by the expanding patient population and advancements in healthcare infrastructure[2][5].

Emerging Markets

Emerging markets, particularly in the Asia Pacific region, are expected to play a significant role in the future growth of the Pyridostigmine Bromide API market. Countries like China, India, and Japan are anticipated to contribute substantially to the market's expansion[5].

Key Takeaways

  • Clinical Efficacy: Pyridostigmine bromide remains a cornerstone in the symptomatic treatment of myasthenia gravis, with a median effectiveness of 60 on a VAS scale.
  • Clinical Trials: Ongoing and completed trials explore its potential in HIV treatment, showing promising results in increasing CD4 cell counts.
  • Side Effects: Patients report various side effects, with male patients more likely to discontinue the drug.
  • Market Growth: The global Pyridostigmine Bromide API market is projected to grow significantly by 2030, driven by increasing demand and technological advancements.
  • Regional Segmentation: Key regions include North America, Europe, and the Asia Pacific, with notable contributions from emerging markets.

FAQs

What is the primary use of pyridostigmine bromide?

Pyridostigmine bromide is primarily used in the symptomatic treatment of myasthenia gravis (MG), a chronic autoimmune disorder.

What are the common side effects of pyridostigmine bromide?

Common side effects include muscle cramps, diarrhea, nausea, and abdominal pain, which can lead to discontinuation in some cases.

Is pyridostigmine bromide being investigated for other conditions?

Yes, it is being investigated in clinical trials for its potential in treating HIV-related conditions, such as increasing CD4 cell counts in individuals with incomplete immune reconstitution.

Who are the key manufacturers in the Pyridostigmine Bromide API market?

Key manufacturers include Bausch Health, Patheon Austria, PCI Synthesis, Procos SpA, Maithri Laboratories, Shanghai Zhongxi Sunve Pharmaceutical, and Hainan Healthcare Pharma.

What factors have influenced the Pyridostigmine Bromide API market recently?

The market has been influenced by economic environments, the COVID-19 pandemic, and the Russia-Ukraine War, leading to significant market fluctuations.

Sources

  1. The effectiveness and side effects of pyridostigmine in the treatment of myasthenia gravis. NMD Journal, 2022.
  2. Global Pyridostigmine Bromide API Market Research Report 2024. QYResearch, 2024.
  3. Myasthenia Gravis Treatment Market - Companies and Therapies. DelveInsight, 2021.
  4. Pyridostigmine Patient Drug Record. NIH - Clinical Info HIV.gov.
  5. Global Pyridostigmine Bromide API Market Research Report 2023. QYResearch, 2023.

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