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Last Updated: January 5, 2025

CLINICAL TRIALS PROFILE FOR MESTINON


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All Clinical Trials for MESTINON

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00075101 ↗ Sleep, Fatigue, and Dexamethosone in Children With Leukemia Completed National Institute of Nursing Research (NINR) Phase 3 2000-09-01 The purpose of this study is to determine the relationship between dexamethosone (steroid) and children's sleep and fatigue.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MESTINON

Condition Name

Condition Name for MESTINON
Intervention Trials
Diabetes Mellitus 3
Fibromyalgia 2
Orthostatic Hypotension 2
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Condition MeSH

Condition MeSH for MESTINON
Intervention Trials
HIV Infections 3
Diabetes Mellitus 3
Tachycardia 3
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Clinical Trial Locations for MESTINON

Trials by Country

Trials by Country for MESTINON
Location Trials
United States 12
Mexico 5
Denmark 2
Switzerland 1
Netherlands 1
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Trials by US State

Trials by US State for MESTINON
Location Trials
New York 3
Tennessee 3
Florida 2
Virginia 1
Massachusetts 1
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Clinical Trial Progress for MESTINON

Clinical Trial Phase

Clinical Trial Phase for MESTINON
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for MESTINON
Clinical Trial Phase Trials
Completed 10
Recruiting 2
Active, not recruiting 2
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Clinical Trial Sponsors for MESTINON

Sponsor Name

Sponsor Name for MESTINON
Sponsor Trials
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran 3
National Institute of Nursing Research (NINR) 2
Vanderbilt University Medical Center 2
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Sponsor Type

Sponsor Type for MESTINON
Sponsor Trials
Other 34
NIH 8
Industry 1
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MESTINON Market Analysis and Financial Projection

Mestinon: Clinical Trials, Market Analysis, and Projections

Introduction to Mestinon

Mestinon, also known as pyridostigmine bromide, is an acetylcholinesterase inhibitor widely used in the treatment of myasthenia gravis and other neuromuscular disorders. It works by inhibiting the acetylcholinesterase enzyme, thereby increasing the levels of the neurotransmitter acetylcholine in the peripheral nervous system[4].

Clinical Trials Update

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Mestinon is being explored in clinical trials for its potential in treating ME/CFS, particularly in patients with orthostatic intolerance. The Life Improvement Trial (LIFT) at Brigham and Women’s Hospital of Harvard Medical School is investigating the efficacy of Mestinon and Low-Dose Naltrexone (LDN) in subjects meeting the Canadian consensus criteria for ME/CFS. This trial aims to understand the effects of these drugs separately and in combination, as well as to identify differences between responders and non-responders[1].

Preload Failure and Exercise Intolerance

Another ongoing trial, "The Exercise Response to Pharmacologic Cholinergic Stimulation in Preload Failure," is being conducted by David Systrom in Boston. This trial involves patients with preload failure, ME, CFS, fibromyalgia, and dyspnea, and it compares the effects of a single dose of Mestinon with a placebo. The study focuses on measuring the impact on post-exertional malaise and dyspnea, based on the theory that small fiber neuropathy causes autonomic system dysfunction[4].

Postural Orthostatic Tachycardia Syndrome (POTS)

A three-day trial involving 50 people with POTS is being conducted by Dr. Phillip Low at the Mayo Clinic. This study aims to evaluate the efficacy of Mestinon in managing symptoms associated with POTS[4].

Market Analysis

Current Market Scenario

The global myasthenia gravis drugs market, in which Mestinon is a key player, is experiencing significant growth. The market is driven by advancements in understanding the disease mechanisms and the development of new therapeutic approaches. Mestinon, first launched in the United States in 1955, remains a mainstay in the treatment of myasthenia gravis due to its effectiveness in inhibiting acetylcholinesterase and increasing acetylcholine levels[5].

Market Size and Growth

The myasthenia gravis treatment market is projected to grow at a CAGR of 8.5% by 2030, reaching approximately $4.1 billion. This growth is attributed to factors such as population growth, aging demographics, and improved disease detection, particularly in regions like South Asia and the Pacific[3].

Competitive Landscape

The market for myasthenia gravis treatments is becoming increasingly competitive with the introduction of new therapies. Besides traditional acetylcholinesterase inhibitors like Mestinon, newer targeted therapies such as complement C5 inhibitors (e.g., eculizumab and ravulizumab) and neuronal nicotinic acetylcholine receptor (nAChR) modulators are gaining traction. These innovations are expected to shape the competitive intensity of the market in the coming years[3].

Regional Insights

The South Asia and Pacific region is witnessing rapid growth in the myasthenia gravis treatment market due to a mounting disease burden and increased healthcare awareness. Pharmaceutical companies and healthcare providers in these regions are expanding treatment options and improving accessibility, which is driving market growth[3].

Market Projections

Future Trends

The future of the myasthenia gravis treatment market, including Mestinon, is promising but also faces challenges. Here are some key trends and projections:

  • Targeted Therapies: The market is expected to see more targeted therapies, such as gene therapy and nAChR modulators, which could potentially replace or complement traditional treatments like Mestinon[3].
  • Access and Affordability: Despite the growth, access to innovative therapies and high treatment costs remain significant challenges. Ongoing research and collaboration among medical, pharmaceutical, and regulatory bodies are crucial to address these issues[3].
  • Biomarkers and Personalized Medicine: Efforts to identify biomarkers for predicting treatment response and disease progression will be critical in refining treatment strategies and potentially increasing the efficacy of drugs like Mestinon[3].

Challenges and Future Directions

While Mestinon remains a vital treatment option for myasthenia gravis, the market faces several challenges:

  • High Treatment Costs: The cost of innovative therapies is a significant barrier to access, especially in regions with limited healthcare resources.
  • Long-term Side Effects: Potential long-term side effects of new and existing treatments necessitate continuous monitoring and research.
  • Regulatory and Access Issues: Collaboration between regulatory bodies, pharmaceutical companies, and healthcare providers is essential to ensure that new treatments are accessible and affordable[3].

Key Takeaways

  • Mestinon is being explored in clinical trials for ME/CFS and POTS, in addition to its established use in myasthenia gravis.
  • The myasthenia gravis treatment market is projected to grow significantly, driven by new therapeutic approaches and increased healthcare awareness.
  • The market faces challenges related to access, affordability, and long-term side effects, which need to be addressed through ongoing research and collaboration.
  • Future trends include the development of targeted therapies and the identification of biomarkers for personalized medicine.

FAQs

What is Mestinon used for?

Mestinon, or pyridostigmine bromide, is primarily used to treat myasthenia gravis and other neuromuscular disorders by inhibiting the acetylcholinesterase enzyme and increasing acetylcholine levels.

What are the current clinical trials involving Mestinon?

Current clinical trials include the Life Improvement Trial (LIFT) for ME/CFS, a trial on exercise intolerance in preload failure, and a study on POTS at the Mayo Clinic.

How is the myasthenia gravis treatment market projected to grow?

The market is projected to grow at a CAGR of 8.5% by 2030, reaching approximately $4.1 billion, driven by new therapeutic approaches and increased healthcare awareness.

What are the challenges facing the myasthenia gravis treatment market?

Challenges include high treatment costs, potential long-term side effects, and regulatory and access issues that need to be addressed through ongoing research and collaboration.

What are the future trends in the myasthenia gravis treatment market?

Future trends include the development of targeted therapies such as gene therapy and nAChR modulators, and the identification of biomarkers for personalized medicine.

Sources

  1. The Life Improvement Trial (LIFT) - Open Medicine Foundation.
  2. Myasthenia Gravis Drugs Market Size | Industry Growth, (2020-2027) - Allied Market Research.
  3. Myasthenia Gravis Treatment Market Will Experience Growth, Reaching US$ 4.1 Billion by the End of 2030 - GlobeNewswire.
  4. Mestinon - MEpedia.
  5. Myasthenia Gravis Treatment Market - Companies and Therapies - DelveInsight.

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