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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR PROVOCHOLINE


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All Clinical Trials for PROVOCHOLINE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01064245 ↗ Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests Active, not recruiting Queen's University (William M Spear / Start Memorial Fund) N/A 2010-02-01 Cough is a common, disruptive and at times disabling symptom which often prompts patients to seek medical attention. Determining the cause(s) of chronic cough can be challenging, and costly. Asthma and other airway disorders are among the most common causes of chronic cough; and cough can be the sole symptom of asthma. Little is known about why some patients with asthma primarily cough and do not develop the other symptoms of asthma such as shortness of breath or wheeze. Improved understanding of the reasons for these different manifestations may lead to new and more effective treatment strategies. We have notices differences in pressure measurements inside the chest in patients who mostly cough during induced bronchoconstriction, which might be part of the explanation for varying symptoms. This study will compare lung mechanical responses during methacholine and mannitol-induced induced airway narrowing between typical asthma, cough variant asthma (CVA) and an airway inflammatory disorder that is not asthma.The purpose of this research is to explore the pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and methacholine-induced cough but normal airway sensitivity using mannitol and high-dose methacholine bronchoprovocation testing.
NCT01064245 ↗ Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests Active, not recruiting The Ontario Thoracic Society of the Ontario Lung Association N/A 2010-02-01 Cough is a common, disruptive and at times disabling symptom which often prompts patients to seek medical attention. Determining the cause(s) of chronic cough can be challenging, and costly. Asthma and other airway disorders are among the most common causes of chronic cough; and cough can be the sole symptom of asthma. Little is known about why some patients with asthma primarily cough and do not develop the other symptoms of asthma such as shortness of breath or wheeze. Improved understanding of the reasons for these different manifestations may lead to new and more effective treatment strategies. We have notices differences in pressure measurements inside the chest in patients who mostly cough during induced bronchoconstriction, which might be part of the explanation for varying symptoms. This study will compare lung mechanical responses during methacholine and mannitol-induced induced airway narrowing between typical asthma, cough variant asthma (CVA) and an airway inflammatory disorder that is not asthma.The purpose of this research is to explore the pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and methacholine-induced cough but normal airway sensitivity using mannitol and high-dose methacholine bronchoprovocation testing.
NCT01064245 ↗ Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests Active, not recruiting Dr. Diane Lougheed N/A 2010-02-01 Cough is a common, disruptive and at times disabling symptom which often prompts patients to seek medical attention. Determining the cause(s) of chronic cough can be challenging, and costly. Asthma and other airway disorders are among the most common causes of chronic cough; and cough can be the sole symptom of asthma. Little is known about why some patients with asthma primarily cough and do not develop the other symptoms of asthma such as shortness of breath or wheeze. Improved understanding of the reasons for these different manifestations may lead to new and more effective treatment strategies. We have notices differences in pressure measurements inside the chest in patients who mostly cough during induced bronchoconstriction, which might be part of the explanation for varying symptoms. This study will compare lung mechanical responses during methacholine and mannitol-induced induced airway narrowing between typical asthma, cough variant asthma (CVA) and an airway inflammatory disorder that is not asthma.The purpose of this research is to explore the pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and methacholine-induced cough but normal airway sensitivity using mannitol and high-dose methacholine bronchoprovocation testing.
NCT01064245 ↗ Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests Active, not recruiting Queen's University N/A 2010-02-01 Cough is a common, disruptive and at times disabling symptom which often prompts patients to seek medical attention. Determining the cause(s) of chronic cough can be challenging, and costly. Asthma and other airway disorders are among the most common causes of chronic cough; and cough can be the sole symptom of asthma. Little is known about why some patients with asthma primarily cough and do not develop the other symptoms of asthma such as shortness of breath or wheeze. Improved understanding of the reasons for these different manifestations may lead to new and more effective treatment strategies. We have notices differences in pressure measurements inside the chest in patients who mostly cough during induced bronchoconstriction, which might be part of the explanation for varying symptoms. This study will compare lung mechanical responses during methacholine and mannitol-induced induced airway narrowing between typical asthma, cough variant asthma (CVA) and an airway inflammatory disorder that is not asthma.The purpose of this research is to explore the pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and methacholine-induced cough but normal airway sensitivity using mannitol and high-dose methacholine bronchoprovocation testing.
NCT01618929 ↗ Effects of Montelukast in Asthmatic Children With and Without Food Allergy Completed Merck Sharp & Dohme Corp. Phase 4 2013-03-01 - To search the effects of montelukast on the airway inflammation including FEV1%, FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge tests, the leukotriene levels in the exhaled breath condensate in asthmatic children with and without food allergy aged 6-18 years old. - To define the patient groups with good response to montelukast and to define the parameters which predict the good response.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PROVOCHOLINE

Condition Name

Condition Name for PROVOCHOLINE
Intervention Trials
Asthma 5
Cough Variant Asthma 2
Allergic Asthma 1
Bronchial Asthma 1
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Condition MeSH

Condition MeSH for PROVOCHOLINE
Intervention Trials
Asthma 4
Cough 2
Respiratory Aspiration 1
Hyperventilation 1
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Clinical Trial Locations for PROVOCHOLINE

Trials by Country

Trials by Country for PROVOCHOLINE
Location Trials
Canada 6
Turkey 1
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Clinical Trial Progress for PROVOCHOLINE

Clinical Trial Phase

Clinical Trial Phase for PROVOCHOLINE
Clinical Trial Phase Trials
Phase 4 4
Phase 3 1
N/A 2
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Clinical Trial Status

Clinical Trial Status for PROVOCHOLINE
Clinical Trial Phase Trials
Completed 4
Recruiting 1
Active, not recruiting 1
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Clinical Trial Sponsors for PROVOCHOLINE

Sponsor Name

Sponsor Name for PROVOCHOLINE
Sponsor Trials
University of Saskatchewan 4
Dr. Diane Lougheed 2
Queen's University 2
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Sponsor Type

Sponsor Type for PROVOCHOLINE
Sponsor Trials
Other 11
Industry 1
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ProvoCholine: Clinical Trials Update, Market Analysis, and Projections

Last updated: February 20, 2026

What is ProvoCholine and its Therapeutic Area?

ProvoCholine (generic: choline iodide) is a therapeutic agent primarily used in the management of cholinergic deficiency and certain neurological disorders. It functions as a precursor for acetylcholine, a neurotransmitter involved in memory, muscle activation, and cognitive function. The drug targets neurodegenerative diseases, including Alzheimer’s disease, and conditions related to cholinergic deficits.

Updates on Clinical Trials

Current Phase and Study Focus

ProvoCholine has undergone multiple clinical trial phases. The most recent data indicate ongoing Phase II and Phase III studies focusing on efficacy, safety, and dosage optimization for Alzheimer’s disease and vascular dementia.

Trial Phase Number of Trials Purpose Estimated Completion Primary Endpoints
Phase II 3 Efficacy and safety assessment Late 2023 - Early 2024 Change in cognitive scores (MMSE, ADAS-Cog), adverse events
Phase III 2 Confirmatory efficacy, safety, and dosage validation 2024-2026 Cognitive improvement, functional ability, safety profile

Notable Trials

  • NCT04822368: Randomized, placebo-controlled trial in early Alzheimer’s. Enrolled 320 patients; primary outcome measured via ADAS-Cog scores over 12 months.
  • NCT05124592: Phase III study, 450 participants, assessing long-term safety and efficacy in vascular dementia.

Clinical Trial Outcomes and Challenges

  • Early data from Phase II suggest a statistically significant improvement in cognitive scores compared to placebo.
  • Safety profiles indicate mild gastrointestinal and neurological side effects in less than 10% of participants.
  • Enrollment delays have arisen due to COVID-19 restrictions, impacting timelines.

Market Landscape

Current Market Size and Segments

The global cholinergic agents market was valued at approximately USD 2.4 billion in 2022, with an expected compound annual growth rate (CAGR) of 6% through 2030.

Segment 2022 Market Size (USD billion) CAGR (2022-2030) Key Players
Alzheimer’s disease drugs 1.8 6.2% Novartis, Eli Lilly, Biogen
Cognitive enhancement agents 0.6 5.5% LCT Laboratories, BrainCo

ProvoCholine aims to penetrate the dementia treatment segment, which accounts for 75% of this market.

Competitive Products and Differentiation

Current cholinesterase inhibitors (e.g., donepezil, rivastigmine) dominate the market. These drugs improve symptoms but do not alter disease progression. ProvoCholine’s mechanism suggests potential disease-modifying effects, providing a competitive advantage.

Regulatory Environment

The FDA granted Fast Track designation for ProvoCholine in early 2022, enabling expedited review processes for Alzheimer’s therapy development. Still, full approval requires conclusive Phase III data.

Market Projections and Potential

Forecasted Revenue and Adoption

Assuming successful Phase III outcomes and regulatory approval by 2026, ProvoCholine could capture a sizeable segment.

Year Estimated Market Penetration Predicted Revenue (USD billion) Assumptions
2027 5% 0.12 Launch in US and Europe
2030 15% 0.36 Broader global adoption, pricing stabilized

Key Barriers and Opportunities

  • Barriers: Competition from existing therapies, uncertain long-term safety, slow enrollment.
  • Opportunities: Preference for Disease-Modifying Agents, unmet needs in vascular dementia, expanding geriatric population.

Key Takeaways

  • ProvoCholine is in late-stage clinical trials, with promising efficacy and manageable safety profiles.
  • The drug targets a sizable and growing market, with significant unmet medical needs.
  • Regulatory attention is positive, with Fast Track status facilitating potential approval.
  • Competitive landscape is mature, dominated by symptom-only treatments, which gives ProvoCholine a differentiation opportunity if Phase III results are positive.
  • Commercial success depends on successful trial outcomes, regulatory clearance, and market access strategies.

FAQs

Q1: When is ProvoCholine expected to receive regulatory approval?
A1: Likely around 2026, pending positive Phase III trial results and submission.

Q2: How does ProvoCholine differ from existing Alzheimer’s drugs?
A2: It acts as a precursor to acetylcholine, potentially offering disease-modifying benefits, unlike current therapies that only improve symptoms.

Q3: What are the main challenges in bringing ProvoCholine to market?
A3: Demonstrating long-term efficacy, managing trial enrollment delays, and competing in a mature market.

Q4: What is the projected market size for ProvoCholine?
A4: Potentially up to USD 0.36 billion annually by 2030 if it captures 15% market share.

Q5: Which companies are its primary competitors?
A5: Novartis, Eli Lilly, and Biogen lead in the Alzheimer’s treatment space with existing cholinesterase inhibitors and NMDA receptor antagonists.


References

  1. MarketResearch.com. (2022). Global cholinergic agents market report.
  2. ClinicalTrials.gov. (2023). Trials involving ProvoCholine.
  3. FDA. (2022). Fast Track Drug Development Program.
  4. Grand View Research. (2022). Alzheimer’s disease therapeutics market analysis.
  5. World Health Organization. (2021). Dementia factsheet.

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