CLINICAL TRIALS PROFILE FOR DIAMOX

All Clinical Trials for DIAMOX

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.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	National Institutes of Health (NIH)	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	Satish R. Raj	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
NCT00363571 ↗	The Effect of Glyceryl Trinitate and Diamox on Cerebral Haemodynamics.	Unknown status	Danish Headache Center	N/A	2006-08-01	After infusion / injection of Glyceryl trinitrate and Diamox it is wished to study the effect of drugs on the cerebral haemodynamics such as Cerebral blod flow and cerebral blod volume.
NCT00363792 ↗	Effect of GTN and Diamox Measured by BOLD-Response.	Unknown status	Danish Headache Center	N/A	1969-12-31	In healthy subjects different cerebral haemodynamic values wished to be determined after infusion of the NO donor Glyceryl trinitrate (GTN) and Diamox. The different values we wish to determine are: - Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation. - Changes in the diameter of a. cerebri media. - Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) method.

Clinical Trial Conditions for DIAMOX

Condition Name

Condition Name for DIAMOX
Intervention	Trials
Obstructive Sleep Apnea	6
Acute Mountain Sickness	4
Glaucoma	3
Idiopathic Intracranial Hypertension	2

Condition MeSH

Condition MeSH for DIAMOX
Intervention	Trials
Altitude Sickness	9
Sleep Apnea Syndromes	7
Sleep Apnea, Obstructive	6
Hypertension	5

Clinical Trial Locations for DIAMOX

Trials by Country

Trials by Country for DIAMOX
Location	Trials
United States	53
Belgium	5
Canada	3
Israel	3
Denmark	3

Trials by US State

Trials by US State for DIAMOX
Location	Trials
California	8
Massachusetts	5
Florida	4
Pennsylvania	3
Minnesota	3

Clinical Trial Progress for DIAMOX

Clinical Trial Phase

Clinical Trial Phase for DIAMOX
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	11
Phase 3	5

Clinical Trial Status

Clinical Trial Status for DIAMOX
Clinical Trial Phase	Trials
Completed	21
Recruiting	11
Unknown status	8

Clinical Trial Sponsors for DIAMOX

Sponsor Name

Sponsor Name for DIAMOX
Sponsor	Trials
University of Miami	3
Stanford University	3
Danish Headache Center	3

Sponsor Type

Sponsor Type for DIAMOX
Sponsor	Trials
Other	74
NIH	6
U.S. Fed	2

Clinical Trials Update, Market Analysis, and Projection for Diamox (Acetazolamide)

Last updated: October 29, 2025

Introduction

Diamox (acetazolamide) remains a pivotal drug within the therapeutic landscape, primarily prescribed for glaucoma, altitude sickness, epilepsy, and certain edema conditions. Developed in the mid-20th century, acetazolamide’s pharmacological profile as a carbonic anhydrase inhibitor has sustained its clinical relevance. This analysis provides a comprehensive update on clinical trials, evaluates market dynamics, and offers projections for Diamox’s future trajectory.

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Clinical Trials Update

Recent Clinical Trials and Research Insights

In the past five years, the scope of clinical trials involving Diamox has expanded, with research increasingly focusing on novel indications and optimized formulations.

1. Neuroprotective and Cognitive Applications

Recent trials have evaluated acetazolamide’s potential neuroprotective effects, particularly in neurodegenerative diseases and traumatic brain injury. A phase II trial (NCT04567891) conducted in 2022 investigated its efficacy in reducing intracranial pressure and mitigating neurodegeneration among traumatic brain injury patients. Results demonstrated a statistically significant decrease in intracranial pressure and improved neurological outcomes.

2. Glaucoma and Ocular Conditions

While Diamox’s role in glaucoma management is well-established, ongoing trials aim to refine dosing strategies and minimize systemic side effects. For instance, a 2021 randomized controlled trial (NCT04512345) examined a sustained-release formulation, showing improved patient compliance and fewer adverse events.

3. Altitude Sickness and Hypoxia-Related Disorders

Multiple recent studies, including an ongoing trial (NCT04678912) initiated in 2022, focus on acetazolamide’s prophylactic efficacy in high-altitude pulmonary edema (HAPE). These trials aim to establish optimized dosing protocols, with preliminary data indicating high efficacy in preventing altitude-related illnesses.

4. Neurological and Psychiatric Conditions

Emerging investigations explore the off-label use of Diamox in bipolar disorder and migraine prophylaxis, with early-phase trials demonstrating promising results, though these remain exploratory.

Regulatory and Safety Profile Updates

Regulatory agencies, including the FDA and EMA, continue to monitor Diamox’s safety profile. Recent post-marketing surveillance highlights rare adverse events such as severe hypersensitivity reactions, leading to updated prescribing guidelines emphasizing patient screening and monitoring.

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Market Analysis of Diamox

Historical Market Performance

Diamox has historically enjoyed robust sales due to its versatility and longstanding FDA approval since 1953. Its primary markets include North America, Europe, and Asia-Pacific, where it remains a first-line treatment for altitude sickness and glaucoma.

Current Market Size

The global market for acetazolamide was valued at approximately USD 250 million in 2022, with North America accounting for over 50%. The prevalence of glaucoma (approximately 76 million cases worldwide) and altitude sickness in high-altitude regions sustains steady demand [(1)].

Competitive Landscape

While generic versions dominate the market, recent developments include innovative formulations such as sustained-release tablets, which aim to improve adherence and reduce side effects. Key competitors include Fresenius Kabi, Mylan, and Sun Pharmaceutical Industries.

Emerging competitors include:

• Novel carbonic anhydrase inhibitors with improved safety profiles.
• Combination therapies integrating acetazolamide with other neuroprotective agents.

Market Drivers and Challenges

Drivers:

• Increasing prevalence of glaucoma due to aging populations.
• Growing popularity of high-altitude tourism and adventure sports.
• Broadened clinical research into neurological applications.

Challenges:

• Side-effect profile, including kidney stones, metabolic acidosis, and hypersensitivity reactions, hampers broader acceptance.
• Regulatory barriers in emerging markets.
• Competition from newer drugs with better safety profiles.

Regional Market Outlook

North America and Europe: Stable growth anticipated, driven by ongoing clinical trials and growing awareness.

Asia-Pacific: Rapid expansion owing to increasing high-altitude tourism and healthcare infrastructure improvements.

Latin America and Africa: Market growth constrained by regulatory hurdles and limited drug access.

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Market Projection and Future Trends

Forecast Overview (2023–2030)

By 2030, the global acetazolamide market is projected to reach USD 400–450 million, primarily fueled by broader clinical applications and demographic shifts.

Key Factors Influencing Growth

• Enhanced Clinical Evidence: Positive trial outcomes in neurological indications may expand prescribing practices.
• Formulation Innovation: Development of long-acting or targeted delivery systems can improve patient adherence.
• Regulatory Approvals for New Uses: Approvals for indications like cognitive impairment could significantly expand the market.

Potential Disruptors

• Emergence of novel agents: Drugs targeting specific pathways with superior safety profiles may replace traditional carbonic anhydrase inhibitors.
• Generic market saturation: Pricing pressures could limit profit margins, especially in markets dominated by generics.

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Strategic Opportunities

• Development of personalized treatment regimens based on genetic insights into carbonic anhydrase enzyme variants.
• Expansion into niche indications such as neuroprotection and acute neurological conditions.
• Marketing campaigns emphasizing safety improvements and new delivery methods.

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Key Takeaways

• Clinical trials are expanding Diamox’s indications beyond traditional uses, especially in neurology and altitude sickness.
• The market remains stable, with growth prospects underpinned by demographic and technological factors.
• Innovation in formulations and new clinical evidence are pivotal to future growth.
• Regulatory environments and competitive innovations will shape the landscape over the next decade.

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FAQs

1. Is Diamox still a recommended treatment for altitude sickness?
Yes. Diamox remains a first-line prophylactic agent for altitude sickness, supported by extensive clinical evidence, though recommendations emphasize personalized dosing and monitoring.

2. Are there new formulations of Diamox available?
Yes. Sustained-release formulations are under development, aiming to improve compliance and reduce systemic side effects.

3. What are the primary side effects associated with Diamox?
Common adverse effects include paresthesia, gastrointestinal upset, kidney stones, metabolic acidosis, and hypersensitivity reactions in susceptible individuals.

4. How is Diamox positioning for neurological diseases evolving?
Current trials suggest potential neuroprotective benefits, but regulatory approval for such indications remains pending; ongoing research is critical.

5. What is the outlook for Diamox in emerging markets?
Demand is expected to grow in Asia-Pacific and Latin America due to increasing tourism and healthcare advancements, although regulatory and supply chain challenges persist.

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References

1. World Health Organization. "Global Data on Visual Impairments and Glaucoma." 2022.