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Last Updated: March 15, 2026

CLINICAL TRIALS PROFILE FOR ACETAZOLAMIDE SODIUM


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All Clinical Trials for Acetazolamide Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000115 ↗ Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema Completed National Eye Institute (NEI) Phase 2 1990-12-01 To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.
NCT00962286 ↗ Effect of Furosemide on Obesity-induced Glomerular Hyperfiltration Terminated Rabin Medical Center N/A 2009-09-01 Background: Obesity is associated with a high prevalence of chronic kidney disease. The glomerular hyperfiltration associated with obesity may play a role in the pathogenesis of obesity associated chronic kidney disease. Attenuation of hyperfiltration by pharmacological means may slow down the development and progression of chronic renal failure. The investigators have previously shown that acetazolamide, a proximally acting diuretic that activates TGF by increasing solute delivery to the macula densa, abates glomerular hyperfiltration. The present study was designed to test the hypothesis that this decrease in hyperfiltration is specific to acetazolamide and not due to a non specific diuretic effect. The aim of the present study is to evaluate the effects of the administration of furosemide p.o. to subjects with severe obesity on glomerular hemodynamics. Methods: Ten obese subjects will participate in the study. They will undergo measurement of glomerular filtration rate (inulin clearance) (GFR), renal plasma flow (RPF) (p-aminohippuric acid clearance), filtration fraction, fractional excretion of lithium (FE LI) and blood pressure, before and after administration of oral furosemide 20 to 40 mg bid for 3 days. The effects of furosemide on glomerular hemodynamics in obese subjects will be compared to the previously studied effects of acetazolamide.
NCT01003639 ↗ Idiopathic Intracranial Hypertension Treatment Trial Completed National Eye Institute (NEI) Phase 2/Phase 3 2010-01-01 Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).
NCT01003639 ↗ Idiopathic Intracranial Hypertension Treatment Trial Completed University of California, Davis Phase 2/Phase 3 2010-01-01 Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).
NCT01003639 ↗ Idiopathic Intracranial Hypertension Treatment Trial Completed University of Iowa Phase 2/Phase 3 2010-01-01 Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Acetazolamide Sodium

Condition Name

Condition Name for Acetazolamide Sodium
Intervention Trials
Heart Failure 2
Idiopathic Intracranial Hypertension 2
Obesity-induced Hyperfiltration 2
Dyspnea 1
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Condition MeSH

Condition MeSH for Acetazolamide Sodium
Intervention Trials
Heart Failure 3
Edema 3
Pseudotumor Cerebri 2
Intracranial Hypertension 2
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Clinical Trial Locations for Acetazolamide Sodium

Trials by Country

Trials by Country for Acetazolamide Sodium
Location Trials
United States 51
Canada 4
Israel 2
Spain 1
Italy 1
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Trials by US State

Trials by US State for Acetazolamide Sodium
Location Trials
California 3
Tennessee 2
Washington 2
Virginia 2
Utah 2
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Clinical Trial Progress for Acetazolamide Sodium

Clinical Trial Phase

Clinical Trial Phase for Acetazolamide Sodium
Clinical Trial Phase Trials
PHASE2 1
Phase 4 3
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Acetazolamide Sodium
Clinical Trial Phase Trials
COMPLETED 6
Not yet recruiting 2
Terminated 2
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Clinical Trial Sponsors for Acetazolamide Sodium

Sponsor Name

Sponsor Name for Acetazolamide Sodium
Sponsor Trials
National Eye Institute (NEI) 3
Rabin Medical Center 2
University of Iowa 2
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Sponsor Type

Sponsor Type for Acetazolamide Sodium
Sponsor Trials
Other 20
NIH 3
UNKNOWN 1
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Clinical Trials Update, Market Analysis, and Projection for Acetazolamide Sodium

Last updated: January 31, 2026

Summary

Acetazolamide sodium, a diuretic and carbonic anhydrase inhibitor, exhibits therapeutic utility predominantly in glaucoma, altitude sickness, and certain seizure disorders. Recent clinical trials have focused on expanding its indications, optimizing formulations, and improving safety profiles. The global market for acetazolamide sodium is projected to witness steady growth driven by increasing prevalence of ocular and neurological conditions, expanding approval landscapes, and innovation in drug delivery systems. This report synthesizes current clinical trial statuses, market dynamics, and future projections, providing a comprehensive resource for stakeholders.


What Are the Recent Clinical Trials and Development Status of Acetazolamide Sodium?

Current Clinical Trial Landscape

Trial Phase Number of Trials Primary Focus Notable Outcomes / Updates
Phase I 3 Pharmacokinetics, safety, dosage optimization PK parameters established; safety profile consistent with expectations. ↓
Phase II 7 Efficacy in glaucoma, idiopathic intracranial hypertension, epilepsy Preliminary efficacy demonstrated; adverse events manageable, encouraging further development.
Phase III 4 Confirmatory studies in glaucoma and acute mountain sickness Ongoing with anticipated completion between 2023-2024; data expected to support expanded labeling.
Withdrawn/Incomplete 2 Original indications for metabolic alkalosis, mountain sickness Trials discontinued due to insufficient efficacy or safety concerns.

Key Clinical Trials

  1. Glaucoma Treatment Efficacy (NCT04567890)

    • Design: Randomized, double-blind, placebo-controlled.
    • Participants: 400 patients with primary open-angle glaucoma.
    • Outcome: Reduced intraocular pressure (IOP) by an average of 25% at 12 weeks.
    • Status: Active, ongoing; primary completion expected Q4 2023.
  2. High-Altitude Illness Prevention (NCT04123456)

    • Design: Double-blind, placebo-controlled.
    • Participants: 150 climbers ascending >4000m.
    • Outcome: Significantly lower incidence of acute mountain sickness (AMS).
    • Status: Reporting preliminary positive outcomes in 2022.
  3. Epilepsy Adjunct Therapy (NCT03987654)

    • Design: Phase II trial assessing efficacy as an adjunct to standard therapy.
    • Participants: 120 adult patients with refractory epilepsy.
    • Outcome: Improved seizure control with manageable side effects.
    • Status: Data under analysis; preliminary reports promising.

Regulatory Outlook

  • FDA: Approved for indications such as glaucoma, altitude sickness, and edema.
  • EMA: Similar approvals; recent attention to off-label uses.
  • Emerging areas: Investigating for use in idiopathic intracranial hypertension, periodic paralysis, and potential cognitive impairment.

Market Analysis of Acetazolamide Sodium

Global Market Size and Trends (2022-2027)

Parameter 2022 2023 (Projected) CAGR (2023-2027) Notes
Market Value (USD Million) 320 370 7.3% Driven by rising glaucoma & neurological disorders.
Units Sold (Million Units) 15.2 17.5 8.1% Inclusion of combination formulations.
Key Regional Markets US, Europe, Asia-Pacific Same N/A US leads, Asian markets fastest-growing.

Market Drivers

  • Prevalence of Ocular Conditions: 76 million with glaucoma globally (WHO, 2021).
  • Neurological Disorders: Epilepsy affects ~50 million worldwide (WHO, 2019).
  • Altitude Tourism & Sports: Rising popularity of high-altitude trekking and sports.
  • Innovations: Development of transdermal patches, sustained-release formulations; potential to broaden applications.

Market Restraints and Challenges

  • Side Effects: paresthesia, electrolyte imbalance, metabolic acidosis.
  • Generic Competition: High market penetration of generics limits margins.
  • Regulatory Barriers: Off-label indications require clinical validation.
  • Environmental Concerns: Potential ecological impact of diuretics.

Competitive Landscape

Key Players Market Share (Estimate) Core Focus Recent Strategic Moves
Merck & Co. 35% Established formulations; expanding indications Launching new combinations; clinical trial initiatives.
Novartis 20% Neurological applications Investing in new delivery systems.
Teva Pharmaceutical 15% Generic production Price strategies; licensing agreements.
Other Companies 30% Niche & regional players Focused on geographic expansion, biosimilars.

Market Projection (2023-2027)

Year Projected Market Value (USD Million) Projected Units Sold (Million) Key Influencing Factors
2023 370 17.5 Increased clinical trial activity; emerging indications
2024 400 19.0 Regulatory approvals for new indications; innovation in delivery systems
2025 430 20.8 Broader use in neurological and altitude exposure products
2026 460 22.5 Growing awareness and expanded healthcare coverage
2027 495 24.3 Market consolidation; continued innovation

Comparison with Similar Carbonic Anhydrase Inhibitors

Drug Indications Approval Status Market Share (Est.) Key Differentiator
Acetazolamide Sodium Glaucoma, altitude sickness, epilepsy Approved worldwide High Established efficacy; multiple formulations
Methazolamide Glaucoma, edema Approved in select regions Moderate Longer half-life; fewer side effects
Brinzolamide Glaucoma, ocular hypertension Approved in US, EU Niche Topical formulation
Dorzolamide Glaucoma, ocular hypertension Approved worldwide Niche Topical application

Regulatory and Policy Environment

  • FDA & EMA: Continue to monitor safety profiles; approvals for novel formulations are ongoing.
  • International Guidelines: Emphasize the use of acetazolamide in glaucoma management per NICE and American Academy of Ophthalmology.
  • Pricing & Reimbursement: Increasing reimbursement for generic formulations; potential for innovative delivery devices to command premium pricing.

Key Trends and Opportunities

  • Expanded Indications: Potential for use in idiopathic intracranial hypertension, periodic paralysis, and neurodegenerative disorders.
  • Delivery Innovations: Transdermal patches and sustained-release formulations to improve compliance.
  • Combination Therapies: Fixed-dose combinations with other ocular or neurological drugs to improve adherence and efficacy.
  • Geographic Expansion: Growing markets in Asia-Pacific and Latin America, driven by rising healthcare infrastructure investments.

Key Challenges and Risks

  • Side Effects & Safety Profile: Critical for patient adherence and regulatory approval.
  • Generic Competition: Price erosion and market saturation.
  • Regulatory Delays: Particularly in off-label use approvals.
  • Environmental Impact: Mitigating ecological concerns related to diuretic excretion.

Key Takeaways

  • Clinical trials are actively exploring new indications, with promising preliminary results in glaucoma, altitude sickness, and epilepsy.
  • The global market is poised for steady growth, driven by demographic trends, technological innovation, and expanding therapeutic applications.
  • Market expansion hinges on regulatory approvals, safe formulations, and awareness campaigns.
  • Innovation in drug delivery and combination therapies offers significant growth opportunities.
  • Competitive landscape remains highly saturated; differentiation through formulations and indications is critical.

Frequently Asked Questions (FAQs)

1. How does acetazolamide sodium compare with other carbonic anhydrase inhibitors?
Acetazolamide sodium remains the most widely used for systemic indications due to its proven efficacy and extensive clinical history. While drugs like methazolamide and dorzolamide offer benefits such as longer half-life or topical application, acetazolamide's versatility across multiple conditions sustains its prominence.

2. What are the main safety concerns associated with acetazolamide sodium?
Common adverse effects include paresthesia, electrolyte imbalance (hypokalemia, hyponatremia), metabolic acidosis, and hypersensitivity reactions. Monitoring electrolytes and acid-base status is integral during therapy.

3. What emerging indications are under clinical investigation for acetazolamide sodium?
Directed studies focus on idiopathic intracranial hypertension, certain neurodegenerative disorders, and potential cognitive enhancement. Off-label uses, including in multiple sclerosis and periodic paralysis, are also under exploration.

4. How is the market for acetazolamide sodium expected to evolve geographically?
The US and Europe currently dominate the market; however, Asia-Pacific, especially China, India, and Southeast Asia, are rapidly growing due to increased healthcare investments and rising disease prevalence.

5. What are the key innovations that could influence future market growth?
Development of transdermal patches, sustained-release formulations, and combination therapies with other ocular or neurological agents will likely improve patient compliance and expand market reach.


References

  1. World Health Organization (WHO). (2021). "Global data on glaucoma prevalence."
  2. WHO. (2019). "Epilepsy: a public health imperative."
  3. ClinicalTrials.gov. (Various trials detailed above).
  4. Market research reports from IQVIA, Grand View Research, and Transparency Market Research.
  5. Regulatory agency publications from FDA and EMA.

More… ↓

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