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Last Updated: April 27, 2025

CLINICAL TRIALS PROFILE FOR NEPTAZANE


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All Clinical Trials for NEPTAZANE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01702025 ↗ Rapid Acclimatization to Hypoxia at Altitude Completed Defense Advanced Research Projects Agency Phase 1/Phase 2 2012-06-01 In low oxygen environments, such as altitude, some adults may become ill and suffer from acute mountain sickness. Further, all adults will find that exercising becomes much more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of this investigation is to study the effects of two drugs that may help people adjust to high-altitude quickly, prevent them from becoming ill and improve their exercise performance. The drugs are Methazolamide and Aminophylline.
NCT01702025 ↗ Rapid Acclimatization to Hypoxia at Altitude Completed University of Colorado, Denver Phase 1/Phase 2 2012-06-01 In low oxygen environments, such as altitude, some adults may become ill and suffer from acute mountain sickness. Further, all adults will find that exercising becomes much more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of this investigation is to study the effects of two drugs that may help people adjust to high-altitude quickly, prevent them from becoming ill and improve their exercise performance. The drugs are Methazolamide and Aminophylline.
NCT01702025 ↗ Rapid Acclimatization to Hypoxia at Altitude Completed Colorado State University Phase 1/Phase 2 2012-06-01 In low oxygen environments, such as altitude, some adults may become ill and suffer from acute mountain sickness. Further, all adults will find that exercising becomes much more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of this investigation is to study the effects of two drugs that may help people adjust to high-altitude quickly, prevent them from becoming ill and improve their exercise performance. The drugs are Methazolamide and Aminophylline.
NCT01587027 ↗ Safety Evaluation of Aminophylline and Methazolamide Completed Defense Advanced Research Projects Agency Phase 1 2011-12-01 This safety study is the first in a series of studies testing the application of the combination of aminophylline and methazolamide.
NCT01587027 ↗ Safety Evaluation of Aminophylline and Methazolamide Completed University of Colorado, Denver Phase 1 2011-12-01 This safety study is the first in a series of studies testing the application of the combination of aminophylline and methazolamide.
NCT01587027 ↗ Safety Evaluation of Aminophylline and Methazolamide Completed Poudre Valley Health System Phase 1 2011-12-01 This safety study is the first in a series of studies testing the application of the combination of aminophylline and methazolamide.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for NEPTAZANE

Condition Name

1110-0.100.10.20.30.40.50.60.70.80.911.1Physiological Function in Low Oxygen EnvironmentGlaucomaMountain Sickness[disabled in preview]
Condition Name for NEPTAZANE
Intervention Trials
Physiological Function in Low Oxygen Environment 1
Glaucoma 1
Mountain Sickness 1
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Condition MeSH

11110-0.100.10.20.30.40.50.60.70.80.911.1GlaucomaHypoxiaAnoxiaAltitude Sickness[disabled in preview]
Condition MeSH for NEPTAZANE
Intervention Trials
Glaucoma 1
Hypoxia 1
Anoxia 1
Altitude Sickness 1
[disabled in preview] 0
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Clinical Trial Locations for NEPTAZANE

Trials by Country

+
Trials by Country for NEPTAZANE
Location Trials
United States 3
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Trials by US State

+
Trials by US State for NEPTAZANE
Location Trials
Colorado 2
Florida 1
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Clinical Trial Progress for NEPTAZANE

Clinical Trial Phase

33.3%33.3%33.3%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 3Phase 1/Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for NEPTAZANE
Clinical Trial Phase Trials
Phase 3 1
Phase 1/Phase 2 1
Phase 1 1
[disabled in preview] 0
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Clinical Trial Status

66.7%33.3%0-0.200.20.40.60.811.21.41.61.822.2CompletedActive, not recruiting[disabled in preview]
Clinical Trial Status for NEPTAZANE
Clinical Trial Phase Trials
Completed 2
Active, not recruiting 1
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Clinical Trial Sponsors for NEPTAZANE

Sponsor Name

trials0112233Defense Advanced Research Projects AgencyUniversity of Colorado, DenverPoudre Valley Health System[disabled in preview]
Sponsor Name for NEPTAZANE
Sponsor Trials
Defense Advanced Research Projects Agency 2
University of Colorado, Denver 2
Poudre Valley Health System 1
[disabled in preview] 3
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Sponsor Type

62.5%25.0%12.5%0-0.500.511.522.533.544.555.5OtherU.S. FedNIH[disabled in preview]
Sponsor Type for NEPTAZANE
Sponsor Trials
Other 5
U.S. Fed 2
NIH 1
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Methazolamide (Neptazane): Clinical Trials, Market Analysis, and Projections

Introduction to Methazolamide (Neptazane)

Methazolamide, marketed under the brand name Neptazane, is a carbonic anhydrase inhibitor used primarily in the treatment of glaucoma, epilepsy, and other conditions requiring the reduction of intraocular pressure or the management of cerebral edema.

Clinical Trials and Efficacy

Current Clinical Use

Methazolamide has been established as an effective treatment for reducing intraocular pressure in patients with glaucoma. Clinical studies have shown that methazolamide can lower intraocular pressure significantly. For instance, a study published in JAMA Ophthalmology demonstrated that patients with open-angle glaucoma who received weekly courses of methazolamide experienced mean intraocular pressure reductions of 3.3 to 5.6 mm Hg with varying dosages[5].

Ongoing and Future Trials

While there are no major ongoing clinical trials specifically focused on methazolamide, pharmaceutical companies are exploring modified release formulations to maintain therapeutic efficiency while reducing undesirable side effects. These efforts aim to improve patient compliance and overall quality of life by minimizing adverse reactions[5].

Market Analysis

Global Market Overview

The global market for glaucoma treatments, which includes methazolamide, is driven by increasing investments and capacity expansions in the pharmaceutical industry. The demand for effective glaucoma treatments is rising due to the growing prevalence of the disease.

Market Trends

The market is shifting towards the development of variants that maintain therapeutic efficiency while reducing side effects. Modified release formulations are being explored to achieve this goal. Additionally, the market is influenced by the overall trend in the ophthalmic drugs sector, which is seeing advancements in drug delivery systems and formulations[5].

Competition

Methazolamide competes with other carbonic anhydrase inhibitors and a range of other glaucoma treatments, including prostaglandin analogs, beta-blockers, and alpha agonists. The competitive landscape is dynamic, with new drugs and formulations entering the market regularly.

Market Projections

Sales and Revenue

While specific sales projections for methazolamide alone are not readily available, the overall glaucoma treatment market is expected to grow. The increasing demand for effective and safe treatments, coupled with advancements in drug formulations, is likely to drive the market forward. Pharmaceutical companies are investing heavily in research and development to improve existing treatments like methazolamide, which should contribute to steady market growth.

Regional Breakdown

The global methazolamide market can be segmented region-wise, with significant markets in North America, Europe, and Asia-Pacific. The report by IMARC Group provides a detailed segment-wise and region-wise breakup of the global methazolamide industry, highlighting key markets and growth opportunities[5].

Manufacturing and Production

Plant Setup and Requirements

For companies looking to establish a methazolamide manufacturing plant, detailed reports such as the one by IMARC Group provide comprehensive insights into business plans, setup costs, raw material requirements, and other necessary aspects. These reports cover unit operations, machinery, and technology requirements, as well as financial projections including capital investments, operating expenses, and expected ROI[5].

Quality Assurance and Technical Tests

Manufacturing methazolamide involves adhering to strict quality assurance criteria and conducting various technical tests to ensure the product meets regulatory standards. The manufacturing process flow and mass balance are critical components of the production process, and companies must ensure compliance with these standards to maintain product quality and safety.

Safety and Adverse Reactions

Warnings and Precautions

Methazolamide, like other sulfonamide derivatives, carries several warnings and precautions. Patients should be cautious of severe reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and other serious adverse effects. The drug should be discontinued if hypersensitivity or other serious reactions occur. Additionally, caution is advised for patients with cirrhosis, hepatic insufficiency, pulmonary obstruction, or emphysema[1].

Pregnancy and Nursing Considerations

Methazolamide is classified under Pregnancy Category C, meaning it should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. It is also not known whether methazolamide is excreted in human milk, and a decision should be made whether to discontinue nursing or the drug, considering its importance to the mother[1].

Patient Counseling and Compliance

Patient Education

Patients should be advised to detect adverse reactions common to all sulfonamide derivatives and to discontinue methazolamide if such reactions develop. They should also be informed about the potential interactions with other medications, such as high-dose aspirin, and the importance of monitoring their condition closely while on the medication[1].

Key Takeaways

  • Efficacy: Methazolamide is effective in reducing intraocular pressure in glaucoma patients.
  • Market Trends: The market is driven by the development of modified release formulations to reduce side effects.
  • Manufacturing: Detailed reports are available for setting up a manufacturing plant, including financial and technical requirements.
  • Safety: The drug carries significant warnings and precautions, particularly for patients with certain medical conditions.
  • Patient Counseling: Patients should be educated on potential adverse reactions and interactions.

FAQs

What is methazolamide used for?

Methazolamide is used primarily in the treatment of glaucoma, epilepsy, and other conditions requiring the reduction of intraocular pressure or the management of cerebral edema.

What are the potential side effects of methazolamide?

Methazolamide can cause severe reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, and other blood dyscrasias. It also increases potassium excretion, which could result in hepatic coma in patients with cirrhosis or hepatic insufficiency[1].

Can methazolamide be used during pregnancy?

Methazolamide is classified under Pregnancy Category C, meaning it should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus[1].

How is methazolamide administered?

Methazolamide is typically administered orally, and the dosage can vary depending on the condition being treated. For glaucoma, it may be given in varying dosages to achieve the desired reduction in intraocular pressure[1].

What are the manufacturing requirements for methazolamide?

Manufacturing methazolamide involves adhering to strict quality assurance criteria, conducting various technical tests, and ensuring compliance with regulatory standards. Detailed reports such as the one by IMARC Group provide comprehensive insights into the necessary aspects of setting up a manufacturing plant[5].

Sources

  1. Methazolamide Prescription & Dosage Information - eMPR.com
  2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - GlobalData
  3. Quarterly Drug Pipeline: October 2024 - Prime Therapeutics
  4. FDA Guidance Provides New Details on Diversity Action Plans - FDA
  5. Methazolamide (Neptazane) Manufacturing Plant Report 2024 - IMARC Group

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