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Last Updated: February 15, 2025

CLINICAL TRIALS PROFILE FOR BUMETANIDE


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All Clinical Trials for Bumetanide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00372762 ↗ Bumetanide Versus Furosemide in Heart Failure Withdrawn University of Western Ontario, Canada Phase 3 2011-01-01 Patients with NYHA FC II-III heart failure will be randomized in a cross-over fashion to 8 weeks of bumetanide versus furosemide therapy (equipotent dose), to test whether bumetanide therapy has a superior effect on insulin resistance compared to furosemide. Patients will be subject to a frequently sampled intravenous glucose tolerance test (FSIGT) with minimal model (MINMOD) analysis to assess insulin resistance and to a 6-minute walk test (6MWT) to assess functional capacity; patient recruitment and retention success, as well as medication adherence, will also be assessed.
NCT00372762 ↗ Bumetanide Versus Furosemide in Heart Failure Withdrawn Lawson Health Research Institute Phase 3 2011-01-01 Patients with NYHA FC II-III heart failure will be randomized in a cross-over fashion to 8 weeks of bumetanide versus furosemide therapy (equipotent dose), to test whether bumetanide therapy has a superior effect on insulin resistance compared to furosemide. Patients will be subject to a frequently sampled intravenous glucose tolerance test (FSIGT) with minimal model (MINMOD) analysis to assess insulin resistance and to a 6-minute walk test (6MWT) to assess functional capacity; patient recruitment and retention success, as well as medication adherence, will also be assessed.
NCT00830531 ↗ Pilot Study of Bumetanide for Newborn Seizures Completed Charles H. Hood Foundation Phase 1 2010-01-01 The main goal of the study is to obtain pharmacokinetic and safety data of bumetanide in newborns with refractory seizures. The overall hypothesis is that bumetanide, added to conventional antiepileptic (antiseizure) medications, will be a safe and well tolerated medication, compared with conventional antiepileptic drugs alone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bumetanide

Condition Name

Condition Name for Bumetanide
Intervention Trials
Heart Failure 5
Acute Decompensated Heart Failure 3
Congestive Heart Failure 2
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Condition MeSH

Condition MeSH for Bumetanide
Intervention Trials
Heart Failure 14
Autistic Disorder 5
Child Development Disorders, Pervasive 3
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Clinical Trial Locations for Bumetanide

Trials by Country

Trials by Country for Bumetanide
Location Trials
France 20
United States 12
Italy 10
Poland 8
Spain 8
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Trials by US State

Trials by US State for Bumetanide
Location Trials
New York 2
Texas 2
Minnesota 1
Illinois 1
New Jersey 1
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Clinical Trial Progress for Bumetanide

Clinical Trial Phase

Clinical Trial Phase for Bumetanide
Clinical Trial Phase Trials
Phase 4 5
Phase 3 6
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Bumetanide
Clinical Trial Phase Trials
Completed 9
Not yet recruiting 5
Active, not recruiting 3
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Clinical Trial Sponsors for Bumetanide

Sponsor Name

Sponsor Name for Bumetanide
Sponsor Trials
ADIR, a Servier Group company 2
Yale University 2
Institut de Recherches Internationales Servier 2
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Sponsor Type

Sponsor Type for Bumetanide
Sponsor Trials
Other 46
Industry 12
NIH 1
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Bumetanide: Clinical Trials Update, Market Analysis, and Projections

Introduction to Bumetanide

Bumetanide is a loop diuretic commonly used to treat edema associated with congestive heart failure, nephrotic syndrome, and hepatic disease. Recently, it has been explored for its potential in treating autism spectrum disorder (ASD).

Clinical Trials Update for Bumetanide in ASD

Phase III Trials for ASD Treatment

Two significant phase III clinical trials, known as the SIGN 1 and SIGN 2 trials, were conducted to evaluate the efficacy and safety of bumetanide oral solution for treating ASD in children and adolescents. The SIGN 1 trial enrolled patients aged 7-17 years, while the SIGN 2 trial included younger patients aged 2-6 years. Both trials were randomized, double-blind, and placebo-controlled, with patients receiving bumetanide oral solution or placebo twice daily for a 6-month period[1][4].

Outcomes of the Trials

The primary endpoint of these trials was the change in the Childhood Autism Rating Scale 2 (CARS2) total raw score from baseline to Week 26. However, both studies were terminated early due to the absence of any significant difference between the bumetanide and placebo groups. The CARS2 total raw score decreased similarly in both the bumetanide and placebo groups, with no statistically significant difference observed. Additionally, no differences were found in secondary efficacy endpoints, including the Social Responsiveness Scale-2, Clinical Global Impression Scale, and Vineland Adaptive Behavior Scale[1][4].

Adverse Events

The trials also reported treatment-emergent adverse events that occurred more frequently with bumetanide than with placebo, including thirst, polyuria, hypokalemia, and dry mouth[1].

Future Directions

Despite the disappointing results, researchers suggest that it may be too soon to give up on bumetanide for ASD treatment. They propose that future trials should have stricter inclusion criteria and use methods like electroencephalography to identify participants who are more likely to respond to the drug. A study led by Hilgo Bruining used brain-wave markers to predict with 92% accuracy which participants would show a greater reduction in repetitive behaviors in response to bumetanide[4].

Market Analysis for Bumetanide

Current Market Status

The global market for bumetanide tablets has reached a substantial value as of 2023. The market includes various segments such as pharmaceutical manufacturing, healthcare, and pharma & healthcare industries[3][5].

Market Segmentation

The bumetanide market can be segmented by type (e.g., 1mg and 5mg tablets), region, and country. The market report provides detailed segmentation, including global, regional, and country-level data, as well as competitor analysis and market trends[2][5].

Growth Projections

The global bumetanide market is anticipated to experience significant growth from 2025 to 2031. Market research reports provide forecasts and CAGR (Compound Annual Growth Rate) for this period. The base year for these calculations is typically 2023, with historical data from 2019 to 2023[2][5].

Regional Dominance

The market is expected to be dominated by certain regions, although specific regional details vary depending on the report. Customized data and regional analysis are available to provide a more detailed insight into the market dynamics[2][5].

Drivers and Restraints

Key factors affecting the bumetanide market include market trends, drivers, opportunities, and restraints. These factors are analyzed in detail in market research reports, which also include PESTEL analysis, SWOT analysis, and COVID-19 impact analysis[2][5].

Pharmacology and Medical Use of Bumetanide

Drug Class and Mechanism

Bumetanide is classified as a loop diuretic, which increases diuresis at the loop of Henle in the kidneys. This mechanism is primarily used to treat conditions associated with fluid retention, such as congestive heart failure and nephrotic syndrome[3].

Medical Subject Headings (MeSH)

Bumetanide is categorized under various MeSH headings, including loop diuretics and diuretics, reflecting its primary use in managing fluid balance in the body[3].

Market Trends and Opportunities

Technological Trends

The market is influenced by technological advancements, including improvements in drug formulation and delivery systems. These trends can impact the market attractiveness and competitiveness of bumetanide products[2].

Competitive Analysis

The bumetanide market involves several competitors, with multiple applicants, NDAs (New Drug Applications), and finished product suppliers. The competitive landscape is analyzed in market research reports to provide insights into market share and potential brand extensions[2][3].

Customized Data and Report Options

Market research reports offer customized data options, including global, regional, and country-level data, as well as additional qualitative and quantitative data analysis. This allows clients to tailor the report to their specific research requirements[2][5].

Key Takeaways

  • Clinical Trials: Phase III trials for bumetanide in treating ASD were terminated due to lack of efficacy compared to placebo.
  • Market Status: The global bumetanide market has significant value and is projected to grow from 2025 to 2031.
  • Segmentation: The market is segmented by type, region, and country, with detailed competitor and trend analysis.
  • Pharmacology: Bumetanide is a loop diuretic primarily used for treating conditions associated with fluid retention.
  • Future Directions: Researchers suggest stricter inclusion criteria and the use of predictive methods for future ASD treatment trials.

FAQs

What were the outcomes of the phase III trials for bumetanide in treating ASD?

The phase III trials (SIGN 1 and SIGN 2) were terminated early due to the absence of any significant difference between the bumetanide and placebo groups in treating ASD in children and adolescents[1][4].

What are the common adverse events associated with bumetanide?

Common adverse events include thirst, polyuria, hypokalemia, and dry mouth, which occurred more frequently with bumetanide than with placebo[1].

What is the projected growth of the global bumetanide market?

The global bumetanide market is anticipated to experience significant growth from 2025 to 2031, with detailed forecasts and CAGR provided in market research reports[2][5].

How is bumetanide primarily used in medical practice?

Bumetanide is primarily used as a loop diuretic to treat conditions associated with fluid retention, such as congestive heart failure, nephrotic syndrome, and hepatic disease[3].

What are the potential future directions for bumetanide in treating ASD?

Future trials may use stricter inclusion criteria and methods like electroencephalography to identify participants who are more likely to respond to bumetanide, based on its proposed mechanism of action[4].

Sources

  1. PubMed: "Bumetanide oral solution for the treatment of children and adolescents with autism spectrum disorder: results from two phase 3 trials" - PubMed.
  2. Cognitive Market Research: "Bumetanide Tablets Market Report 2024 (Global Edition)" - Cognitive Market Research.
  3. Drug Patent Watch: "Generic BUMETANIDE INN equivalents, pharmaceutical patent and more" - Drug Patent Watch.
  4. The Transmitter: "French pharma firms terminate trials of bumetanide for autism" - The Transmitter.
  5. Market Research Reports: "Global Bumetanide Market Growth 2024-2030" - Market Research Reports.

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