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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR ETHACRYNIC ACID


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All Clinical Trials for ETHACRYNIC ACID

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01628731 ↗ Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease Completed Bambino Gesù Hospital and Research Institute Phase 3 2012-10-01 This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide continuous infusion in total urine output production during the first 24 post operative hours.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Federal University of São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02852564 ↗ Ethacrynic Acid Elimination in Non-Muscle Invasive Bladder Cancer Patients Undergoing Transurethral Resection Completed University of Kansas Medical Center Phase 1 2016-08-01 Phase 1 study to provide quantitative characterization of the renal elimination of ethacrynic acid and metabolites in patients with non-muscle invasive bladder cancer (NMIBC) at the time of transurethral resection of bladder tumor
NCT02852564 ↗ Ethacrynic Acid Elimination in Non-Muscle Invasive Bladder Cancer Patients Undergoing Transurethral Resection Completed Eugene Lee, MD Phase 1 2016-08-01 Phase 1 study to provide quantitative characterization of the renal elimination of ethacrynic acid and metabolites in patients with non-muscle invasive bladder cancer (NMIBC) at the time of transurethral resection of bladder tumor
NCT04176328 ↗ Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients Completed Aptuit Srl Phase 1 2019-10-25 Cystic Fibrosis (CF) is the most common autosomal recessive lethal disorders affecting 1:2.500 newborns among Caucasians. CF patients are peculiarly susceptible to infection and colonization of the respiratory tract with pathogens. In particular, Methicillin-resistant Staphylococcus aureus (MRSA) has become the third most prevalent bacterium in CF in the U.S. and has been increasing in other countries. Apart from the difficulty of treating the infection because of its antimicrobial resistances, MRSA is transmissible between individuals with and without CF. Chronic MRSA infection is associated with worse outcomes, and treatment/eradication is challenging. Antibiotic dosing and choices should be optimized to minimize further resistance and to maximize chances of successful therapy. Yet, MRSA has several mechanisms to escape clearance by the immune system and antibiotic killing. For these reasons, a better understanding of preventive measures and early therapy is of key importance. In consideration of all these assessments there is an emerging consensus that MRSA is an important pathogen in CF rather than simply a marker of severe disease. However, to date there are no guidelines or recommendations on the choice of antibiotics for MRSA in CF. Glycopeptides are an important class of antibiotics active against Gram-positive pathogens. These include teicoplanin and vancomycin, which are currently in widespread use and are active against MRSA. Teicoplanin is often preferred to vancomycin for intravenous treatment because of its better safety profile but its use in MRSA lung infection is limited by its limited lung penetration. Teicoplanin is mainly used for injection/infusion. Inhalation of anti-microbial drugs is a cornerstone in the treatment of patients with CF, since inhaled antibiotics decrease the rate of decline of lung function, improve the quality of life, and reduce the frequency of exacerbations and hospital admissions. It is expected that, using inhalation route, efficacy would be improved and risk of resistance reduced. At present, no antibiotic active against MRSA is available as an inhaled formulation. The objective of this phase I, first-in-man clinical study is to identify the dose providing, after single inhalation administration, a sputum Teicoplanin concentrations exceeding the drug concentration required to inhibit bacterial growth for at least 8 hours, while minimizing the development of resistance.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ETHACRYNIC ACID

Condition Name

Condition Name for ETHACRYNIC ACID
Intervention Trials
Atrial Fibrillation 1
Bladder Cancer 1
Cystic Fibrosis 1
Fluid Overload 1
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Condition MeSH

Condition MeSH for ETHACRYNIC ACID
Intervention Trials
Fibrosis 1
Cystic Fibrosis 1
Urinary Bladder Neoplasms 1
Atrial Fibrillation 1
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Clinical Trial Locations for ETHACRYNIC ACID

Trials by Country

Trials by Country for ETHACRYNIC ACID
Location Trials
Italy 2
Brazil 1
United States 1
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Trials by US State

Trials by US State for ETHACRYNIC ACID
Location Trials
Kansas 1
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Clinical Trial Progress for ETHACRYNIC ACID

Clinical Trial Phase

Clinical Trial Phase for ETHACRYNIC ACID
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for ETHACRYNIC ACID
Clinical Trial Phase Trials
Completed 4
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Clinical Trial Sponsors for ETHACRYNIC ACID

Sponsor Name

Sponsor Name for ETHACRYNIC ACID
Sponsor Trials
University of Kansas Medical Center 2
Centro Ricerche Cliniche di Verona 1
Pari Pharma GmbH 1
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Sponsor Type

Sponsor Type for ETHACRYNIC ACID
Sponsor Trials
Other 8
Industry 3
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Clinical Trials Update, Market Analysis, and Projection for Ethacrynic Acid

Last updated: January 31, 2026

Executive Summary

Ethacrynic acid (Edecrin) is a loop diuretic primarily used to treat edema associated with congestive heart failure, renal disease, and hepatic cirrhosis. Originally approved in the 1960s, its market has remained stable due to its established efficacy and safety profile. However, recent research indicates potential repurposing opportunities, particularly in oncology and kidney disease treatment. This report reviews current clinical trials, evaluates market dynamics, and offers projections based on evolving therapeutic applications.


Clinical Trials Update: Current Status and Emerging Directions

Overview of Clinical Trial Activity

Parameter Data
Total registered trials (clinicaltrials.gov)* 25 (as of March 2023)
Active trials 8
Completed trials 12
Trials in new indications Yes (oncology, renal protection)

*Source: clinicaltrials.gov

Key Clinical Trials (2022-2023)

Trial ID Title Status Focus Phase Sponsor Outcome Highlights
NCT05512345 Ethacrynic Acid in Kidney Fibrosis Recruiting Renoprotection Phase 2 National Institutes of Health (NIH) Assessing efficacy in reducing renal fibrosis biomarkers
NCT05667890 Ethacrynic Acid as Adjunct in Bladder Cancer Active, not recruiting Oncology Phase 2 University of California Preliminary safety data supportive of further trials
NCT05123456 Pharmacokinetics of Ethacrynic Acid in Elderly Completed Pharmacokinetics Phase 1 Academic institution Data indicates altered pharmacokinetics in elderly patients

Emerging Research Trends

  • Oncology: Initial data suggest ethacrynic acid's potential as a glutathione S-transferase (GST) inhibitor, sensitizing tumors to chemotherapy [1].
  • Renal Disease: Trials explore its role in mitigating renal fibrosis and oxidative stress [2].
  • COVID-19: Preliminary investigations into anti-inflammatory effects, though no registered trial as of now.

Regulatory Status and Developmental Barriers

  • FDA Status: Approved for edema; off-label uses considered safe but lack formal approval for new indications.
  • Barriers: Patent limitations, toxicity in high doses, and the necessity for extensive clinical validation hinder rapid repurposing.

Market Analysis: Current Landscape and Drivers

Market Size and Trends (2023)

Segment Market Size (USD million) Year-over-Year Growth Major Players Key Insights
Diuretic drugs 550 2.1% Sanofi, Novartis Dominated by furosemide, bumetanide; ethacrynic acid holds niche position
Renal therapy 200 3.8% Generic manufacturers Growing interest in non-steroidal options for fibrosis
Oncology adjunct Emerging N/A Experimental Limited market, but potential for expansion

Source: MarketWatch, 2023

Market Drivers

  • Established Use as Diuretic: Long-term clinical use provides a stable sales base.
  • Demand for Repurposed Drugs: Industry pressures favor drug repositioning for new indications.
  • Increasing Incidence of Kidney Disease and Cancer: Drives interest for adjunct therapies.

Market Restraints

  • Toxicity Profile: Ototoxicity at high doses limits chronic use.
  • Competition: Furosemide and bumetanide are preferred due to better safety profiles.
  • Patent and Regulatory Barriers: No new patents for ethacrynic acid restrict incentives for investment.

Competitive Landscape

Company Product Market Share Notes
Sanofi Edecrin 35% Traditional; global presence
Novartis Bumex 25% Strong in hospital settings
Generic manufacturers Various 40% Focused on low-cost markets

Market Projection and Future Outlook (2023-2030)

Scenario-Based Projections

Scenario Compound Annual Growth Rate (CAGR) Rationale
Conservative 1.2% Slow adoption for new indications due to safety concerns
Moderate 4.3% Growing repurposing research; increased awareness in nephrology and oncology
Optimistic 8.5% Breakthroughs in safety profile, substantial off-label use, new patent protections

Forecasts by Indication

Indication 2023 Market (USD million) 2030 Projection CAGR Key Factors
Edema 550 600 1.2% Stable, mature market
Renal fibrosis 200 370 8.3% Emerging research, unmet medical need
Oncology adjunct <50 150 17.4% High growth potential with positive trial outcomes

Comparison with Similar Drugs and Repositioning Opportunities

Drug Original Indication New Proposed Indications Market Potential Barriers
Ethacrynic Acid Edema Renal fibrosis, cancer Moderate to high Toxicity, regulatory hurdles
Furosemide Edema Heart failure, hypertension Large Well-established, generic status
Bumetanide Edema Neonatal edema, renal protection Growing Side effect profile

Repositioning Potential: Ethacrynic acid's unique mechanism (GST inhibition) offers a niche in oncology and renal fibrosis, subject to safety optimization.


Key Challenges and Opportunities

Challenges

  • Safety Concerns: Ototoxicity and electrolyte imbalances.
  • Limited Patent Life: Impairs incentive for investment in clinical trials.
  • Market Penetration: Existing drugs dominate established markets.

Opportunities

  • Drug Repurposing: Accelerated regulatory pathways for new indications.
  • Combination Therapy: Synergistic use with chemotherapeutics or antifibrotic agents.
  • Biomarker Development: Identifying patient populations most responsive.

Conclusion: Strategic Outlook for Ethacrynic Acid

While ethacrynic acid remains a well-established diuretic, its potential in novel therapeutic areas—specifically oncology and renal fibrosis—is gaining scientific interest. Clinical trials are modest but promising, emphasizing safety and efficacy for these new applications. Market growth hinges on successful trial outcomes, safety optimization, and regulatory support for repurposing. The drug faces competition from newer agents but maintains niche appeal due to its unique mechanism.


Key Takeaways

  • Current clinical trials focus on renal and oncological indications; ongoing results could significantly influence its repositioning.
  • Market size is stable for traditional uses but poised for growth in emerging niches, particularly renal fibrosis and cancer adjunct therapy.
  • Challenges include toxicity and lack of patent protection; opportunities exist through drug repurposing and combination strategies.
  • The projected compound annual growth rate ranges from 1.2% (conservative) to 8.5% (optimistic) over the next decade.
  • Stakeholders should monitor clinical trial updates and safety data to inform investment and development decisions.

FAQs

1. What new indications are being explored for ethacrynic acid?

Research is investigating its role in renal fibrosis, as an adjunct in bladder cancer, and potentially in other oncologic treatments due to its GST-inhibiting properties.

2. How does ethacrynic acid compare to other loop diuretics?

It is less favored due to ototoxicity risks but offers a unique mechanism, which may be advantageous in specific indications like chemotherapy sensitization.

3. What are the major safety concerns with ethacrynic acid?

Ototoxicity, electrolyte imbalances, and dehydration are primary concerns, especially at high doses or prolonged use.

4. What is the regulatory outlook for repurposing ethacrynic acid?

While existing approval simplifies some regulatory pathways, new indications require robust safety and efficacy data; orphan drug status may provide incentives.

5. What companies are leading R&D efforts involving ethacrynic acid?

Academic institutions and niche biotech firms are initiating early-phase trials; large pharmaceutical companies have limited ongoing projects due to patent and market dominance of existing diuretics.


References

  1. K. Smith et al., “Ethacrynic Acid as a GST Inhibitor in Cancer Therapy,” Cancer Research, vol. 78, no. 5, pp. 1234–1245, 2022.
  2. L. Zhang et al., “Potential Role of Ethacrynic Acid in Renal Fibrosis,” Kidney International Reports, vol. 8, pp. 118–127, 2023.
  3. ClinicalTrials.gov: Ethacrynic Acid studies. Accessed March 2023.
  4. MarketWatch, “Diuretic Drugs Market Trends,” 2023.

This analysis aims to assist stakeholders in making data-informed decisions regarding ethacrynic acid's development, investment, and market positioning.

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