CLINICAL TRIALS PROFILE FOR ETHACRYNIC ACID

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.

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

Condition MeSH

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

Clinical Trial Locations for ETHACRYNIC ACID

Trials by Country

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

Trials by US State

Trials by US State for ETHACRYNIC ACID
Location	Trials
Kansas	1

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

Clinical Trial Status

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

Clinical Trial Sponsors for ETHACRYNIC ACID

Sponsor Name

Sponsor Name for ETHACRYNIC ACID
Sponsor	Trials
University of Kansas Medical Center	2
Aptuit Srl	1
Centro Ricerche Cliniche di Verona	1

Sponsor Type

Sponsor Type for ETHACRYNIC ACID
Sponsor	Trials
Other	8
Industry	3

Last updated: May 1, 2026

Ethacrynic Acid: Clinical Trials Update, Market Snapshot, and Projection

What is ethacrynic acid and where is it used?

Ethacrynic acid is a loop diuretic historically used for conditions requiring rapid diuresis, including edema states. Commercial supply has shifted over time toward legacy, region-specific availability rather than broad, actively expanding global R&D. In practice, ethacrynic acid is treated as a mature, off-patent active pharmaceutical ingredient (API) with limited contemporary sponsor-led clinical development compared with newer loop diuretics.

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What do the latest clinical-trial records show?

No actionable, current-cycle clinical-trial program for ethacrynic acid is evident from standard public trial registries in the form of late-stage (Phase 3) registration-level studies that would support a near-term label expansion or line-extension plan. The contemporary clinical footprint is dominated by:

• Historical studies and older comparative pharmacology work
• Low-frequency, registry entries without clear progression into new pivotal efficacy/safety data

Operational implication: the drug is not positioned like a modern pipeline asset. Any “update” is primarily about whether new interventional trials exist in recent years and whether they appear likely to generate regulatory-grade endpoints.

Evidence basis (trial record approach): without a registry-level dataset of newly enrolling or actively recruiting interventional trials tied to pivotal outcomes, the defensible characterization for decision-making is that there is no active, sponsor-driven clinical development ramp for label expansion.

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What is the competitive market structure?

Ethacrynic acid competes inside the loop-diuretic class against widely available generics and branded products. The market is characterized by:

• Class substitution: clinicians typically switch within loop diuretics based on tolerability, availability, and cost
• Price pressure from generics: ethacrynic acid’s off-patent status compresses margins and reduces sponsor incentive for expensive trials without differentiation
• Formulation and access constraints: when supply is uneven, procurement can matter more than pharmacologic differentiation in day-to-day usage

Comparables that typically dominate prescribing:

• Furosemide (and combinations)
• Torsemide
• Bumetanide

Ethacrynic acid is generally less dominant than these agents in routine practice, which directly affects demand durability and the feasibility of near-term volume growth absent a differentiated niche.

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How should market size and growth be projected for ethacrynic acid?

A decision-grade projection requires an anchored baseline. In the absence of a current, sponsor-reported sales dataset and without a documented, active clinical pipeline likely to trigger label expansion, the only defensible projection framework is a mature-drug model:

• Baseline: stable-to-declining demand tied to medical use persistence
• Downside: generic erosion, hospital formulary rationalization, and regional manufacturing/supply swings
• Upside: niche re-entry driven by shortages of alternatives, formulary exceptions, or renewed availability

Projection direction (business conclusion):

• Short term (1 to 3 years): flat to mild decline in most markets, driven by generics substitution and formulary consolidation.
• Medium term (3 to 7 years): gradual contraction with intermittent volatility tied to manufacturing continuity.
• Long term (7+ years): becomes increasingly region-dependent and procurement-driven rather than growth-driven.

Market logic that supports this projection:

• Ethacrynic acid does not show signals of a late-stage development cycle that would create incremental demand via new indications.
• Loop-diuretic prescribing is standardized and substitution is routine.
• Off-patent drugs face persistent price compression.

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What is the patent and exclusivity landscape likely to imply?

Ethacrynic acid itself is a legacy small molecule. For an investor or R&D sponsor, the critical implication is that the market behaves like a generic API/finished-dose commodity:

• Entry barriers are manufacturing and regulatory maintenance, not exclusivity-driven pricing power
• Clinical differentiation would need to be clinically and commercially compelling enough to justify a large trial and label path
• Without a credible development plan, demand growth depends on supply continuity and procurement relationships

Business impact: absent new IP or a credible differentiated formulation program, the drug’s valuation case is limited. New clinical work would likely target specific populations or formulation improvements, but that would still have to overcome substitution dynamics.

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Where are opportunities most likely to exist?

If demand exists, it is more likely to be found in:

• Formulary niche retention where ethacrynic acid remains an option after intolerance to alternatives
• Institutional procurement channels that preserve legacy order habits
• Regional manufacturing continuity where supply of alternatives is constrained or pricing dynamics favor switching back

The practical “growth lever” is not a new label but access: consistent supply at predictable cost.

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Market projection table

Directional forecast (not a revenue valuation):

Time horizon	Expected demand trend	Main drivers
0 to 12 months	Flat to slight decline	Generic substitution, formulary consolidation
1 to 3 years	Mild decline	Ongoing price compression, limited clinical differentiation
3 to 7 years	Gradual contraction	Procurement-driven availability; fewer legacy prescribers
7+ years	Region-dependent	Supply continuity and hospital-specific policies

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What would change the projection materially?

A materially different outcome would require one of these:

• A new regulatory-approved indication or clinically meaningful differentiation supported by pivotal data
• A differentiated formulation strategy that resolves a persistent usability or safety limitation in a way that the market cannot substitute away quickly
• A major supply disruption of standard loop diuretics that forces durable reversion to ethacrynic acid

Without these catalysts, the forecast remains a mature-drug baseline.

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Key Takeaways

• Ethacrynic acid is a legacy loop diuretic with a mature, off-patent commercial profile and limited contemporary clinical development signals suitable for a near-term label expansion thesis.
• Current-trial visibility does not indicate an active late-stage program that would drive new demand.
• Market outlook is stable-to-declining with volatility tied to supply and regional procurement rather than growth from clinical innovation.
• The only credible “upside” paths are access-driven (supply continuity) or differentiation strong enough to overcome rapid therapeutic substitution.

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FAQs

1) Is ethacrynic acid seeing new Phase 3 development?
No clear, registration-grade evidence indicates an active Phase 3 program tied to pivotal efficacy or safety endpoints.

2) What most constrains ethacrynic acid commercial growth?
Substitution within the loop diuretic class and persistent generic price pressure.

3) What would be the most likely demand catalyst?
A durable supply issue affecting alternative loop diuretics or a regulatory approval supported by pivotal differentiation.

4) Is the value proposition more manufacturing-driven than clinical-driven?
Yes. For mature off-patent products, supply reliability and procurement relationships typically dominate over new clinical differentiation.

5) How should investors model near-term performance?
Use a mature-drug scenario: flat-to-slight decline with episodic volatility tied to regional availability and pricing cycles.

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References

[1] ClinicalTrials.gov. “Ethacrynic acid” (search results and record listings). https://clinicaltrials.gov/
[2] Drugs@FDA. Ethacrynic acid-related records (if applicable by listing and historical product availability). https://www.accessdata.fda.gov/scripts/cder/daf/
[3] National Library of Medicine (PubMed). Ethacrynic acid publications and historical clinical studies. https://pubmed.ncbi.nlm.nih.gov/