CLINICAL TRIALS PROFILE FOR FUROSEMIDE

505(b)(2) Clinical Trials for FUROSEMIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00409942 ↗	Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure.	Completed	Ferrer Internacional S.A.	Phase 4	2007-03-01	Torasemide is a loop diuretic (pyridine-sulfonylurea)with a wide experience in the treatment of oedema associated to heart failure, kidney or liver disease and either in the treatment of arterial hypertension (alone or combined with other anti-hypertensive drugs). It has been developed a new formulation of Torasemide (Torasemide prolonged release). The aim of this trial is to study the effects of Torasemide prolonged released in comparison with furosemide, in the reduction of myocardial fibrosis in patients with chronic heart failure (Class II-IV of the New York Heart Association Classification.
New Formulation	NCT01887379 ↗	Magnetic Marker Monitoring of Furosemide-containing Gastroretentive Formulation in Healthy Male Subjects (Fasting and Fed Conditions)	Completed	LTS Lohmann Therapie-Systeme AG	Phase 1	2013-06-01	Furosemide is a diuretic drug, used in the treatment of oedematous states associated with cardiac, renal, and hepatic disorder, and may be effective in patients unresponsive to thiazide diuretics. Furosemide is also used in the treatment of hypertension. Absorption of furosemide from the gastrointestinal tract is fairly rapid; bioavailability is 60-70%, but variable and not predictable, with large intra- and inter-individual variability, and are influenced by dosage form, underlying diseases, and by the presence of food after oral administration. Data from animal model show that furosemide administered into the stomach is more rapidly absorbed than if is administered into the small intestine. To increase the residency of furosemide in the stomach after oral administration, a gastroretentive dosage form (GRDF) of furosemide has been developed. In the current study, the new formulation (30mg furosemide coated tablet) will be tested in healthy male subjects. Absorption will be characterised by an effective and safe imaging technique - Magnetic Marker Monitoring (MMM), based on Fe3O4 added to the drug product to generate magnetic signal that can be used for up to 12 h after furosemide administration to localize the medication in the gastrointestinal tract. Fe3O4 is frequently used as colouring pigment in medicinal products. It does not exhibit own pharmacodynamic activity and is considered as an inactive ingredient. In the current study, GRDF formulation of furosemide will be evaluated for: gastric residence as well as pharmacokinetic and pharmacodynamic characteristics under fasting and fed conditions. As part of the study, the subjects will be hospitalized for 1 day during each drug administration. The duration of the stay will depend on the intestinal behaviour of the investigational product.

All Clinical Trials for FUROSEMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	Centers for Disease Control and Prevention	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Eye Institute (NEI)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute on Aging (NIA)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.

Clinical Trial Conditions for FUROSEMIDE

Condition Name

Condition Name for FUROSEMIDE
Intervention	Trials
Heart Failure	40
Congestive Heart Failure	21
Healthy	15
Acute Heart Failure	14

Condition MeSH

Condition MeSH for FUROSEMIDE
Intervention	Trials
Heart Failure	100
Renal Insufficiency	18
Acute Kidney Injury	17
Hypertension	16

Clinical Trial Locations for FUROSEMIDE

Trials by Country

Trials by Country for FUROSEMIDE
Location	Trials
United States	307
Italy	36
Canada	26
Germany	20
Spain	17

Trials by US State

Trials by US State for FUROSEMIDE
Location	Trials
California	20
Texas	19
Ohio	19
Florida	15
North Carolina	15

Clinical Trial Progress for FUROSEMIDE

Clinical Trial Phase

Clinical Trial Phase for FUROSEMIDE
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	4
PHASE2	4

Clinical Trial Status

Clinical Trial Status for FUROSEMIDE
Clinical Trial Phase	Trials
Completed	134
Recruiting	55
Terminated	26

Clinical Trial Sponsors for FUROSEMIDE

Sponsor Name

Sponsor Name for FUROSEMIDE
Sponsor	Trials
scPharmaceuticals, Inc.	9
Boehringer Ingelheim	7
National Heart, Lung, and Blood Institute (NHLBI)	6

Sponsor Type

Sponsor Type for FUROSEMIDE
Sponsor	Trials
Other	316
Industry	114
NIH	19

Clinical Trials Update, Market Analysis and Projection for Furosemide

Last updated: April 26, 2026

What is the current clinical-trials landscape for furosemide?

Furosemide is an established loop diuretic with extensive clinical use and a large legacy data footprint. Trial activity in recent years is typically driven by formulation, administration route, bioequivalence, dosing in specific populations, and safety/tolerability rather than new mechanism-of-action development.

Trial focus patterns (typical recent activity)

Across recent registrations and publications, furosemide studies cluster into four repeat themes:

• Bioequivalence and formulation (oral vs oral, IR vs alternative release, fixed-dose combinations where permitted)
• Route and administration (IV administration protocols, transition from IV to oral in inpatient settings)
• Population-specific dosing (renal impairment, heart failure subgroups, pediatrics where applicable)
• Safety endpoints (electrolyte balance, dehydration, ototoxicity risk monitoring protocols)

Practical implication for R&D and investment

No late-stage “new drug” program is indicated by the evidence base typically associated with furosemide. Market and clinical value tends to shift through:

• Formulation differentiation (faster onset, improved dosing convenience, reduced peak-trough swings)
• Payer-driven hospital protocols (standard-of-care order sets that can be influenced by local guidelines and contracting)
• Generic competition and supply execution (price and continuity often matter more than novel efficacy)

How large is the furosemide market and what drives demand?

Furosemide demand is anchored to chronic and acute cardiovascular indications and the stability of loop diuretic prescribing patterns.

Core demand drivers

• Heart failure (chronic congestion control, acute decompensation diuresis)
• Edema syndromes (renal insufficiency edema, hepatic edema, other fluid overload states)
• Hypertension regimens (less dominant vs other classes, but still relevant)
• Inpatient use (IV loop diuretics used in acute care and emergency settings)

Commercial structure: how the product sells

Furosemide is widely genericized in most markets. The commercial structure is therefore shaped by:

• Low unit prices and high sales volume
• Tender and hospital contracting
• Distribution and supply reliability
• Formulary position across hospital systems

Competitive set

The market is dominated by:

• Generic manufacturers of furosemide tablets and injectable products
• Multiple branded legacy products in some geographies where residual brand share persists
• Parallel substitutes (other loop diuretics such as bumetanide, torsemide), which can capture share when payer and protocol prefer them for specific patient profiles

What is the market outlook and projection path for furosemide?

Because furosemide is established and largely generic, the outlook is typically driven by pricing dynamics, volume stability in core indications, and substitution effects from other loop diuretics.

Base-case projection logic (market mechanics)

A credible projection for furosemide usually follows this structure:

1. Volume stability tied to heart failure prevalence and inpatient utilization of diuretics
2. Price pressure from generic competition and tender cycles
3. Share shifts vs torsemide and bumetanide in certain patient subgroups
4. Switching behavior influenced by guideline updates and formulary preference

Directionally expected trajectory

• Nominal growth is likely modest and driven primarily by population and volume, not by premium pricing.
• Unit pricing is the main headwind, especially in regions with aggressive generics penetration and repeated tenders.
• Market value can remain stable if volume growth offsets price compression, but brand-like premium is structurally limited.

What does “clinical trials update” mean for a legacy generic molecule?

Clinical evidence for furosemide still matters, but it usually appears as:

• Bioequivalence studies supporting generic approvals
• Comparative operational trials (IV-to-oral transitions, dosing schedules)
• Tolerability studies focusing on electrolytes and renal function monitoring

Why this still affects commercial outcomes

• Bioequivalence-driven launches can increase available supply and lower price.
• Protocol studies can expand or restrict formulary use in hospital settings.
• Safety monitoring evidence can shape standard order sets (how labs are scheduled and how clinicians respond).

Where can new value be created: formulation and protocol levers

Even without “new MOA,” value creation is possible through:

• Oral formulation differentiation that improves dosing convenience or patient adherence
• Injection stability and supply reliability (reducing shortages drives hospital loyalty)
• Clinical pathway design that standardizes diuresis monitoring and reduces adverse events in practice

Commercial KPIs that typically matter most

• Hospital adoption rate in heart failure pathways
• Tender win frequency and contract duration
• Stock-out rate (missed doses in acute care can shift clinicians to competitors)
• Low lab burden protocols if supported by evidence (electrolyte monitoring workflow)

Key Takeaways

• Furosemide clinical activity is dominated by formulation and protocol-oriented studies rather than breakthrough mechanism trials.
• Market demand is structurally supported by heart failure and edema indications, but value growth is constrained by generic pricing pressure.
• Outlook is primarily a function of volume stability, tender-driven pricing, and share shifts versus other loop diuretics.
• The most actionable differentiation levers are supply reliability, formulation execution, and alignment with hospital diuresis pathways.

FAQs

1) Is furosemide still seeing meaningful clinical-trial activity?

Yes, but it is typically oriented around bioequivalence, formulation, administration protocols, and safety monitoring rather than new mechanism trials.

2) What drives furosemide sales most: heart failure or hypertension?

Heart failure and edema syndromes are the dominant demand drivers, with hypertension use playing a smaller role relative to other diuretic classes.

3) How does generic competition impact furosemide market value?

It compresses pricing through tender cycles and widespread approvals, so market value tends to grow modestly if volume holds.

4) Can other loop diuretics take market share from furosemide?

Yes, torsemide and bumetanide can capture share in selected patient profiles and in settings where protocols favor them.

5) Where are the best commercial opportunities in furosemide?

Supply execution, formulary placement in hospital heart failure pathways, and product differentiation in dosing convenience or operational reliability.

References

[1] U.S. Food and Drug Administration. Drug trials snapshots: Furosemide. FDA. https://www.fda.gov/ (accessed via FDA trials databases and snapshots where available)