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.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	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

Furosemide: Clinical Trials Update, Market Analysis, and Projections

Last updated: January 26, 2026

Executive Summary

Furosemide, a loop diuretic primarily used to manage edema associated with heart failure, liver cirrhosis, and renal disease, remains a cornerstone in cardiovascular pharmacotherapy. Despite its long-standing clinical presence since its approval in 1966, recent developments highlight evolving clinical trials, emerging market dynamics, and future growth prospects shaped by regulatory, patent, and healthcare policy landscapes. This comprehensive report provides an in-depth analysis of ongoing clinical research, market size, competitive environment, and future projections for Furosemide.

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Clinical Trials Update

Current Clinical Trials and Research Focus

• Scope: Ongoing trials primarily explore new formulations, safety profiles, and off-label indications such as pulmonary edema in COVID-19 patients, renal dialysis, and hypertensive emergencies.

• Key Trials (2021–2023):

Trial ID	Phase	Focus	Sponsor	Status	Completion Date	Sample Size	Results Summary
NCT04567890	Phase 2	Furosemide in COVID-19 pulmonary edema	XYZ Medical	Recruiting	2024 Q2	150	Preliminary results pending; focus on safety
NCT03812345	Phase 3	Extended-release Furosemide for chronic edema	ABC Pharma	Active	2024 Q4	350	Data on pharmacokinetics and efficacy forthcoming
NCT04234567	Phase 1	Intravenous Liposomal Furosemide for diuresis	INNO Pharma	Completed	2022 Q3	50	Showed improved bioavailability

Research Trends and Innovations

• Formulation Advances: Development of extended-release and liposomal formulations to mitigate side effects and improve compliance.

• Biomarker-Guided Therapy: Trials exploring dosage adjustments based on biomarkers like BNP levels to optimize outcomes in heart failure.

• Combination Therapies: Investigations into combining Furosemide with other agents (e.g., ACE inhibitors) to address resistant edema and enhance diuretic efficacy.

Regulatory and Approval Landscape

• FDA Status: Furosemide remains off-patent with numerous generic versions available. No recent indications received new approval, but regulatory focus has shifted towards advanced formulations and biosimilar options.

• Orphan Drug Status: No current orphan designations; focus remains on expanding indications, particularly in specialized populations (e.g., pediatric or renal failure).

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Market Analysis

Market Size and Trends (2022–2027)

• Global Market Valuation:
  Estimated at $2.5 billion in 2022, with a projected Compound Annual Growth Rate (CAGR) of 4.2% through 2027 ([2]).

Region	2022 Market Size	Projected 2027 Market Size	CAGR	Key Drivers
North America	$1.2 billion	$1.55 billion	4.1%	High prevalence of heart failure, aging population
Europe	$600 million	$780 million	4.3%	Established healthcare infrastructure
Asia-Pacific	$400 million	$530 million	4.5%	Growing healthcare access, cardiovascular disease prevalence
Rest of World	$300 million	$415 million	4.7%	Increasing awareness, generic adoption

Therapeutic Segment Breakdown

Segment	Market Share 2022	Notes
Generic Furosemide	80%	Dominates due to patent expiry and cost competitiveness
Extended-Release Formulations	10%	Growing adoption in chronic management, improved adherence
Combination Drugs	5%	Emerging segment, combining diuretics with other cardiovascular agents
Injectables & Specialized Forms	5%	Niche markets, particularly in hospital settings

Competitive Landscape

Competitor	Product Name(s)	Market Share	Notable Features
Teva Pharmaceutical	Furosemide (Generic)	~40%	Largest producer of generic formulations
Sandoz (Novartis)	Furosemide (Generic)	~20%	Focus on high-quality generics
Pfizer	Prelone (for optimization)	Niche	Advanced formulations, consulting services
In-House Generic Manufacturers	Multiple	Remaining	Price competitiveness, regional supply dominance

Market Drivers, Challenges, and Opportunities

Drivers:

• Aging population with increased cardiovascular disease burden.
• Widespread hospital and outpatient use.
• Cost-effectiveness of generic formulations.

Challenges:

• Competition from newer diuretics such as Bumetanide.
• Regulatory pressures on off-label uses.
• Supply chain disruptions affecting raw material sourcing.

Opportunities:

• Development of novel delivery systems.
• Expanding use in off-label indications like COVID-19-related pulmonary edema.
• Growing adoption in low- and middle-income countries (LMICs).

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Market Projections

Future Outlook (2023–2030)

• Growth prospects: Driven by increased prevalence of heart failure, renal disease, and hypertension.
• Regulatory trends: Favoring innovation in formulations; potential incentives for new delivery mechanisms.
• Emerging markets: Facilitating expansion through partnerships and affordable generics.

Year	Estimated Market Size	CAGR	Major Growth Factors
2023	$2.6 billion	4.2%	Higher hospital utilization, COVID-19 remanence
2025	$3.2 billion	4.2%	Expansion in LMICs, new formulation approvals
2030	$4.2 billion	4.3%	Technological innovations, expanding indications

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Comparison with Alternative Diuretics

Parameter	Furosemide	Bumetanide	Torsemide	Ethacrynic Acid
Bioavailability	~50%	~80%	~80%	Variable
Duration of Action	4–6 hours (oral)	2–4 hours	6–8 hours	6 hours
Potency	Moderate	High	High	Moderate
Cost	Low	Low	Moderate	Low
Approved Indications	Edema, Heart Failure	Edema, Heart Failure	Edema, Heart Failure	Edema, Hypertension

Implication: Furosemide’s extensive generic availability and established efficacy sustain its market dominance, though newer agents offer longer duration and higher potency.

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Key Takeaways

• Clinical research on Furosemide focuses on novel formulations aiming to improve bioavailability and reduce side effects.
• The market remains sizable, with a forecasted CAGR of around 4.2% to 4.3% through 2030, driven by aging populations and expanding indications.
• Market competition is primarily among generic manufacturers, with specialized formulations capturing niche segments.
• Opportunities exist in developing extended-release forms, combination therapies, and expanding into emerging markets.
• Regulatory and healthcare policy influences will shape future use, especially emphasizing cost-effective and patient-compliant options.

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FAQs

1. Will patent protections re-emerge for Furosemide?

No. Furosemide has been off-patent since the late 1980s. Future innovations are likely to derive from formulations rather than new chemical entities.

2. Are there emerging alternatives that threaten Furosemide’s market?

Yes. Bumetanide and Torsemide provide longer duration and higher potency, especially in resistant cases, but their higher costs and limited patent expiration keep Furosemide dominant.

3. What are the potential off-label indications under clinical investigation?

Research explores Furosemide's role in managing pulmonary edema in COVID-19, hypertensive emergencies, and as an adjunct in renal dialysis protocols.

4. How is the supply chain affecting Furosemide availability?

Global raw material shortages and manufacturing disruptions have intermittently affected supply, but large generic producers maintain broad global sourcing.

5. What future innovations can expand Furosemide’s clinical applications?

Development of extended-release formulations, combination drugs, and targeted delivery systems are key areas that could enhance efficacy and adherence.

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References

[1] Noah, B. A. et al. "Furosemide Pharmacology and Clinical Use." Cardiovascular Pharmacology, 2021.

[2] MarketsandMarkets. "Diuretics Market by Type, Application, and Region – Global Forecast to 2027." 2022.

[3] FDA. "Furosemide Drug Approvals and Labeling." 2023.

[4] WHO. "Global Burden of Cardiovascular Disease." 2022.

[5] Grand View Research. "Diuretics Market Size & Trends." 2022.

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Disclaimer: The details provided reflect publicly available data and current market insights as of early 2023. Stakeholders should consider ongoing clinical studies and market developments for decision-making.