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	14
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	3

Clinical Trial Status

Clinical Trial Status for FUROSEMIDE
Clinical Trial Phase	Trials
Completed	132
Recruiting	54
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	312
Industry	112
NIH	19

Last updated: October 28, 2025

inical Trials Update, Market Analysis, and Projection for Furosemide

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Introduction

Furosemide, a potent loop diuretic primarily used to treat edema associated with congestive heart failure, liver cirrhosis, and renal disease, remains a cornerstone in managing fluid overload. Since its discovery, the drug has historically enjoyed broad clinical application. However, recent advancements in pharmacology, the advent of new diuretic agents, and evolving regulatory environments necessitate comprehensive analysis of Furosemide's clinical pipeline, market positioning, and future growth trajectory.

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Clinical Trials Landscape for Furosemide

Current Status and Recent Innovations

While Furosemide's patent expired decades ago, research efforts have not ceased. The drug’s mechanism—loop inhibition of sodium, potassium, chloride reabsorption in the nephron—has undergone refinements to optimize efficacy and minimize adverse effects.

Recent clinical trials focus on Furosemide’s role in specialized populations and its combination therapies. For instance, ongoing studies examine its application in managing acute heart failure with biomarker-guided dosing, aiming to improve outcomes and reduce hospitalization duration. Notably, the NCT04456333 trial assesses intravenous Furosemide's efficacy in acute decompensated heart failure; preliminary results indicate improved symptom relief with manageable side effects.

Repurposing and Expanded Indications

Some trials explore Furosemide's potential beyond edema management, including its off-label use to treat conditions like pulmonary hypertension and idiopathic intracranial hypertension. These studies seek to assess safety profiles in these contexts, potentially broadening Furosemide's therapeutic scope.

Regulatory and Patent Dynamics

Furosemide’s status is predominantly that of a generic drug, with multiple formulations approved globally. Its patent expiry has deprived patent holders of exclusivity; however, pharmaceutical innovators focus on formulation enhancements or combination therapies to restore market differentiation.

Market Analysis

Current Market Size and Growth Drivers

The global diuretics market was valued at approximately USD 8.4 billion in 2022, with Furosemide accounting for a significant share due to its widespread use and cost-effectiveness. The increase in chronic cardiovascular conditions globally propels demand, especially in emerging markets with expanding healthcare infrastructure.

Key growth drivers include:

• Rising prevalence of heart failure, chronic kidney disease, and liver cirrhosis.
• Expanding geriatric population, more susceptible to fluid overload states.
• Cost considerations favoring generic Furosemide over newer, branded agents.

Market Challenges

Despite its extensive use, Furosemide faces challenges:

• Adverse Effects: Risk of electrolyte imbalance, dehydration, and ototoxicity can limit its use in some patient populations.
• Therapeutic Alternatives: The development of more selective loop diuretics (e.g., Torsemide, Bumetanide) with longer half-lives and improved tolerability presents competitors.
• Regulatory Scrutiny: Clean labels and evidence of safety in specific demographics remain critical for sustained market presence.

Regional Market Dynamics

North America maintains dominance due to higher prevalence of cardiovascular diseases, robust healthcare systems, and extensive clinical research. Asia-Pacific shows rapid growth potential driven by population expansion, urbanization, and increasing access to healthcare services. Europe sustains steady demand, with some countries emphasizing cost-effective generics.

Market Projection and Future Outlook

Short to Mid-Term (2023-2028)

The market is projected to grow at a compound annual growth rate (CAGR) of approximately 3.5%. The expansion is primarily fueled by an aging population and increased cardiovascular disease management. The popularity of combination therapies, where Furosemide is paired with other cardiotropics, is expected to sustain demand.

Long-Term Prospects (2028 and beyond)

Innovations in drug delivery, such as controlled-release formulations or injectable-targeted delivery systems, could enhance therapeutic outcomes, creating niche markets. Additionally, ongoing trials of Furosemide in novel indications could yield new approval pathways, reinforcing its market standing.

Furthermore, regulatory shifts toward cost-effective treatment guidelines favor the continued utilization of generic Furosemide, especially in resource-limited settings.

Strategic Considerations for Stakeholders

• Pharmaceutical Developers: Focus on reformulations, combination therapies, and targeted delivery systems to differentiate from competitors.
• Investors: Prioritize companies engaged in innovative formulations or clinical trials exploring new indications involving Furosemide.
• Healthcare Providers: Monitor emerging evidence for optimized dosing strategies to minimize adverse effects while maximizing efficacy.

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Key Takeaways

• Stable Core with Growth Potential: Furosemide remains integral to cardio-nephrology, with steady demand driven by demographic trends and disease prevalence.
• Clinical Pipeline Focuses on niche and combination therapies: While no major new indications are imminent, ongoing studies aim to optimize use in specific patient subsets.
• Market Competition is Intensifying: Alternative loop diuretics with improved tolerability challenge Furosemide's dominance, necessitating formulation innovations.
• Global Market Expansion: Emerging markets present significant growth opportunities, supported by increasing healthcare access and affordability.
• Innovation and Regulatory Support: New delivery mechanisms and evidence-based guidelines will shape the drug’s future trajectory.

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FAQs

1. Is Furosemide still patent-protected?
No, Furosemide’s patent expired decades ago. It is available globally as a generic medication, though formulations may be protected under new patents for delivery or combination products.

2. What are the latest clinical applications of Furosemide?
Recent trials explore its use in acute heart failure management, certain pulmonary hypertension cases, and off-label indications like intracranial hypertension, with ongoing research aiming to expand its role.

3. How does Furosemide compare to newer loop diuretics?
While effective and widely used, newer agents like Torsemide offer longer half-lives and potentially fewer side effects. Nonetheless, Furosemide's low cost sustains its prevalent use, especially in resource-limited settings.

4. What are the primary challenges facing Furosemide’s market?
Adverse effects, competition from newer diuretics, and regulatory emphasis on safety profiles challenge its dominance, prompting innovation in formulations and combination therapies.

5. What is the future market outlook for Furosemide?
Market growth will likely be steady, driven by demographic shifts and disease burden. Opportunities exist in formulation innovation, niche indications, and emerging markets. Long-term prospects depend on clinical research outcomes and regulatory developments.

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References

[1] Grand View Research. (2022). Diuretics Market Size & Trends.
[2] ClinicalTrials.gov. (2023). Ongoing Trials Involving Furosemide.
[3] IQVIA. (2022). Global Cardiovascular Drugs Market Data.
[4] Johnson, P. et al. (2021). Innovations in Loop Diuretic Delivery. Journal of Cardiology & Therapy.
[5] World Health Organization. (2022). Global Burden of Cardiovascular Diseases.

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This comprehensive review provides emerging insights necessary for strategic decision-making regarding Furosemide’s clinical utility, market dynamics, and future growth potential.