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	37
Congestive Heart Failure	21
Acute Heart Failure	14
Healthy	12

Condition MeSH

Condition MeSH for furosemide
Intervention	Trials
Heart Failure	96
Renal Insufficiency	18
Hypertension	16
Acute Kidney Injury	16

Clinical Trial Locations for furosemide

Trials by Country

Trials by Country for furosemide
Location	Trials
United States	299
Italy	36
Canada	25
Germany	19
Spain	16

Trials by US State

Trials by US State for furosemide
Location	Trials
Ohio	19
California	18
Texas	17
North Carolina	15
Florida	14

Clinical Trial Progress for furosemide

Clinical Trial Phase

Clinical Trial Phase for furosemide
Clinical Trial Phase	Trials
Phase 4	67
Phase 3	46
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for furosemide
Clinical Trial Phase	Trials
Completed	126
Recruiting	45
Terminated	26

Clinical Trial Sponsors for furosemide

Sponsor Name

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

Sponsor Type

Sponsor Type for furosemide
Sponsor	Trials
Other	298
Industry	103
NIH	19

Furosemide Market Analysis and Financial Projection

FUROSEMIDE: Clinical Trials Update, Market Analysis, and Projections

Clinical Trials Update

scPharmaceuticals' Autoinjector Trial

scPharmaceuticals has made significant progress in the development of a subcutaneous autoinjector for furosemide, known as SCP-111. This autoinjector is designed to provide an alternative to the FDA-approved FUROSCIX on-body infusor, offering patients and prescribers greater treatment flexibility.

• Enrollment and Study Design: The first participant has been enrolled in the pivotal trial for this autoinjector. The study is an open-label, single-center, single-dose, randomized, two-way crossover trial involving 21 healthy volunteers aged 45 to 80. Participants are randomly assigned to receive either IV furosemide followed by SCP-111 via the autoinjector or vice versa[1][4].
• Objectives and Outcomes: The study aims to estimate the bioavailability and describe the pharmacokinetics (PK) and pharmacodynamics (PD) of SCP-111 compared to IV furosemide. The topline results have been positive, indicating that the company is on track to submit a Supplemental New Drug Application (sNDA) to the FDA by the end of 2024[1][4].

Implications of the Autoinjector

The development of this autoinjector is seen as a potential long-term growth driver for scPharmaceuticals. If approved, it could significantly reduce manufacturing costs and provide a more convenient treatment option for patients with fluid overload, particularly those with New York Heart Association (NYHA) Class II and Class III heart failure[1].

Market Analysis

Global Market Size and Growth

The global furosemide market is experiencing steady growth driven by several key factors:

• Market Size: As of 2021, the furosemide injection market was valued at $659.73 million and is projected to reach $954.07 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.53% from 2023 to 2030[5].
• Regional Analysis: The market is segmented into North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. North America holds the largest market share due to the high number of specialty clinics and the ease of availability of furosemide. However, the Asia-Pacific region is expected to be the fastest-growing market due to increasing awareness about chronic disease management and the rise in ambulatory surgical centers[2][3].

Drivers of Market Growth

Several factors are driving the growth of the furosemide market:

• Increasing Incidence of Cardiovascular Diseases: The rising number of patients with cardiovascular illnesses, such as heart failure, hypertension, and edema, is a significant driver. Furosemide is often used to reduce fluid excess and improve symptoms in these conditions[3][5].
• Aging Population: The global senior population is growing, and older individuals are more prone to cardiovascular diseases, thereby increasing the demand for furosemide[5].
• Technological Innovations: Advances in healthcare technology and the development of new delivery methods, such as the subcutaneous autoinjector, are enhancing treatment options and patient compliance[1][4].
• Government Initiatives and Healthcare Access: Government campaigns and regulations aimed at expanding access to essential medications, including diuretics like furosemide, are also contributing to market growth[5].

Market Segmentation

The furosemide market is segmented based on several criteria:

• Type: The market is segmented into injection, solution, and tablet forms. The 40mg/40ml injection segment holds a significant market share due to its efficacy in treating conditions like edema and hypertension[5].
• Application: The market is segmented into hospitals, clinics, and recovery centers. Hospitals dominate the market due to the critical role of furosemide in treating severe heart failure, renal disease, and edema[5].
• Geography: The Asia-Pacific region accounts for a significant share of the global furosemide injection market due to the high prevalence of heart failure, hypertension, and renal disease in this region[3][5].

Market Projections

Future Growth Prospects

The furosemide market is expected to continue growing over the forecast period from 2025 to 2031:

• CAGR: The market is projected to grow at a CAGR of 4.20% to 4.53% during the forecast period, driven by the increasing incidence of chronic diseases and the aging population[3][5].
• Regional Opportunities: The Asia-Pacific region is anticipated to remain a key growth area due to rising awareness about chronic disease management and the expansion of healthcare infrastructure[3][5].
• Technological Advancements: The approval and adoption of new delivery methods, such as the subcutaneous autoinjector, are expected to further boost market growth by offering more convenient and cost-effective treatment options[1][4].

Challenges and Restraints

Despite the positive growth prospects, the market faces several challenges:

• Regulatory Hurdles: Stringent FDA regulations for drug approval can slow down market growth. Additionally, product recalls and lack of patient awareness can also act as restraints[3].
• Alternative Treatments: The availability of other diuretics or medications with similar therapeutic effects can limit the market penetration of furosemide[5].

Key Takeaways

• The furosemide market is driven by the increasing incidence of cardiovascular diseases, an aging population, and technological innovations.
• The Asia-Pacific region is expected to be the fastest-growing market segment.
• scPharmaceuticals' subcutaneous autoinjector for furosemide is a significant development that could enhance treatment flexibility and reduce manufacturing costs.
• Regulatory challenges and the availability of alternative treatments are key restraints to market growth.

FAQs

What is the primary use of furosemide?

Furosemide is primarily used as a diuretic to treat conditions such as congestive heart failure, high blood pressure, and edema by reducing fluid excess in the body.

What is the current status of scPharmaceuticals' furosemide autoinjector trial?

The first participant has been enrolled in the pivotal trial for scPharmaceuticals' furosemide autoinjector, with positive topline results reported. The company plans to submit a Supplemental New Drug Application (sNDA) to the FDA by the end of 2024.

Which region is expected to dominate the furosemide market?

North America currently holds the largest market share, but the Asia-Pacific region is expected to be the fastest-growing market due to increasing awareness about chronic disease management and expanding healthcare infrastructure.

What are the key drivers of the furosemide market growth?

Key drivers include the increasing incidence of cardiovascular diseases, an aging population, technological innovations, and government initiatives to expand access to essential medications.

What are the potential restraints to furosemide market growth?

Stringent FDA regulations, product recalls, lack of patient awareness, and the availability of alternative treatments are potential restraints to market growth.

Sources

1. scPharmaceuticals Announces First Participant Enrolled in Pivotal Trial for Furosemide Autoinjector - Investor Overview - scPharmaceuticals.
2. Global Furosemide Market Report 2024 Edition - Cognitivemarketresearch.com.
3. Global Frusemide Market - Industry Trends and Forecast to 2028 - Data Bridge Market Research.
4. scPharmaceuticals Announces Positive Topline Study Results for SCP-111 (Furosemide 80 mg/1 mL) Autoinjector - scPharmaceuticals, Inc.
5. Furosemide Injection Market Size, Share, Trends & Forecast - Verified Market Research.