Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fursemide for administration · 1 trial · 1 indication
Maximum observed plasma concentration of Furosemide
Time to achieve maximum observed Furosemide plasma concentration
The area under the plasma concentration versus time curve from time 0 (pre-dose) to the last quantifiable time point.
The area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration.
The percentage of AUC that is extrapolated beyond the last measurable concentration
Apparent plasma terminal-phase elimination rate constant
Terminal-phase half life
Systemic Volume of distribution, terminal phase for IV furosemide and Apparent Volume of distribution, terminal phase for SC furosemide
Systemic Clearance for IV furosemide and Apparent Systemic Clearance for SC furosemide
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours followed by i.v. Furosemide Injection, USP (80 mg)by i.v. bolus in second period |
| Treatment Sequence 2 | EXPERIMENTAL | Furosemide Injection, USP (80 mg) by i.v. bolus, followed by Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours in second period. |
| Name | Type | Description |
|---|---|---|
| Fursemide Injection Solution for subcutaneous administration (80 mg) | DRUG | Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL) |
| Furosemide Injection, USP | DRUG | Furosemide Injection, USP (10mg/mL), 80 mg by intravenous administration. |
Inclusion Criteria: * An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. * Male and female subjects ≥18 years of age, with body volume and weight \<130 kg and body mass index (BMI) \<38 kg/m2 * Females will be non-pregnant, non-l...
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Fursemide for administration is an injectable formulation of furosemide, a small molecule diuretic, developed by MannKind Corporation for subcutaneous delivery in patients with heart failure. It is also known as Fursemide Injection Solution for subcutaneous administration (80 mg). The drug is designed to be given under the skin rather than intravenously.
Fursemide for administration is being developed for heart failure, within the cardiovascular therapeutic area. Furosemide is a diuretic used to remove excess fluid, and this subcutaneous formulation is intended to provide an alternative route of administration for patients with chronic heart failure who need furosemide therapy.
Fursemide for administration is developed by MannKind Corporation, which trades under the ticker MNKD. MannKind is the sponsor of the clinical program evaluating this subcutaneous furosemide formulation in heart failure patients.
Fursemide for administration is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 2 program consists of one completed trial, and no trials are currently active.
Fursemide for administration has been studied in one completed Phase 2 trial, NCT02329834. That randomized, controlled crossover study compared the pharmacokinetics and bioavailability of a novel furosemide regimen given subcutaneously versus the same dose given intravenously in 23 subjects with chronic heart failure in the United States.