Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Furosemide for administration · 1 trial · 1 indication
Statistical summaries with a graphical presentation will show mean and individual diuresis and natriuresis time profiles such as time to first void, volume of first void, diuresis and natriuresis measured at 60 minute intervals up to 480 minutes following furosemide injection solution for subcutaneous administration or oral tablets. The diuretic response will be compared between therapies using t-tests or Wilcoxon test.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Furosemide injection solution for subcutaneous administration (80 mg) over 5 hours followed by Oral Furosemide tablets (80 mg) in second period. |
| Group 2 | EXPERIMENTAL | Oral Furosemide tablets (80 mg) followed by Furosemide injection solution for subcutaneous administration (80 mg) over 5 hours in second period. |
| Name | Type | Description |
|---|---|---|
| Furosemide injection solution for subcutaneous administration (80 mg) | DRUG | - |
| Oral Furosemide tablets (80 mg) | DRUG | - |
Inclusion Criteria: * Written informed consent obtained before any assessment is performed * Male and female subjects ≥18 years of age, with body weight \<120 kg and body mass index (BMI) \<30 kg/m2 * Female subjects must be at least 2 years post-menopausal * Participant must have been on oral furo...
Top 16 of 30 competitors
Furosemide for subcutaneous administration is an injectable formulation of furosemide, a small molecule diuretic, being developed by MannKind Corporation as an 80 mg injection solution. It is intended for patients with heart failure and is designed to be given under the skin rather than by mouth or intravenous infusion.
It is being developed for the treatment of heart failure. Furosemide is a loop diuretic used to promote fluid removal in patients with fluid overload, and the subcutaneous formulation is intended to provide an alternative route of administration for that same purpose in heart failure patients.
Furosemide for subcutaneous administration targets SLC12A1, the sodium-potassium-chloride cotransporter 2 in the thick ascending limb of the loop of Henle. It acts as an inhibitor of this transporter, which reduces sodium reabsorption and increases urine output, the established diuretic mechanism of the furosemide molecule.
MannKind Corporation, which trades under the ticker MNKD, is developing furosemide for subcutaneous administration. The company is advancing the 80 mg injectable solution as a subcutaneous alternative for delivering furosemide in heart failure patients.
Furosemide for subcutaneous administration is in Phase 1 development. It is an investigational product and has not been approved by the FDA. The Phase 1 program has completed, with no trials currently listed as active.
One completed Phase 1 trial has evaluated furosemide for subcutaneous administration: NCT02350725, titled Furosemide Pharmacodynamics and Pharmacokinetics After Subcutaneous or Oral Administration. It enrolled 10 adults with heart failure in the Netherlands, was randomized and controlled, and was not double blind.