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Label indication FUROSCIX is indicated for the treatment of edema in pediatric patients weighing 43 kg and above and in adult patients adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome. FDA label
Also known as subcutaneous furosemide
Furoscix · 1 trial · 1 indication
Post-treatment diuretic efficiency is measured by cumulative urine output in mL per mg of treatment, observed hourly through 8 hours following the administration of study therapy (Furoscix vs. oral furosemide).
| Arm | Type | Description |
|---|---|---|
| ≥ 12 BAN-ADHF, Furoscix | EXPERIMENTAL | Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive Furoscix over 5 hours at 8 mg/mL. |
| <= 11 BAN-ADHF, Furoscix | EXPERIMENTAL | Patients without diuretic resistance as determined by BAN-ADHF score \<= 11 will receive Furoscix over 5 hours at 8 mg/mL. |
| ≥ 12 BAN-ADHF, control | ACTIVE_COMPARATOR | Patients with diuretic resistance as determined by a BAN-ADHF score ≥ 12 will receive home dose oral diuretic. |
| <= 11 BAN-ADHF, control | ACTIVE_COMPARATOR | Patients without diuretic resistance as determined by BAN-ADHF score \<= 11 will receive home dose oral diuretic |
| Name | Type | Description |
|---|---|---|
| Furoscix | COMBINATION_PRODUCT | Study Drug: Furoscix®, (Furosemide Injection), 80 mg/10 mL is a proprietary furosemide formulation that is buffered to a neutral pH to enable subcutaneous administration and contained in a prefilled Crystal Zenith® (CZ) cartridge. Study Device: The Infusor is a compact, ethylene oxide (EtO) sterilized, single-use, electro-mechanical (battery powered, micro-processor controlled), on-body subcutaneous delivery system based on the SmartDose® Gen II 10 mL (West Pharmaceutical Services). The Furoscix Infusor is an investigational drug-device combination product. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours). |
| Diuretic Therapy | DRUG | Patients will receive home dose oral furosemide or oral furosemide per standard of care. |
Inclusion Criteria: * English-speaking patients discharged after ward hospitalization for acute decompensated heart failure * Able to be screened and enrolled within 14 days of hospitalization * Recent echocardiogram (6 months or less) * Discharged with home diuretic regimen Exclusion Criteria: *...
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Furoscix is being developed for heart failure, specifically for heart failure patients with diuretic resistance. It is a small molecule therapeutic candidate from MannKind Corporation. The clinical work to date has focused on this cardiovascular indication, and the program remains in clinical development rather than being a marketed product.
Furoscix is being developed by MannKind Corporation, which trades under the ticker MNKD. The company is the sponsor of the clinical program studying the drug in heart failure. MannKind is a biopharmaceutical company, and Furoscix is one of its cardiovascular development assets.
Furoscix is in Phase 2 clinical development. The program has completed one Phase 2 trial in heart failure patients with diuretic resistance. There are currently no active trials listed for the drug, and it is an investigational therapy that has not been approved by the FDA.
Furoscix has been studied in one completed Phase 2 trial, NCT05528588, titled Furoscix in Heart Failure Patients With Diuretic Resistance. The trial enrolled 70 participants in the United States, was randomized and active controlled, and included adults 18 years and older of all sexes.
Furoscix is not approved by the FDA. It is an investigational small molecule in Phase 2 clinical development for heart failure, and its only listed trial, NCT05528588, has completed. Approval status would only change if the developer advanced the program through later-stage trials and regulatory review.