Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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: *...
Top 20 of 31 competitors
Furoscix is an investigational small molecule being studied for use in heart failure, specifically in patients with diuretic resistance. It is being developed as a treatment option for this patient population, though it remains in clinical development and is not yet approved.
Furoscix is being developed by MannKind Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol MNKD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in heart failure patients.
Furoscix is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its potential as a treatment for heart failure with diuretic resistance.
Furoscix has been studied in one completed Phase 2 clinical trial, identified as NCT05528885, titled "Furoscix in Heart Failure Patients With Diuretic Resistance." The trial enrolled 70 participants in the United States and was active-controlled, meaning it compared Furoscix against an existing treatment.
Furoscix is a small molecule, but its specific molecular target has not been disclosed. The drug is being investigated for its ability to address diuretic resistance in heart failure patients, a condition where standard diuretic therapy becomes less effective.