Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sc2Wear Furosemide · 2 trials · 1 indication
Freedom from failures leading to infusion errors.
| Arm | Type | Description |
|---|---|---|
| sc2Wear Furosemide Combination Product | EXPERIMENTAL | Drug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump) for subcutaneous administration of 80 mg dose delivered over 5 hours. |
| Name | Type | Description |
|---|---|---|
| sc2Wear Furosemide | COMBINATION_PRODUCT | Drug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump) |
Inclusion Criteria: 1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. 2. Male and female Subjects ≥18 years of age 3. New York Heart Association (NYHA) Class II-IV Heart Failure. 4. In the opinion of the Investigator, able to...
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sc2Wear Furosemide is an investigational small molecule being developed for heart failure. It is a combination product studied in clinical trials for this condition. The drug is not approved and remains in clinical development.
sc2Wear Furosemide is being developed by MannKind Corporation, traded on the NASDAQ under the ticker MNKD. The company is conducting clinical trials to evaluate this combination product for heart failure.
sc2Wear Furosemide is in Phase 3 clinical development. Two trials have been completed, including a Phase 2 pilot study and a Phase 3 product design clinical performance study. The drug is investigational and not yet approved.
sc2Wear Furosemide has been studied in two completed trials. NCT02804035 was a Phase 2 pilot study with 27 participants, and NCT02804282 was a Phase 3 product design clinical performance study with 74 participants. Both trials enrolled adults with heart failure.
sc2Wear Furosemide is a combination product that includes furosemide, a diuretic. The sc2Wear designation refers to the delivery system or product design. It is being studied specifically for heart failure, and the trials are not randomized or controlled.