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sc2Wear Furosemide

Phase 3

Heart Failure | Small molecule | Cardiovascular |MannKind Corporation|Last Updated: Jun 27, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment101

FDA Designations

No designations recorded

Clinical trial landscape

sc2Wear Furosemide · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT02804282Product Design Clinical Performance Study of sc2Wear Furosemide Combination ProductHeart Failure
COMPLETED74 Analytics
PHASE3COMPLETED
Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Absence of Major Product Failure
1-5 hours

Freedom from failures leading to infusion errors.

Secondary Endpoints

Local Pain Tolerance
1-5 hours
Local Skin Tolerance
1-8 days
Incidence of treatment-emergent Adverse Events and Serious Adverse Events
1-8 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
sc2Wear Furosemide Combination ProductEXPERIMENTALDrug-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.

Interventions

NameTypeDescription
sc2Wear FurosemideCOMBINATION_PRODUCTDrug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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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Frequently asked questions about sc2Wear Furosemide

What is sc2Wear Furosemide used for?

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.

Who makes sc2Wear Furosemide?

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.

What phase is sc2Wear Furosemide in?

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.

What clinical trials is sc2Wear Furosemide in?

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.

Is sc2Wear Furosemide the same as furosemide?

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.