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Open-label, Single-dose, Randomized, Two-way (Two-period) Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80mg) Administered Intravenously in Subjects With Chronic Heart Failure

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Trial Profile

Open-label, Single-dose, Randomized, Two-way (Two-period) Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80mg) Administered Intravenously in Subjects With Chronic Heart Failure

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 21 May 2024

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At a glance

  • Drugs Furosemide (Primary) ; Furosemide (Primary)
  • Indications Chronic heart failure
  • Focus Pharmacokinetics; Registrational
  • Sponsors scPharmaceuticals

Most Recent Events

  • 14 May 2024 According to a scPharmaceuticals media release, company Announced that the Company's sNDA submission to the FDA seeking to expand the FUROSCIX indication to include New York Heart Association Class IV heart failure patients is currently under review by the FDA. A PDUFA date has been scheduled for August 2024
  • 19 Sep 2023 According to a scPharmaceuticals media release, company plans to report data from a pivotal pharmacokinetic (PK) study in first half of 2024, and submitting a Supplemental New Drug Application (sNDA) to the FDA by the end of 2024.
  • 10 Oct 2022 According to a scPharmaceuticals media release, USFDA has approved FUROSCIX (furosemide injection) delivered via an On-Body Infusor for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure, based on the IV equivalence established in this study.

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