FDA Accepts sNDA for Furosemide Autoinjector for Chronic Heart Failure and CKD

The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the FUROSCIX ReadyFlow Autoinjector (SCP-111), which delivers a subcutaneous injection of furosemide in <10 seconds to treat edema in patients with chronic heart failure (CHF) or chronic kidney disease (CKD).1

Announced on December 1, 2025, by parent company MannKind Corporation, this acceptance was supported in part by positive study results announced in August 2024, which compared a furosemide treatment via SCP-111 to the FDA-approved FUROSCIX On-body Infusor. If approved, SCP-111 could reduce administration time from 5 hours to under 10 seconds.1

“By delivering treatment in under 10 seconds, the ReadyFlow Autoinjector has the potential to transform how adults with chronic heart failure or chronic kidney disease manage episodes of fluid buildup—providing faster relief, reducing hospital admissions, and lowering overall healthcare costs,” Michael Castagna, PharmD, chief executive officer at MannKind Corporation, said in a statement. “We are excited about the opportunity to bring this innovation forward and empower patients with greater convenience and control in their treatment journey.”1

The study in question was an open-label, single-center, single-dose, randomized, 2-way crossover study conducted by scPharmaceuticals. Patients were included if they were between the ages of 45 and 80. Patients were excluded if they exhibited systolic blood pressure <90 mmHg at screening or baseline, a heart rate >110 BPM, serum potassium <3 or >5.5 mEq/L at screening, or other significant cardiac abnormalities, among other factors.2

A total of 21 patients were included in the trial, who were then randomly assigned in a 1:1 ratio to either IV furosemide followed by SCP-111 via the autoinjector or vice versa. Each patient completed the screening, baseline, treatment, and follow-up phases of the trial. Full data from the trial will be presented at a forthcoming medical meeting or publication but has not been released yet.3

Ultimately, SCP-111 showed a bioavailability of 107.3% (90% CI, 103.9-110.8), achieving the 90% confidence interval limit of 80-125%. Additionally, participants who received SCP-111 had similar urine output, urinary sodium excretion, and urinary potassium excretion at 6, 8, and 12 hours compared to IV furosemide. Patients reported a median pain score of 0 across all time points assessed, and the most common adverse events with SCP-111 were localized to the injection site and were consistent with those reported in the prescribing information for intravenous and oral furosemide.3

“If approved, we believe administration of furosemide via an autoinjector would provide treatment flexibility to cardiologists and heart failure specialists and their patients,” John Tucker, chief executive officer of scPharmaceuticals, said in a statement.3

SCP-111 has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.1

References

1. MannKind Therapeutics. MannKind Announces US FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney Disease. GlobeNewswire. December 1, 2025. Accessed December 1, 2025. https://www.globenewswire.com/news-release/2025/12/01/3196982/29517/en/MannKind-Announces-U-S-FDA-Accepts-for-Review-its-Supplemental-New-Drug-Application-sNDA-of-FUROSCIX-ReadyFlow-Autoinjector-for-the-Treatment-of-Edema-in-Adults-with-Chronic-Heart-.html

2. scPharmaceuticals, Inc. Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers. ClinicalTrials.gov identifier: NCT06167707. Updated June 27, 2024. Accessed December 1, 2025. https://clinicaltrials.gov/study/NCT06167707

3. scPharmaceuticals, Inc. scPharmaceuticals Announces Positive Topline Study Results for SCP-111 (Furosemide 80 mg/1mL) Autoinjector. GlobeNewswire. August 12, 2024. Accessed December 1, 2025. https://www.globenewswire.com/news-release/2024/08/12/2928204/0/en/scPharmaceuticals-Announces-Positive-Topline-Study-Results-for-SCP-111-Furosemide-80-mg-1-mL-Autoinjector.html