FDA Approves Furosemide Injection (Furoscix ReadyFlow) for Edema in HF, CKD

The US Food and Drug Administration has approved MannKind Corporation’s furosemide injection (Furoscix ReadyFlow) for the treatment of edema (fluid overload) in adults with heart failure (HF) or chronic kidney disease (CKD).

As described in a July 24, 2026, press release from the Company, furosemide injection is the first and only autoinjector delivering subcutaneous furosemide with IV-equivalent exposure (based on comparisons of AUC and PD endpoints), providing a full 80 mg/mL dose in a simple, patient-friendly format administered in < 10 seconds.

“Too often, patients living with heart failure or chronic kidney disease find themselves caught in a cycle of worsening fluid overload that can disrupt daily life and lead to ER visits and hospitalization,” said Hunter Champion, MD, PhD, Emory University Healthcare Network and Director of the Heart Failure and Pulmonary Hypertension program at Southeastern Cardiology Associates in Columbus, Georgia. “An at-home option that delivers similar IV-equivalent furosemide exposure through a simple autoinjector gives clinicians an important new tool to intervene as soon as signs and symptoms of fluid overload appear helping appropriate patients manage congestion outside the hospital setting while reducing the disruption and burden associated with hospital-based treatment.”

What Is Furosemide Injection?

Furosemide injection is an at-home treatment option designed to help adults with HF or CKD address fluid overload earlier, before worsening symptoms may lead to emergency department visits, hospitalization, or readmission. The therapy is absorbed into the bloodstream, and symptom relief may begin in an hour or less.

The FDA-approved furosemide injection (Furoscix) delivered via an On-body infusor is currently available and was approved for adult patients with edema in HF in 2022 and CKD in 2025. Furoscix ReadyFlow is expected to be commercially available in the United States by the end of August 2026 and will reduce administration time from 5 hours with the currently available On-body infusor to 10 seconds or less.

Furoscix ReadyFlow Pharmacokinetic Data and Bioavailability

The FDA approval of the autoinjector is supported by positive clinical data demonstrating that furosemide injection achieved its primary pharmacokinetic endpoint. In the study, furosemide injection demonstrated a bioavailability of 107.3% (90% CI, 103.9 - 110.8), achieving the 90% confidence interval limit of 80 to 125 percent. The study also demonstrated equivalent urine output, sodium excretion and potassium excretion at 6, 8 and 12 hours compared to IV furosemide.

Furosemide injection was generally well tolerated, with a safety profile consistent with known effects of oral and intravenous furosemide. The most common adverse events were localized to the injection site and systemic adverse events were consistent with those reported in the prescribing information for intravenous and oral furosemide

“The approval of Furoscix ReadyFlow marks an important milestone for patients living with heart failure or chronic kidney disease who experience fluid overload,” Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation, said in a statement. “By combining IV-equivalent diuretic performance with the simplicity of an autoinjector, Furoscix ReadyFlow has the potential to advance how fluid overload is managed outside traditional care settings and reach appropriate patients at different intervention points—from the onset of worsening symptoms and, when hospitalization cannot be avoided, through the transition home. We believe this represents a meaningful step forward for patients, practitioners, payers and hospitals—helping ease fluid burden for patients while reducing pressure on an increasingly burdened healthcare system.”

References

1. MannKind Corporation. MannKind Announces FDA Approval of Furoscix ReadyFlow™, the First and Only Autoinjector Delivering IV-Equivalent Diuretic Therapy for the Treatment of Edema in Adults with Heart Failure or Chronic Kidney Disease. July 24, 2026. Accessed July 24, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-furoscix-readyflowtm-first-and

2. sC Pharmaceuticals. scPharmaceuticals Announces Positive Topline Study Results for SCP-111 (Furosemide 80 mg/1 mL) Autoinjector. August 12, 2024. Accessed July 24, 2026. 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