FDA Approves Furosemide Autoinjector for Treatment of Edema in CKD or Heart Failure

The FDA approved furosemide injection via an autoinjector (Furoscix ReadyFlow; Mannkind Corp) for the treatment of edema, or fluid overload, in adults with heart failure or chronic kidney disease (CKD).¹

Furosemide treats fluid buildup, which can cause congestion or swelling in adult patients with chronic heart failure or CKD. The autoinjector is an at-home treatment option specifically designed to help adults with heart failure or CKD address fluid overload earlier, before worsening symptoms could lead to emergency department visits, hospitalization, or readmission. According to the manufacturer news release, announcing the approval, furosemide is first and only autoinjector delivering subcutaneous furosemide with intravenous (IV)-equivalent exposure. It is absorbed into the bloodstream, and symptom relief can begin in an hour or less.^1,2

Furosemide injection (Furoscix), delivered via an on-body infuser, was initially approved in 2022 for adult patients with edema in heart failure, and then received an expanded approval to include CKD in 2025.^1,3

The autoinjector, which had its supplemental new drug application accepted in December 2025, will reduce administration time from about 5 hours with the currently available on-body infuser to 10 seconds or less. It provides a full 80 mg/mL dose in a patient-accessible format, which may help expand opportunities for earlier intervention and extend IV-equivalent furosemide exposure beyond the hospital for patients across outpatient, postdischarge, and home-based care settings.^1,2

“The approval of [furosemide autoinjector] marks an important milestone for patients living with heart failure or CKD who experience fluid overload,” Michael Castagna, PharmD, CEO of MannKind Corporation, said in the news release. “…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 health care system.”

What Clinical Data Supported the Furosemide’s Approval?

The approval is supported by findings from an open-label, single-dose, randomized, 2-way crossover phase 1 clinical trial (NCT06167707)⁴ that compared the pharmacokinetics and pharmacodynamics of subcutaneous furosemide with an IV injection of furosemide in 21 healthy volunteers. The participants were 45 to 80 years, all of whom completed the screening, baseline, treatment, and follow-up phases. Participants were randomly assigned to receive either the IV formulation of furosemide followed by the autoinjector, or vice versa.^1,2,4

According to the findings, the autoinjector demonstrated a bioavailability of approximately 107.3% (90% CI, 103.9-110.8), which achieved the 90% CI limit of 80% to 125%. Of note, participants who received the autoinjector had similar urine output, urinary sodium excretion, and urinary potassium excretion at the 6-, 8-, and 12-hour periods compared with IV furosemide. Notably, participants reported a median pain score of 0 across all of the assessed time points.²

The most common adverse events (AEs) reported with the furosemide autoinjector were localized to the injection site and systemic AEs that were consistent with those reported in the prescribing information for both IV and oral formulations. The treatment is contraindicated in patients with anuria and in those with a history of hypersensitivity to furosemide, any component of the Furoscix formulation, or medical adhesives.²

“Too often, patients living with heart failure or CKD find themselves caught in a cycle of worsening fluid overload that can disrupt daily life and lead to ER visits and hospitalization,” 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, said in the news release.

“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.”¹

REFERENCES

1. 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. Mannkind. News release. 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. McGovern G. FDA Accepts Furosemide Autoinjector sNDA for Treatment of Edema in Chronic Kidney Disease or Chronic Heart Failure. Pharmacy Times. December 3, 2025. Accessed July 24, 2026. https://www.pharmacytimes.com/view/fda-accepts-furosemide-autoinjector-snda-for-treatment-of-edema-in-chronic-kidney-disease-or-chronic-heart-failure

3. McGovern G. FDA Approves Expansion for Furosemide Injection to Treat Edema in Patients With CKD. Pharmacy Times. March 6, 2025. Accessed July 24, 2026. https://www.pharmacytimes.com/view/fda-approves-expansion-for-furosemide-injection-to-treat-edema-in-patients-with-ckd

4. Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers. ClinicalTrials.gov identifier: NCT06167707. Updated March 30, 2026. Accessed July 24, 2026. https://clinicaltrials.gov/study/NCT06167707