Furoscix ReadyFlow (furosemide injection) received US Food and Drug Administration approval for the treatment of edema in adults with heart failure or chronic kidney disease, according to a press release from MannKind Corporation. The product delivers furosemide by a subcutaneous autoinjector and is expected to become commercially available in the US by the end of August 2026 .
The autoinjector administers furosemide (80 mg/mL), with administration completed in 10 seconds or less. According to MannKind, symptom relief may begin within 1 hour of administration. Pharmacokinetic and pharmacodynamic comparisons supported intravenous-equivalent furosemide exposure following subcutaneous administration. MannKind described the autoinjector as an option for outpatient, postdischarge, and home-based care.
The US Food and Drug Administration approval was supported by data showing that Furoscix ReadyFlow met its primary pharmacokinetic endpoint. Urine output and sodium and potassium excretion at 6, 8, and 12 hours were comparable with those observed following intravenous furosemide, according to MannKind. According to MannKind, the reported safety profile was consistent with the known effects of oral and intravenous furosemide.
"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," said Hunter Champion, MD, PhD, of Emory University Healthcare Network and director of the Heart Failure and Pulmonary Hypertension Program at Southeastern Cardiology Associates in Columbus, Georgia.
According to the company, an estimated 6.7 million US adults currently live with heart failure, and that number is projected to exceed 8 million by 2030. MannKind also stated that fluid overload is a common reason for emergency department visits, hospitalization, and readmission among patients with heart failure or chronic kidney disease.
Furoscix delivered through an on-body infusor received FDA approval for edema associated with heart failure in 2022 and for chronic kidney disease in 2025. MannKind stated that the ReadyFlow autoinjector will reduce administration time from approximately 5 hours with the on-body infusor to 10 seconds or less.
Safety information included in the press release identifies dehydration and electrolyte loss, transient hypotension, increased blood glucose in patients with diabetes mellitus, hearing-related effects, photosensitivity, and incomplete dosing as potential risks. The most common adverse events listed are administration-site and skin reactions, including bruising, erythema, swelling, and administration-site pain.
Source: MannKind