Furoscix ReadyFlow (Furosemide) and its Impact on HF, CKD Edema Treatment

The US Food and Drug Administration (FDA) has approved the Furoscix ReadyFlow furosemide injection for edema in patients with heart failure (HF) or chronic kidney disease (CKD).¹

The approval, announced by MannKind on July 24, 2026, marked the ReadyFlow as the first and only autoinjector for subcutaneous furosemide with IV-equivalent exposure. Designed as an at-home treatment option to help patients address fluid overload without requiring hospitalization, the ReadyFlow administers 80 mg/mL of furosemide in 10 seconds via a single pen.¹

“We’ve been very excited about the ReadyFlow approval. We’ve been using the original Furoscix cartridge for a couple of years now and have had great success with it in terms of being able to keep people out of the hospital,” Hunter Champion, MD, PhD, director of the Heart Failure and Pulmonary Hypertension program at Southeastern Cardiology Associates and clinical associate professor of medicine at Mercer University, told HCPLive in an exclusive interview. “This being an easier way for patients to utilize subcutaneous furosemide is going to be a big change for a lot of our patients and will allow us to treat patients who otherwise may not feel comfortable with the previous device.”

Data Supporting the FDA’s Decision

The FDA’s decision was based in large part on positive clinical data from a prior trial, which enrolled 21 healthy volunteers to receive either IV furosemide followed by the ReadyFlow or vice versa. During the study, the ReadyFlow achieved its primary pharmacokinetic endpoint. The injection demonstrated a substantial 107.3% bioavailability (90% CI, 103.9-110.8). Additionally, the study showed equivalent urine output, sodium excretion, and potassium excretion at 6, 8, and 12 hours versus IV furosemide.²

During the trial, investigators reported a safety profile consistent with known effects of existing oral and intravenous furosemide. Most adverse events were localized to the injection site, and systemic adverse events were consistent with those in the prescribing information for oral and intravenous furosemide.²

Next Steps for the ReadyFlow

In the interview, Champion highlighted the opportunities presented by the Furoscix ReadyFlow, primarily the ability for patients to treat their edema at home rather than being admitted into the hospital. In addition to easing access to care and minimizing interruptions to lifestyle, the ReadyFlow allows patients to forego the cost of hospital care by managing symptoms of HF- and CKD-related edema from home. Champion cites his own experience with prior furosemide treatment, noting that intravenous injections were capable of reducing hospital readmission rates for HF substantially.

“This represents a newer model in treating heart failure and fluid overload in general,” Champion said. “This is something that pretty much anyone can do – put a pin against your skin, press the button, and you’re ready. I think at the end of the day, you will see a lot more uptake. We believe in Furoscix devices so much that they’ve really become an integral part of how we treat these patients.”

The ReadyFlow is expected to be commercially available at the end of August 2026.¹

Editors’ Note: Champion reports disclosures with Actelion, Gilead, Pfizer, and United Therapeutics.

References

1. MannKind Therapeutics. 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 28, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-furoscix-readyflowtm-first-and

2. Brooks A. FDA Approves Furosemide Injection (Furoscix ReadyFlow) for Edema in HF, CKD. HCPLive. July 24, 2026. Accessed July 28, 2026. https://www.hcplive.com/view/fda-approves-furosemide-injection-furoscix-readyflow-for-edema-in-hf-ckd