MannKind's Furoscix ReadyFlow autoinjector receives US FDA approval
MannKind Corp. received US Food and Drug Administration approval for its Furoscix ReadyFlow autoinjector, a sub‑cutaneous device that delivers an 80 mg/mL dose of furosemide in about ten seconds. The product is targeted at adults with heart failure or chronic kidney disease to treat fluid overload at home and prevent emergency‑room infusions.
Clinical data showed the autoinjector achieved urine output, sodium and potassium excretion comparable to intravenous furosemide at 6, 8 and 12 hours, with a bioavailability of roughly 107 % in a trial of 21 healthy volunteers. Safety findings indicated mainly local injection‑site reactions and systemic effects consistent with known furosemide profiles. An earlier version, the Furoscix On‑Body Infuser approved in 2022, required a five‑hour infusion. MannKind expects the ReadyFlow device to be commercially available in the United States by the end of August. The company also disclosed a recent acquisition of scPharmaceuticals for up to $360 million.
Entities: Chronic Kidney Disease · Furoscix ReadyFlow · MannKind Corp. · U.S. Food and Drug Administration · US Food and Drug Administration · chronic kidney disease · heart failure · heart failure
Claims
What the coverage asserts, and how well corroborated each claim is across sources.
- [○ 1 SOURCE] A trial with 21 healthy volunteers showed the ReadyFlow injection had 107.3% bioavailability (90% CI, 103.9‑110.8). (Phase‑1 pharmacokinetic study)
- [● 2 SOURCES] MannKind expects the ReadyFlow device to be commercially available in the United States by the end of August. (Company rollout plan)
- [○ 1 SOURCE] MannKind agreed to acquire scPharmaceuticals for up to $360 million, paying $5.35 per share plus a $1 contingent value right. (Company acquisition announcement)
- [● 2 SOURCES] The earlier Furoscix On‑Body Infuser was FDA‑approved in 2022 and delivered furosemide over five hours. (Company product history)
- [● 3 SOURCES] The US FDA approved the Furoscix ReadyFlow autoinjector for adult patients with heart failure or chronic kidney disease on July 24, 2026. (FDA approval announcement)
- [○ 1 SOURCE] Adverse events were mainly localized injection‑site reactions; systemic events matched the known safety profile of oral and IV furosemide. (Study safety results)
- [● 4 SOURCES] The Furoscix ReadyFlow autoinjector delivers furosemide subcutaneously in about ten seconds. (MannKind product description and FDA briefing)
- [● 3 SOURCES] The autoinjector achieved equivalent urine output, sodium excretion, and potassium excretion at 6, 8 and 12 hours compared with intravenous furosemide. (Clinical Therapeutics study data)