The U.S. Food and Drug Administration has approved Lasix ONYU, a groundbreaking subcutaneous drug-device combination that enables heart failure patients to receive diuretic treatment at home rather than in hospital settings. The approval, granted on October 7, 2025, represents a significant shift in managing edema associated with chronic heart failure, a condition affecting approximately 6.7 million Americans.
Novel Drug-Device Technology
Lasix ONYU combines a high-concentration furosemide formulation (30 mg/mL) with an innovative infusor device designed for home use. The system delivers 80 mg of furosemide subcutaneously over five hours through a 29-gauge needle placed on the abdomen. This controlled delivery method contrasts sharply with traditional intravenous bolus administration, which produces brief, intense diuretic effects.
The device features a two-component design consisting of a reusable electromechanical unit containing battery, motor, and electronic components that can be used for up to 48 treatments, paired with a sterile, single-use disposable unit containing the drug cartridge and delivery mechanism.
Clinical Efficacy Data
Clinical studies demonstrated that Lasix ONYU achieved complete bioavailability of 112% compared to intravenous administration, resulting in similar diuresis (115%) and natriuresis (117%). The biphasic delivery pattern produced by the infusor created a more tempered diuretic response while maintaining therapeutic effectiveness. These results were published in the European Heart Journal - Cardiovascular Pharmacotherapy.
"Lasix ONYU has the potential to be transformative in the care of patients experiencing worsening heart failure due to fluid overload," said Dr. Pieter Muntendam, founder, President and CEO of SQ Innovation. "Treating selected patients at home offers important benefits to patients, health systems and payors."
Addressing Healthcare System Pressures
The approval comes as heart failure prevalence is expected to rise from 6.7 million to 8.7 million Americans by 2030. Heart failure represents the leading cause of hospitalizations for individuals aged 65 and older, with approximately 1.2 million hospitalizations annually.
Dr. Javed Butler, Professor of Medicine at University of Mississippi and President of Baylor Scott and White Research Institute, emphasized the healthcare system challenges: "The number of patients affected is expected to double over the next 20 years and we currently already often lack adequate resources to take care of the 6.7 million patients affected presently – there are not enough beds, clinicians and funds."
Clinical Care Transformation
S. Craig Thomas, Immediate Past President of the American Association of Heart Failure Nurses, highlighted the clinical significance: "Decongestion through use of IV diuretics has been the cornerstone of treatment for reducing edema and hypervolemia in heart failure patients for over five decades. The availability of accessible, affordable, and novel options that do not require the presence of a healthcare professional allows for transformative new clinical care-delivery."
The device enables patients who would typically require several days of intravenous treatment in hospital settings to remain home with periodic or remote monitoring support.
Safety Profile and Considerations
The FDA approval includes comprehensive safety information addressing potential side effects including dehydration, temporary low blood pressure, elevated blood sugar in diabetic patients, hearing effects, increased sun sensitivity, and infusion site reactions. The device requires specific handling precautions, including protection from moisture and activity limitations during infusion to ensure complete dosing.
Market Launch and Availability
SQ Innovation plans to launch Lasix ONYU in the fourth quarter of 2025 through leading pharmaceutical distributors, enabling availability at participating medical facilities and affiliated retail pharmacies. The company's two-component design strategy aims to reduce manufacturing complexity and costs, potentially improving accessibility for widespread adoption.
The Swiss biopharmaceutical company, with offices in Zug, Switzerland, Burlington, Massachusetts, and Rotterdam, Netherlands, developed the system with consideration for patients, healthcare providers, payers, and environmental impact through its reusable component design.
