Interim Results Show At-Home Subcutaneous Furosemide Effective for Heart Failure

BURLINGTON, Mass., Oct. 12, 2026 /CourierPR/ -- SQ Innovation, a Swiss biopharmaceutical company, has announced interim results from a study showing that its novel subcutaneous furosemide treatment, Lasix® ONYU, can effectively decongest patients at imminent risk of hospital admission for heart failure. The study, Gator SCALES-WHF, was presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 in Phoenix, Arizona, on October 11.

The study, conducted at the University of Florida, involved 21 patients with heart failure-associated edema who were deemed at imminent risk for hospital admission. Among these patients, 86% were successfully decongested at home without hospitalization, marking a significant improvement in managing heart failure patients. Three patients were admitted within 30 days for additional treatment, indicating the treatment's effectiveness and safety.

Gator SCALES-WHF is a prospective, open-label, single-arm, real-world study. It evaluates a site-specific clinical pathway for at-home treatment of patients with worsening heart failure who failed oral up-titration and were deemed at imminent risk for hospitalization. The study setup reflects future routine clinical practice with subcutaneous furosemide infusion but imposes some study-related constraints. Eligible adults aged 18 to 80 with congestive heart failure and signs of fluid overload despite oral diuretic up-titration were enrolled. Patients self-administered Lasix ONYU at home, either independently or with the help of a caregiver. The study followed patients for 30 days after treatment initiation.

The patients had a mean age of 63.1 years, with 38% being women. Among them, 67% had heart failure with reduced ejection fraction. At enrollment, median brain natriuretic peptide (BNP) values were 1,125 pg/mL [IQR, 204-4,300], comparable to levels found in patients with heart failure presenting to the emergency room and typically admitted for inpatient treatment.

Participants successfully self-administered a total of 95 doses. User, device, or safety issues were minimal, and no patient discontinued for user, device, or adverse event-related reasons. The study demonstrates that a treatment is an alternative to inpatient IV diuretics, providing value to payors and providers while potentially benefiting patients by avoiding a burdensome hospital stay.

Edema, a leading cause of hospitalizations globally for people over 65 years old with heart failure, typically requires inpatient IV diuretic therapy that can take up to one week. In the U.S., more than 1.2 million people are admitted for heart failure each year, significantly contributing to Medicare and other health insurance expenses amid ongoing hospital overcrowding.

Lasix ONYU, a drug-device combination approved by the U.S. Food and Drug Administration (FDA) in October 2025, is designed for the treatment of edema in adult patients with chronic heart failure. The Lasix ONYU Infusor slowly administers 80 mg of the diuretic furosemide over a period of five hours, resulting in significant diuresis similar to IV, but in a controlled manner designed for at-home administration. This method avoids the brief, intense diuretic effect that occurs with rapid IV infusion or injection.

The advanced two-component design of Lasix ONYU offers benefits for patients, healthcare providers, payors, and the environment. The reusable unit can be used up to 48 times before it can be recycled, while the disposable unit is a sterile, single-use plastic component that holds the drug cartridge. It includes a micro-piston pump, fluid path, needle insertion and retraction mechanism, and a 29-gauge needle. After the device is placed on the abdomen and activated, the needle penetrates the skin, and the furosemide is slowly administered over five hours.

This study, Gator SCALES-WHF (ClinicalTrials.gov: NCT06979726), is a prospective, open-label, single-arm study sponsored by the University of Florida. It is designed to develop, implement, and evaluate a site-specific clinical pathway for at-home treatment with subcutaneous furosemide (Lasix ONYU) in adults presenting with worsening heart failure and fluid overload despite oral diuretic up-titration. The study follows patients for 30 days after treatment initiation and evaluates patient factors, safety, and device operation under real-world conditions ahead of routine clinical implementation.

The results of this study underscore the potential of subcutaneous furosemide for managing heart failure patients at home, reducing hospital admissions and improving patient outcomes.