SQ Innovation’s Lasix Onyu, a drug-device combination therapy for fluid retention (oedema) treatment in chronic heart failure patients, has demonstrated value in comparison to hospital-based care for the condition.
A common condition in individuals with heart failure, oedema occurs because the heart cannot pump blood efficiently, resulting in blood backing up in the veins, thereby forcing fluid into surrounding tissues.
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SQ Innovation’s Lasix Onyu comprises a high-concentration formulation of the diuretic furosemide and an on-body cartridge-based infuser for drug delivery.
Topline data from the biopharma’s 172-patient SUBCUT HF II (NCT05419115) comparator study in the UK met its primary endpoints of avoidance of a minimum of 3.5 days of inpatient care. Patients randomised to receive at-home oedema treatment with Onyu spent an average of four fewer days in hospital, compared to those treated with standard-of-care intravenous (IV) furosemide.
Ninety-two patients were randomised to receive at-home treatment with Lasix Onyu, while 80 received in-hospital treatment with IV diuretics.
The topline data were presented at the European Society of Cardiology’s (ESC) Heart Failure 2026 annual congress, taking place from 9-12 May in Barcelona, Spain.
Secondary endpoints of the study supported that, aside from the avoidance of inpatient days, at-home Lasix ONYU treatment was equivalent to in-hospital treatment, SQ Innovation stated.
Adverse events (AEs) during the study were infrequent, and no device-related serious AEs occurred.
Professor Mark Petrie of the Glasgow Cardiovascular Research Centre, University of Glasgow, who served as a principal investigator for the study, commented: “Oedema in heart failure is a leading reason for hospital admissions worldwide.
“This novel treatment option relies on the same therapeutic fundamentals that have been in place in the hospital since the 1960s, and enabling this to now be done at home by a patient or caregiver fundamentally changes the nature and trajectory of this very common and burdensome disorder.”
SQ Innovation’s Lasix Onyu received full US Food and Drug Administration (FDA) approval in October 2025 after receiving ‘tentative’ approval from the agency in December 2024, the product has an automatic needle insertion and retraction and uses the infuser with a reusable electromechanical component designed for the delivery of 48 treatments, and a single-use sterile disposable component that is in contact with the drug solution and the body.
