FDA Approves Lasix ONYU: At-Home Drug-Device Combination for Subcutaneous Furosemide in Edema and Heart Failure

The U.S. Food and Drug Administration (FDA) has approved Lasix ONYU (furosemide 80 mg/2.67 mL oral suspension) as a novel, subcutaneous, drug-device combination for treating edema associated with chronic heart failure, liver cirrhosis, and renal disease.

The development and commercialization of Lasix ONYU involved a multi-company collaboration. SQ Innovation, Inc is the primary developer and Marketing Authorization Holder of Lasix ONYU. SQ Innovation designed the complete Lasix ONYU therapy model including clinical protocols to enable subcutaneous administration at home. Gerresheimer, a German-based medical device engineering company, was responsible for designing, developing, and manufacturing the ONYU Infusor system. Ligand Pharmaceuticals supplied the Captisol® technology, a proprietary cyclodextrin platform that enhances aqueous solubility, bioavailability, and stability of furosemide at high concentration (30 mg/mL).

About Lasix ONYU and how it works

Lasix ONYU integrates a high-concentration formulation of furosemide (30 mg/mL) with an on-body Infusor that enables subcutaneous (under-the-skin) infusion at home.

The drug is delivered via the Lasix ONYU Infusor, a small, wearable, two-part device that attaches to the patient’s abdomen. The disposable unit holds an 80 mg (2.67 mL) furosemide glass cartridge and a 29-gauge needle, which inserts under the skin upon activation.

This biphasic slow delivery leads to steady therapeutic plasma concentrations of furosemide within 30 minutes that are maintained across the infusion period, avoiding the rapid peak and drop seen with IV bolus injections.

The reusable electromechanical unit controls the infusion pump, delivering the full dose over approximately five hours at a constant, controlled rate, mimicking a slow intravenous infusion but without the need for a catheter or hospital stay.

 This design eliminates the need for intravenous administration and offers portability and convenience for patients. Ligand’s Captisol® technology ensures solubility and stability of the furosemide formulation while reducing irritation at the infusion site.​

About the Indications

FDA approval covers Lasix ONYU for managing edema resulting from heart failure, liver cirrhosis, and renal disease. The drug aims to treat patients with fluid overload outside the hospital setting. Heart failure currently affects around 6.7 million Americans, a number expected to rise to 8.7 million by 2030, making accessible home-based diuretic therapies a priority for the healthcare system.​

Clinical Evidence

Clinical studies related to bioavailability and diuretic response conducted by SQ Innovation and University of Glasgow teams, demonstrated complete bioavailability (112%) compared with IV furosemide bolus administration, and equivalent diuresis (115%) and natriuresis (117%) levels. Lasix ONYU’s controlled, prolonged delivery mitigated the rapid, high-peak diuretic effect seen with IV bolus, providing a more balanced fluid removal response. These data confirmed non-inferiority at the same time offering improved tolerability and patient comfort.​

Safety Profile

The most common adverse effects included mild local site reactions such as erythema or pruritus. Systemic side effects paralleled those of conventional furosemide therapy, including electrolyte imbalance and dehydration risk. The subcutaneous administration route also reduced the frequency of hospitalization-related infections and adverse events linked to IV catheterization.​