The United States Food and Drug Administration (USFDA) has approved Lasix® ONYU (furosemide injection) for the treatment of edema in adults with chronic heart failure. This drug was developed by Ligand Pharmaceuticals’ partner, SQ Innovation Inc., as a novel drug-device combination that allows subcutaneous self-administration at home under clinician guidance without requiring a healthcare professional’s drug administration.
Edema resulting from fluid overload was frequently observed in heart failure patients. These patients were required to be hospitalized for intravenous (IV) diuretic therapy, especially furosemide. This newly approved product provides diuretic efficacy comparable to IV therapy but can be administered at home, offering greater convenience for patients and reducing hospital-related costs.
Currently, approximately 6.7 million U.S. people are living with heart failure, a number projected to reach 8.7 million by 2030. This condition remains a major cause of hospitalization among adults aged ≥65 years, accounting for about 1.2 million hospitalizations annually. Lasix® ONYU may help manage these patients more effectively in home settings.
Lasix® ONYU offers a new, highly concentrated formulation of furosemide delivered through an advanced small infusor, designed for convenient and safe home treatment. This innovative system includes a sterile, single, disposable unit and a reusable unit that is suitable for up to 48 treatments. Captisol®, a ligand technology, enhances the stability, solubility, and bioavailability of furosemide at a high concentration of 80mg/2.67mL (30mg/mL).
Currently, 17 FDA-approved products (Kyprolis®, Veklury®, Nexterone®, Noxafil®, Evomela®, etc.) were utilized for highlighting their effectiveness in improving drug performance. This Captisol® supports multiple administration routes such as oral, intramuscular, subcutaneous, and IV.
Dr. Pieter Muntendam, MD, founder and CEO of SQ Innovation Inc., said, “In developing Lasix® ONYU, we evaluated multiple solubility enhancers and found Captosol® to be the only one capable of enabling a stable, pH-neutral, room temperature formulation at a concentration of 30 mg/mL. This Captisol® team provided vital formulation, regulatory, and safety support.”
Todd Davis, CEO of Ligand Pharmaceuticals, added, “Lasix® ONYU offers a breakthrough option for millions of patients with heart failure who currently require hospital-based IV diuretic therapy. Our collaboration with SQ Innovation highlights Captisol®’s crucial role in enhancing bioavailability, solubility, and stability, empowering the development of safer and more effective therapies that improve patient care and treatment.”
In 2019, Ligand Pharmaceuticals signed an exclusive global Captisol® license agreement with SQ Innovation for the development of high-concentration furosemide (Lasix® ONYU). Under the agreement, Ligand Pharmaceuticals will supply Captisol® and receive royalties, earn milestone payments, and receive material sales revenue. SQ Innovation plans to launch Lasix® ONYU in late 2025.
Reference: Ligand Pharmaceuticals. Ligand Partner SQ Innovation Receives FDA Approval for Lasix® ONYU, an At-Home Treatment for Edema in Heart Failure Patients. Published October 9, 2025. Accessed October 14, 2025. Ligand Pharmaceuticals Incorporated – Ligand Partner SQ Innovation Receives FDA Approval for Lasix® ONYU, an At-Home Treatment for Edema in Heart Failure Patients
