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Ligand Partner SQ Innovation Receives FDA Approval for Lasix® ONYU, an At-Home Treatment for Edema in Heart Failure Patients
Second-generation delivery device offers cost-effective alternative to hospital care benefiting patients, providers, and payors Lasix ONYU is the 17th
About this update from Ligand Pharmaceuticals Incorporated
[{"type":"text","content":"Second-generation delivery device offers cost-effective alternative to hospital care benefiting patients, providers, and payors Lasix ONYU is the 17th Captisol-enabled™ approved product JUPITER, Fla., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that its partner SQ Innovation Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Lasix® ONYU (furosemide injection), a novel drug-device combination for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure. Lasix ONYU can be administered subcutaneously outside the healthcare setting for selected patients, as prescribed by a clinician, without the need for a healthcare professional to administer the drug. Lasix ONYU provides a novel high-concentration formulation of furosemide combined with a state-of-the-art small Infusor for treatment at home. The innovative design features a reusable unit that can be used for 48 treatments and a plastic sterile single-use unit that is discarded after treatment. Captisol®, a Ligand technology, is a key part of the Lasix ONYU novel, high- concentration formulation of furosemide 80mg/2.67mL (30mg/mL). There are now seventeen approved products formulated with Captisol demonstrating its ability to optimize the solubility, stability, and bioavailability of medicines. Captisol can be used across multiple routes of administration including intravenous, intramuscular, oral, and subcutaneous. “Lasix ONYU has the potential to benefit millions of heart failure patients who would otherwise receive treatment with IV diuretics in the hospital,” said Todd Davis, CEO of Ligand. “Our partnership with SQ Innovation further demonstrates the powerful role Captisol plays in the development and delivery of new medicines. By optimizing drug solubility, stability, and bioavailability, we are paving the way for companies to develop safer and more effective therapies that can change patient lives for the better.” Episodes of edema due to fluid overload are common in patients with heart failure. This condition commonly leads to hospitalization, where patients are treated with IV diuretics, most commonly furosemide. Lasix ONYU offers similar diuresis when compared to IV treatment but can now be used outside of a healthcare setting. About 6.7 million American...