Ligand Partner SQ Innovation Receives FDA Approval for Lasix® ONYU, an At-Home Treatment for Edema in Heart Failure Patients
Ligand (Nasdaq: LGND) said partner SQ Innovation received FDA approval on October 9, 2025 for Lasix ONYU (furosemide injection), a drug‑device combo enabling subcutaneous, at‑home treatment of edema in adults with chronic heart failure.
Lasix ONYU is a high‑concentration furosemide formulation (80mg/2.67mL; 30mg/mL) using Captisol and pairs with a reusable Infusor (48 treatments) plus a sterile single‑use cartridge. Captisol is cited as a key enabler and this is the 17th Captisol‑enabled product. Ligand holds exclusive Captisol license/supply terms with SQ Innovation signed in 2019 and will receive milestone payments, a low‑single‑digit royalty, and material sales revenue. SQ Innovation expects product availability in Q4 2025.
Ligand (Nasdaq: LGND) ha dichiarato che la partner SQ Innovation ha ricevuto l'approvazione FDA il 9 ottobre 2025 per Lasix ONYU (iniezione di furosemide), una combinazione farmaco-dispositivo che consente il trattamento a domicilio, per via sottocutanea, dell'edema in adulti con insufficienza cardiaca cronica.
Lasix ONYU è una formulazione ad alta concentrazione di furosemide (80 mg/2,67 mL; 30 mg/mL) che utilizza Captisol e si integra con un Infusor riutilizzabile (48 trattamenti) più una cartuccia sterile usa e getta. Captisol è indicato come abilitante chiave ed è il 17° prodotto abilitato Captisol. Ligand detiene accordi esclusivi di licenza/supply di Captisol con SQ Innovation firmati nel 2019 e riceverà pagamenti legati a milestone, una royalty a una cifra bassa e un notevole fatturato da vendite. SQ Innovation prevede la disponibilità del prodotto nel Q4 2025.
Ligand (Nasdaq: LGND) dijo que su socia SQ Innovation recibió la aprobación de la FDA el 9 de octubre de 2025 para Lasix ONYU (inyección de furosemida), una combinación fármaco-dispositivo que permite el tratamiento en casa por vía subcutánea de edema en adultos con insuficiencia cardíaca crónica.
Lasix ONYU es una formulación de furosemida de alta concentración (80 mg/2,67 mL; 30 mg/mL) que utiliza Captisol y se acopla con un Infusor reutilizable (48 tratamientos) más un cartucho estéril de un solo uso. Captisol se cita como habilitador clave y este es el 17.º producto habilitado por Captisol. Ligand mantiene acuerdos exclusivos de licencia/suministro de Captisol con SQ Innovation firmados en 2019 y recibirá pagos por hitos, una regalía de un dígito bajo y ingresos de ventas relevantes. SQ Innovation espera la disponibilidad del producto en el Cuarto Trimestre de 2025.
Ligand (Nasdaq: LGND)은 파트너 SQ Innovation이 2025년 10월 9일 FDA 승인을 받았다고 발표했습니다. 이는 성인 만성 심부전 환자의 부종에 대해 피하 주사로 가정에서 치료가 가능하도록 하는 약물-장치 조합인 Lasix ONYU(푸로세미드 주사제)입니다.
Lasix ONYU는 고농축 푸로세마이드 제형(80 mg/2.67 mL; 30 mg/mL)을 사용하며 Captisol를 활용하고 재사용 가능한 Infusor(48회 치료)와 멸균 일회용 카트리지를 결합합니다. Captisol은 핵심 엔abler로 인용되며 이번이 17번째 Captisol-enabled 제품입니다. Ligand는 SQ Innovation과 2019년에 독점 Captisol 면허/공급 조건을 체결했고, 이로써 이정의 마일스톤 지급, 낮은 십자릿 로열티, 상당한 매출 수익을 받을 예정입니다. SQ Innovation은 2025년 4분기에 제품 가용을 기대합니다.
Ligand (Nasdaq: LGND) a déclaré que son partenaire SQ Innovation a reçu l'approbation FDA le 9 octobre 2025 pour Lasix ONYU (injection de furosemide), une association médicament-dispositif permettant un traitement sous-cutané à domicile de l'œdème chez les adultes souffrant d'insuffisance cardiaque chronique.
Lasix ONYU est une formulation de furosemide à haute concentration (80 mg/2,67 mL ; 30 mg/mL) utilisant Captisol et s'accompagne d'un Infusor réutilisable (48 traitements) plus une cartouche stérile à usage unique. Captisol est cité comme un élément clé et ceci est le 17e produit activé par Captisol. Ligand détient des accords exclusifs de licence/approvisionnement Captisol avec SQ Innovation signés en 2019 et recevra des paiements d'étape, une redevance à faible chiffre et des revenus importants issus des ventes. SQ Innovation prévoit la disponibilité du produit au Q4 2025.
Ligand (Nasdaq: LGND) sagte, dass der Partner SQ Innovation die FDA-Zulassung am 9. Oktober 2025 für Lasix ONYU (Furosemid-Injektion), eine Medikamenten-Device-Kombination, erhalten hat, die eine subkutane Behandlung von Ödemen bei Erwachsenen mit chronischer Herzinsuffizienz zu Hause ermöglicht.
Lasix ONYU ist eine hochkonzentrierte Furosemid-Formulierung (80 mg/2,67 mL; 30 mg/mL), verwendet Captisol und wird mit einem wiederverwendbaren Infusor (48 Behandlungen) sowie einer sterilen Einweg-Patrone kombiniert. Captisol wird als Schlüsselfaktor genannt und dies ist das 17. Captisol-fähige Produkt. Ligand hält exklusive Captisol-Lizenz-/Lieferbedingungen mit SQ Innovation, die 2019 unterzeichnet wurden; es wird Meilensteinzahlungen, eine niedrige Einstellen-Royalty und nennenswerte Verkaufsumsätze geben. SQ Innovation rechnet mit der Verfügbarkeit des Produkts im Q4 2025.
Ligand (بورصة ناسداك: LGND) قال شريكته SQ Innovation إن اعتماد FDA في 9 أكتوبر 2025 لـ Lasix ONYU (حقنة فورو semide)، وهو مزيج دواء-جهاز يتيح العلاج تحت الجلد في المنزل للوذمة لدى البالغين المصابين بفشل قلب مزمن.
Lasix ONYU هو صيغة ف grotes مفرطة التركيز من فوروسيمايد (80 mg/2.67 mL؛ 30 mg/mL) تستخدم Captisol وتزدان مع Infusor قابل لإعادة الاستخدام (48 علاجًا) بالإضافة إلى خرطوشة معقمة للاستخدام الواحد. Captisol مذكور كممكن رئيسي وهذا هو أول منتج Captisol-enabled رقم 17. تمتلك Ligand شروط ترخيص/إمداد حصرية لـ Captisol مع SQ Innovation مُوقَّعة في 2019 وسوف تتلقى دفعات لتحقيق أهداف، وروايالتي بقيمة منخفضة نسبياً، وإيرادات بيع كبيرة. تتوقع SQ Innovation توفر المنتج في الربع الرابع من 2025.
Ligand (纳斯达克：LGND) 表示合作伙伴 SQ Innovation 已在 2025 年 10 月 9 日 获得 FDA 批准，用于 Lasix ONYU（呋喹酮注射液），这是一种药物-装置组合，使成年慢性心力衰竭患者的水肿能够在家中皮下治疗。
Lasix ONYU 是高浓度的呋喹酮制剂（80 mg/2.67 mL；30 mg/mL），使用 Captisol，并配有一个可重复使用的 Infusor（48 次治疗）以及一个无菌一次性芯柱。Captisol 被视为关键促成因素，这也是第 17 个 Captisol 启用的产品。Ligand 拥有与 SQ Innovation 签署的 Captisol 独家许可/供应条款，时间在 2019 年，将获得里程碑支付、低位数的特许权使用费以及可观的销售收入。SQ Innovation 预计产品将在 2025 年第 4 季上市。
- FDA approval granted on October 9, 2025
- Enables at‑home subcutaneous treatment for edema
- High‑concentration furosemide at 30mg/mL (80mg/2.67mL)
- Reusable Infusor supports 48 treatments
- 17th product formulated with Captisol
- Commercial availability expected in Q4 2025
- None.
Insights
FDA approval for a home-administered Lasix device expands outpatient care and creates recurring Captisol revenue streams for Ligand.
The approval of Lasix ONYU permits subcutaneous, at‑home administration of furosemide, shifting care from inpatient IV diuresis to outpatient use and enabling a reusable infusion device plus disposable cartridges. The business link is clear: Ligand will supply Captisol under exclusive license arrangements and receive milestone payments, material sales and a low‑single‑digit royalty, creating product‑linked, manufacturing‑scale revenue exposure.
Key dependencies and risks include patient selection and clinician adoption for home use, payer coverage for device plus drug, and timely commercial launch; SQ Innovation targets availability in
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 Americans suffer from heart failure, with the prevalence expected to rise to 8.7 million by 2030. Heart failure is a leading cause of hospitalizations for individuals aged 65 and older with approximately 1.2 million hospitalizations a year.1
“In our formulation research we considered all solubility enhancers widely accepted in pharmaceutical products for human use and discovered Captisol was the only one that allowed us to achieve a room temperature stable pH-neutral product at 30mg/mL,” said Pieter Muntendam, MD, founder, president, and CEO of SQ Innovation. “The Captisol laboratories helped us optimize the composition of Lasix ONYU and provided extensive preclinical safety and regulatory expertise. They were a trusted partner every step of the way.”
Ligand entered into exclusive worldwide Captisol license and supply agreements with SQ Innovation for high-concentration furosemide formulation in 2019. Under the terms of the agreements, Ligand will supply SQ Innovation Captisol for the pharmaceutical formulation of Lasix ONYU and is entitled to milestone payments, a low-single-digit royalty, and revenue from material sales.
SQ Innovation expects Lasix ONYU to be available in the fourth quarter of 2025. For important safety information and full prescribing information go to www.lasix-onyu.com.
About Captisol®
Captisol, a Ligand technology, is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility, stability, and bioavailability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas' Higuchi Biosciences Center, for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, Amgen's Kyprolis®, Baxter's Nexterone®, Acrotech Biopharma's Evomela®, Gilead’s Veklury®, and Merck's Noxafil®. More information is available at www.captisol.com.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Our business model seeks to generate value for stockholders by creating a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Our business model is based on funding programs in mid- to late-stage drug development in return for economic rights, purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing our technology to help partners discover and develop medicines. We partner with other pharmaceutical companies to attempt to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate our revenue. We operate two infrastructure-light royalty generating technology IP platform technologies. Our Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Our NITRICIL™ platform technology facilitates tunable dosing, permitting an adjustable drug release profile to allow proprietary formulations that target a broad range of indications. We have established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Gilead Sciences and Baxter International. For more information, please visit www.ligand.com. Follow Ligand on X and LinkedIn.
We use our investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts.
Forward-Looking Statements
This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include: the timing of commercial launch of Lasix ONYU; the potential that Lasix ONYU can benefit patients who would otherwise be treated with IV diuretics in the hospital; and the potential market size of patients who can be treated with Lasix ONYU. Actual events or results may differ from Ligand’s or its partner’s expectations due to risks and uncertainties inherent in Ligand’s and its partner’s business, including, without limitation: SQ Innovation may not be able to successfully commercialize Lasix ONYU which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; the market size for Lasix ONYU may be smaller than estimated; Ligand is dependent on SQ Innovation for the commercialization of Lasix ONYU; and other risks described in Ligand’s prior press releases and filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts
Investors:
Melanie Herman
investors@ligand.com
(858) 550-7761
Media:
Kellie Walsh
media@ligand.com
(914) 315-6072
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1 HF STATS 2025: Heart Failure Epidemiology and Outcomes Statistics An Updated 2025 Report from the Heart Failure Society of America. J Card Fail. 2025 Aug 29:S1071-9164(25)00326-4. doi: 10.1016/j.cardfail.2025.07.007. Epub ahead of print. PMID: 40987671.
FAQ
What did Ligand and SQ Innovation announce about Lasix ONYU on October 9, 2025?
How is Lasix ONYU administered and what dose does Nasdaq: LGND note?
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What role does Captisol play in Lasix ONYU and Ligand's business (LGND)?
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Does Lasix ONYU require a healthcare professional for administration?
