SCIENTURE announces the U.S. FDA Approval of its NDA for SCN-102, to be launched as ArbliTM, (losartan potassium) Oral Suspension, 10mg/mL. The global market for losartan potassium was approximately $1.5 billion in sales in 2024.
Scienture Holdings (NASDAQ: SCNX) has received FDA approval for ArbliTM (losartan potassium) Oral Suspension, 10 mg/mL, the first and only FDA-approved ready-to-use oral liquid losartan in the U.S. market. The product is indicated for treating hypertension in patients over 6 years old, reducing stroke risk in hypertensive patients with left ventricular hypertrophy, and treating diabetic nephropathy in certain type 2 diabetes patients.
ArbliTM features two USPTO-issued patents and addresses the need for a liquid formulation, eliminating risks associated with crushing tablets. The product offers reduced dosing volume and long-term shelf life at room temperature storage. According to IQVIA data (MAT December 2024), the U.S. losartan market represents approximately $292 million in annual sales with 68 million prescriptions. The company plans to launch ArbliTM in Q3 2025.
Scienture Holdings (NASDAQ: SCNX) ha ricevuto l'approvazione della FDA per ArbliTM (losartan potassico) sospensione orale, 10 mg/mL, il primo e unico losartan liquido pronto all'uso approvato dalla FDA nel mercato statunitense. Il prodotto è indicato per il trattamento dell'ipertensione in pazienti oltre i 6 anni, per ridurre il rischio di ictus nei pazienti ipertesi con ipertrofia ventricolare sinistra e per trattare la nefropatia diabetica in alcuni pazienti con diabete di tipo 2.
ArbliTM presenta due brevetti rilasciati dall'USPTO e risponde alla necessità di una formulazione liquida, eliminando i rischi associati alla triturazione delle compresse. Il prodotto offre un volume di dosaggio ridotto e una lunga durata di conservazione a temperatura ambiente. Secondo i dati di IQVIA (MAT dicembre 2024), il mercato statunitense del losartan rappresenta circa 292 milioni di dollari di vendite annuali con 68 milioni di prescrizioni. L'azienda prevede di lanciare ArbliTM nel terzo trimestre del 2025.
Scienture Holdings (NASDAQ: SCNX) ha recibido la aprobación de la FDA para ArbliTM (losartán potásico) suspensión oral, 10 mg/mL, el primer y único losartán líquido listo para usar aprobado por la FDA en el mercado de EE. UU. El producto está indicado para tratar la hipertensión en pacientes mayores de 6 años, reducir el riesgo de accidente cerebrovascular en pacientes hipertensos con hipertrofia ventricular izquierda y tratar la nefropatía diabética en ciertos pacientes con diabetes tipo 2.
ArbliTM cuenta con dos patentes emitidas por la USPTO y aborda la necesidad de una formulación líquida, eliminando los riesgos asociados con la trituración de tabletas. El producto ofrece un volumen de dosificación reducido y una larga vida útil a temperatura ambiente. Según los datos de IQVIA (MAT diciembre de 2024), el mercado de losartán en EE. UU. representa aproximadamente 292 millones de dólares en ventas anuales con 68 millones de recetas. La empresa planea lanzar ArbliTM en el tercer trimestre de 2025.
Scienture Holdings (NASDAQ: SCNX)는 ArbliTM (로사르탄 칼륨) 경구 현탁액 10 mg/mL에 대해 FDA 승인을 받았습니다. 이는 미국 시장에서 FDA 승인을 받은 유일한 즉시 사용 가능한 경구 액체 로사르탄입니다. 이 제품은 6세 이상의 환자에서 고혈압 치료, 좌심실 비대가 있는 고혈압 환자에서 뇌졸중 위험 감소, 특정 제2형 당뇨병 환자의 당뇨병성 신병증 치료에 적합합니다.
ArbliTM는 두 개의 USPTO 발급 특허를 보유하고 있으며, 정제를 분쇄하는 것과 관련된 위험을 없애고 액체 제형의 필요성을 해결합니다. 이 제품은 감소된 복용량과 실온에서의 긴 유통기한을 제공합니다. IQVIA 데이터에 따르면 (2024년 12월 기준), 미국의 로사르탄 시장은 연간 약 2억 9천 2백만 달러의 매출과 6천 8백만 개의 처방전을 나타냅니다. 회사는 2025년 3분기에 ArbliTM을 출시할 계획입니다.
Scienture Holdings (NASDAQ: SCNX) a reçu l'approbation de la FDA pour ArbliTM (losartan potassium) suspension orale, 10 mg/mL, le premier et unique losartan liquide prêt à l'emploi approuvé par la FDA sur le marché américain. Le produit est indiqué pour le traitement de l'hypertension chez les patients de plus de 6 ans, pour réduire le risque d'accident vasculaire cérébral chez les patients hypertendus avec hypertrophie ventriculaire gauche, et pour traiter la néphropathie diabétique chez certains patients atteints de diabète de type 2.
ArbliTM présente deux brevets délivrés par l'USPTO et répond au besoin d'une formulation liquide, éliminant les risques associés au broyage des comprimés. Le produit offre un volume de dosage réduit et une longue durée de conservation à température ambiante. Selon les données d'IQVIA (MAT décembre 2024), le marché américain du losartan représente environ 292 millions de dollars de ventes annuelles avec 68 millions d'ordonnances. L'entreprise prévoit de lancer ArbliTM au troisième trimestre de 2025.
Scienture Holdings (NASDAQ: SCNX) hat die FDA-Zulassung für ArbliTM (Losartan-Kalium) orale Suspension, 10 mg/mL, erhalten, das erste und einzige FDA-zugelassene gebrauchsfertige orale Flüssiglosartan auf dem US-Markt. Das Produkt ist zur Behandlung von Bluthochdruck bei Patienten über 6 Jahren angezeigt, zur Verringerung des Schlaganfallrisikos bei hypertensiven Patienten mit linksventrikulärer Hypertrophie und zur Behandlung der diabetischen Nephropathie bei bestimmten Typ-2-Diabetes-Patienten.
ArbliTM verfügt über zwei vom USPTO erteilte Patente und erfüllt den Bedarf an einer flüssigen Formulierung, die die Risiken des Zerkleinerns von Tabletten beseitigt. Das Produkt bietet ein reduziertes Dosierungsvolumen und eine lange Haltbarkeit bei Raumtemperatur. Laut IQVIA-Daten (MAT Dezember 2024) repräsentiert der US-Markt für Losartan einen jährlichen Umsatz von etwa 292 Millionen Dollar mit 68 Millionen Verschreibungen. Das Unternehmen plant, ArbliTM im dritten Quartal 2025 auf den Markt zu bringen.
- First and only FDA-approved ready-to-use liquid losartan in U.S. market
- Two USPTO-issued patents provide market exclusivity
- Targeting established market with $292M annual sales and 68M prescriptions
- Addresses unmet need for liquid formulation with reduced dosing volume
- Launch planned for Q3 2025 with clear commercialization timeline
- Will need to compete in established market with existing tablet formulations
- to specific patient population requiring liquid formulation
- Launch not immediate - several months delay until Q3 2025
Insights
The FDA approval of Arbli™ represents a transformative milestone for Scienture Holdings. With a modest market cap of just
This approval significantly derisks SCNX's business model in three key ways: it validates their development capabilities, establishes their first branded product revenue stream, and secures valuable IP protection through two issued patents. The patent protection creates a substantial competitive moat in this niche formulation space.
While the Q3 2025 launch timeline means revenue impact isn't immediate, this approval fundamentally changes the company's risk profile. The market opportunity is particularly compelling given the size disparity between the company's current valuation and the addressable market. Even capturing a small percentage of losartan prescriptions could generate significant revenue relative to SCNX's current scale.
The commercialization phase will be critical, requiring investment in sales infrastructure, medical education, and market access strategies to maximize adoption. The company's ability to execute this launch efficiently will determine how quickly this approval translates to meaningful revenue.
Arbli™ fills a significant clinical gap as the first and only FDA-approved ready-to-use oral liquid losartan in the U.S. market. This novel formulation addresses substantial unmet needs across multiple patient populations, including pediatric patients over 6 years, individuals with swallowing difficulties, and patients requiring precise dosing.
The current standard practice of crushing losartan tablets or compounding introduces several clinical risks: dosing inconsistencies, potential stability issues, and medication errors. Arbli™ eliminates these concerns while offering practical advantages including room temperature storage and reduced dosing volume.
The broad approval across multiple indications - hypertension, stroke risk reduction in patients with left ventricular hypertrophy, and diabetic nephropathy - maximizes the potential patient population. This comprehensive labeling provides treatment options for patients across various cardiovascular and renal conditions who require liquid medication.
The formulation innovations reflected in Arbli™ demonstrate Scienture's strategic approach to pharmaceutical development - identifying widely-used medications with formulation limitations and creating proprietary solutions that address specific clinical challenges. This approval validates their development model and sets the stage for their pipeline of specialty products targeting similar unmet needs.
TAMPA, FL, March 18, 2025 (GLOBE NEWSWIRE) -- – SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name ArbliTM (losartan potassium) Oral Suspension, 10 mg/mL. ArbliTM is meant for the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes. ArbliTM is the first and only FDA approved ready-to-use oral liquid losartan in the U.S. market.
ArbliTM is a novel proprietary formulation of losartan, a proven therapy for treating hypertension, which provides a tailored approach to patients that require or prefer an oral liquid option of losartan. Appropriate dosing is now easier, safe and effective, while providing the assurance of quality as an FDA-approved product. ArbliTM provides a safe and convenient option to patients requiring a liquid formulation and addresses the intrinsic risks associated with potential inconsistencies in the process of crushing tablets to extemporaneously compound losartan prescriptions. ArbliTM has two issued patents from the USPTO, which are also expected to be listed in the FDA Orangebook.
Losartan is classified as an angiotensin receptor blocker (ARB) for treating hypertension and is one of the highest prescribed molecules for this indication. Current products in the market containing losartan are available only as oral solids, which can be further compounded to a liquid formulation. ArbliTM is the first liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. IQVIA data (MAT December 2024) indicates a total annual sales of approximately
“The approval of ArbliTM exemplifies our deep commitment to develop high value products that address unique and underserved patient needs. A significant number of patients can benefit from a safe and efficacious ready-to-use oral liquid formulation of losartan. We are excited with the approval of our first brand product which is part of our upcoming pipeline of novel specialty products,” remarked Shankar Hariharan, CEO of Scienture, LLC.
“We are pleased to bring to market, ArbliTM, a transformative therapy option containing losartan, one of the most widely prescribed molecules in its class, to patients, caregivers and healthcare professionals (HCPs). We expect to commercially launch and make ArbliTM available to patients in the U.S. in Q3 2025,” said Narasimhan Mani, President of Scienture, LLC.
“This announcement is extremely exciting and is a clear demonstration of the value Scienture, LLC brings to the combined company and its shareholders,” said Suren Ajjarapu, Chairman of the Board, Scienture Holdings, Inc.
About ArbliTM
ArbliTM is the first and only oral liquid formulation of losartan approved by the U.S. FDA. Arbli™ comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration, and has been approved for a shelf life of 18 months from the date of manufacture when stored at room temperature, based on the data submitted in the NDA. Once the 24-months stability data is submitted to the FDA, the shelf-life of the product is expected to be extended to 24-months at room temperature.
INDICATION
ArbliTM is an angiotensin II receptor blocker (ARB) indicated for:
- Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.
- Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.
IMPORTANT SAFETY INFORMATION
- Do not take ArbliTM when pregnant. When pregnancy is detected, discontinue ArbliTM as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ArbliTM can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
- Do not co-administer ArbliTM with aliskiren in patients with diabetes. Avoid use of aliskiren with ArbliTM in patients with renal impairment (GFR <60 mL/min).
- Do not administer ArbliTM in patients with severe hepatic impairment. ArbliTM has not been studied in patients with severe hepatic impairment.
- The most common adverse reactions are (incidence ≥
2% and greater than placebo): dizziness, upper respiratory infection, nasal congestion, and back pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Scienture at 1-833-754-4917.
Please see the full Prescribing Information for complete product information. For more information, talk to your healthcare provider.
About Hypertension
Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg.
About Scienture Holdings, Inc.
SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), through its wholly owned subsidiaries, Scienture, LLC and Integra Pharma Solutions, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Integra Pharma Solutions, LLC, is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug products to healthcare markets including government organizations, hospitals, clinics and independent pharmacies nationwide. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit www.scienture.com.
Cautionary Statements Regarding Forward-Looking Statements
This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch and the success those products may have in the marketplace. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.
Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.
Contact:
SCIENTURE HOLDINGS, INC.
6308 Benjamin Rd, Suite 708
Tampa, Florida 33634
Phone: (866) 468-6535
Email: IR@Scienture.com
FAQ
What is the market size for losartan potassium that Scienture's ArbliTM (SCNX) is targeting?
When will Scienture (SCNX) launch ArbliTM in the U.S. market?
What unique features does Scienture's ArbliTM (SCNX) offer compared to existing losartan products?
What patents does Scienture's ArbliTM (SCNX) have for protection?
What medical conditions can Scienture's ArbliTM (SCNX) treat?
