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SCIENTURE’S Arbli™ Becomes First FDA-Approved Ready-to-Use Liquid Losartan Available Through Major U.S. Wholesalers

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Scienture Holdings (NASDAQ: SCNX) announced that Arbli™ (losartan potassium) Oral Suspension, 10mg/mL is commercially available through full-line wholesalers nationwide as of Oct 16, 2025.

Arbli is described as the first FDA-approved ready-to-use liquid losartan, targeting patients unable to swallow tablets (including elderly and children six and older). The U.S. losartan market is noted at $256M annually with 71M prescriptions, positioning Arbli as a new entrant into the broader hypertension market and a replacement for inconsistent compounded liquids.

Scienture Holdings (NASDAQ: SCNX) ha annunciato che Arbli™ (losartan potassico) Suspension orale, 10mg/mL è disponibile commercialmente tramite grossisti di tutta la rete nazionale a partire dal 16 ottobre 2025.

Arbli è descritto come il primo losartan liquido pronto all'uso approvato dalla FDA, rivolto a pazienti incapaci di deglutire le compresse (inclusi anziani e bambini di sei anni e oltre). Si segnala che il mercato statunitense del losartan è di $256M all'anno con 71M prescrizioni, posizionando Arbli come un nuovo entrante nel mercato più ampio dell'ipertensione e come sostituto per liquidi composti incoerenti.

Scienture Holdings (NASDAQ: SCNX) anunció que Arbli™ (losartán potásico) Suspensión oral, 10 mg/mL está disponible comercialmente a través de mayoristas de toda la red nacional a partir del 16 de octubre de 2025.

Arbli se describe como el primer losartán líquido listo para usar aprobado por la FDA, dirigido a pacientes que no pueden tragar tabletas (incluidos ancianos y niños de seis años en adelante). Se señala que el mercado estadounidense de losartán es de $256 millones anuales con 71 millones de recetas, posicionando a Arbli como un nuevo participante en el mercado más amplio de la hipertensión y como sustituto de líquidos compuestos inconsistentes.

Scienture Holdings (NASDAQ: SCNX)Arbli™ (로르탄칼륨) 구강 현탁액, 10mg/mL가 2025년 10월 16일부로 전국의 풀라인 도매상들을 통해 상용화 가능하다고 발표했습니다.

Arbli는 FDA 승인된 최초의 사용하기 쉬운 로르탄 액체 제제로 설명되며, 삼키기 어려운 환자들(노인 및 6세 이상 아동 포함)을 대상으로 합니다. 미국 로르탄 시장은 연간 약 $256M, 처방전 7100만 건으로 기록되어 Arbli를 고혈압 시장의 새로운 진입자로 위치시키고, 불일치된 혼합 액체를 대체하는 제품으로서의 역할을 가집니다.

Scienture Holdings (NASDAQ: SCNX) a annoncé que Arbli™ (losartan potassique) Suspension buvable, 10 mg/mL est disponible commercialement via les grossistes de toute la chaîne nationale à partir du 16 octobre 2025.

Arbli est décrit comme le premier losartan liquide prêt à l'emploi approuvé par la FDA, destiné aux patients incapables d'avaler des comprimés (y compris les personnes âgées et les enfants de six ans et plus). Le marché américain du losartan est noté à 256 millions de dollars annuels avec 71 millions d'ordonnances, positionnant Arbli comme un nouvel entrant sur le marché plus vaste de l'hypertension et comme un remplacement pour les liquides constitués incohérents.

Scienture Holdings (NASDAQ: SCNX) hat angekündigt, dass Arbli™ (Losartan-Kalium) Oralsuspension, 10 mg/mL ab dem 16. Oktober 2025 über Volllinien-Großhändler landesweit kommerziell erhältlich ist.

Arbli wird als erstes von der FDA zugelassenes fertiges flüssiges Losartan beschrieben und richtet sich an Patienten, die Tabletten nicht schlucken können (einschließlich älterer Menschen und Kinder ab sechs Jahren). Der US-amerikanische Losartan-Markt wird mit 256 Mio. USD jährlich bei 71 Mio. Verschreibungen angegeben, was Arbli als Neuzugang im breiteren Bluthochdruckmarkt positioniert und als Ersatz für inkonsistente gemischte Flüssigkeiten dient.

Scienture Holdings (NASDAQ: SCNX) أعلنت أن Arbli™ (بوتاسيوم لوسارتان) تعليق فموي، 10mg/mL متاح تجارياً عبر تجار جملة معتمدين في جميع أرجاء البلاد اعتباراً من 16 أكتوبر 2025.

يُوصف Arbli بأنه أول لوسارتان سائل جاهز للاستخدام ومعتمد من FDA، مخصص للمرضى غير القادرين على بلع الأقراص (بما في ذلك كبار السن والأطفال من عمر ست سنوات فما فوق). يذكر أن سوق لوسارتان في الولايات المتحدة يبلغ 256 مليون دولار سنوياً مع 71 مليون وصفة، مما يجعل Arbli لاعباً جديداً في السوق الأوسع لارتفاع ضغط الدم وبديل للمحاليل المركبة غير المتسقة.

Scienture Holdings (NASDAQ: SCNX) 宣布,Arbli™ (洛沙坦钾) 口服悬浮液,10 mg/mL 已于2025年10月16日起通过全国范围的全线批发商上市销售。

Arbli 被描述为 首个经 FDA 批准的现成可用洛沙坦口服液,面向无法吞咽药片的患者(包括老年人及六岁及以上儿童)。美国洛沙坦市场的规模为 2.56亿美元/年,71百万处方,使 Arbli 成为更广泛的高血压市场中的新进入者,以及对不稳定混合液体的替代品。

Positive
  • First FDA-approved ready-to-use liquid losartan
  • Commercial availability through full-line wholesalers nationwide
  • Addresses dysphagia patients, including children as young as six
  • U.S. losartan market: $256M annually across 71M prescriptions
Negative
  • None.

Insights

FDA approval and national wholesale distribution of a ready-to-use losartan liquid materially expands access for patients unable to swallow tablets.

Arbli™ now being FDA-approved and available through full-line wholesalers converts a regulatory milestone into immediate commercial reach. The product targets patients with dysphagia, including elderly patients and children aged six and up, and addresses a market where all existing losartan offerings are oral solids. The release cites a U.S. losartan market of $256 million in annual sales and 71 million prescriptions (MAT June 2025), framing a meaningful addressable opportunity.

The business mechanism is straightforward: an FDA-cleared ready-to-use oral suspension reduces reliance on variable compounded formulations and fits existing pharmacy supply chains via major wholesalers. This should lower logistic friction for providers and caregivers and could improve adherence for the specific patient segment. Risks and dependencies include actual uptake by pharmacies and prescribers, reimbursement and formulary placement relative to existing oral solids, and the pace at which prescribers switch from compounded products; these factors will determine revenue conversion from the cited market size.

Near-term items to watch are wholesale stocking and initial order volumes, any payer coverage statements or formulary listings, and early real-world reports on substitution from compounded products over the next 6–12 months. The announcement supports a positive near-term commercial signal, contingent on distribution and payer execution.

Novel oral suspension addresses critical patient safety needs for hypertension treatment for patients unable to swallow tablets

U.S. losartan market totals $256M annually with 71M prescriptions, creating a significant opportunity for Arbli as the first FDA-approved ready-to-use oral suspension

COMMACK, NY, Oct. 16, 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 the development, commercialization, and distribution of novel specialty products that address unmet market needs, today announced that Arbli (losartan potassium) Oral Suspension, 10mg/mL, is commercially available through full-line wholesalers nationwide. This milestone establishes Arbli™ (www.arbli.com) as the first and only FDA-approved ready-to-use liquid losartan formulation accessible through established pharmaceutical distribution channels across the United States. Losartan, an angiotensin II receptor blocker (ARB), is widely prescribed for the treatment of high blood pressure.

According to IQVIA data (MAT June 2025), the U.S. losartan market totals approximately $256 million in annual sales across 71 million prescriptions (TRx), with all currently marketed products available only in oral solid form. The launch of Arbli through wholesale channels marks a significant advancement for underserved patients with dysphagia, including elderly patients and children as young as six, who have long relied on inconsistent compounded formulations, while also representing a strategic expansion into the broader hypertension market. As the first FDA-approved ready-to-use liquid losartan, Arbli eliminates compounding risks and offers a flexible, convenient option that supports better treatment adherence.

“The commercial launch of Arbli marks an important step forward for Scienture as we begin converting regulatory milestones into tangible market results,” said Narasimhan Mani, Ph.D., MBA, President and co-CEO of Scienture Holdings, Inc. “As the first and only FDA-approved ready-to-use liquid losartan, Arbli opens access to a meaningful new patient segment while expanding our reach across the broader hypertension market. We see this launch not only as a driver of near-term revenue growth, but also as a validation of our strategy to bring innovative, patient-focused formulations to multiple therapeutic categories.”

“This represents a paradigm shift in how we approach hypertension treatment for vulnerable patient populations,” said Shankar Hariharan, Ph.D., Executive Chairman and co-CEO of Scienture Holdings, Inc. “By making Arbli available through major wholesalers, we're ensuring that pharmacies and healthcare providers can immediately access this breakthrough therapy within their existing supply chains.”

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 24 months from the date of manufacture when stored 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 subsidiary, Scienture, 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. 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.scientureholdings.com and 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, the success those products may have in the marketplace, and our strategies related to those products. 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.
20 Austin Blvd
Commack, NY 11725
Phone: (866) 468-6535
Email: IR@Scienture.com


FAQ

What did Scienture announce about Arbli (SCNX) on Oct 16, 2025?

Arbli oral suspension became commercially available through full-line U.S. wholesalers as the first FDA-approved ready-to-use liquid losartan.

How large is the U.S. losartan market cited for Arbli (SCNX)?

The release cites approximately $256M in annual sales across 71M prescriptions (MAT June 2025 IQVIA data).

Which patients does Arbli oral suspension target according to Scienture (SCNX)?

Arbli targets patients unable to swallow tablets, including elderly individuals with dysphagia and children aged six and older.

Why is Arbli considered significant for pharmacies and providers (SCNX)?

As the first FDA-approved ready-to-use liquid losartan, Arbli aims to eliminate compounding risks and be accessible via existing supply chains.

Will Arbli be available through major distributors for SCNX investors to track?

Yes; Scienture stated Arbli is commercially available through full-line wholesalers nationwide.

What near-term business impact did Scienture (SCNX) expect from the Arbli launch?

Management described the launch as a driver of near-term revenue growth and validation of the company's patient-focused formulation strategy.
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