SCIENTURE announces the shipment of launch quantities of Arbli™ (losartan potassium Oral Suspension) to its 3PL/Distribution Center and receipt of first wholesaler order, marking major commercialization milestones.

Rhea-AI Summary

Scienture (NASDAQ:SCNX) has achieved a major commercialization milestone with the shipment of launch quantities of Arbli™ (losartan potassium Oral Suspension) to its distribution center and receipt of its first wholesaler order for August 2025.

Arbli™, the first and only FDA-approved ready-to-use oral liquid losartan in the U.S. market, 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 type 2 diabetes patients.

The product addresses a significant market opportunity, with U.S. losartan sales reaching $276 million annually and a global market of approximately $1.5 billion in 2024. Arbli™ is protected by two USPTO patents and offers advantages over traditional tablet formulations.

Positive

• First and only FDA-approved ready-to-use oral liquid losartan in the U.S. market
• Protected by two USPTO patents listed in FDA Orangebook
• Addresses large market opportunity with U.S. losartan sales of $276M and global market of $1.5B
• Provides safer alternative to crushed tablets and compounded formulations
• Offers reduced dosing volume and long-term shelf life at room temperature

Negative

• Entering a highly competitive market with established tablet formulations
• Will need to compete against lower-cost generic tablet versions of losartan

Insights

Pharmaceutical Industry Analyst

Scienture reaches critical commercialization milestone with Arbli™ - first FDA-approved liquid losartan entering $276M US market.

Scienture's announcement represents a significant commercial milestone as the company transitions from development to revenue generation with Arbli™, the first and only FDA-approved ready-to-use oral liquid losartan in the US market. This differentiated product addresses an unmet need in the sizable hypertension market, particularly for patients who have difficulty swallowing tablets or require precise dosing.

The product's market opportunity is substantial, with the press release citing $276 million in annual US losartan sales and 69 million prescriptions (IQVIA data from March 2025). The global market for losartan potassium reached approximately $1.5 billion in 2024. While Scienture will capture only a portion of this market, their novel formulation creates a defensible niche with two issued patents listed in the FDA Orangebook.

From a competitive standpoint, Arbli™ offers several advantages over compounded alternatives: consistent quality as an FDA-approved product, reduced dosing volume, and long-term shelf stability at room temperature. These features address legitimate safety concerns around extemporaneous compounding of crushed tablets.

The company has established distribution infrastructure with wholesaler agreements in place and received its first order for August 2025 shipment, indicating the commercial launch is imminent. This suggests Scienture has successfully navigated manufacturing, regulatory, and supply chain complexities to bring this product to market.

COMMACK, NY, Aug. 13, 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 shipment of launch quantities of Arbli^™ (losartan potassium) Oral Suspension, 10 mg/mL to its 3PL/Distribution Center for the intended commercial launch of the product. This shipment marks a major milestone accomplishment for Scienture, which has agreements in place for the distribution of the product through wholesalers and has received its first order for shipment in August 2025.

Arbli^™ 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. Arbli^™ is the first and only FDA approved ready-to-use oral liquid losartan in the U.S. market.

Arbli^™ 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. Arbli^™ 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. Arbli^™ has two issued patents from the USPTO, which are also 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. Arbli^™ 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 (March 2025) indicates a total annual sales of approximately $276 million and a prescription volume of 69 million (TRx) for losartan in the US market. The global market for losartan potassium was approximately $1.5 billion in sales in 2024.

“Shipping launch quantities of Arbli^™ to our 3PL/Distribution Center and receiving the first order of the product mark critical milestones in our journey to bring Arbli^™ to patients who need it the most.” said Narasimhan Mani, President and co-CEO, “We’re proud of the cross-functional effort that made this possible, from development through to manufacturing and logistics.”

“We’re proud to have completed this shipment in full alignment with GMP and GDP standards, poising the company for the next phase of product distribution,” remarked Shankar Hariharan, Executive Chairman and co-CEO. “This shipment puts us on track to meet our goal of delivering Arbli^™ to healthcare providers in the very near future.”

About Arbli^™

Arbli^™ 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

Arbli^™ 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 Arbli^™ when pregnant. When pregnancy is detected, discontinue Arbli^™ as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Arbli^TM 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 Arbli^™ with aliskiren in patients with diabetes. Avoid use of aliskiren with Arbli^™ in patients with renal impairment (GFR <60 mL/min).
  
• Do not administer Arbli^™ in patients with severe hepatic impairment. Arbli^™ 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 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.
20 Austin Blvd
Commack, NY 11725
Phone: (866) 468-6535
Email: IR@Scienture.com

FAQ

What is Arbli and when will it be available in the market?

Arbli is the first FDA-approved ready-to-use oral liquid losartan (10 mg/mL) for hypertension treatment. The product has been shipped to distribution centers with first orders received for August 2025 delivery.

What are the main advantages of Scienture's Arbli over existing losartan medications?

Arbli is the only FDA-approved liquid losartan that eliminates the need for tablet crushing or compounding, offers reduced dosing volume, and provides long-term shelf stability at room temperature.

What is the market size for losartan that Scienture's Arbli (NASDAQ:SCNX) is targeting?

The U.S. market for losartan has annual sales of $276 million with 69 million prescriptions, while the global market reached $1.5 billion in 2024.

What medical conditions can Arbli treat?

Arbli is approved 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.

How is Scienture's Arbli protected from competition?

Arbli is protected by two USPTO-issued patents that are listed in the FDA Orangebook, providing market exclusivity for its novel liquid formulation.