FDA Approves First Liquid Losartan Formulation for Hypertension Treatment
核心洞察
Scienture Holdings (搜索) announced FDA approval of Arbli (搜索)™ (losartan potassium) Oral Suspension, the first and only ready-to-use liquid losartan formulation in the U.S. market for treating hypertension (搜索) in patients over 6 years old.
The novel formulation addresses significant unmet needs for patients requiring liquid medications, eliminating risks associated with crushing tablets and providing consistent dosing with an 18-month shelf life at room temperature.
Arbli (搜索)™ is indicated for hypertension (搜索) treatment, stroke (搜索) risk reduction in patients with left ventricular hypertrophy (搜索), and diabetic nephropathy (搜索) management, with commercial launch expected in Q3 2025.
The U.S. Food and Drug Administration (FDA) has approved Arbli (搜索)™ (losartan potassium) Oral Suspension, 10 mg/mL, the first ready-to-use liquid formulation of losartan in the United States. The approval was announced on March 18, 2025, by Scienture Holdings (搜索), Inc. (NASDAQ: SCNX), whose wholly owned subsidiary Scienture, LLC (搜索) developed the product.
Arbli (搜索)™ is indicated for the treatment of hypertension (搜索) in patients older than 6 years, for reducing stroke (搜索) risk in patients with hypertension and left ventricular hypertrophy (搜索), and for treating diabetic nephropathy (搜索) in certain patients with type 2 diabetes.
First Liquid Formulation Addresses Critical Unmet Need
Losartan, an angiotensin receptor blocker (ARB), is one of the most widely prescribed antihypertensive medications in the United States. Until now, losartan has only been available in tablet form, requiring healthcare providers to compound liquid formulations for patients unable to swallow pills.
"The approval of Arbli (搜索)™ exemplifies our deep commitment to develop high value products that address unique and underserved patient needs," said Shankar Hariharan, CEO of Scienture, LLC (搜索). "A significant number of patients can benefit from a safe and efficacious ready-to-use oral liquid formulation of losartan."
The novel formulation eliminates inconsistencies associated with extemporaneous compounding of crushed tablets, providing more reliable dosing and improved safety. The product comes as a peppermint-flavored suspension in 165 mL bottles with an 18-month shelf life at room temperature. The company expects this shelf life to be extended to 24 months once additional stability data is submitted to the FDA.
Market Impact and Commercial Launch
According to IQVIA data from December 2024, the U.S. market for losartan generates approximately $292 million in annual sales with 68 million prescriptions. Globally, the losartan potassium market was valued at approximately $1.5 billion in 2024.
Narasimhan Mani, President of Scienture, LLC (搜索), stated, "We are pleased to bring to market Arbli (搜索)™, a transformative therapy option containing losartan, one of the most widely prescribed molecules in its class. We expect to commercially launch and make Arbli™ available to patients in the U.S. in Q3 2025."
The product is protected by two issued patents from the U.S. Patent and Trademark Office, which are expected to be listed in the FDA Orange Book.
Hypertension: A Significant Public Health Challenge
Hypertension (搜索) affects nearly half of U.S. adults—approximately 119.9 million people—and is a major risk factor for stroke (搜索) and heart disease, leading causes of death in the United States. The condition is defined as systolic blood pressure of 140 mmHg or higher and/or diastolic blood pressure of 90 mmHg or higher.
Risk factors for hypertension (搜索) include older age, genetics, obesity, physical inactivity, high-salt diet, and excessive alcohol consumption. Clinical diagnosis requires elevated blood pressure readings on two separate days.
Safety Information and Administration
As with all medications that act on the renin-angiotensin system (搜索), Arbli (搜索)™ is contraindicated during pregnancy due to potential fetal harm. The product should not be co-administered with aliskiren in patients with diabetes or in those with renal impairment (GFR <60 mL/min). It is also not recommended for patients with severe hepatic impairment.
The most common adverse reactions reported in clinical trials (incidence ≥2% and greater than placebo) include dizziness, upper respiratory infection, nasal congestion, and back pain.
About Scienture Holdings
Scienture Holdings (搜索), Inc. operates through its subsidiaries Scienture, LLC (搜索) and Integra Pharma Solutions, LLC, focusing on developing and distributing novel specialty pharmaceutical products. The company aims to address unmet market needs across various therapeutic areas.
"This announcement is extremely exciting and is a clear demonstration of the value Scienture, LLC (搜索) brings to the combined company and its shareholders," said Suren Ajjarapu, Chairman of the Board, Scienture Holdings (搜索), Inc.