Scienture's Arbli Becomes First FDA-Approved Ready-to-Use Liquid Losartan, Securing Major Market Access
核心洞察
Scienture Holdings (搜索) launched Arbli (搜索)™, the first and only FDA-approved ready-to-use liquid losartan formulation, now commercially available through major U.S. wholesalers nationwide.
The company secured a major PBM-led GPO rebate agreement providing formulary access with health plans covering more than 100 million lives in the $256 million U.S. losartan market.
Arbli (搜索)™ addresses critical unmet needs for patients with dysphagia (搜索), including elderly patients and children as young as six, who previously relied on inconsistent compounded formulations.
Scienture Holdings (搜索) has achieved a significant milestone in hypertension (搜索) treatment with the commercial launch of Arbli (搜索)™ (losartan potassium) Oral Suspension, establishing it as the first FDA-approved ready-to-use liquid losartan formulation available through major U.S. pharmaceutical distribution channels. The company has also secured a major Pharmacy Benefit Manager (PBM)-led Group Purchasing Organization (GPO) rebate agreement, positioning the product for broad market access.
Market Opportunity and Commercial Launch
According to IQVIA data from June 2025, the U.S. losartan market represents approximately $256 million in annual sales across 71 million prescriptions, with all currently marketed products available only in oral solid form. Arbli (搜索)™'s launch through wholesale channels marks the first liquid alternative in this substantial market, addressing a critical gap for patients unable to swallow tablets.
"The commercial launch of Arbli (搜索)™ marks an important step forward for Scienture (搜索) as we begin converting regulatory milestones into tangible market results," said Narasimhan Mani, Ph.D., MBA, President and co-CEO of Scienture Holdings (搜索). "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 (搜索) market."
Addressing Unmet Medical Needs
The liquid formulation specifically targets underserved patients with dysphagia (搜索), including elderly patients and children as young as six years old, who have historically relied on inconsistent compounded formulations. As an FDA-approved product, Arbli (搜索)™ eliminates compounding risks while ensuring consistent quality and dosing accuracy.
"This represents a paradigm shift in how we approach hypertension (搜索) treatment for vulnerable patient populations," said Shankar Hariharan, Ph.D., Executive Chairman and co-CEO of Scienture Holdings (搜索). "By making Arbli (搜索)™ available through major wholesalers, we're ensuring that pharmacies and healthcare providers can immediately access this breakthrough therapy within their existing supply chains."
Product Specifications and Market Access
Arbli (搜索)™ comes as a peppermint-flavored suspension in a 165 mL bottle that does not require refrigeration and maintains a 24-month shelf life when stored at room temperature. The formulation offers reduced dosing volume compared to traditional compounded alternatives and has received two issued patents from the USPTO, which are listed in the FDA Orange Book.
The company's recent PBM-led GPO rebate agreement advances formulary access with health plans covering more than 100 million lives, with additional discussions underway to expand both commercial and government coverage. "This is an important milestone that reflects our commitment to ensuring that patients who need Arbli (搜索)™ can access it affordably," said Mani. "By signing the rebate agreement, we are in the process of securing formulary access with health plans covering more than 100 million lives and positioning Arbli™ for rapid adoption in the $256 million U.S. losartan market."
Clinical Indications and Safety Profile
Arbli (搜索)™ is indicated for treatment of hypertension (搜索) to lower blood pressure in adults and children greater than 6 years old, reduction of stroke risk in patients with hypertension and left ventricular hypertrophy (搜索), and treatment of diabetic nephropathy (搜索) with elevated serum creatinine and proteinuria in patients with type 2 diabetes (搜索) and hypertension history.
The most common adverse reactions include dizziness, upper respiratory infection, nasal congestion, and back pain, with incidence ≥2% and greater than placebo. The product carries important contraindications including pregnancy, co-administration with aliskiren in diabetic patients, and use in patients with severe hepatic impairment.
Disease Burden Context
According to CDC data referenced in the company materials, hypertension (搜索) affects nearly half of adults in the United States, representing 119.9 million people. Hypertension is defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, serving as a major risk factor for stroke and heart disease, which are leading causes of death in the U.S.