Scienture Holdings, Inc. announced U.S. Food and Drug Administration approval of its new drug application for SCN-102, to be marketed as ArbliTM (losartan potassium) Oral Suspension, 10 mg/mL. ArbliTM is indicated for hypertension in patients older than 6 years, stroke risk reduction in patients with hypertension and left ventricular hypertrophy, and diabetic nephropathy in select patients with type 2 diabetes. It is the first FDA-approved, ready-to-use oral liquid formulation of losartan in the U.S.
Losartan, an angiotensin II receptor blocker, is widely prescribed for hypertension. Existing formulations are limited to oral solids and require compounding for patients who need a liquid form. ArbliTM provides a standardized, FDA-approved alternative that ensures dosing accuracy and eliminates variability associated with extemporaneous compounding. The formulation is designed for ease of administration, with a reduced dosing volume and room temperature stability.
ArbliTM has two U.S. patents, and listing in the FDA Orange Book is expected.
Shankar Hariharan, CEO of Scienture, LLC, stated that ArbliTM aligns with the company’s objective of developing specialty pharmaceuticals that meet specific patient needs. Narasimhan Mani, President of Scienture, LLC, confirmed that commercial availability is expected in the third quarter of 2025.
ArbliTM is contraindicated in pregnancy due to risks of fetal harm associated with drugs that affect the renin-angiotensin system. It should not be coadministered with aliskiren in patients with diabetes or renal impairment and is not recommended for those with severe hepatic impairment. The most common adverse effects include dizziness, upper respiratory infection, nasal congestion, and back pain.
Hypertension affects nearly half of U.S. adults and is a major risk factor for cardiovascular disease. ArbliTM provides an FDA-approved liquid formulation of losartan that eliminates the need for extemporaneous compounding.
Reference:
Scienture Holdings, Inc. Scienture announces the U.S. FDA approval of its NDA for SCN-102, to be launched as ArbliTM (losartan potassium) Oral Suspension, 10 mg/mL. Globe Newswire. Published March 18, 2025. Accessed March 18, 2025. scienture.com/news/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/
