SCIENTURE Secures FDA Approval for Arbli, a Losartan Oral Suspension

March 18, 2025

DENVER, Colo., Mar 18, 2025 (247marketnews.com)- SCIENTURE Holdings (NASDAQ:SCNX) announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for SCN-102, to be marketed as Arbli (losartan potassium) Oral Suspension, 10 mg/mL. Developed by its wholly owned subsidiary, Scienture, LLC, Arbli marks a milestone as the first and only FDA-approved ready-to-use oral liquid losartan in the U.S., targeting a global market for losartan potassium that hit $1.5 billion in sales in 2024.

Shankar Hariharan, Scienture’s CEO, said, “The approval of Arbli exemplifies our deep commitment to develop high value products that address unique and underserved patient needs. A significant number of patients can benefit from a safe and efficacious ready-to-use oral liquid formulation of losartan. We are excited with the approval of our first brand product which is part of our upcoming pipeline of novel specialty products.”

Arbli is designed to treat hypertension in patients over six years old, reduce stroke risk in those with hypertension and left ventricular hypertrophy, and manage diabetic nephropathy in specific type 2 diabetes patients. As an angiotensin receptor blocker (ARB)—one of the most prescribed classes for hypertension—losartan has long been a cornerstone therapy. Until now, it’s been limited to oral solids, often requiring risky compounding into liquids. Arbli changes that with a novel, proprietary liquid formulation, offering a safe, convenient alternative for patients who need or prefer an oral suspension. With two issued USPTO patents (slated for FDA Orange Book listing), Arbli ensures precise dosing without the inconsistencies of crushing tablets, delivering quality and reliability in every dose.

The U.S. market alone underscores Arbli’s potential: IQVIA data (MAT December 2024) pegs losartan’s annual sales at $292 million, with 68 million prescriptions. Unlike existing solid-dose options, Arbli’s ready-to-use format slashes dosing volume, boasts an 18-month shelf life at room temperature (extendable to 24 months pending FDA review of stability data), and comes in a 165 mL peppermint-flavored bottle

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