The stock price of Scienture Holdings, Inc. (NASDAQ: SCNX) saw a significant increase, rising 23.79% to $3.07 during pre-market activity. This spike comes after a major regulatory change involving one of its medications.
FDA Gives Arbli Oral Suspension Approval
The FDA has approved SCN-102, a losartan potassium oral suspension (10 mg/mL) produced by Scienture, LLC, a fully owned subsidiary of Scienture Holdings (SCNX), to be sold under the brand name Arbli.
Arbli is used to treat hypertension in patients six years of age and older, manage diabetic nephropathy in some patients with type 2 diabetes, and lower the risk of stroke in those with hypertension and left ventricular hypertrophy. However, Arbli is the first ready-to-use oral liquid version of losartan that has received FDA approval and is offered for sale in the United States.
A New Composition for Improved Patient Comfort
Arbli is a patented development in losartan medication that provides a customized liquid formulation for patients who need or want an alternative to tablets. Arbli guarantees precise dosage, safety, and consistency by doing away with the necessity for tablet crushing and impromptu compounding. The product has secured two patents from the U.S. Patent and Trademark Office (USPTO), which are anticipated to be listed in the FDA’s Orange Book.
Market Impact and Future Prospects
One of the most often recommended medications for hypertension is still losartan, an angiotensin receptor blocker (ARB). The only formulations currently on the market are solid oral dose forms, which medical professionals frequently combine to create liquid solutions. Arbli distinguishes itself as the first commercially available liquid formulation requiring no additional preparation while offering extended shelf stability at room temperature.
According to IQVIA data (MAT December 2024), losartan recorded total annual U.S. sales of approximately $292 million with 68 million prescriptions issued. The approval of Arbli underscores Scienture’s strategic focus on developing high-value pharmaceutical products tailored to underserved patient needs.
With this milestone marking its first FDA-approved proprietary brand, Scienture (SCNX) plans to launch Arbli commercially in Q3 2025, broadening its portfolio of specialty treatments.