SCIENTURE HOLDINGS announced the initiation of supply chain activities by its wholly owned subsidiary Scienture, LLC to manufacture launch quantities of ArbliTM (losartan potassium) Oral Suspension, 10 mg/mL for the intended commercial launch of the product in July 2025. Scirenture, LLC’s contract manufacturing partner, Saptalis Pharmaceuticals, LLC for ArbliTM has indicated to Scienture that Saptalis has the materials and capabilities to produce the batches and supply product inventory in time for the target commercial launch. In addition, Scienture, LLC has also entered into agreements with strategic partners for warehousing and distributing the product to the market through various wholesalers.
ArbliTM is meant for the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes. ArbliTM is the first and only FDA approved ready-to-use oral liquid losartan in the U.S. market.
ArbliTM is a novel proprietary formulation of losartan, a proven therapy for treating hypertension, which provides a tailored approach to patients that require or prefer an oral liquid option of losartan. Appropriate dosing is now easier, safe and effective, while providing the assurance of quality as an FDA-approved product. ArbliTM provides a safe and convenient option to patients requiring a liquid formulation and addresses the intrinsic risks associated with potential inconsistencies in the process of crushing tablets to extemporaneously compound losartan prescriptions. ArbliTM has two issued patents from the USPTO, which are also expected to be listed in the FDA Orangebook.
Losartan is classified as an angiotensin receptor blocker (ARB) for treating hypertension and is one of the highest prescribed molecules for this indication. Current products in the market containing losartan are available only as oral solids, which can be further compounded to a liquid formulation. ArbliTM is the first liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. IQVIA data (MAT December 2024) indicates a total annual sales of approximately $292 million and a prescription volume of 68 million (TRx) for losartan in the US market.
“Achieving manufacturing and distribution readiness for the targeted launch in July 2025 of ArbliTM, is a testament to the hard work of our cross-functional teams and the strength of our production infrastructure partnership” said Narasimhan Mani, President of Scienture, LLC. “We are now in a strong position to support the timely access of ArbliTM for patients and caregivers and deliver value to our stakeholders.”
“Our manufacturing and supply chain readiness in support of the commercial launch of ArbliTM , reflects not only our technical capabilities but also our commitment to the highest standards of quality, compliance, and patient safety,” remarked Shankar Hariharan, CEO of Scienture, LLC. “This marks a pivotal milestone in our mission to deliver therapeutic benefit to patients in need.