FDA Approves SCN-102, Liquid Oral Suspension Formulation of Losartan

The FDA approved SCN-102 (Arbli; Sceinture LLC), the 10-mg/mL oral suspension formulation of losartan potassium (Cozaar; Organon & Co.), for the treatment of adult and pediatric patients aged 6 years and older with hypertension, 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.¹ SCN-102 provides a tailored approach to patients that require or prefer an oral liquid option of treatment.^2,3

Image credit: vchalup | stock.adobe.com

Hypertension, or high blood pressure, is a cardiovascular condition that occurs when the pressure within the blood vessels becomes too high (140/90 mmHg or higher), and it is a risk factor for stroke and heart disease, which are leading causes of death in the US. The CDC has reported that hypertension affects nearly half of the US adult population, which equates to about 119.9 million people. It is clinically diagnosed if, when blood pressure is measured on 2 different days, the systolic blood pressure readings on both days are 140 mmHg or greater, and/or the diastolic blood pressure readings on both days are 90 mmHg or greater. Factors that increase the risk of having high blood pressure include the following: older age, genetics, being overweight or obese, not being physically active, high-salt diet, and drinking too much alcohol.²

“The approval of [SCN-102] 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,” said Shankar Hariharan, CEO of Scienture, in a news release.¹

SCN-102 is an oral liquid suspension that was developed to increase patient convenience and ease of dosing. Its initial new drug application had also covered the use of this treatment to reduce the likelihood of stroke in patients with hypertension and left ventricular hypertrophy, as well as treat diabetic nephropathy in patients with type 2 diabetes. Its reference drug is an angiotensin 2 receptor blocker that is used to treat hypertension, and is one of the highest prescribed molecules for this condition. With this action, the SCN-102 has become the first liquid formulation of losartan that does not require compounding, has reduced dosing volume, and a long-term shelf life at room temperature storage.^2,3

Supporting its application is phase 1 pharmacokinetic data, which demonstrates SCN-102’s close comparability to immediate-release losartan tablets. It also achieved peak concentration earlier—which the experts noted was expected because of its liquid formulation—when compared with the pill formulation.³

“We are pleased to bring to market, [SCN-102], a transformative therapy option containing losartan, one of the most widely prescribed molecules in its class, to patients, caregivers, and health care professionals. We expect to commercially launch and make [SCN-102] available to patients in the US in Q3 2025,” said Narasimhan Mani, president of Scienture, in the news release.¹

REFERENCES

1. 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 $1.5 billion in sales in 2024. News release. March 18, 2025. Accessed March 18, 2025. https://www.globenewswire.com/news-release/2025/03/18/3044475/0/en/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-ap.html#.

2. GlobeNewswire. Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc. (NASDAQ: SCNX) Announces Issuance of a New Patent Covering its first product SCN-102 (Losartan Potassium Oral Suspension, 10mg/mL) through 2041. News release. December 10, 2024. Accessed March 14, 2025. https://www.globenewswire.com/news-release/2024/12/10/2994526/0/en/Scienture-LLC-a-wholly-owned-subsidiary-of-Scienture-Holdings-Inc-NASDAQ-SCNX-Announces-Issuance-of-a-New-Patent-Covering-its-first-product-SCN-102-Losartan-Potassium-Oral-Suspensi.html

3. BioSpace. FDA Action Alert: GSK, Alnylam, Sanofi and More. News release. March 10, 2025. Accessed March 14, 2025. https://www.biospace.com/fda/fda-action-alert-gsk-alnylam-sanofi-and-more