Advicenne submits Sibnayal® to the US FDA

On November 4, 2025, Advicenne, a Paris-based pharmaceutical company listed on Euronext Growth, announced the submission of its application for registration of Sibnayal® to the FDA. Sibnayal®, a combination of potassium citrate and bicarbonate, is intended to treat distal renal tubular acidosis. The FDA's review of the application could take approximately 12 months. Advicenne plans to provide updates on the process and the expected decision date from the U.S. authorities soon.

The company will hold a web conference on November 5, 2025, to discuss this filing. In Europe and Great Britain, Sibnayal® is already authorized to treat ATRd.