Drug intelligence / Profile preview

Sibnayal

Development stage
Phase 3
Lead developer
Advicenne
Modality
Small Molecules
Administration
Oral
01

Overview

Sibnayal is a fixed-dose, prolonged‑release oral combination of potassium citrate and potassium hydrogen carbonate (potassium bicarbonate) developed by Advicenne for the treatment of distal renal tubular acidosis (dRTA) in adults and children from one year of age.[1][3][7][10] Both components act as systemic alkalising agents: after absorption, their metabolism provides an alkaline load that neutralises excess hydrogen ions, elevates plasma bicarbonate, and corrects chronic metabolic acidosis, while the potassium content helps restore or maintain normokalaemia and citrate additionally chelates urinary calcium to reduce stone formation.[1][4][5][7][10] In clinical studies, Sibnayal demonstrated non‑inferiority and, by predefined criteria, superiority versus standard alkalising regimens in normalising blood bicarbonate, with sustained control and improved treatment acceptability using twice‑daily dosing of prolonged‑release granules.[1][10]

Brand names
Sibnayal
Other names
potassium citrate + potassium hydrogen carbonatepotassium citrate/potassium hydrogen carbonatepotassium citrate/potassium bicarbonate

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