Potassium citrate/potassium hydrogen carbonate

Potassium citrate/potassium hydrogen carbonate, sold under the brand name Sibnayal, is a fixed-dose combination medication intended for the treatment of distal renal tubular acidosis. It contains potassium citrate and potassium hydrogen carbonate.

Potassium citrate/potassium hydrogen carbonate was approved for medical use in the European Union in April 2021.

Medical uses
Potassium citrate/potassium hydrogen carbonate is indicated for the treatment of distal renal tubular acidosis (dRTA) in people aged one year and older.

Legal status
In December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Sibnayal. The applicant for this medicinal product is Advicenne S.A. Potassium citrate/potassium hydrogen carbonate was approved for medical use in the European Union in April 2021.

Potassium citrate/potassium hydrogen carbonate is recommended for approval in the United Kingdom.

Research
Potassium citrate/potassium hydrogen carbonate is undergoing phase III trials in preparation for evaluation by the US Food and Drug Administration (FDA).