Potassium citrate/potassium hydrogen carbonate

Potassium citrate/potassium hydrogen carbonate

Combination of
Potassium citrate	Mineral supplement
Potassium hydrogen carbonate	Mineral supplement
Clinical data
Trade names	Sibnayal
Other names	ADV7103, potassium citrate/potassium hydrogencarbonate, potassium citrate/potassium bicarbonate
Routes of administration	By mouth
ATC code	A12BA30 (WHO)
Legal status
Legal status	EU: Rx-only[1][2]

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.^[1] It contains potassium citrate and potassium hydrogen carbonate.^[1]

Potassium citrate/potassium hydrogen carbonate was approved for medical use in the European Union in April 2021.^[1]

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.^[1]

Society and culture

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.^[1] The applicant for this medicinal product is Advicenne S.A.^[1] Potassium citrate/potassium hydrogen carbonate was approved for medical use in the European Union in April 2021.^[1]

Potassium citrate/potassium hydrogen carbonate is recommended for approval in the United Kingdom.^[3]

Research

Potassium citrate/potassium hydrogen carbonate is undergoing phase III trials in preparation for evaluation by the US Food and Drug Administration (FDA).^[4]

References

1. "Sibnayal EPAR". European Medicines Agency (EMA). 9 December 2020. Retrieved 22 May 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
2. "Sibnayal Product information". Union Register of medicinal products. Retrieved 3 March 2023.
3. "Potassium bicarbonate + potassium citrate". SPS - Specialist Pharmacy Service. 19 February 2021. Archived from the original on 23 May 2021. Retrieved 22 May 2021.
4. "Advicenne receives positive feedback from the US FDA on pathway to approval and amended Phase III study protocol for its treatment of distal renal tubular acidosis (dRTA)" (Press release). Advicenne. 17 May 2021. Retrieved 22 May 2021 – via GlobeNewswire.