On 22 March 2022, the European Commission withdrew the marketing authorisation for Zynquista (sotagliflozin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Guidehouse Germany GmbH, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. Zynquista was granted marketing authorisation in the EU on 26 April 2019 for use as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus. The marketing authorisation was initially valid for a 5\-year period. The European Public Assessment Report (EPAR) for Zynquista is updated to indicate that the marketing authorisation is no longer valid.
Therapeutic Indication
Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ? 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.
Therapeutic Area (MeSH)
ATC Code
A10
ATC Item
N/A
Pharmacotherapeutic Group
Drugs used in diabetes
Active Substance (Summary)
INN / Common Names
EMA Name
Zynquista
Medicine Name
Zynquista
Aliases
N/ANo risk management plan link.
