Is Doxecitine + Doxribtimine approved by the US FDA?

Drugs@FDA lists 1 application product line for Doxecitine + Doxribtimine, including KYGEVVI (Prescription).

Is Doxecitine + Doxribtimine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Doxecitine + Doxribtimine: Kygevvi.

Active substances

Doxecitine + Doxribtimine

US FDA 1
EMA 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
KYGEVVI	2GM/PACKET;2GM/PACKET	for solution · oral	UCB INC	Prescription	3 Nov 2025

EMA European Union — centrally authorised medicines

Kygevvi UCB Pharma · Authorised · authorised 26 Mar 2026 · ATC A16AX29

Therapeutic indication (EMA)

Kygevvi is indicated for the treatment of paediatric and adult patients with genetically confirmed thymidine kinase 2 deficiency (TK2d) with an age of symptom onset on or before 12 years.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.