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Doxecitine and Doxribtimine-Expanded Access

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Trial Profile

Doxecitine and Doxribtimine-Expanded Access

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 28 Nov 2025

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At a glance

Most Recent Events

  • 03 Nov 2025 According to an UCB media release, company announced that a regulatory review of doxecitine and doxribtimine is currently underway by the EMA (European Medicines Agency), and further regulatory submissions are planned. KYGEVVI is currently not approved for use in any indication by any regulatory authority outside of the U.S. UCB expects KYGEVVI to be commercially available in the U.S. in Q1, 2026.
  • 03 Nov 2025 According to an UCB media release, company announced that KYGEVVI has been granted approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults and pediatric patients living with thymidine kinase 2 deficiency (TK2d).
  • 01 Oct 2024 New trial record

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