🇺🇸 copper histidinate in United States

FDA authorised copper histidinate on 12 January 2026

Marketing authorisation

FDA — authorised 12 January 2026

  • Application: NDA211241
  • Marketing authorisation holder: SENTYNL THERAPS INC
  • Local brand name: ZYCUBO
  • Indication: POWDER — SUBCUTANEOUS
  • Status: approved

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Frequently asked questions

Is copper histidinate approved in United States?

Yes. FDA authorised it on 12 January 2026.

Who is the marketing authorisation holder for copper histidinate in United States?

SENTYNL THERAPS INC holds the US marketing authorisation.