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Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency

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Trial Profile

Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jan 2026

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At a glance

  • Drugs Copper histidinate (Primary)
  • Indications Menkes kinky hair syndrome
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 12 Jan 2026 According to Food and Drug Administration media release, The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.
  • 15 Dec 2025 According to a Fortress Biotech media release, U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class I response and as a result, the Company has received January 14, 2026 as the new PDUFA date.
  • 01 Oct 2025 According to Sentynl Therapeutics media release, the U.S. Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) relating to its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients.

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