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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: 10 Nov 2025

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At a glance

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

Most Recent Events

  • 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.
  • 15 May 2025 According to Fortress Biotech media release, The FDA accepted the NDA submission for CUTX-101 (copper histidinate for Menkes disease) for priority review with a PDUFA goal date of September 30, 2025.
  • 06 Jan 2025 According to Sentynl Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and Priority review Sentynl's New Drug Application (NDA) for CUTX-101.Under the Prescription Drug User Fee Act (PDUFA), the FDA set a six-month period with a target action date of June 30, 2025.

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