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Copper Histidinate Treatment for Menkes Disease

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Trial Profile

Copper Histidinate Treatment for Menkes Disease

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 21 May 2025

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At a glance

  • Drugs Copper histidine (Primary)
  • Indications Menkes kinky hair syndrome
  • Focus Adverse reactions; Expanded access; Therapeutic Use
  • Sponsors Cyprium Therapeutics; Sentynl Therapeutics

Most Recent Events

  • 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.
  • 14 Nov 2024 According to a Fortress Biotech Media Release, in Dec 2023, company completed the asset transfer of CUTX-101 for Menkes disease to Sentynl Therapeutics, a subsidiary of Zydus Lifesciences Ltd. Sentynl completed the rolling submission of the New Drug Application for CUTX-101 in the fourth quarter of 2024. Cyprium Therapeutics, subsidiary company that developed CUTX-101, will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101.

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