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Copper histidine subcutaneous - Cyprium Therapeutics

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Drug Profile

Copper histidine subcutaneous - Cyprium Therapeutics

Alternative Names: Copper histidinate; CUTX 101

Latest Information Update: 28 Jan 2025

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At a glance

  • Originator National Institute of Child Health and Human Development
  • Developer Cyprium Therapeutics; National Institute of Child Health and Human Development
  • Class Heavy metals; Imidazoles; Small molecules
  • Mechanism of Action Heavy metal replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Menkes kinky hair syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Menkes kinky hair syndrome

Most Recent Events

  • 28 Jan 2025 No recent reports of development identified for clinical-Phase-Unknown development in Menkes-kinky-hair-syndrome(In children) in USA (SC, Injection)
  • 06 Jan 2025 FDA assigns PDUFA action date of 30/09/2025 for copper histidine subcutaneous for Menkes kinky hair syndrome
  • 06 Jan 2025 US FDA grants six-month priority review for copper histidine subcutaneous for Menkes kinky hair syndrome in USA

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