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  1. Home
  3. Copper Histidinate: Pediatric First Approval.
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  3. Copper Histidinate: Pediatric First Approval.

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Copper Histidinate: Pediatric First Approval.

Hannah A Blair1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. pdd@adis.com.

Paediatric Drugs
|April 22, 2026

View abstract on PubMed

Summary
This summary is machine-generated.

Copper histidinate (ZYCUBO®) offers a new treatment for Menkes disease, a rare genetic disorder. This bioavailable copper therapy is now approved in the USA for pediatric patients, providing a vital subcutaneous injection option.

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Area of Science:

  • Biochemistry
  • Genetics
  • Pharmacology

Background:

  • Menkes disease is a rare genetic disorder affecting copper transport due to ATP7A gene variants.
  • Impaired gastrointestinal copper absorption necessitates alternative delivery methods.
  • Copper histidinate (ZYCUBO®) was developed as a bioavailable copper replacement therapy.

Purpose of the Study:

  • To summarize the development milestones of copper histidinate.
  • To highlight the regulatory approvals for Menkes disease treatment.

Main Methods:

  • Review of development and regulatory history of copper histidinate.
  • Focus on its administration as a subcutaneous injection.

Main Results:

  • Copper histidinate (ZYCUBO®) received U.S. FDA approval in January 2026 for pediatric Menkes disease.
  • Orphan Designation granted by the European Commission for Menkes disease treatment.

    • Conclusions:

    • Copper histidinate represents a significant advancement in Menkes disease therapy.
    • The subcutaneous administration provides a crucial treatment route for patients with absorption issues.