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FDA Medication Tracker

← All approvals · Rare & genetic · 2026

Zycubo (copper histidinate)

The FDA approved Zycubo (copper histidinate) on January 12, 2026 to treat Menkes disease.
Brand name
Zycubo
Generic name
copper histidinate
FDA approval date
January 12, 2026
Approved use (FDA wording)
To treat Menkes disease
Company
Sentynl Theraps Inc.
Application
NDA211241
Dosage form / route
POWDER · SUBCUTANEOUS
Boxed warning on label
Not listed
Category on this site
Rare & genetic

Indications and usage, from the FDA label

ZYCUBO is indicated for the treatment of Menkes disease in pediatric patients. ZYCUBO is a copper replacement product indicated for the treatment of Menkes disease in pediatric patients. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome.

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.