Skip to main content
PlainMeds

Prescription medicine

Copper histidinate Brand names: Zycubo

Copper histidinate (Zycubo) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the copper histidinate FDA label on DailyMed (effective January 12, 2026, Sentynl Therapeutics, Inc.); the NDA 211241 record on Drugs@FDA; every copper histidinate label on DailyMed.

Highlights of the record

FDA label of January 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

ZYCUBO is indicated for the treatment of Menkes disease in pediatric patients.

Forms and strengths

  • 2.9 mg

Injection (powder) (lyophilized) for solution.

On the market

Earliest approval on file
January 12, 2026 Zycubo, Sentynl Theraps Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
1 through July 30, 2026

What is copper histidinate used for?

From the label: indications and usage

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.

Source: FDA drug label (Zycubo), Sentynl Therapeutics, Inc., effective January 12, 2026 (SPL set e3aeefc2-f44d-4337-9c2e-3dba44a89e48), via openFDA; the full label on DailyMed

Is there a generic for copper histidinate (Zycubo)?

No generic copper histidinate is approved (Drugs@FDA, October 8, 2026).

  • 2026 earliest approval on file

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for copper histidinate?

The FDA Adverse Event Reporting System holds 1 report that list copper histidinate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

  • Urosepsis1

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Copper histidinate side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other