Quick answers
- What is Copper histidinate used for?
- The FDA-approved label (Zycubo, Sentynl Therapeutics, Inc., January 12, 2026) says: “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. Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome. Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Copper histidinate have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Copper histidinate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Copper histidinate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Copper histidinate?
- 1 company lists prescription products of Copper histidinate in the FDA NDC Directory, including Sentynl Therapeutics, Inc..
What Copper histidinate is used for
Quoted from the “Indications and Usage” section of the FDA-approved 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. Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome. Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome.
— FDA label: Zycubo, Sentynl Therapeutics, Inc., effective January 12, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Zycubo |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sentynl Therapeutics, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA211241 ZYCUBO | Sentynl Theraps Inc | January 12, 2026 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2732219, 2732224 |
|---|---|
| SPL set ID of the quoted label | e3aeefc2-f44d-4337-9c2e-3dba44a89e48 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA211241 |
| Active ingredients (FDA) | COPPER HISTIDINATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zycubo, Sentynl Therapeutics, Inc., effective January 12, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →