Molecule
Copper histidinate is a prescription medicine indicated for the treatment of Menkes disease in pediatric patients, among other approved uses. It is available as powder for injection for subcutaneous use. MedsAcross supplies Copper histidinate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Menkes disease is an X-linked recessive disorder caused by pathogenic variants in the copper transport ATPase encoded by ATP7A. Patients with Menkes disease have impaired absorption of copper from their diet, impaired transport of copper across the blood-brain barrier, and dysregulation of many copper-dependent enzymes. ZYCUBO is a bioavailable copper replacement therapy that is administered as a subcutaneous injection to bypass the impaired gastrointestinal absorption observed in patients with Menkes disease.
Source: US FDA prescribing information
Before initiating ZYCUBO, obtain baseline serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count. The recommended dosage of ZYCUBO in pediatric patients: Less than 1 year of age is 1.45 mg twice daily (8-12 hours between injections). 1 year of age to less than 17 years of age is 1.45 mg once daily. Monitor serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC). Reconstitute ZYCUBO and administer subcutaneously. See Full Prescribing Information for additional preparation, storage, and administration instructions.
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Copper Accumulation and Risk of Toxicity: Exogenous administration of copper with ZYCUBO may lead to further copper accumulation and has the potential to result in drug-induced kidney injury, liver dysfunction, and hematological abnormalities. Monitor patients during ZYCUBO treatment. Adjust dosage if necessary.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Copper Accumulation and Risk of Toxicity: Drug-Induced Kidney Injury, Liver Dysfunction, Hematological Abnormalities Most common adverse reactions (incidence ≥7%) were pneumonia, viral infection, respiratory failure, seizure, bacterial infection, hemorrhage, hypotension, vomiting, tachycardia, pyrexia, volume depletion, fracture, dyspnea, transaminases elevation, diarrhea, fungal infection, anemia, and local administration reaction.
Source: US FDA prescribing information
Store ZYCUBO vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton. Store ZYCUBO reconstituted solution either refrigerated or at controlled room temperature.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Copper histidinate, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Zycubo 2.9 mg powder for injectionSubcutaneous Cold chain | Sentynl Therapeutics | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 12 January 2026 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Copper histidinate and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Copper histidinate, including Zycubo.
Yes. The US FDA first approved Copper histidinate on 12 January 2026, according to Drugs@FDA.
At least one listed presentation of Copper histidinate must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.