Copper Histidinate Injection Suppliers & Bulk Manufacturers

Available Forms: Subcutaneous injection

Available Strengths: 250 mcg copper (as copper histidinate) per dose

Reference Brands: Zycubo (Sentynl Therapeutics)

Category: Orphan Drugs

Copper histidinate (Zycubo, Sentynl Therapeutics) is a subcutaneous copper replacement for children with Menkes disease, approved by the US FDA in January 2026 as the first treatment for the condition. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.

Product Description:

Menkes disease is a rare inherited disorder, almost always in boys, caused by faults in the ATP7A gene. ATP7A moves copper out of the gut and into the brain, so children with Menkes disease cannot absorb dietary copper and copper-dependent enzymes fail. Without treatment, the disease causes seizures, loss of developmental skills, brittle "kinky" hair and early death. Copper histidinate gives copper by injection under the skin, bypassing the gut.

The US FDA approved copper histidinate as Zycubo in January 2026 for children with Menkes disease, the first approved treatment for it. Treatment works best when started very early, ideally in the first weeks of life, before brain damage has developed. Doses are given by subcutaneous injection, more often in the first year and then less often.

Sourcing and licensing notes. Zycubo is made only by Sentynl Therapeutics, a Zydus company, and has no generic. Supply outside the US is on a named-patient basis, which we confirm for each destination.