Copper histidinate

CAS 12561-67-0 AND 13870-80-9

MF C₁₂H₁₆CuN₆O₄

FDA 2026, JAN/12/26, Zycubo, To treat Menkes disease, APPROVALS 2026, 9078K3MO9U, MN 88, CUTX 101

copper bis((2S)-2-amino-3-(1H-imidazol-5-yl)propanoate)

• L-Histidine, copper(2+) salt (2:1)
• Copper, bis(L-histidinato-kappaN,kappaO)-

Copper histidinate, sold under the brand name Zycubo, is a medication used for the treatment of Menkes disease.^[1] Copper histidinate is a copper replacement therapy given by subcutaneous injection.^[1][2]

The most common side effects include infections, respiratory problems, seizures, vomiting, fever, anemia and injection site reactions.^[2]

Copper histidinate was approved for medical use in the United States in January 2026.^[2]

Medical uses

Copper histidinate is indicated for the treatment of Menkes disease in children.^[1]

Menkes disease is a neurodegenerative disorder caused by a genetic defect that impairs a child’s ability to absorb copper.^[2] The disease is characterized by seizures, failure to gain weight and grow, developmental delays, and intellectual disability.^[2] It leads to abnormalities of the vascular system, bladder, bowel, bones, muscles, and nervous system.^[2]

SYN

A275388 — Flores-Pulido AA, Jimenez-Perez VM, Garcia-Chong NR: Sintesis y uso de histidinato de cobre en ninos con enfermedad de Menkes en Mexico. Gac Med Mex. 2019;155(2):191-195. doi: 10.24875/GMM.18004310. [PubMed:31056589]

PAT

https://patentscope.wipo.int/search/en/detail.jsf?docId=US38595012&_cid=P22-ML09JO-91481-1

PAT

Copper amino acidate diimine nitrate compounds and their methyl derivatives and a process for preparing them

Publication Number: US-5576326-A

Priority Date: 1989-12-20

Grant Date: 1996-11-19

• Wilson disease genePublication Number: CA-2108927-CPriority Date: 1993-09-21Grant Date: 2008-09-02
• Wilson disease genePublication Number: CA-2106602-A1Priority Date: 1993-09-21
• Wilson disease genePublication Number: WO-9508641-A1Priority Date: 1993-09-21
• Process to obtain new mixed copper aminoacidate complexes from phenanthrolines and their alkyl derivatives to be used as anticancerigenic agentsPublication Number: EP-0434445-A2Priority Date: 1989-12-20
• Method for producing a novel mixed copper amino acid complex used in anticancer drugsPublication Number: JP-H04316581-APriority Date: 1989-12-20METHOD FOR DETECTION OF BIOLOGICAL AGENTSPublication Number: EP-1097242-A4Priority Date: 1999-05-05
• Method for detecting biological agentsPublication Number: US-2004023272-A1Priority Date: 1999-05-05
• Method for detecting biological agentsPublication Number: WO-0066790-A1Priority Date: 1999-05-05
• Method for detecting biological agentsPublication Number: EP-1097242-A1Priority Date: 1999-05-05
• Process for producing nitrosonium ionsPublication Number: AU-773835-B2Priority Date: 1999-02-24Grant Date: 2004-06-10

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Side effects

The most common side effects include infections, respiratory problems, seizures, vomiting, fever, anemia and injection site reactions.^[2]

Society and culture

Legal status

Copper histidinate was approved for medical use in the United States in January 2026.^[2] The US Food and Drug Administration (FDA) granted the application for copper histidinate priority review, fast track, breakthrough therapy, and orphan drug designations.^[2] The FDA granted approval of Zycubo to Sentynl Therapeutics.^[2]

Names

Copper histidinate is the international nonproprietary name^[3] and the United States Adopted Name.^[4]

Copper histidinate is sold under the brand name Zycubo.^[5]

References

1.  Sentynl Therapeutics (12 January 2026). “Zycubo (copper histidinate) for injection, for subcutaneous use” (PDF). Retrieved 15 January 2026.
2.  “FDA Approves First Treatment for Children With Menkes Disease”. U.S. Food and Drug Administration (FDA) (Press release). 12 January 2026. Retrieved 15 January 2026.  This article incorporates text from this source, which is in the public domain.
3.  World Health Organization (2025). “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 94”. WHO Drug Information. 39 (3). hdl:10665/383022.
4.  “Copper histidinate”. American Medical Association. Retrieved 15 January 2026.
5.  “Sentynl Therapeutics Inc. Announces FDA Approval of Zycubo (copper histidinate)”. Sentynl Therapeutics. 13 January 2026. Retrieved 15 January 2026 – via PR Newswire.

Further reading

• Scanga R, Scalise M, Marino N, Parisi F, Barca D, Galluccio M, et al. (October 2023). “LAT1 (SLC7A5) catalyzes copper(histidinate) transport switching from antiport to uniport mechanism”. iScience. 26 (10) 107738. Bibcode:2023iSci…26j7738S. doi:10.1016/j.isci.2023.107738. PMC 10492218. PMID 37692288.

External links

• Clinical trial number NCT00001262 for “Copper Histidine Therapy for Menkes Diseases” at ClinicalTrials.gov
• Clinical trial number NCT00811785 for “Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency” at ClinicalTrials.gov

Clinical data
Trade names	Zycubo
Other names	Copper(II) bis(histidinate)
AHFS/Drugs.com	zycubo
License data	US DailyMed: Copper histidinate
Routes of administration	Subcutaneous
ATC code	None
Legal status
Legal status	US: ℞-only[1]
Identifiers
IUPAC name
CAS Number	13870-80-9
PubChem CID	151722
DrugBank	DB32041
ChemSpider	133722
UNII	9078K3MO9U
KEGG	D13117
CompTox Dashboard (EPA)	DTXSID30154803
Chemical and physical data
Formula	C12H16CuN6O4
Molar mass	371.844 g·mol−1
3D model (JSmol)	Interactive image
SMILES
InChI

/////////////Copper histidinate, FDA 2026, JAN/12/26, Zycubo, To treat Menkes disease, APPROVALS 2026,
9078K3MO9U, 9078K3MO9U, MN 88, CUTX 101