ZYCUBO® (formerly CUTX-101) (Copper Histidinate)

ZYCUBO® is the first and only FDA-approved, bioavailable copper replacement therapy for the treatment of Menkes disease, a copper transport deficiency caused by mutations in ATP7A.  ZYCUBO is a subcutaneous injectable formulation of copper histidinate that is given daily to deliver elemental copper to the body.  In a pooled analysis of two open label, single-arm clinical trials, early treatment with ZYCUBO (ZYCUBO-ET) demonstrated significant improvement in overall survival for Menkes disease patients with a nearly 80% reduction in the risk of death compared to the overall survival of patients in the untreated contemporaneous external control cohort. (Copper Histidinate Treatment for Menkes Disease (Kinky Hair Syndrome) | Pediatrics | American Academy of Pediatrics)  For more information, visit https://zycubo.com.

In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”) assumed full responsibility for the development and commercialization of ZYCUBO® (copper histidinate, formerly known as CUTX-101) from Cyprium. A PRV was issued upon approval of ZYCUBO® by the U.S. Food and Drug Administration (“FDA”) on January 12, 2026. Pursuant to the transaction with Sentynl, the PRV was immediately transferred to Cyprium and has now been sold by Cyprium.

Cyprium remains eligible to receive tiered royalties on net sales of ZYCUBO® and up to approximately $128 million in aggregate sales milestones from Sentynl.

ZYCUBO has received Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug Designation from the FDA. Copper histidinate has also been granted Orphan Designation by the European Medicines Agency.

Please see full U.S. Prescribing Information including Instructions for Use (IFU) for ZYCUBO® at https://zycubo.com.

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