Copper Histidinate

Treats Menkes disease. Sold as Zycubo. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Copper Histidinate (sold as Zycubo), first approved Jan 12, 2026, with 0 new uses approved and 1 published complete response letter.

First approved: Jan 12, 2026
Applications: 1
New uses approved: 0
Complete response letters: 1
Orphan exclusivity until: Jan 12, 2033

Who Was in the Trials

129 participants in the largest population FDA reports for the Jan 12, 2026 approval, from FDA's Drug Trials Snapshot; see every snapshot

Women: 0%
65 and older: Not reported
White: 11%
Black: under 1%
Asian: 0%
Hispanic or Latino: under 1%

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of Menkes diseaseSentynl Therapeutics, Inc. · designated May 14, 2012 · approved Jan 12, 2026 · exclusive to Jan 12, 2033

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Long Term Follow-up on Menkes Disease PatientsMenkes Disease · Sentynl Therapeutics, Inc.	—	Active, not recruiting	Apr 8, 2020

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Jan 12, 2026	ZycuboNDA 211241 · New molecular entity	Sentynl Theraps Inc	0	Marketed

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
Sep 30, 2025	Copper histidinateFacility Inspections	Unapproved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA