Drug

Copper histidine

As of the edition of 20 October 2026, Copper histidine is a drug: marketed, first approved in 2026 (US); US protection ends in 2033.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2026
Kind
Unknown
Brand name
Zycubo
First approved
12 January 2026 (US)
Approvals on record
1 in 1 region
Holder of the most recent approval
Sentynl Therapeutics
Registered trials
4, 0 stopped early
Disease areas
Inherited and neonatal; Nervous system; Nutrition and metabolism; Skin and connective tissue

US protection

US protection ends in 2033.

The last listed US exclusivity ends in 2033. The application that gives this date is held by Sentynl Therapeutics.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

2 listings count towards this date. The exact date and each listing are in the product.

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Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated2010
Phase 21100
Phase 31100
All trials4

Who has held its approvals

CompanyRoleYears
Sentynl TherapeuticsOriginator and Lead sponsor of trials2019 to now