Short answer
GHK-Cu is not an FDA-approved drug [openFDA]. FDA lists “GHK-Cu (for injectable routes of administration)” in Category 2 of bulk substances that may present significant safety risks in compounding [FDA 2026]. It is registered in FDA’s substance system as prezatide copper [FDA GSRS] and used in cosmetics as copper tripeptide-1[PubChem]. Checked against primary sources on November 11, 2026.
United States: FDA
Drug approval
Queries of Drugs@FDA and the NDC directory for prezatide, copper tripeptide and GHK returned no approved application and no listed drug product [openFDA].
Compounding: Category 2
On its page of bulk drug substances that may present significant safety risks (content current as of April 22, 2026), FDA lists GHK-Cu for injectable routes in Category 2. FDA states that compounded injectable drugs containing GHK-Cu may pose a risk of immunogenicity due to the potential for aggregation and peptide-related impurities, and that there are limited data in humans to inform safety-related considerations [FDA 2026].
Substance registration
- Prezatide (copper-free GHK): UNII 39TG2H631E [FDA GSRS].
- Prezatide copper (GHK-Cu): UNII 6BJQ43T1I9 [FDA GSRS].
A UNII is an identifier for a substance. It does not indicate approval.
Cosmetic ingredient names
PubChem lists the INCI names tripeptide-1 for copper-free GHK [PubChem] and copper tripeptide-1 for prezatide copper [PubChem]. Under US law, whether a product is regulated as a cosmetic or a drug depends on its intended use, which is judged partly from the claims made for it.
Registered clinical studies
Four studies matched a ClinicalTrials.gov search at our last check, none with posted results [ClinicalTrials.gov]. Two concern GHK-Cu directly:
- A phase 2, randomised, quadruple-masked trial of a topical GHK-Cu gel against vehicle gel in standardised skin wounds, estimated 60 participants, recruiting [NCT07437586].
- A sponsor-run study of circulating GHK and GHK-Cu levels with a patch product, not yet recruiting [NCT07706361].
Frequently asked questions
Is GHK-Cu FDA approved?
No. Queries of FDA’s Drugs@FDA and NDC directory for prezatide, copper tripeptide and GHK returned no approved application or listed drug product.
Can pharmacies compound injectable GHK-Cu?
FDA lists GHK-Cu for injectable routes in Category 2 of bulk drug substances that may present significant safety risks. This page describes FDA’s listing; it is not legal advice on any specific activity.
Is GHK-Cu legal in cosmetics?
GHK-Cu is used in cosmetics under the ingredient name copper tripeptide-1. Cosmetic status depends on the product and the claims made for it; claims about treating or affecting the body’s structure or function can make a product a drug under US law.