GHK-Cu
Also called: copper peptide, ghk copper peptides, ghk peptide, ghk copper
Clinical reviewer: Jacob Moore, MD · Last checked September 16, 2026
Is GHK-Cu safe and legal?
GHK-Cu is a copper-bound tripeptide, glycyl-L-histidyl-L-lysine, found naturally in the body. A 2018 review by its developers reports tissue-repair effects in skin, bone and other tissues. FDA currently lists non-injectable GHK-Cu in Category 1, under evaluation, but the injectable form's nomination was withdrawn over immunogenicity concerns, and a further review is scheduled by February 2027.
What does research say GHK-Cu does?
A 2018 review written by GHK-Cu's own developers reports it stimulates blood vessel and nerve growth and increases collagen, elastin and glycosaminoglycan production [1]. It also describes tissue-repair effects in skin, lung connective tissue, bone, liver and stomach lining [1]. FDA says there are limited data in humans to inform safety considerations [3], so read these findings as preliminary rather than established clinical benefit.
Is GHK-Cu FDA-approved or legal to compound?
No GHK-Cu product is FDA-approved. Compounding under section 503A requires a USP monograph, use in an approved drug, or listing on FDA's bulks list [2]. Non-injectable GHK-Cu sits in Category 1, under evaluation [2], where FDA says it does not intend to act against a compounder provided its guidance conditions are met [4]. Injectable GHK-Cu's nomination was withdrawn after FDA flagged immunogenicity risk from aggregation and peptide-related impurities, citing limited human data [3].
What happens by February 2027?
FDA will consult its Pharmacy Compounding Advisory Committee on adding GHK-Cu to the 503A bulks list before the end of February 2027 [2]. The nomination history has shifted: GHK-Cu left Category 1 in April 2026 when nominators withdrew it, then was restored for non-injectable routes only after a May 5, 2026 clarification from a nominator [2]. Until FDA acts, its compounding status stays provisional and route-dependent.
Related terms
Sources
- Pickart L, Margolina A. Regenerative and Protective Actions of the GHK-Cu Peptide in the Light of the New Gene Data. Int J Mol Sci, 2018.
- FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Updated May 14, 2026)
- FDA — Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (current as of April 22, 2026)
- FDA — Bulk Drug Substances Used in Compounding Under Section 503A (categories and interim policy)
This entry is for education and is not medical advice. Talk with a licensed clinician about your own situation before starting, stopping, or changing any treatment.
