Regulatory record
- April 2026
- Injectable GHK-Cu removed from Category 2 without Category 1 listing; not among the seven peptides reviewed at the July 2026 PCAC meeting.
- FDA final action
- None as of August 2026.
Status verified for this index · August 2026
Definition
GHK-Cu is a naturally occurring tripeptide, glycyl-histidyl-lysine, complexed with copper; it was identified in human plasma and declines with age, and it has a long history in topical cosmetics.
The molecule's two lives must be kept separate: as a cosmetic ingredient in creams and serums it is unremarkable and legal, while the injectable form sold for regeneration is a different product with a different legal position.
Evidence
The topical literature describes effects on skin regeneration and collagen signaling, largely from in vitro and small cosmetic studies [1]. A 2026 review of peptide therapies for musculoskeletal and performance uses finds no clinical trial support for injectable GHK-Cu [2].
The distance between a cosmetic ingredient's cell-culture record and an injected drug's evidentiary bar is the whole story here; the first does not carry the second.
Lawful access
Injectable GHK-Cu was removed from Category 2 of the interim 503A bulks list in April 2026 without being added to Category 1, and it was not among the seven peptides reviewed at the July 2026 PCAC meeting; no lawful compounding route exists for the injectable form today. Topical cosmetic use is regulated as a cosmetic and is unaffected.
Injectable material sold online is research-use-only chemical supply, outside pharmacy licensure and quality standards.
References
- BioMed Research International. GHK peptide as a natural modulator of multiple cellular pathways in skin regeneration. 2015. PMID 26236730
- Sports Medicine. Safety and efficacy of approved and unapproved peptide therapies for musculoskeletal injuries and athletic performance. 2026. PMID 41966639