LongevityNot approvedEvidence tier: Animal Only

GHK-Cu

Last updated October 21, 2026. Approval line checked October 21, 2026. Compounding sources checked October 10, 2026.

FDA status

Not approved

Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.

FDA primary source on file

Evidence tier

Animal Only. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 2/5. 81 PubMed citations indexed.

GHK-Cu in the literature

Tripeptide-copper chelate modulating hundreds of genes via SIRT1/STAT3 pathway; promotes VEGF/FGF-2 angiogenesis and wound healing.

What the literature studies

Collagen Synthesis & Tissue Remodeling

Evidence tier

Animal Only

Compounding record

Route-dependent status

Confidence
2/5

Regulatory record

Route-dependent status. FDA substance context: GHK-Cu. Injectable: nomination withdrawn. Previously in Category 2; FDA still identifies potential significant safety risks. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Non-injectable: 503A Category 1, under evaluation. Neither route is an approval claim. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source checked October 10, 2026. This compounding label is separate from the approval line above.

FDA primary source 1 FDA primary source 2

Regulatory context and verification limits are documented below.

Questions

Related peptides

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

GHK-Cu is a natural copper-binding tripeptide with decent cosmetic-skin data when applied topically; injecting it is a different, unapproved and largely unstudied practice.

What it is

Glycyl-L-histidyl-L-lysine bound to copper, found in human plasma; declines with age [R1].

Legal / FDA status (as of Oct 27 2026)

  • Topical cosmetic use: sold legally in skincare as a cosmetic ingredient.
  • Injectable: FDA lists "GHK-Cu (for injectable routes)" among nominated-but-withdrawn substances (previously Category 2), citing immunogenicity and limited human data [FDA-RISK]. Not FDA-approved as a drug.

Human evidence

Small controlled cosmetic studies of topical creams reported improved skin density, fine lines and photodamage markers, reviewed in [R1]. No quality trials of injected GHK-Cu.

Animal / lab evidence

Wound healing, collagen synthesis and gene-expression effects in cell and animal models [R1].

Risks and unknowns

Injection: immunogenicity, aggregation, impurities, limited human data [FDA-RISK]; copper load unknown.

What's coming

Not on the July 2026 PCAC agenda; no known FDA action pending.

Sources

  1. [R1] 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;19(7):1987. doi:10.3390/ijms19071987
  2. [FDA-RISK] FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  3. [FDA-PCAC] FDA. July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
  4. [OIRA] OIRA. Pending EO 12866 Review, RIN 0910-ZD94. https://www.reginfo.gov/public/do/eoDetails?rrid=1568964 ; meetings: https://www.reginfo.gov/public/do/eom12866SearchResults?pubId=&rin=0910-ZD94

Last checked 2026-10-27

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