GHK-Cu

Also known as: copper tripeptide

Not FDA-approved Category 2 nomination withdrawn

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 1 of 103 publications on PubMed
Registered clinical trials 3 3 active
Adverse event reports 3 3 classified as serious
  • GHK-Cu is not an FDA-approved drug: Drugs@FDA has no record of it.
  • It was on FDA's Category 2 safety-risk list until the nomination was withdrawn. A withdrawal is not an approval.
  • PubMed lists 103 publications mentioning it, including 1 randomized controlled trial and 14 animal-only studies.
  • ClinicalTrials.gov lists 3 registered studies testing it (3 active).
  • FDA's adverse event system (FAERS) holds 3 reports mentioning it; 3 classified as serious. Reports do not prove causation.

Research topics

  • Skin 14
  • Wound Healing 14
  • Antioxidants 9
  • Fibroblasts 9
  • Anti-Inflammatory Agents 7
  • Growth Substances 7
  • Inflammation 7
  • Administration, Cutaneous 6
  • Collagen 5
  • Oxidative Stress 5

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Category 2 nomination withdrawn
FDA's stated risk · Original FDA text (English) Compounded injectable drugs containing GHK-Cu may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities. There are limited data in humans to inform safety-related considerations.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 103
  • Human (MeSH) 40
  • Animal only 14
  • Clinical trials 1
  • Randomized controlled trials 1
  • Systematic reviews & meta-analyses 0
  • Case reports 0
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
3
Active
3
With posted results
0

Conditions studied

  • GHK and GHK-Cu Blood Levels 1
  • Aging 1
  • Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds) 1
Study Status Phase Start
Two-Part Study of the Effects of the X39 Patch on Circulating GHK and GHK-Cu Levels in Healthy Adults
NCT07706361 LifeWave, Inc.
Not yet recruiting N/A Jan 2027
Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks
NCT07888595 Frontiers in Bioscience Research Institute and Aging
Enrolling by invitation Early phase 1 October 21, 2026
Topical GHK-Cu Gel for Acute Skin Wound Healing
NCT07437586 Hudson Biotech
Recruiting Phase 2 February 2, 2026

All 3 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
3
Serious
3
With death outcome
0

Most reported reactions

  • Adverse drug reaction 1
  • Anaphylactic shock 1
  • Blood pressure decreased 1
  • Flushing 1
  • Haemorrhage 1
  • Heart rate decreased 1
  • Hyperhidrosis 1
  • Hypersensitivity 1
  • Immobile 1
  • Loss of consciousness 1
  • Malignant lymphoid neoplasm 1
  • Pain 1

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

Boxed warning YVTYVT Copper Peptides Face Serum · March 16, 2025
Original FDA text (English) For external use only. Keep out of reach of children.Avoid contact with eyes.

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.