← All compounds · evidence tier first, by design
| Use | E1 | E2 | E3 | E4 | E5 | E6 | E7 | E8 |
|---|---|---|---|---|---|---|---|---|
| E3 Diabetic foot ulcers (topical gel) | E3 | |||||||
| E3 Skin ageing, wrinkles and post-procedure skin (topical cosmetic) | E3 | |||||||
| E6 Injected GHK-Cu for tissue healing, inflammation or anti-ageing | E6 |
GHK-Cu
GHK
Copper(II) complex of the tripeptide glycyl-L-histidyl-L-lysine (GHK). The peptide occurs naturally in human plasma.
Also: Copper peptide GHK-Cu, Copper tripeptide, Glycyl-L-histidyl-L-lysine copper(II)
A copper complex of a three-amino-acid peptide found naturally in human plasma. It is a common ingredient in topical cosmetic skin products and is also sold on the gray market as an injectable with anti-ageing and tissue-healing claims. A topical gel was tested for diabetic foot ulcers in the 1990s; no approval of it was identified. It is not an FDA-approved medicine, and in the US FDA treats injectable and non-injectable use separately for compounding.
- US C gray market
- EU ? not verified
- UK ? not verified
- CA ? not verified
- AU ? not verified
- JP ? not verified
- CN ? not verified
01Regulatory status, by jurisdiction
| Jurisdiction | Status | Detail and primary source |
|---|---|---|
| US | FDA 503A Category 1 | Not FDA-approved. For non-injectable routes only, GHK-Cu is in 503A Category 1 (under evaluation) on FDA's list updated 14 May 2026. It had been removed from Category 1 on 22 April 2026 after nominations were withdrawn, and was restored after one nominator clarified that it had withdrawn only the injectable route. FDA states it intends to consult the Pharmacy Compounding Advisory Committee before the end of February 2027.“GHK-Cu (except for injectable routes of administration) will be added back to category 1.”Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (Updated May 14, 2026) · retrieved 2026-10-10 |
| US | Not approved | For injectable routes, GHK-Cu appears on FDA's list of substances nominated but withdrawn (previously in 503A Category 2), with FDA's stated risks. Page content current as of 22 April 2026.“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.”Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks · retrieved 2026-10-10 |
| EU UK CA AU JP CN | Not yet verified from a primary source. No status is shown rather than an unsourced one. | |
Sport (WADA): Prohibited · class S0. GHK-Cu is not named on the 2026 Prohibited List. As a pharmacological substance with no current regulatory approval for human therapeutic use, it falls within the general definition of class S0; how WADA treats its presence in topical cosmetic products was not verified: “Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use” WADA source
02What the human evidence shows
Diabetic foot ulcers (topical gel)
A multicentre, randomised, evaluator-blinded, vehicle-controlled trial of a GHK-copper gel (Iamin Gel) in diabetic neuropathic plantar ulcers, published in 1994, reported greater median ulcer closure and fewer infections than vehicle when added to standard wound care. The number of participants was not stated in the abstract reviewed. No confirmatory trial was identified, and no approval of the gel was found.
- [1] Greater median plantar ulcer closure and lower infection incidence than vehicle in a randomised, evaluator-blinded trial in patients with diabetes
Registered-study counts: ClinicalTrials.gov intervention search “GHK-Cu”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.
Skin ageing, wrinkles and post-procedure skin (topical cosmetic)
Topical GHK-Cu is widely used in cosmetics, but controlled clinical data are sparse. In a small randomised study of 13 patients after carbon-dioxide laser resurfacing around the mouth, skin products with GHK-Cu did not reduce redness or improve blinded ratings of wrinkles or skin quality compared with products without it; only patient-reported satisfaction differed. Other published cosmetic studies mostly test multi-ingredient products, so the contribution of GHK-Cu cannot be isolated.
- [2] No difference in erythema, wrinkles or blinded skin-quality ratings versus control regimen in 13 patients; higher patient-reported satisfaction
Registered-study counts: ClinicalTrials.gov intervention search “GHK-Cu”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.
Injected GHK-Cu for tissue healing, inflammation or anti-ageing
No human trial of any design has been published for this use.
No human study of injected GHK-Cu has been published. In rats, injections into the knee joint after ligament reconstruction improved knee laxity and graft stiffness at 6 weeks but not at 12 weeks. In mice with chemically induced colitis, GHK-Cu reduced inflammatory markers and colon damage. FDA states that there are limited data in humans to inform safety for injectable use.
- [3] Smaller knee laxity difference at 6 weeks but no difference at 12 weeks after ACL reconstruction in rats
- [4] Lower disease-activity scores and inflammatory cytokines in mice with DSS-induced colitis
Registered-study counts: ClinicalTrials.gov intervention search “GHK-Cu”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.
Key registered trials
| NCT | Title (as registered) | Phase | Status |
|---|---|---|---|
| NCT07437586 | Topical GHK-Cu Gel for Acute Skin Wound Healing | 2 | Recruiting |
03Safety signals
- Regulator-identified risk for injectable use [5]
FDA lists GHK-Cu for injectable routes among substances previously in 503A Category 2 whose nominations were withdrawn, citing immunogenicity risk from aggregation and peptide-related impurities and limited human data. This is a stated risk, not a documented case of harm.
04What is unknown
- No published human study of injected GHK-Cu, for efficacy, pharmacokinetics or safety
- How much topically applied GHK-Cu penetrates intact human skin is not established
- The 1994 diabetic ulcer trial has not been independently replicated, and its full participant numbers were not verified for this record
- Whether injected GHK-Cu alters copper balance or copper-related toxicity in humans has not been studied
- Purity, copper content and aggregation of gray-market injectable products are uncharacterised; FDA cites aggregation and impurities as an immunogenicity concern
- Regulatory status outside the US, including cosmetic-ingredient rules, was not verified from regulator sources for this record
05Product quality
No independent purity results have been published for this compound yet. The purity programme will publish full methods and vendor-named results, passes and failures, once its protocol has had legal review.
06Citations
- Enhanced healing of ulcers in patients with diabetes by topical treatment with glycyl-l-histidyl-l-lysine copper (1994). doi:10.1046/j.1524-475x.1994.20406.x
- Effects of topical copper tripeptide complex on CO2 laser-resurfaced skin (2006). doi:10.1001/archfaci.8.4.252
- Tripeptide-copper complex GHK-Cu (II) transiently improved healing outcome in a rat model of ACL reconstruction (2015). doi:10.1002/jor.22831
- Exploring the beneficial effects of GHK-Cu on an experimental model of colitis and the underlying mechanisms (2025). doi:10.3389/fphar.2025.1551843
- 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
Every DOI is resolved against Crossref and every NCT number against ClinicalTrials.gov, title for title, before publication. Regulatory sources are cited inline above with a verbatim quote and retrieval date.
07Mechanism
GHK forms a complex with copper(II) ions. In mice with chemically induced colitis GHK-Cu lowered inflammatory cytokines and increased SIRT1 protein expression; its molecular targets in human tissue are not established.
Mechanism is placed last on purpose: a plausible mechanism is not evidence that a compound works in people.
Reviewed by OSMF research team (AI-assisted, source-verified) on 2026-10-10. Found an error? It goes in the corrections log: report it.