# GHK-Cu: FDA Status, Research and Uses

> GHK-Cu copper peptide: FDA 503A status after the 2026 changes, cosmetic versus drug rules, topical human studies, safety notes and WADA status.

- Canonical URL: https://livingpluspeptides.com/peptides/ghk-cu/
- Last updated: October 25, 2026
- Publisher: Living+

GHK-Cu is a three-amino-acid peptide (glycyl-histidyl-lysine) bound to copper, found in human plasma. It is not an FDA-approved drug. Non-injectable GHK-Cu is in FDA 503A Category 1, while the injectable nomination was withdrawn in 2026. Topical GHK-Cu was studied for skin ulcers and laser-treated skin [1, 7, 9, 16].

## Regulatory status

- FDA approved: No
- 503A compounding: [Category 1 (may be compounded while FDA evaluates)](https://www.fda.gov/media/94155/download). Non-injectable routes only: removed from Category 1 on April 22, 2026 after nominators withdrew, then to be added back after a May 5, 2026 clarification (list updated May 14, 2026). Injectable GHK-Cu is on the 'nominated but withdrawn' list. PCAC consult planned before end of February 2027.
- 503B bulks list: [Not nominated](https://www.fda.gov/media/94164/download). Not on the FDA 503B nominated substances list (updated March 21, 2025).
- WADA prohibited: [Unclear](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf) (Not named on the 2026 or 2027 List. S0 (non-approved substances) may apply, since it covers substances no government has approved for human use. The 2027 List, in force January 1, 2027, adds peptides as an S0 example.)
- FDA drug shortage: [Not on the shortage list](https://api.fda.gov/drug/shortages.json?search=generic_name:%22GHK%22)
- DEA schedule: [Not scheduled](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)
- Last verified: November 2, 2026

Checked against: [FDA: 503A nominated bulk drug substances categories (updated May 14, 2026)](https://www.fda.gov/media/94155/download), [FDA: Certain bulk drug substances 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), [FDA: Upcoming Pharmacy Compounding Advisory Committee meeting](https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee), [FDA: 503B nominated bulk drug substances list (March 21, 2025)](https://www.fda.gov/media/94164/download), [FDA: Is it a cosmetic, a drug, or both?](https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap), [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf), [openFDA Drugs@FDA query: GHK (no matches)](https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22GHK%22), [openFDA drug shortages query: GHK](https://api.fda.gov/drug/shortages.json?search=generic_name:%22GHK%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: Copper-binding tripeptide (glycyl-L-histidyl-L-lysine-Cu2+) [11, 16]
- Amino-acid length: 3 amino acids, bound to a copper ion [11, 16]
- Half-life: Not established in humans; FDA notes limited human data [2]
- Route used in studies: Topical in human studies; injection into the joint in a rat study [7, 8, 9, 10]
- First studied: 1973 [5, 16]

## How it works

GHK is a tripeptide, a chain of just three amino acids: glycine, histidine and lysine. It binds tightly to copper, and the copper-bound form is called GHK-Cu. It is found naturally in human plasma. One review reports plasma levels of about 200 ng/mL at age 20, falling to about 80 ng/mL by age 60 [16].

The peptide was first reported in 1973. Researchers found a tripeptide in human serum that helped normal liver cells survive in the lab [5, 16]. A synthetic version was described the same year [6].

Most of what is known about how it acts comes from cell and animal studies. In skin cell cultures, GHK-Cu raised levels of MMP-2, an enzyme that remodels the tissue around cells. It also raised the enzyme's natural inhibitors, TIMP-1 and TIMP-2. Copper alone had a similar effect, but GHK without copper did not [11].

In a rat model of knee ligament surgery, GHK-Cu given into the joint was studied for graft repair. It improved some knee measures at 6 weeks, but the effect did not last to 12 weeks [10].

Cosmetic and drug use are separate. FDA says whether a product is a cosmetic or a drug depends on its intended use. A cream sold to change how skin looks can be a cosmetic, but claims to treat disease or affect body structure make it a drug [4].

## What the research shows

| Study | Year | Participants | Design | Result | Link |
| --- | --- | --- | --- | --- | --- |
| Human trial: Skin care after CO2 laser resurfacing (Miller et al.) | 2006 | 13 patients completed the study | Randomized, blinded-evaluator comparison of skin regimens with or without GHK-Cu | No significant difference in redness, wrinkles or skin quality. Patient-rated satisfaction was higher with GHK-Cu [9]. | [Source](https://pubmed.ncbi.nlm.nih.gov/16847171/) |
| Human trial: Topical GHK-Cu gel in diabetic foot ulcers (Mulder et al.) | 1994 | Adults with diabetic neuropathic foot ulcers | Multicenter, randomized, evaluator-blinded, placebo-controlled trial of a topical gel | Studied for diabetic ulcers. Median plantar ulcer closure was 98.5% with the GHK-Cu gel versus 60.8% with vehicle [7]. | [Source](https://pubmed.ncbi.nlm.nih.gov/17147644/) |
| Human trial: Venous stasis ulcer trial (Bishop et al.) | 1992 | 86 evaluable patients with venous stasis ulcers | Prospective, randomized, evaluator-blinded trial versus silver sulfadiazine and placebo | Studied for venous ulcers. The 0.4% tripeptide copper cream did not differ from placebo. Silver sulfadiazine reduced ulcer size more [8]. | [Source](https://pubmed.ncbi.nlm.nih.gov/1495150/) |
| Animal study: Rat ACL reconstruction (Fu et al.) | 2015 | Rats (72) | Randomized to saline or two GHK-Cu doses given into the joint weekly for 4 weeks | Less knee laxity at 6 weeks, with no difference at 12 weeks [10]. | [Source](https://pubmed.ncbi.nlm.nih.gov/25731775/) |
| Lab study: Dermal fibroblast cultures (Simeon et al.) | 2000 | Cell culture | Human skin fibroblasts exposed to GHK-Cu, copper, or GHK alone | GHK-Cu raised MMP-2, TIMP-1 and TIMP-2. Copper alone had a similar effect on MMP-2, GHK alone did not [11]. | [Source](https://pubmed.ncbi.nlm.nih.gov/11045606/) |
| Lab study: First report of the serum tripeptide (Pickart et al.) | 1973 | Cell culture | Liver cell and hepatoma cell culture study | Reported a tripeptide in human serum that prolonged survival of normal liver cells [5]. | [Source](https://pubmed.ncbi.nlm.nih.gov/4349963/) |

## Doses used in studies

The venous ulcer trial used a 0.4% tripeptide copper cream on the skin [8]. The diabetic ulcer trial used a metered daily dose of a topical gel, and the abstract does not give a strength [7].

In the rat study, GHK-Cu was given into the knee joint at 0.3 or 3 mg/ml, once a week for 4 weeks [10]. No injected dose has been tested in human trials found for this page, and FDA notes limited human data for injectable GHK-Cu [2].

**Dosing is set by a licensed provider.**

## Side effects and safety

There is no FDA-approved GHK-Cu drug and no FDA label, so there are no label side effect rates [1].

For injection, FDA said compounded injectable GHK-Cu may pose a risk of immune reactions because of possible clumping (aggregation) and peptide impurities. FDA also said there are limited data in humans to inform safety. This statement sits on FDA's page of bulk substances that may present significant safety risks [2].

The human trials found for this page tested topical products only, in small groups. The abstracts do not report serious side effects, but they were not designed to measure long-term safety [7, 8, 9].

Topical cosmetic use and drug use follow different rules. A cosmetic that claims to treat disease or change body structure is regulated as a drug [4].

- [FDA: Bulk substances that may present significant safety risks (GHK-Cu for injectable routes, nominated but withdrawn)](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) (2026-04-22)

## Legal and regulatory status

- 2026-05-14: FDA's updated 503A list says GHK-Cu (except injectable routes) will be added back to Category 1, after a nominator said on May 5, 2026 it meant to withdraw only the injectable route [1]. [Source](https://www.fda.gov/media/94155/download)
- 2026-05-14: FDA says it intends to consult its Pharmacy Compounding Advisory Committee on GHK-Cu before the end of February 2027. The meeting date is not set [1, 3]. [Source](https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee)
- 2026-04-22: FDA removed non-injectable GHK-Cu from Category 1 because nominators withdrew. Injectable GHK-Cu now appears on FDA's list of substances previously in Category 2 whose nominations were withdrawn [1, 2]. [Source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
- 2026-01-01: The WADA 2026 Prohibited List took effect. GHK-Cu is not named on it [12]. [Source](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
- 2020-04-01: An FDA warning letter to a compounding pharmacy listed GHK-Cu among bulk substances that did not meet section 503A at that time [13]. [Source](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-ghk-cu).

## Frequently asked questions

### Is GHK-Cu FDA approved?

No. There is no FDA-approved GHK-Cu drug [1]. It is used as a cosmetic ingredient, and FDA says intended use decides if a product is a cosmetic or a drug [4, 16].

### Can a compounding pharmacy make GHK-Cu?

As of FDA's May 14, 2026 update, GHK-Cu for non-injectable routes is being added back to 503A Category 1, substances under evaluation. The injectable nomination was withdrawn [1, 2]. GHK-Cu does not appear on the FDA 503B nominated list [14].

### Is injectable GHK-Cu legal?

Injectable GHK-Cu was previously in Category 2, and it left that category only because the nominator withdrew it. FDA still notes risks of immune reactions and limited human data [2]. No injectable GHK-Cu drug is FDA approved [1].

### What happens next for GHK-Cu?

FDA says it will consult its compounding advisory committee before the end of February 2027 about adding GHK-Cu to the 503A bulks list [1, 3].

### Is GHK-Cu in skin care the same as a drug?

Not always. A skin care product is a cosmetic if it is sold to change appearance, but claims to treat disease or affect body structure make it a drug [4].

### What has GHK-Cu been studied for?

Topical GHK-Cu was studied for diabetic foot ulcers, venous ulcers and skin care after laser resurfacing, with mixed results [7, 8, 9].

### Is GHK-Cu banned by WADA?

GHK-Cu is not named on the WADA 2026 List. The S0 class bans substances with no government approval for human therapeutic use, and WADA has not said whether that covers GHK-Cu [12].

### What are the risks of GHK-Cu injections?

FDA says compounded injectable GHK-Cu may cause immune reactions from clumping and impurities, and that human safety data are limited [2].

## Sources

1. [FDA: 503A nominated bulk drug substances categories (updated May 14, 2026)](https://www.fda.gov/media/94155/download)
2. [FDA: Certain bulk drug substances 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: Upcoming Pharmacy Compounding Advisory Committee meeting](https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee)
4. [FDA: Is it a cosmetic, a drug, or both?](https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap)
5. [Pickart et al. 1973, Nat New Biol (PubMed)](https://pubmed.ncbi.nlm.nih.gov/4349963/)
6. [Pickart et al. 1973, Biochem Biophys Res Commun (PubMed)](https://pubmed.ncbi.nlm.nih.gov/4356974/)
7. [Mulder et al. 1994, Wound Repair Regen (PubMed)](https://pubmed.ncbi.nlm.nih.gov/17147644/)
8. [Bishop et al. 1992, J Vasc Surg (PubMed)](https://pubmed.ncbi.nlm.nih.gov/1495150/)
9. [Miller et al. 2006, Arch Facial Plast Surg (PubMed)](https://pubmed.ncbi.nlm.nih.gov/16847171/)
10. [Fu et al. 2015, J Orthop Res (PubMed)](https://pubmed.ncbi.nlm.nih.gov/25731775/)
11. [Simeon et al. 2000, Life Sci (PubMed)](https://pubmed.ncbi.nlm.nih.gov/11045606/)
12. [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
13. [FDA warning letter to a compounding pharmacy (Apr 1, 2020)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020)
14. [FDA: 503B nominated bulk drug substances list (March 21, 2025)](https://www.fda.gov/media/94164/download)
15. [FDA: Bulk drug substances used in compounding under section 503A](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)
16. [Pickart and Margolina 2018, Int J Mol Sci (PMC)](https://pmc.ncbi.nlm.nih.gov/articles/PMC6073405/)

Educational information, not medical advice. This site sells nothing.