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Peptide profile

GHK-Cu: FDA Status, Research and Uses

By Living+. Updated October 25, 2026.

Key takeaway

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 Non-injectable GHK-Cu is in FDA 503A Category 1, while the injectable nomination was withdrawn in 2026.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].

At a glance

Where it stands

Checked

  • FDA approvedNoNo approved product
  • Pharmacy compounding (503A)Category 1Non-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 Injectable GHK-Cu is on the 'nominated but withdrawn' list.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.
  • Outsourcing facilities (503B)Not nominatedNot on the FDA 503B nominated substances list (updated March 21, 2025).
  • WADA (sport)UnclearNot 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.
Same data as the Status Tracker. Checked against 9 sources

Key facts

Class
Copper-binding tripeptide (glycyl-L-histidyl-L-lysine-Cu2+) [11, 16]
Length
3 amino acids, bound to a copper ion [11, 16]
Half-life
Not established in humans; FDA notes limited human data [2]
Route 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

3 human trials1 animal study2 lab studies

  1. 2006Human trial

    Skin care after CO2 laser resurfacing (Miller et al.)

    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].

    Read the study
  2. 1994Human trial

    Topical GHK-Cu gel in diabetic foot ulcers (Mulder et al.)

    Studied for diabetic ulcers

    Adults with diabetic neuropathic foot ulcers Multicenter, randomized, evaluator-blinded, placebo-controlled trial of a topical gel

    Median plantar ulcer closure was 98.5% with the GHK-Cu gel versus 60.8% with vehicle [7].

    Read the study
  3. 1992Human trial

    Venous stasis ulcer trial (Bishop et al.)

    Studied for venous ulcers

    86 evaluable patients with venous stasis ulcers Prospective, randomized, evaluator-blinded trial versus silver sulfadiazine and placebo

    The 0.4% tripeptide copper cream did not differ from placebo. Silver sulfadiazine reduced ulcer size more [8].

    Read the study
  4. 2015Animal study

    Rat ACL reconstruction (Fu et al.)

    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].

    Read the study
  5. 2000Lab study

    Dermal fibroblast cultures (Simeon et al.)

    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].

    Read the study
  6. 1973Lab study

    First report of the serum tripeptide (Pickart et al.)

    Cell culture Liver cell and hepatoma cell culture study

    Reported a tripeptide in human serum that prolonged survival of normal liver cells [5].

    Read the study

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].

Common 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)
  2. FDA: Certain bulk drug substances that may present significant safety risks
  3. FDA: Upcoming Pharmacy Compounding Advisory Committee meeting
  4. FDA: Is it a cosmetic, a drug, or both?
  5. Pickart et al. 1973, Nat New Biol (PubMed)
  6. Pickart et al. 1973, Biochem Biophys Res Commun (PubMed)
  7. Mulder et al. 1994, Wound Repair Regen (PubMed)
  8. Bishop et al. 1992, J Vasc Surg (PubMed)
  9. Miller et al. 2006, Arch Facial Plast Surg (PubMed)
  10. Fu et al. 2015, J Orthop Res (PubMed)
  11. Simeon et al. 2000, Life Sci (PubMed)
  12. WADA: 2026 Prohibited List
  13. FDA warning letter to a compounding pharmacy (Apr 1, 2020)
  14. FDA: 503B nominated bulk drug substances list (March 21, 2025)
  15. FDA: Bulk drug substances used in compounding under section 503A
  16. Pickart and Margolina 2018, Int J Mol Sci (PMC)

Updated October 25, 2026. Educational information, not medical advice.