Regulatory status

Status at a glance

503A compounding status

Not nominated

We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.

Status recorded · FDA source document

Also known as
the Copper Peptide
FDA approval
Not FDA-approved for any use
503B outsourcing
Not determined
Anti-doping (WADA)
Not on the WADA Prohibited List
DEA schedule
Not a controlled substance

About peptide status

Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.

This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.

If you think you are having a medical emergency, call 911.

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Status as of

Key takeaway

GHK-Cu is a copper-binding tripeptide involved in tissue repair, sold on the wellness market as an injectable for skin, hair, and tissue repair. For this systemic use the evidence is preclinical, with no controlled human trials; its better-studied role is topical. As of 2026 the injectable/systemic use is not FDA-approved.

At a glance

FDA status
Not FDA-approved (systemic/injectable use)
What it is
Copper-binding tripeptide involved in matrix remodeling and repair
Research
For systemic use, evidence is animal and laboratory only; human data relate mostly to topical use
Topical form
Cosmetic form cataloged separately as Copper tripeptide-1
Evidence strength
Low research

Summary

GHK-Cu is a copper-binding tripeptide tied to tissue repair. See what animal and lab research shows, how it works, and why injectable use is not FDA-approved.

What is GHK-Cu?

GHK-Cu is the tripeptide glycyl-L-histidyl-L-lysine bound to copper. It occurs naturally in the body and declines with age, and it is one of the most studied "copper peptides." This entry concerns the systemic, injectable wellness use for skin, hair, and tissue repair; the topical cosmetic form is cataloged separately under its ingredient name, Copper tripeptide-1. The injectable use is not an approved medicine.

How does it work?

In laboratory and animal models, GHK-Cu is described as a signal for tissue remodeling. It is reported to:

  • Influence the extracellular matrix
  • Deliver copper
  • Act as an antioxidant and anti-inflammatory
  • Support new blood-vessel formation
  • Switch on gene programs linked to repair

These are cell and animal findings. This describes the proposed mechanism, separate from demonstrated benefit from systemic use in people.

Is it FDA-approved?

Safety note

Status: Not FDA-approved (systemic/injectable use)

Category: Wellness and performance · Primary body area: Skin & aging

No, not for systemic use. Injectable or systemic GHK-Cu is not an FDA-approved drug. Copper peptides sit in the contested peptide-compounding space; the FDA advisory committee reviewed several peptides in 2026, but those recommendations are non-binding and no additions to the compounding list have been finalized, so lawful compounding remains unsettled. (Topical cosmetic use is regulated separately as a cosmetic ingredient.)

What does the research show?

Editor’s note

Evidence strength: Low research (1 human · 2 animal/cell studies)

Systemic efficacy rests on animal and laboratory signaling data, with no controlled human trials for the injectable wellness use.

For systemic use, the evidence is preclinical. The table sets out what has been studied in each model, with both animal studies drawn from PubMed:

Study findings for GHK-Cu
Model Finding
RatInjected GHK-Cu transiently improved ligament-graft healing
MouseGHK-Cu reduced acute lung injury
HumanData essentially limited to topical cosmetic and wound contexts; no robust human trials establish efficacy or safety of injected GHK-Cu for skin, hair, or tissue repair

The systemic benefit is therefore an extrapolation from cell and animal work.

Sources: a rat ligament-healing study (Journal of Orthopaedic Research, 2015, DOI: 10.1002/jor.22831) and a mouse lung-injury study (Oncotarget, 2016, DOI: 10.18632/oncotarget.11168), indexed on PubMed. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.

Registered human trials

1 registered human trial on ClinicalTrials.gov that we reviewed

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