Peptide dossier, updated Oct 31, 2026

GHK-Cu

A three-amino-acid peptide (glycyl-histidyl-lysine) bound to copper. GHK is a natural tripeptide, and GHK-Cu is its copper complex, which is also used in cosmetic products. FDA’s safety-risk listing covers it “for injectable routes of administration” and says nothing we read about topical products. This page lays out what each source actually says.

See all 13 verified records for GHK-Cu on the Records page

FDA safety-risk page

Listed, injectable routes

FDA says compounded injectable drugs containing it may pose immunogenicity risk, and that there are limited data in humans to inform safety.

HHS enforcement, Oct 30

Not covered

Two law-firm summaries list the six peptides the draft policy covers. GHK-Cu is not one of them. We could not open the policy attachment itself.

FDA advisory panel, July

Not reviewed

FDA’s Federal Register notice for the July 23–24 meeting lists seven peptides. GHK-Cu is not among them.

WADA prohibited list

Not named

The 2022 and 2026 lists do not name GHK-Cu. Section S0 covers substances with no approval from any government health authority.

Human evidence

Small, mostly topical

A 2026 systematic review calls the human literature thin and fragmented, with small trials on facial creams. We found no study of injected GHK-Cu.

Human studies

ClinicalTrials.gov returns three records that test GHK-Cu, or a product built to change GHK-Cu levels, as of Oct 31, 2026.

Registry	Study	Sponsor	Status	What the record says
NCT07437586	Phase 2: topical GHK-Cu gel for acute skin wound healing	Hudson Biotech	Recruiting	Healthy adults get two small punch-biopsy wounds on the upper arm, each randomly assigned GHK-Cu gel or vehicle gel, assessed over 3 weeks with a scar follow-up. Planned 60 participants. One site, Peking University Shenzhen Hospital. Started Feb 2, 2026. First posted Feb 27, 2026. No results posted.
NCT07706361	Effects of the X39 patch on circulating GHK and GHK-Cu levels in healthy adults	LifeWave, Inc.	Not yet recruiting	Tests a patch, not GHK-Cu itself: whether it changes blood levels of GHK and GHK-Cu versus a placebo patch. Planned 100 participants. One site in London, Canada. Estimated start Jan 2027. First posted Jul 15, 2026.
NCT07888595	Early Phase 1: geroprotective agents and a topical anti-aging peptide serum, assessed with “aging clocks”	Frontiers in Bioscience Research Institute in Aging and Cancer	Enrolling by invitation	Adults take agents by mouth or by injection, and a skin serum of five small peptides, including GHK-Cu at about 1–3 mg/mL, goes on defined skin sites that are compared with untreated sites. GHK-Cu is not studied alone, and it is applied to the skin. Planned 48 participants. One site in Irvine, California. Estimated start Oct 21, 2026. First posted Oct 22, 2026. No results posted.

Same sponsor as flagged records. Hudson Biotech is also the sponsor of the BPC-157, TB-500, MOTS-c and Melanotan II records, which share the same site and a Feb 2, 2026 start. The TB-500 record’s summary calls itself a fictional example. The GHK-Cu record does not contain that wording. We cannot independently confirm any of these studies is running as described.

Registry entries are written by the sponsors and are not reviewed for scientific merit. A registered study is not a result.

FDA review

FDA’s safety-risk page (content current Apr 22, 2026) is the one FDA document on GHK-Cu that we read.

What FDA’s page says

FDA lists “GHK-Cu (for injectable routes of administration)” among bulk drug substances that were nominated and later withdrawn, previously in category 2 under its interim compounding policies.
It says compounded injectable drugs containing it may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities.
It says there are limited data in humans to inform safety-related considerations.

What we did not find

We found no FDA briefing document or advisory committee evaluation for GHK-Cu. FDA’s notice for the July meeting does not name it, so the safety-risk page entry is the only FDA statement on it that we read.
The page’s wording is limited to injectable routes. We found no FDA statement on topical GHK-Cu products.
Whether any topical GHK-Cu product is lawful to compound or sell is a separate legal question that we did not research.

Sources: FDA: bulk substances that may present significant safety risks Federal Register notice of the July meeting

Published research

PubMed returns 84 results for “GHK-Cu” in the title or abstract, plus 38 for the full tripeptide name. Many are materials, cosmetic-delivery and sensor studies. The human evidence is thin.

What the studies show

Laser-resurfaced skin, 2006. A randomized trial in which patients got post-treatment skin care with or without GHK-Cu after CO₂ laser resurfacing. 13 patients completed it. Blinded evaluators found no significant difference in erythema, and all patients improved. A questionnaire found a significant difference in overall skin quality favoring GHK-Cu (P = .04). Arch Facial Plast Surg PubMed
Systematic review, 2026. It retained 64 of 1,247 records and says the human literature is thin and fragmented, with most randomized trials small and on facial cosmetic creams. Arch Intern Med Res PubMed
Mouse preprint, 2026. Middle-aged mice given GHK-Cu intraperitoneally or intranasally. A preprint, not peer reviewed. Res Sq PubMed

Read with care

The human evidence we found is topical. FDA’s listing concerns injectable routes, and we found no study of injected GHK-Cu.
The 2006 trial was small, and its main objective measures showed no difference between groups.
Most recent papers are reviews, materials science or animal work.
We read abstracts only, not full text, funding or author disclosures. We did not assess the journals.

FDA warning letters

We found one FDA warning letter that names GHK-Cu. It is addressed to a compounding pharmacy and is not a finding about GHK-Cu’s safety. This rests on web searches, not a full pull of FDA’s database.

Recipient	Date	Letter	What it says
Tailor Made Compounding LLC, a compounding pharmacy	Apr 1, 2020	Warning letter 594743	FDA says an inspection found the firm compounding with a list of 22 bulk substances that includes GHK-Cu, and that drugs made from them were not eligible for the section 503A exemptions. The letter says none of them is covered by a USP or NF monograph or is a component of an FDA-approved drug, and that the listed substances “have not been nominated” for the bulks list. We read the letter text.

A warning letter is FDA’s statement about one firm’s conduct on one date. It is not a finding about the substance. FDA’s list of letters cannot be searched by peptide, so other letters could exist that we did not find.

SEC filings

We found two SEC filings that name GHK-Cu. EDGAR’s full-text search was not available to us, so this rests on web searches of sec.gov.

Filer	Filing	What it says
BioScience Health Innovations Inc.	Form 10-Q Filed May 11, 2026	Lists GHK-Cu among 14 peptides it expects to return to Category 1, following a Feb 27, 2026 statement by the HHS Secretary on a podcast. It also says it has a product containing GHK-Cu with two other peptides. It adds that reclassification would not be FDA approval and that formal rulemaking had not been published as of April 2026.
A Paradise Acquisition Corp.	Rule 425 filing Dated Mar 16, 2026	A shareholder email from its merger partner, Enhanced Ltd., lists GHK-Cu among “additional, already allowed peptides we plan to launch in the coming weeks.” We could not verify what “already allowed” refers to. FDA’s safety-risk page covers injectable GHK-Cu.

What a company says in a filing is its own claim about its business. It is not a finding about GHK-Cu. We read the passages naming GHK-Cu, not the whole documents.

Timeline

Newest first. Every entry links to the document it comes from.

Government or registry record
Journal

Oct 30, 2026Regulatory
HHS publishes draft policy pausing enforcement on six peptides; GHK-Cu is not one of them
Per two law-firm summaries the six are BPC-157, TB-500, epitalon, Semax, KPV and MOTS-c. The policy is a draft and not FDA approval. We could not open the policy attachment, so this rests on the summaries.
Federal Register Docket BakerHostetler summary
Oct 22, 2026Trials
Registry entry posted for a study that applies a five-peptide serum including GHK-Cu to skin
Estimated start Oct 21, 2026. GHK-Cu is one of five peptides and is applied topically.
NCT07888595
July 23–24, 2026Regulatory
FDA advisory committee meets on seven peptides; GHK-Cu is not among them
The committee recommended six of the seven, all nonbinding. FDA’s notice of the meeting does not list GHK-Cu.
Federal Register notice Holland & Knight summary
Apr 22, 2026Regulatory
FDA’s safety-risk page lists GHK-Cu
FDA says compounded injectable drugs containing GHK-Cu may pose immunogenicity risk and that human safety data are limited.
FDA page
Mar 16, 2026Filings
SEC filing describes GHK-Cu as an “already allowed” peptide
A company claim in a merger-related shareholder email. See SEC filings above.
SEC filing
Feb 2, 2026Trials
Topical GHK-Cu wound-healing study starts, per its registry entry
Hudson Biotech’s record was first posted Feb 27, 2026. See the sponsor note above.
NCT07437586
Apr 1, 2020Enforcement
FDA warning letter to a compounding pharmacy names GHK-Cu among 22 substances
The letter says drugs the firm compounded from these bulk substances were not eligible for the 503A exemptions.
Warning letter 594743
2006Literature
Randomized trial of GHK-Cu skin care after CO₂ laser resurfacing
13 patients completed it. Main objective measures showed no difference between groups.
PubMed

Still not covered

Left off rather than guessed:

Policy coverage: HHS’s list of covered peptides sits in a policy attachment we could not open. That GHK-Cu is outside it comes from two law-firm summaries, not from the document itself.
FDA review: We found no FDA briefing document or advisory committee evaluation for GHK-Cu. FDA’s notice for the July meeting does not name it, so the safety-risk page entry is the only FDA statement on it that we read.
Patents: not researched for this dossier.
Seller claims and independent lab reports: how it is marketed versus what testing finds. We have not collected testing data.
Topical products: FDA’s page covers injectable routes. We did not research the status of topical GHK-Cu.
Unread items: full text of every paper; WADA lists for years other than 2022 and 2026; EU and other non-US trial registries.
Warning letter and SEC completeness: web searches only.