GHK-Cu
Also sold as: Copper tripeptide-1, Glycyl-L-histidyl-L-lysine copper(II), GHK-Cu(II), Tripeptide-copper complex, TCC, Iamin
GHK-Cu is not approved by FDA for any use: FDA lists GHK-Cu in Category 1 of its 503A nomination process — under evaluation, which is not approval and not a finding of safety — and only for non-injectable routes, with FDA intending to consult its Pharmacy Compounding Advisory Committee about GHK-Cu before the end of February 2027. FDA has separately stated that injectable GHK-Cu may pose an immunogenicity risk and that there are limited data in humans to inform safety, and the only two randomised trials of GHK-Cu that have reported results were both topical and both reported no significant benefit on their objective endpoints.
Which molecule this is. The tripeptide glycyl-L-histidyl-L-lysine (GHK) complexed with copper(II). GHK and GHK-Cu are distinct substances, and FDA's Category 1 entry names only GHK-Cu. The older wound-healing literature calls the same complex 'tripeptide-copper complex' (TCC) or by the Procyte trade name Iamin, so a search for 'GHK-Cu' alone misses the two human RCTs that actually exist.
FDA status
FDA has not approved this and it is not in active development toward approval. That says nothing about whether it is being sold — most substances in this category are.
Not an FDA-approved drug for any indication, and not in active development toward approval. That says nothing about whether it is sold — it is.
“GHK-Cu (except for injectable routes of administration) was removed from category 1 on April 22, 2026, because the nominations for GHK-Cu were withdrawn by the nominators. On May 5, 2026, one of those nominators clarified that it intended to withdraw only its nomination of the injectable route of administration with respect to GHK-Cu and would like to retain its nomination for GHK-Cu for non-injectable routes of administration.”Checked against the source on .
503A compounding
FDA is evaluating this substance. Being under evaluation is not an approval, an endorsement, or a safety finding.
SCOPE IS EVERYTHING, AND THE SCOPE EXCLUDES INJECTION. Verified by fetching and text-extracting the list updated 2026-05-14: GHK-Cu appears exactly once in the categories, in Category 1, written as 'GHK-Cu (except for injectable routes of administration)'. It is not in Category 2 (which contains exactly six substances, and GHK-Cu is not among them) and not in Category 3. But do not read that as GHK-Cu never having carried a safety concern: FDA's safety-risks page lists 'GHK-Cu (for injectable routes of administration)' among substances PREVIOUSLY in category 2 and withdrawn by the nominators — see fdaFindings. Absence from the current Category 2 table reflects the withdrawal of the injectable nomination, not a resolution of the concern. The sequence was: nominations withdrawn 2026-04-22, removing it from Category 1 entirely; one nominator clarified on 2026-05-05 that it meant to withdraw only the INJECTABLE route; the non-injectable scope will be added back to Category 1. FDA has announced it intends to consult the Pharmacy Compounding Advisory Committee before the end of February 2027 regarding potential inclusion on the 503A bulks list — so GHK-Cu is NOT among the seven substances before PCAC on 2026-07-23/24. Two things this status is not. It is not the 503A bulks list — Category 1 means under evaluation, and evaluation is not approval, endorsement, or a safety finding. And it is not a licence for the injectable route, which is the one route the nominator affirmatively dropped.
“GHK-Cu (except for injectable routes of administration) was removed from category 1 on April 22, 2026, because the nominations for GHK-Cu were withdrawn by the nominators. On May 5, 2026, one of those nominators clarified that it intended to withdraw only its nomination of the injectable route of administration with respect to GHK-Cu and would like to retain its nomination for GHK-Cu for non-injectable routes of administration.”Checked against the source on .
Evidence
There is human data, but efficacy is not established. This includes programmes that were tested and failed.
THE TRIAL COUNT IS REAL AND IT POINTS THE WRONG WAY. Both cited studies were opened and confirmed to ADMINISTER GHK-Cu to humans — neither is an endogenous-biomarker study — and both are null on their objective endpoints. Bishop 1992 (J Vasc Surg, n=86 evaluable, venous stasis ulcers, randomised, evaluator-blinded, vehicle-placebo-controlled): tripeptide-copper complex 0.4% cream was NO DIFFERENT FROM PLACEBO, and silver sulfadiazine beat both. This is a controlled human trial in which GHK-Cu failed. Miller 2006 (Arch Facial Plast Surg, n=13 completers, CO2 laser-resurfaced circumoral skin, randomised): researchers reported no statistically significant difference between groups for resolution of erythema, and no significant improvement in wrinkles or overall skin quality on objective evaluation; only a patient-completed questionnaire reached significance (P = .04). Limitations: thirteen completers, and the single positive endpoint is self-reported satisfaction in a trial whose blinded and computer-analysed endpoints were negative. Tier reasoning: not animal-or-in-vitro-only, because genuine human administration RCTs exist; not no-credible-evidence, because controlled ANIMAL wound-healing data reporting benefit does exist (rabbit and rat models); not proven-in-humans, because the human trials did not establish efficacy. 'Promising-but-unproven' is the enum's bucket for programmes that were tested and failed, which is what this is — the label is more generous than the data. ROUTE ASYMMETRY: both human RCTs are TOPICAL. We found no human administration data for injectable GHK-Cu by any route, at any phase — which is precisely the route being sold and precisely the route whose nomination was withdrawn. NOT COUNTED, DELIBERATELY: NCT07437586 ('Topical GHK-Cu Gel for Acute Skin Wound Healing') is a Hudson Biotech registration — a sponsor that sells research peptides — start date 2026-02-02, still RECRUITING, hasResults false. It matches the contamination pattern of eight registrations from one sponsor and one site, all starting February 2026. A registration is a self-reported filing, not evidence, and this one has produced no data. Also not counted: Watson 2009 (Br J Dermatol), which vendor pages and AI summaries routinely cite as GHK-Cu's strongest human evidence. We read it. It tests an unnamed over-the-counter 'cosmetic anti-ageing product' and never identifies GHK-Cu as an ingredient anywhere in the record, so it cannot support a GHK-Cu claim — and its own 6-month between-group comparison for facial wrinkles was non-significant regardless.
“Silver sulfadiazine 1% in a cream proved to statistically reduce the ulcer size compared with a biologically active tripeptide copper complex 0.4% cream formulation or the placebo. There was no difference between the latter two treatments.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA has not made any determination on GHK-Cu. It is in Category 1 — under evaluation — for non-injectable routes only, and FDA intends to consult the Pharmacy Compounding Advisory Committee before the end of February 2027 regarding its potential inclusion on the 503A bulks list.
Unlike the seven substances before PCAC on 2026-07-23/24, GHK-Cu has no FDA briefing document, so there is no full FDA efficacy review of GHK-Cu to quote and no 'we propose not adding' finding, because FDA has not yet written one. The absence of that finding is not a positive FDA finding — it is a pending evaluation with a stated deadline. CORRECTED 2026-07-16: an earlier version of this note said GHK-Cu had 'no published FDA safety or efficacy review to quote' at all. That was wrong, and wrong in the direction that flatters the compound. FDA has published a safety characterisation of the INJECTABLE route on its safety-risks page — immunogenicity risk, limited human data — quoted in full below. What GHK-Cu lacks is a PCAC briefing document, which is a narrower claim than the one this note used to make.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026“FDA has announced it intends to consult the Pharmacy Compounding Advisory Committee (PCAC) before the end of February 2027 regarding the potential inclusion of GHK-Cu on the 503A bulks list.”
Checked against the source on .The injectable route of administration is excluded from the surviving nomination, so the route most commonly sold to consumers is not the route FDA is evaluating.
The Category 1 entry is written verbatim as 'GHK-Cu (except for injectable routes of administration)'. Read plainly: a nominator withdrew the injectable nomination and kept the non-injectable one. Any future addition to the bulks list under this nomination would carry the same carve-out. Coverage framing this as 'GHK-Cu is back in Category 1' drops the parenthetical, which is the only part that determines what a compounder could ever lawfully make.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .FDA has published a safety characterisation of INJECTABLE GHK-Cu specifically: it lists 'GHK-Cu (for injectable routes of administration)' among bulk drug substances it describes as previously in category 2 — its category for substances that may present significant safety risks — and withdrawn by the nominators. FDA's stated concern is immunogenicity, and FDA characterises the human data as limited.
THIS IS THE FDA FINDING THE RECORD PREVIOUSLY LACKED, AND IT INVERTS THE OBVIOUS READING OF THE CARVE-OUT. The 503A bulks list alone makes the injectable exclusion look like a clerical act — a nominator narrowing its own paperwork. This page shows FDA had already written a significant-safety-risk characterisation for the injectable route. The two documents are consistent and they are not the same fact: one records that the injectable nomination is gone, the other records what FDA said about it while it was there. Scope discipline, because the sentence is quotable and therefore easy to over-read. 'There are limited data in humans to inform safety-related considerations' is FDA reporting an ABSENCE OF INFORMATION, not a finding of harm. It is not evidence that injectable GHK-Cu hurt anyone; no such evidence is cited here or anywhere we found. It is also not evidence that it is safe — an agency saying it lacks the data to know is the opposite of an agency saying there is nothing to find. Two limits we hold deliberately. The table mixes the 503A and 503B interim policies and has no date column, so we do not say under which policy or from when injectable GHK-Cu was in category 2. And note the polarity of the parentheticals across the two documents: Category 1 covers GHK-Cu '(except for injectable routes of administration)'; this page covers GHK-Cu '(for injectable routes of administration)'. The route that FDA flagged is exactly the route the surviving nomination excludes, and exactly the route the market sells.
Certain Bulk Drug Substances for Use in Compounding May Present Significant Safety Risks — FDA, 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.”
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Documented safety signals
One serious FAERS report (safetyreportid 25484639, received 2025-06-26) names GHK-Cu as a CONCOMITANT — not a suspect — product in an anaphylactic shock event whose sole suspect drug was sermorelin acetate. The reported reactions include anaphylactic shock, syncope, loss of consciousness, decreased blood pressure and decreased heart rate.
THE CODING IS THE FINDING — DO NOT ATTRIBUTE THIS EVENT TO GHK-Cu. In this report GHK-Cu carries drugcharacterization=2, which openFDA's own field reference defines as 'Concomitant (the drug was reported as being taken along with the suspect drug)'. BPC-157 is likewise coded 2. Only SERMORELIN ACETATE is coded drugcharacterization=1 (Suspect), and it is the only drug in the report carrying a route (058) and an indication (growth hormone deficiency); no route or indication is recorded for GHK-Cu at all. So the reporter did not identify GHK-Cu as a cause — the report affirmatively records it as a drug taken alongside the one that was suspected. It is also a consumer report (primary source qualification 3), unverified by a health professional, and it is exactly one report — the entire FAERS return for this query is one record. We record it because it is the only documented human safety report naming GHK-Cu that we could find, and because omitting it would be as dishonest as overstating it. It establishes that a person who used GHK-Cu had a serious event attributed by the reporter to a different drug. It establishes nothing about GHK-Cu's causation, and it is not a GHK-Cu safety finding.
FDA Adverse Event Reporting System (FAERS) — public dashboard API, GHK-Cu query — FDA, 26 June 2025“{"drugcharacterization": "2", "medicinalproduct": "GHK-Cu"}”
Checked against the source on .A 2026 narrative review in the American Journal of Sports Medicine reported that no clinical data support the use of GHK-Cu for musculoskeletal conditions.
A narrative review, not primary data — cited for its scope statement, not as evidence of effect. Relevant here because it is the injectable-orthopaedic market that the reviewers surveyed, and it is the injectable route that the 503A nomination excludes. The same review notes that indications, dosing, frequency and duration remain unknown for these peptides generally.
Injectable Peptide Therapy: A Primer for Orthopaedic and Sports Medicine Physicians — PubMed, 1 January 2026“GHK-Cu showed promise in wound healing and anti-inflammatory effects, but no clinical data support its use for musculoskeletal conditions.”
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Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Did GHK-Cu become legal again when FDA put it back in Category 1?
No. Category 1 on FDA's 503A list means a substance is under evaluation for possible future inclusion on the compounding bulks list — it is not FDA approval, not a finding that GHK-Cu is safe, and not permission to sell, buy, or use it. GHK-Cu was removed from Category 1 on April 22, 2026 because its nominators withdrew the nominations, and it returns only in the narrowed form FDA writes verbatim as 'GHK-Cu (except for injectable routes of administration)' after one nominator clarified on May 5, 2026 that it had meant to withdraw only the injectable route. Nothing in that sequence was granted to anyone: the status moved sideways, not toward legality.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026“GHK-Cu (except for injectable routes of administration) was removed from category 1 on April 22, 2026, because the nominations for GHK-Cu were withdrawn by the nominators.”
Checked against the source on .- Is injectable GHK-Cu legal to buy or compound in 2026?
No route of GHK-Cu is FDA-approved, and the injectable route is the one route excluded from the only GHK-Cu nomination FDA is still evaluating — its Category 1 entry reads 'GHK-Cu (except for injectable routes of administration)'. FDA's safety-risks page separately lists 'GHK-Cu (for injectable routes of administration)' among substances it describes as previously in category 2 — FDA's category for substances that may present significant safety risks — and withdrawn by the nominators, stating that compounded injectable GHK-Cu may pose a risk for immunogenicity and that there are limited data in humans to inform safety. Injectable GHK-Cu is nonetheless the form most widely sold.
Certain Bulk Drug Substances for Use in Compounding May Present Significant Safety Risks — FDA, 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.”
Checked against the source on .- Is there any human evidence that GHK-Cu works?
Two randomised controlled trials have administered GHK-Cu to humans and reported their results, and both reported no significant benefit on their objective endpoints. In a 1992 evaluator-blinded trial of 86 evaluable patients with venous stasis ulcers, researchers reported that a tripeptide copper complex cream was no different from placebo, and that silver sulfadiazine cream outperformed both. In a 2006 randomised trial of 13 completers with CO2 laser-resurfaced skin, researchers reported that computer analysis and blinded evaluators found no statistically significant difference between groups. Both trials were topical; no human trial data for injectable GHK-Cu was found by any route.
A prospective randomized evaluator-blinded trial of two potential wound healing agents for the treatment of venous stasis ulcers — PubMed, 1 August 1992“Eighty-six evaluable patients completed the trial. Silver sulfadiazine 1% in a cream proved to statistically reduce the ulcer size compared with a biologically active tripeptide copper complex 0.4% cream formulation or the placebo. There was no difference between the latter two treatments.”
Checked against the source on .- Does GHK-Cu help skin healing or wrinkles after laser resurfacing?
Not on any objective measure, in the one randomised trial that tested it. Researchers reporting on 13 patients who completed a 2006 randomised trial of circumoral CO2 laser-resurfaced skin found no statistically significant difference between the copper tripeptide complex group and the control group for earlier resolution of erythema, on both computer analysis and blinded evaluator assessment. Every patient in the trial improved significantly in wrinkles and overall skin quality, but the researchers reported no difference between the groups — so the improvement tracked the laser resurfacing, not the group assignment. One endpoint did separate: on a patient-completed questionnaire, researchers reported a significant difference in improvement of overall skin quality favouring the GHK-Cu group (P = .04). That endpoint is self-reported, in a trial whose blinded and computer-analysed endpoints were negative. GHK-Cu is not FDA-approved for wound healing, skin healing, or any other indication.
Effects of topical copper tripeptide complex on CO2 laser-resurfaced skin — PubMed, 1 July 2006“Thirteen patients completed the study. Computer analysis and blinded evaluators found no statistically significant differences between groups for earlier resolution of erythema. All the patients experienced significant improvement in wrinkles and overall skin quality, but no differences were found between groups. The results of the questionnaire indicated a significant difference in the posttreatment improvement of overall skin quality for patients using GHK-Cu (P = .04).”
Checked against the source on .- Who withdrew the GHK-Cu nomination, and why does it matter?
Private nominators withdrew it, not FDA. In an April 14, 2026 filing to FDA docket FDA-2015-N-3534, Wells Pharmacy Network withdrew its nominations of twelve peptide bulk drug substances, listing GHK-Cu fifth. This matters because it establishes the direction of the change: the parties seeking to have GHK-Cu evaluated for compounding gave up on that request. FDA granted nothing, approved nothing, and made no finding about GHK-Cu in the process.
Withdrawal from Wells Pharmacy Network — Docket FDA-2015-N-3534 — Regulations.gov (FDA), 14 April 2026“Wells Pharmacy Network hereby withdraws the following nominations of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act: 1. Emideltide (DSIP) 2. BPC-157 3. Semax 4. Epitalon (Epithalon) 5. GHK-Cu 6. Melanotan II ...”
Checked against the source on .- Was GHK-Cu withdrawn by more than one nominator?
Yes — two separate filers withdrew GHK-Cu on the same day, April 14, 2026, in FDA docket FDA-2015-N-3534. Wells Pharmacy Network withdrew twelve peptide bulk drug substances, and LDT Health Solutions, Inc. separately withdrew six, GHK-Cu among them. That both filings landed together is why FDA's 503A bulks list refers to 'the nominators' in the plural, and why it records that only one of them later clarified it had meant to withdraw just the injectable route — the clarification that produced the surviving Category 1 entry for non-injectable routes. Neither filing is an FDA action, and neither says anything about whether GHK-Cu works or is safe.
Withdrawal from LDT Health Solutions, Inc. — Docket FDA-2015-N-3534 — Regulations.gov (FDA), 14 April 2026“LDT Health Solutions, Inc. hereby withdraws the nomination of Emideltide (DSIP), BPC-157, Semax, Epitalon, GHK-Cu, and Melanotan II to Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act ...”
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