FDA compounding-list review for non-injectable routes. FDA lists GHK-Cu, except injectable routes, in Category 1 for bulk substances under evaluation. That listing does not establish FDA approval, safety, or effectiveness.↗
Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.
Three selected human reports cover topical wound and post-laser skin care, plus a multi-ingredient intradermal hair formulation containing copper tripeptide-1. Formulation and route are kept separate. This is not an exhaustive review of GHK or GHK-Cu.↗↗↗
What the reviewed sources report
The selected topical studies had different findings: the ulcer study reported improved closure, while the small post-laser study found no objective advantage in erythema or skin appearance. The uncontrolled hair study cannot attribute changes to GHK-Cu alone or establish the safety of other injected formulations.↗↗↗
What remains unresolved?
Which outcomes are supported by adequately controlled studies of a clearly identified GHK-Cu formulation?↗↗↗
How do route, co-ingredients, study size, and follow-up limit what can be concluded about benefits and harms?↗↗↗
The May 14, 2026 nominations list restores GHK-Cu excluding injectable routes to Category 1, meaning under evaluation. FDA explains that a nominator clarified its withdrawal applied only to the injectable route. FDA PDF pp. 1, 2, 3 ↗
More findings and the sources behind them
Route-specific FDA nomination and safety records; these do not constitute approval of a finished product or proof of clinical benefit.
Injectable concerns remain separately documented
FDA’s safety page lists injectable GHK-Cu among withdrawn nominations, with concerns about aggregation, peptide impurities and immune responses, and limited human safety data. It should not be described as currently in Category 2 on that basis. FDA source ↗
What the next review could clarify
The May list announces an intention to consult the advisory committee before the end of February 2027 about potential inclusion on the 503A bulks list. An announced consultation is not a completed review or a finding of effectiveness. FDA PDF pp. 1, 2, 3 ↗
What remains to be checked
Verify any later committee materials or final agency action; keep injectable and non-injectable records separate.
Appraise the full texts of topical and combination studies before drawing conclusions beyond their populations and formulations.
Source dates and review coverage
PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Catalog-name and calibrated alias discovery for human evidence review. Complete query retrieval is separate from clinical eligibility, study-family linkage and appraisal.
306 retrieved · 3 included · 0 excluded · 303 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"GHK-Cu"[Title/Abstract] OR "GHK"[Title/Abstract] OR "copper tripeptide"[Title/Abstract] OR "glycyl-l-histidyl-l-lysine copper"[Title/Abstract] OR "glycyl-l-histidyl-l-lysine"[Title/Abstract] OR "Copper tripeptide-1"[Title/Abstract] OR "GHK copper"[Title/Abstract]
Retrieved IDs completely represent this query response, not all relevant literature. Additional aliases, references and non-PubMed sources require separate searches.
Unscreened records may include animal or cell experiments, reviews, secondary analyses, mixtures, protocols and unrelated name matches.
Study-family mappings use available declared registry IDs; unresolved mappings do not create independent trial counts. Full-text, corrections and registry comparison remain separate work.
GHK, copper complexes, sequence names and topical mixtures require separate identity and formulation decisions. A name hit is not evidence of injected GHK-Cu use.
Showing 25 of 306 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 29482481 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: ghk-cu-PMID29482481-registry-linkage-unresolved.Bibliographic record recheck · 2026-09-15
The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗
PubMed 16847171 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: ghk-cu-PMID16847171-registry-linkage-unresolved.Bibliographic record recheck · 2026-09-15
The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗
PubMed 17147644 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: ghk-cu-PMID17147644-registry-linkage-unresolved.Bibliographic record recheck · 2026-09-15
The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗
PubMed 42712263 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42635865 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42619529 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42586657 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42578445 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42575238 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42573538 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42510549 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42404628 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42354780 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42320090 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42245779 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42193036 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42185208 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42123471 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42084774 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42058630 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42047624 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42041438 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42032121 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42021992 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42016822 — not screened: Name-query match awaiting clinical eligibility screening.
FDA search
Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov search
ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.
2 retrieved · 0 included · 0 excluded · 2 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"GHK-Cu" OR "Copper tripeptide-1" OR "GHK copper" OR "glycyl-l-histidyl-l-lysine copper"
Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
Other registries, unregistered studies and additional aliases remain outside this query.
Showing 2 of 2 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT07437586 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07706361 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
Read the full Human Evidence Review
Supervised synthesis
What do selected human studies report about GHK-Cu?
Three selected human reports cover topical wound and post-laser skin care, plus a multi-ingredient intradermal hair formulation containing copper tripeptide-1. Formulation and route are kept separate. This is not an exhaustive review of GHK or GHK-Cu.123
Bottom line from this bounded source set
The selected topical studies had different findings: the ulcer study reported improved closure, while the small post-laser study found no objective advantage in erythema or skin appearance. The uncontrolled hair study cannot attribute changes to GHK-Cu alone or establish the safety of other injected formulations.123
A multicenter randomized, evaluator-blinded study compared a topical copper-peptide gel with vehicle alongside standardized wound care.1
Population
The report concerns patients with diabetic neuropathic ulcers; the PubMed abstract does not state the total sample size.1
Outcomes reported
The authors reported greater plantar-ulcer area closure and fewer infections in a selected immediate-treatment comparison. These are results for the studied topical formulation and wound-care setting.1
Limitations
Subgroup and treatment-timing comparisons require full-text assessment. The abstract alone does not establish overall healing benefit, general safety, or effectiveness by other routes.1
Reviewed study record
Post-laser skin care: small randomized comparison
Design
Patients receiving carbon-dioxide laser resurfacing were randomized to skin-care regimens with or without GHK-Cu.2
Population
Thirteen patients completed the study; outcomes were assessed through 12 weeks.2
Outcomes reported
Blinded and computer assessments found no significant between-group improvement in erythema resolution, wrinkles, or overall skin quality. Patient-reported skin-quality improvement favored the GHK-Cu regimen.2
Limitations
The sample was small, and subjective and objective findings differed. These findings do not establish a general anti-aging effect or apply to injectable use.2
Reviewed study record
Hair research: multi-ingredient formulation
Design
An open-label, single-arm pilot evaluated an intradermal formulation containing several growth factors and copper tripeptide-1.3
Population
The authors reported treating 1,000 patients with hair loss.3
Outcomes reported
The report described improvements in hair assessments and patient impressions and reported that treatment was well tolerated.3
Limitations
There was no control group and the formulation contained multiple active ingredients. The study cannot isolate a GHK-Cu effect or establish safety for GHK-Cu injections alone.3
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1046/j.1524-475x.1994.20406.x. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1001/archfaci.8.4.252. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1080/14764172.2018.1439965. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Explore status sources, recent additions, and coverage gaps
Living status brief
What is the current status of GHK-Cu?
FDA compounding-list review for non-injectable routes. FDA lists GHK-Cu, except injectable routes, in Category 1 for bulk substances under evaluation. That listing does not establish FDA approval, safety, or effectiveness.↗
The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected clinical trial records, regulatory records, and safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.
This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.
0 of 0 selected trial records include at least one phase value; 0 of 0 include a status value in the retained structured contract.
PubMed bibliography
Publication composition
4 of 16 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Publication typesJournal Article 4Review 1
Bibliography fields unavailable here for 12 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
0
FDA Federal Register documents
0
DailyMed SPL versions
0
Canonical profile
Published
Profile structured data
Published
Linked dated records
16
Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.
PubMed lists PMID 31815212 in ACS omega as Journal Article, with publication-date metadata of 2019-11-19 (day precision). PeptideScanner associated the retained record with the identity slug ghk-cu. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
PubMed lists PMID 37830186 in The Journal of organic chemistry as Journal Article, with publication-date metadata of 2023-10-13 (day precision). PeptideScanner associated the retained record with the identity slug ghk-cu. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
PubMed lists PMID 37896245 in Pharmaceutics as Journal Article, with publication-date metadata of 2023-10-18 (day precision). PeptideScanner associated the retained record with the identity slug ghk-cu. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.
These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.
Evidence summary
What the cited records say
FDA lists GHK-Cu, except injectable routes, in Category 1 for bulk substances under evaluation. That listing does not establish FDA approval, safety, or effectiveness.↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
PeptideScanner retained PubMed bibliographic metadata for PMID 42510549 at 2026-08-10T10:49:10.805Z. PubMed recorded a metadata revision date of 2026-07-30 and an Entrez history date of 2026-07-28. PeptideScanner associated this retained record with the identity slug ghk-cu. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 39451062 at 2026-08-10T18:13:36.036Z. PubMed recorded a metadata revision date of 2026-07-20 and an Entrez history date of 2024-10-25. PeptideScanner associated this retained record with the identity slug ghk-cu. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42084774 at 2026-08-10T18:13:48.846Z. PubMed recorded a metadata revision date of 2026-07-16 and an Entrez history date of 2026-05-05. PeptideScanner associated this retained record with the identity slug ghk-cu. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41997403 at 2026-08-10T18:13:46.888Z. PubMed recorded a metadata revision date of 2026-07-15 and an Entrez history date of 2026-04-17. PeptideScanner associated this retained record with the identity slug ghk-cu. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42041438 at 2026-08-10T18:13:48.795Z. PubMed recorded a metadata revision date of 2026-07-15 and an Entrez history date of 2026-04-27. PeptideScanner associated this retained record with the identity slug ghk-cu. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42245779 at 2026-07-30T16:14:18.092Z. PubMed recorded a metadata revision date of 2026-06-29 and an Entrez history date of 2026-06-05. PeptideScanner associated this retained record with the identity slug ghk-cu. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 37062921 at 2026-07-30T16:31:12.094Z. PubMed recorded a metadata revision date of 2026-01-27 and an Entrez history date of 2023-04-17. PeptideScanner associated this retained record with the identity slug ghk-cu. These dates describe PubMed metadata history, not the article's original publication date.↗
PubMed lists PMID 39795193 in Molecules (Basel, Switzerland) as Journal Article, Review, with publication-date metadata of 2025-01-01 (day precision). PeptideScanner associated the retained record with the identity slug ghk-cu. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 37830186 in The Journal of organic chemistry as Journal Article, with publication-date metadata of 2023-10-13 (day precision). PeptideScanner associated the retained record with the identity slug ghk-cu. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 37896245 in Pharmaceutics as Journal Article, with publication-date metadata of 2023-10-18 (day precision). PeptideScanner associated the retained record with the identity slug ghk-cu. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 31815212 in ACS omega as Journal Article, with publication-date metadata of 2019-11-19 (day precision). PeptideScanner associated the retained record with the identity slug ghk-cu. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 31500015 at 2026-07-30T20:34:13.000Z. PubMed recorded a metadata revision date of 2020-01-28 and an Entrez history date of 2019-09-11. PeptideScanner associated this retained record with the identity slug ghk-cu. These dates describe PubMed metadata history, not the article's original publication date.↗