GHK-Cu official-source update · version 2

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Official-source update

Reviewed 2026-09-19 · Preserved version 2

FDA’s records distinguish non-injectable GHK-Cu

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

Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal. Earlier dated FDA and registry findings remain separately attributed below.

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FDA’s safety page lists injectable GHK-Cu among withdrawn nominations, with concerns about aggregation, peptide impurities and immune responses, and limited human safety data.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 ↗

A registered topical wound study is now identifiable

NCT07437586 describes a phase 2 study of topical GHK-Cu gel in healthy adults. In the February 27, 2026 registry update it is recruiting, with estimated enrollment of 60 and no posted summary results. NCT07437586 ↗

The comparison is within each participant

Each participant is to have two standardized wounds, one assigned to GHK-Cu gel and one to vehicle gel. This paired design means wound counts are not counts of independent people; it is not an injectable study. NCT07437586 ↗

The primary endpoint is complete wound closure

The registered primary outcome is time to complete re-epithelialization, assessed through day 21 using blinded examination and photographs. The entry describes what investigators plan to measure, not an observed acceleration of healing. NCT07437586 ↗

The selected population excludes impaired-healing conditions

The trial excludes diabetes, peripheral vascular disease and other conditions that could impair wound healing. Even eventual positive results in this population would not automatically establish benefit in chronic ulcers or with injected GHK-Cu. NCT07437586 ↗

What remains to be checked

Check later results and eligibility changes for NCT07437586; registration alone is not a clinical finding.
Appraise topical human reports and FDA follow-up separately from injectable claims and product mixtures.

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.

FDA 503A nominations list, May 14, 2026 ↗
Source dated 2026-05-14; retrieved 2026-09-16.
- GHK-Cu correction and Category 1 entry · PDF pp. 1, 2, 3 of 7
SHA-256: 94f3353f1bdf65ac1800dfe747c5efdc33fa542f1ba40344a31e2fe286614415
FDA bulk-substance safety concerns ↗
Source dated 2026-04-22; retrieved 2026-09-16.
- Bulk drug substances nominated but withdrawn: GHK-Cu (for injectable routes of administration)
SHA-256: 1a43f6d8b9da6b1fb5b2da83130882ec18e255f862c773d4cb636d67061c41cf
Topical GHK-Cu Gel for Acute Skin Wound Healing ↗
Source dated 2026-02-27; retrieved 2026-09-19.
- protocolSection.identificationModule, designModule and armsInterventionsModule
- protocolSection.eligibilityModule and armsInterventionsModule
- protocolSection.outcomesModule
- protocolSection.statusModule; presence or absence of resultsSection in retrieved record
SHA-256: c57f70defe49f90fc8b52b29a993f517a64f5ba334ae0a74250855355a452421

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