GHK-Cu official-source update · version 1

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Official-source update

Reviewed 2026-09-16 · Preserved version 1

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

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FDA’s safety page lists injectable GHK-Cu among withdrawn nominations, with concerns about aggregation, peptide impurities and immune responses, and limited human safety data.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

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- Bulk drug substances nominated but withdrawn: GHK-Cu (for injectable routes of administration)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

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