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GHK-Cu
Pending PCAC review
as of October 2026
By Stephen Kimball, 26+ years researching the health, wellness, supplement, and peptide industries
As of October 2026, GHK-Cu’s status depends on how it’s used. For non-injectable uses (like creams), FDA put it back in Category 1 in May 2026, meaning the agency generally doesn’t act against pharmacies compounding it while it’s under review. Injectable GHK-Cu is different: its nomination was withdrawn, FDA still lists immunogenicity concerns (a risk of immune reactions), and no human safety data supports injecting it. FDA says it will consult its advisory panel on GHK-Cu before the end of February 2027. Injectable vials sold online come from “research use only” sellers with no FDA oversight.
Sources
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
U.S. Food & Drug Administration
dated May 2026
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (withdrawn table — "GHK-Cu (for injectable routes of administration)")
U.S. Food & Drug Administration
dated Apr 2026
Change log
September 2023
Lilly reports first Phase 3 (TRIUMPH-1) results.
April 2026
GHK-Cu nominations withdrawn; injectable GHK-Cu moves to the withdrawn table and non-injectable GHK-Cu is removed from Category 1.
May 2026
One nominator clarifies it meant to withdraw only the injectable nomination; FDA adds non-injectable GHK-Cu back to Category 1 and says it will consult PCAC before end of February 2027.