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LL-37
Nomination withdrawn
as of October 2026
By Stephen Kimball, 26+ years researching the health, wellness, supplement, and peptide industries
As of October 2026, LL-37 isn’t approved for any use and isn’t on any list that would let pharmacies compound it. It left FDA’s safety-risk list in April 2026 because its nominators withdrew. FDA’s page still says the agency lacks enough safety information, and notes animal and lab findings suggesting harm to male reproduction and possible tumor-promoting effects in some tissues. A law firm reports LL-37 will go before FDA’s advisory panel before the end of February 2027; FDA hasn’t confirmed that. It’s sold today mainly by “research use only” sites.
Sources
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (withdrawn table — "Cathelicidin LL-37")
U.S. Food & Drug Administration
dated Apr 2026
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (categories list — LL-37 absent from Category 1)
U.S. Food & Drug Administration
dated May 2026
Change log
2023
FDA places cathelicidin LL-37 in Category 2.
April 2026
Moves to the “nominated but withdrawn” table; FDA’s safety note stays listed.
July 27, 2026
McDermott reports LL-37 will be considered at a PCAC meeting before end of February 2027.