U.S. Food and Drug Administration (FDA)
Is LL-37 legal in United States?
Not approvedNo FDA approval; FDA notes lab findings of possible harm to male reproduction and tumour promotion, and its advisers will look at it by February 2027
Not approved as a medicine here.
LL-37 (cathelicidin) is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and says FDA lacks safety information in humans, with non-clinical findings that suggest detrimental effects on male reproduction and possible tumour-promoting effects in some tissues. A law-firm report says the Pharmacy Compounding Advisory Committee will consider LL-37 before the end of February 2027. It is not on the 503A bulks list today.
Last verified 2026-09-29 · how we verify
LL-37 elsewhere
Sources (3)
- 01Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)U.S. Food and Drug Administration · 2026-04-22 · accessed 2026-09-29
- 02Bulk list bound? PCAC backs majority of peptides in two-day public meetingMcDermott Will & Schulte · 2026-07-27 · accessed 2026-09-29
- 03Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29