FDA's bulk drug substance safety review lists Cathelicidin LL-37 as a withdrawn compounding nomination. FDA states it lacks sufficient safety information to know whether the substance would cause harm in humans, and cites nonclinical research findings suggesting detrimental effects on male reproduction and protumorigenic activity in some tissues.[3]
- The cited nonclinical findings are animal/laboratory signals referenced in FDA's summary, not primary studies independently inspected in this batch, and do not establish human reproductive or cancer risk.
- This regulatory safety note is separate from, and does not modify, the topical wound-healing trial findings recorded elsewhere for this compound; the trials used topical LL-37, not the injectable/systemic exposure this FDA row concerns.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· New source relationship identified and added in the peptide-misc batch on 2026-09-09 while rereading the FDA bulk-safety page; proposed addition awaits independent editorial review.