Is LL-37 legal? FDA status and US regulatory standing
Current status
Compounding nomination withdrawn. LL-37 was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists.
Primary source: www.fda.gov
Federal legal status
FDA approval status
LL-37 was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Human cathelicidin antimicrobial peptide. Phase 1/2 trials for wound healing. No FDA approval, no NDA. Early investigational stage only. Not commercially available in US.
Also known as
cathelicidin · CAP18
Frequently asked questions
- Is LL-37 FDA approved?
- LL-37 was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Primary source linked on this page.
- Is LL-37 legal to buy?
- LL-37 is available in the U.S. as a research-use-only compound. It was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Sale for human consumption is not permitted.
Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .