LL-37 is an innate-immune peptide, which puts it in conversations about host defense, inflammation, and tissue repair.
A future advisory review has been announced; the meeting and compound-specific evidence assessment are still pending.
What a visitor should know.
Technical details: aliases, tracked claims, and data record
2 names in this peptide family.
Cathelicidin LL-37 and LL-37 resolve to one record; FDA's forthcoming use-specific review remains separate.
4 evidence questions.
Human benefitAssessment pendingDoes LL-37 have established human clinical benefit for uses to be specified in forthcoming meeting materials?
FDA approvalNo FDA approval identifiedIs LL-37 FDA approved?
503A statusRegulatory recordIs LL-37 on FDA's final 503A Bulks List or generally permitted because of committee activity?
Identity transferIdentity-sensitiveAre every product, alias, form, and related compound labeled LL-37 automatically interchangeable?
See every LL-37 evidence question →Open the machine-readable record ↗FDA placed the meeting before the end of February 2027
LL-37 remains one of five substances on the agenda. FDA has not yet posted the exact meeting date or compound-specific briefing materials.
The review has a public time window.
No committee recommendation or FDA decision has occurred.
How the FDA record developed.
This timeline separates early nominations and scientific reviews from committee votes and final FDA decisions.
FDA placed the meeting before the end of February 2027
LL-37 remains one of five substances on the agenda. FDA has not yet posted the exact meeting date or compound-specific briefing materials.
Read the source ↗FDA announced a future advisory review
LL-37 was named among five bulk drug substances scheduled for committee consideration.
Read the source ↗What has actually been studied?
Human studies appear on the left. Animal, cell, and laboratory studies appear on the right because they cannot establish that a treatment works in people.
FDA says the advisory review will happen before the end of February 2027; the exact date is still pending.
Read the FDA review ↗In 148 patients with hard-to-heal venous leg ulcers, topical LL-37 did not significantly improve healing in the full study group versus placebo. A post-hoc subgroup finding requires confirmation.
Read the study on PubMed ↗Preclinical evidence will be classified when FDA posts the meeting briefing materials.
Important unknowns.
- FDA has identified limited or absent human safety information for the nominated use context.
- Peptide impurities, aggregation, immunogenicity, or API characterization may be material concerns.
- Compound-specific FDA concerns are linked in the source record.
These are evidence and regulatory uncertainties, not an individualized assessment of whether a treatment is appropriate.
Read the original sources.
Technical change history and comparison data
2 dated changes. 1 comparison groups.
These records show what each source added and whether it changed Peplyst's public conclusion.