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This entry or formulation may be investigational and may not correspond to an FDA-approved product; safety and efficacy may not have been established. Kairo lists it for identification and record-keeping only.
Overview
Product & regulatory status
Experimental; the cited wound studies are not approval of a compounded injectable.
Local wound biology
The early trial investigated a host-defence peptide with wound-healing activity. Its biological rationale should be read alongside the subsequent negative overall trial. [1]
What the evidence shows
Small early wound trial
A 2014 randomized trial included 34 people with venous leg ulcers. Some LL-37 groups showed faster healing measures, but the highest-concentration group did not. This was a small exploratory topical study. [1]
Larger trial was negative overall
The 2021 HEAL LL-37 trial studied topical treatment alongside compression in 148 treated patients. Overall healing did not significantly improve versus placebo. A possible large-ulcer subgroup signal needs a specifically powered confirmatory trial. [2]
What remains unknown
There is no established benefit here for treating systemic infections, chronic unexplained symptoms or improving healthy people’s immune function. Topical tolerability cannot define injectable safety.
Safety
Unresolved biological risks
FDA cites insufficient human safety information and nonclinical findings involving male reproduction and tumour-promoting effects in some tissues. These are concerns, not proof that LL-37 causes cancer in people. [3]
Exact product identity
A research vial is not the topical trial formulation. Peptide impurities and characterization are specific issues identified by FDA. [3]
Understanding product quality
Compounded drugs are not FDA-approved finished products. Poor preparation can cause contamination or incorrect strength. A catalog entry or a research paper is not a quality assessment of your product. [4]
When to seek urgent help
Severe allergic symptoms such as trouble breathing, throat or tongue swelling, or fainting need immediate help. Call 911 or your local emergency number. This is general emergency information, not a complete list of risks for this compound. [5]
A starting point for discussion
This is not a complete list of adverse effects or interactions. Your health history, other medicines, and the exact formulation matter. Missing safety data is not evidence of safety.
Common questions
Does antimicrobial activity mean it can replace an antibiotic?
No. Laboratory activity does not establish effective clinical treatment, appropriate exposure or comparative safety.
Why distinguish topical from systemic use?
The wound trials evaluated local treatment with compression; exposure throughout the body is a materially different intervention.
Questions for your clinician
Does the evidence match my condition and this exact product? What risks or interactions matter for me? How would we assess whether it is helping?
Sources
- Grönberg et al.: topical LL-37 pilot trialWound Repair and Regeneration, 2014; randomized placebo-controlled venous-ulcer trial, 34 participants.
- HEAL LL-37 phase IIb trialWound Repair and Regeneration, 2021; topical LL-37 with compression therapy in 148 treated patients.
- FDA: peptide bulk-substance safety concernsFDA identifies route-specific immunogenicity, characterization and evidence gaps; withdrawn nominations are listed separately from current category 2.
- Compounding and the FDA: Questions and AnswersFDA · product quality and regulation
- AnaphylaxisMedlinePlus · recognizing an emergency
Educational information, not a recommendation to use a compound. Kairo does not give dosing advice. Review decisions with a licensed healthcare professional.