At a glance
- LL-37 (cathelicidin) is not an FDA-approved drug: Drugs@FDA has no record of it.
- It was on FDA's Category 2 safety-risk list until the nomination was withdrawn. A withdrawal is not an approval.
- PubMed lists 3,033 publications mentioning it, including 43 randomized controlled trials and 216 animal-only studies.
- ClinicalTrials.gov lists 20 registered studies testing it (2 active).
- FDA’s adverse event system (FAERS) has no reports mentioning it.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
FDA's stated risk · Original FDA text (English) Compounded drugs containing cathelicidin LL-37 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA lacks sufficient safety-related information regarding cathelicidin LL-37 to know whether the drug would cause harm when administered to humans. Nonclinical research findings suggest detrimental effects on male reproduction and that this drug can be protumorigenic in some tissues. Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Isotretinoin Alleviates Rosacea-like Inflammation by Partially Involving TET2 Upregulation and JAK2/STAT3 Suppression.
- A Multifunctional Biomimetic Hydrogel with Antibacterial and Antifibrotic Properties for Scar Minimizing Repair of Infected Skin Wounds.
- Association of Vitamin D Supplementation with VDR and CAMP Expression and Ulcer Healing in Diabetic Foot Infection Involving Biofilm-Forming Bacteria: An Exploratory Prospective Cohort Study.
- Association of Porphyromonas gingivalis peptidylarginine deiminase with CitH3, LL-37, and ACPA in periodontitis and rheumatoid arthritis.
- Antimicrobial Peptoids Show Potent Antifungal Activity against Candidozyma (Candida) auris In Vivo and Broad-Spectrum Activity In Vitro against Other Candida Species.
- MonoXtract: A Deep Learning Framework for Extracting Transmembrane Protein Dynamics from Single-Color Single-Molecule Imaging.
- Mechanism-Guided Antimicrobial Peptide Design through Membrane-Surface Fingerprinting and Graph Diffusion.
- Topical Remibrutinib Attenuates LL37-Induced Rosacea-Like Dermatitis by Inhibiting BTK Activation, NF-κB Signaling and Mast Cell Activation.
- Inflammatory memory as a potential driver of rosacea pathogenesis: integrating mechanisms of chronic relapse and perspectives on disease modification.
- Device-Free Auricular Acupressure for Rosacea: A Randomized Clinical Trial.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 20
- Active
- 2
- With posted results
- 4
Conditions studied
Show 10 more studies
| Study | Status | Phase | Start |
|---|---|---|---|
| Passive Smoking and LL-37 in Children | Completed | — | Nov 2016 |
| Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation. | Completed | Phase 1, Phase 2 | Jul 2016 |
| Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Major Surgical Procedures. | Withdrawn | Phase 3 | Feb 2016 |
| Intratumoral Injections of LL37 for Melanoma | Completed | Phase 1, Phase 2 | July 8, 2015 |
| Vitamin D Status in Lower Extremity Joint Replacement Surgery Patients | Withdrawn | N/A | Jan 2015 |
| Effects of Smoking and Vitamin D3 on the Levels of Human Cathelicidin Peptide LL-37 | Completed | — | Dec 2011 |
| Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation | Completed | Early phase 1 | Jul 2011 |
| Vitamin D in Ventilated ICU Patients | Completed | Phase 2 | Jul 2011 |
| Vitamin D in Active Tuberculosis (TB) Study | Withdrawn | N/A | Oct 2008 |
| Therapeutic Induction of Endogenous Antibiotics | Completed | Phase 2 | Jan 2005 |
All 20 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
No FAERS reports mention this peptide.
Change history
No changes since monitoring began on October 30, 2026.