PP / MONOGRAPH 055 Peptide or related research compound

LL-37

Discovery history, preclinical evidence, human studies, current FDA context, and the questions that still need to be answered.

Evidence is not equivalence.

Research on a named molecule does not establish that a catalog material is the studied drug product. Identity, sequence, salt, formulation, purity, sterility, route, labeling, and indication can change the scientific and regulatory conclusion.

ORIGIN / HISTORY

When was LL-37 first described?

The human cathelicidin precursor hCAP18 and its active peptide LL-37 were characterized by the Agerberth and Gudmundsson research groups in the mid-1990s. [1]

PRECLINICAL EVIDENCE

What do animal and laboratory studies show?

Preclinical wound/infection interest. [2]

Translation limitCell and animal findings can generate mechanisms and safety signals, but they do not predict clinical benefit on their own.

CLINICAL EVIDENCE

Are there human studies?

No qualifying human efficacy evidence was identified in the reviewed summary for the exact named material. A registry search is linked below so readers can check current recruiting, completed, terminated, or unpublished studies. [2][3]

Check the live study registry ↗

U.S. REGULATORY STATUS

Is LL-37 FDA cleared or approved?

Drug terminology: FDA generally approves drug products; “clearance” is typically a medical-device pathway.

FDA’s current compounding materials identify safety or evidence concerns relevant to LL-37 or a related named substance. Category or nomination status is not drug approval. This page does not identify an FDA-approved product corresponding to this catalog name; verify current records directly with FDA. [4][5][6]

RESEARCH OUTLOOK

Where is the scientific promise?

The scientific promise of LL-37 is a hypothesis for further testing, not a demonstrated product benefit. Useful next steps would include independent replication, validated identity and purity, dose–response and toxicology work, pharmacokinetics, prespecified endpoints, and properly registered human trials before clinical conclusions are drawn. [2][3]

LIMITATIONS / PRECAUTIONS

What should professionals keep in view?

Can be pro-inflammatory; unproven; safety-flagged and status contested (may remain restricted). [2]

Professional-use boundary

This page does not provide a diagnosis, treatment recommendation, protocol, dose, reconstitution instruction, route, or administration schedule. Any lawful program requires independent regulatory, quality, toxicology, and clinical review.

SOURCE REGISTER

References and live evidence maps

Primary papers support specific historical claims where available. PubMed and ClinicalTrials.gov links are live evidence maps, not proof that every result applies to the exact catalog material. FDA links should be rechecked because regulatory pages and product labels can change.