LL37 (Human cathelicidin) Clinical Trials

Size	Price	Qty
5mg	USD 359
25mg	USD 970

Clinical Trials

LL37 has been evaluated across multiple clinical trials investigating diverse dermatological, infectious, and oncological conditions. Academic and medical research institutions—including the University of California, San Diego, M.D. Anderson Cancer Center, and Emory University—have sponsored studies spanning Early Phase 1, Phase 1, and Phase 2. Key indications under investigation include dermatological disorders such as rosacea (NCT01398280, NCT02806414) and diabetic foot ulcers (NCT04098562), alongside oncological evaluations in melanoma (NCT02225366) and infectious or metabolic states including tuberculosis, HIV/AIDS, and smoker lung associated with vitamin D deficiency. Recruitment statuses across these trial records encompass completed, unknown, withdrawn, and terminated phases of clinical study.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02225366	COMPLETED	Melanoma	M.D. Anderson Cancer Center	2015-07-08	PHASE1; PHASE2
NCT04098562	UNKNOWN	Diabetic Foot Ulcer	Fakultas Kedokteran Universitas Indonesia	2019-10	PHASE2
NCT02806414	COMPLETED	Rosacea	University of California, San Diego	2016-07	PHASE1; PHASE2
NCT03270709	TERMINATED	HIV/AIDS; Vitamin D Deficiency; Smoker Lung	Emory University	2018-04-11	PHASE1
NCT01398280	COMPLETED	Rosacea	University of California, San Diego	2011-07	EARLY_PHASE1
NCT00788320	WITHDRAWN	Tuberculosis	Atlanta VA Medical Center	2008-10

(data from https://clinicaltrials.gov, updated on 2021-12-09)

Check the LL37 (Human cathelicidin) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LL37 acts as an amphipathic antimicrobial peptide that electrostatically interacts with bacterial cell membranes and cell-surface receptors, mediating membrane permeabilization and downstream immunomodulatory signaling cascades. This dual disruption of microbial integrity and recruitment of immune effector cells suppresses local infection while modulating tissue inflammation, providing a therapeutic rationale for its evaluation in clinical trials for rosacea, diabetic foot ulcers, and melanoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).