LL-37 acetate Clinical Trials

Size	Price	Qty
5mg	USD 290
25mg	USD 870

Clinical Trials

Multiple clinical trials ranging from Early Phase 1 to Phase 2 evaluate the biological function and therapeutic applicability of LL-37 in oral and systemic inflammatory and infectious conditions, including periodontitis, peri-implantitis, oral potentially malignant lesions, rosacea, diabetic foot ulcers, and tuberculosis. Predominantly academic endeavors sponsored by institutions such as Universidad Rey Juan Carlos, Cairo University, and the University of California, San Diego, these studies encompass recruitment statuses including completed, not yet recruiting, withdrawn, and terminated. Key completed evaluations have assessed LL-37 levels and pathways in conditions like periodontal disease and rosacea.

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NCT00788320	WITHDRAWN	Tuberculosis	Atlanta VA Medical Center	2008-10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 LL-37 acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LL-37 acetate binds directly to negatively charged bacterial membrane lipids and host cell surface receptors, inducing membrane permeabilization and altering downstream pro-inflammatory signaling cascades. This membrane disruption and receptor interaction result in rapid microbial cell lysis and attenuated cytokine expression, thereby controlling infection and resolving mucosal inflammation in conditions such as periodontitis, rosacea, and diabetic foot ulcers.

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>).