Clinical Trials

Multiple clinical trials are evaluating lipopolysaccharides and endotoxin pathways across diverse indications, including eosinophilic asthma, non-alcoholic fatty liver disease, Parkinson's disease, and solid tumors. Ranging from Phase 1 and Phase 1/2 interventional trials to observational studies, these initiatives are sponsored by academic institutions, health centers, and industry partners. Recruitment statuses for these studies are reported as either completed or not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06270576 NOT_YET_RECRUITING
Asthma; Eosinophilic; Asthma
National Jewish Health
 2024-04 PHASE1
NCT06279286 Not yet recruiting
Insomnia Disorder
Jiangsu Hansoh Pharmaceutical Co. Ltd.
 2024-05 Phase 1|Phase 2
NCT06292598 Not yet recruiting
Narcolepsy Type 1|Bacterial Translocation
Centre Hospitalier Universitaire de Nīmes
 2024-05 --
NCT06131775 Not yet recruiting
All Types of Solid Cancer
Hospices Civils de Lyon
 2024-04-01 Not Applicable
NCT06342050 Not yet recruiting
Obesity|Metabolic Syndrome
University of Texas Southwestern Medical Center|National Institute on Minority Health and Health Disparities (NIMHD)
 2024-04 --
NCT02009592 COMPLETED
Fatty Liver; Steatohepatitis
Bezmialem Vakif University
 2013-06

(data from https://clinicaltrials.gov, updated on 2024-02-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lipopolysaccharide acts as a pathogen-associated molecular pattern that specifically binds to Toll-like receptor 4 (TLR4) on immune cells, triggering downstream intracellular signaling cascades and stimulating the secretion of pro-inflammatory cytokines and cell migrasomes. This receptor-mediated immune activation induces targeted mucosal and systemic inflammatory responses, making it a pivotal tool for investigating disease mechanisms in conditions such as eosinophilic asthma, fatty liver disease, and solid tumors.

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>).

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Note: Technical data last updated: Sep 1, 2026.