This product is appropriate for researchers doing clinical work under an IND which has been, or will be, submitted to FDA prior to use in humans. US customers can request an authorizing cross reference letter to the drug master file allowing them to cite the DMF, thereby allowing for FDA review. Currently, this product is being used by major pharmaceutical companies and universities, as well as the NIH Clinical Center for human studies.
Endotoxin has been used to study a variety of conditions that can be modeled by an inflammatory challenge with endotoxin/lipopolysaccharide from E. coli type O113. Suffredini, et al, reported the effects of intravenous endotoxin and discussed its role in the study of experimental inflammation.4 Bridging studies evaluated the effects of LPS manufactured by List Labs, administered intravenously, and concluded that a lot produced by List Labs is safe and produced the expected acute self-limiting inflammatory responses including pro-inflammatory cytokine responses with the expected level of adverse effects.5,6,7,8
Endotoxin is used as an inflammatory challenge to study treatment modalities for a variety of conditions that can be induced, such as depression,9,10,11,12 lung inflammation13,14 and cardio-metabolic disease.15,16 Fullerton describes the use of endotoxin by IV challenge to reproducibly model acute or chronic inflammation and to study the effects of therapeutic interventions.17
By the inhalation route, LPS induces inflammation and dendritic cell maturation as a Toll-like receptor 4 (TLR4) ligand.18 Ex vivo preparation of experimental cancer vaccines have utilized LPS in the cocktail to mature dendritic cells.19,20