Dusquetide (also referred to by its research name SGX94) is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability. Preclinical data indicate that dusquetide is active in models of a wide range of therapeutic indications including severe side-effects of chemo- and/or radiation-therapy and life-threatening bacterial infections. Dusquetide, a novel Innate Defense Regulator, has demonstrated both nonclinical and clinical efficacy in ameliorating severe oral mucositis (SOM). Long term follow-up studies from the Phase 2 clinical study evaluating dusquetide as a treatment for SOM in head and neck cancer (HNC) patients receiving CRT have now been completed. Extended analysis indicates that dusquetide therapy was well-tolerated and did not contribute to increased infection, tumor growth or mortality. Potential ancillary benefits of duquetide therapy were also identified. A multi-center, double-blind, placebo-controlled, pivital Phase 3 clinical study in oral mucositis in head and neck cancer patients has been initiated.