Sepsis is a life-threatening organ dysfunction resulting from a dysregulated host response to infection. It is one of the leading causes of death among developed countries, with over 10% mortality rates in sepsis patients and over 40% in patients who develop septic shock. To manage sepsis, immediate interventions are required, which include infection control, hemodynamic restoration with fluid resuscitation and vasopressors, and other supportive care approaches. With the last FDA-approved drug for severe sepsis (Eli Lilly’s Xigris) withdrawn in 2011 due to its failure to show survival benefits, all current therapies for sepsis are either used off-label and/or are generically available. Therefore, opportunity exists for drug developers who can address key areas of unmet need. However, given the field’s limited understanding of sepsis pathophysiology, developers will likely face challenges during clinical development of their novel agents.
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