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Asthma Drug Zileuton Enters First Human Trial to Prevent Food Anaphylaxis

Northwestern University researchers are testing whether the drug can block leukotriene-driven allergen absorption in humans following mouse studies that showed nearly complete protection against anaphylaxis.

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Image
Woman pouring peanuts in measuring bowl.
Peanuts, along with shellfish and cow's milk, are among the most common foods that 1 in 10 people in the US are allergic to

Overview

  • Researchers identified the DPEP1 gene and a leukotriene-mediated gut pathway as key drivers of food-induced anaphylaxis in mice.
  • A single oral dose of zileuton, an FDA-approved 5-lipoxygenase inhibitor, reduced severe allergic reactions in mice by 95%, effectively reversing their risk of anaphylaxis.
  • In July 2025, the team launched a small, early-stage clinical trial to assess zileuton’s safety and its potential to prevent life-threatening food allergy reactions in people.
  • Repurposing zileuton leverages its established approval and safety profile to address the limited options for the 33 million Americans living with food allergies.
  • The research offers insight into why some individuals with positive allergy tests tolerate allergens and lays groundwork for improved diagnostic and preventive strategies.