FDA-Approved Asthma Medication Zileuton Shows Promise in Preventing Severe Food Allergies in Mice

Fri 8th Aug, 2025

A recent study conducted by researchers at Northwestern University has revealed that Zileuton, an asthma medication already approved by the FDA, has the potential to significantly reduce life-threatening allergic reactions to food allergens in mice. This breakthrough could pave the way for innovative treatments for the millions of individuals suffering from food allergies.

The findings, published in the journal Science, highlight the discovery of a previously unknown role for the DPEP1 gene, which is essential in regulating anaphylaxis, a rapid and potentially fatal allergic reaction. By blocking the pathway associated with this gene using Zileuton, researchers observed a dramatic reduction in allergic responses among mice that were previously highly susceptible to food-induced anaphylaxis.

In the study, mice were administered peanut extract orally shortly after receiving Zileuton, with researchers monitoring for any symptoms of anaphylaxis. The results were remarkably positive, with 95% of the treated mice exhibiting little to no symptoms of allergic reactions. This treatment effectively reversed their risk from being 95% susceptible to 95% protected.

The research arose from a comprehensive genetic screening process, where scientists bred generations of mice to identify specific genes linked to biological differences, such as vulnerability to food allergies. Upon discovering that the DPEP1 gene influenced the production of leukotrienes in the gut--molecules already targeted by asthma medications--the team tested Zileuton, which inhibits the production of these inflammatory substances.

Food allergies have been on the rise, impacting more than 33 million individuals in the U.S., which is nearly one in ten people. Currently, there are only two FDA-approved treatments available for certain food allergies, and neither of them is a cure. The existing treatments include an oral immunotherapy for peanut allergies that may not be effective for everyone and a costly injection (omalizumab) that also has variable efficacy among allergic patients.

Zileuton presents a new approach, offering a simple pill that could provide temporary protection for allergic individuals by blocking the body's anaphylactic response before it can trigger. This innovative method of treating food allergies is unlike any previous attempts, as it addresses the underlying pathways that lead to severe reactions.

Furthermore, this research could elucidate a longstanding mystery in allergy medicine: why certain individuals test positive for food allergens yet do not exhibit any symptoms upon consumption. The newly identified pathway may provide insights into why some individuals remain tolerant to specific foods, despite having a recorded allergy.

The study's findings may open new avenues for future research, particularly in understanding how food allergies develop and why reactions vary among different individuals. This breakthrough has been made possible due to long-term investments in scientific research, underscoring the importance of persistent inquiry in the field.

The Northwestern research team is currently conducting a small early-stage clinical trial to evaluate the effectiveness of Zileuton in humans, assessing whether the results observed in mice can be replicated in human subjects.


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