Needle-Free epinephrine film could transform emergency allergy care for kids

NCT ID NCT07703982

Completed Disease control Sponsor: Aquestive Therapeutics Source: ClinicalTrials.gov ↗

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study tests a new dissolving film called DESF that delivers epinephrine under the tongue. It is designed for children ages 7 to 17 who weigh at least 30 kg and have a history of allergic reactions that put them at high risk for severe episodes like anaphylaxis. The goal is to see how the body absorbs the drug, how safe it is, and how well it works compared to standard epinephrine injections. All participants receive a single dose of DESF and are monitored closely.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: a sublingual epinephrine film called DESF
What this could lead to: If successful, DESF could offer a needle-free way to deliver epinephrine quickly during severe allergic reactions, potentially making emergency treatment easier for children and caregivers.
What could go wrong: This is an early phase 1 study with only 32 children, focused on safety and drug levels, not on treating actual allergic reactions. It may not prove effective or safe enough for wider use.

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Conditions

The condition(s) this trial relates to.

allergic disease hypersensitivity reaction disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALLERGIC REACTION

Contacts and locations

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Locations

AllerVie Clinical Research

Birmingham, Alabama, 35209, United States
Children's Hospital Colorado

Aurora, Colorado, 80045, United States
Halton Pediatric Allergy

Burlington, Ontario, L7L 6W6, Canada
IAA Clinical Research

Wheaton, Maryland, 20902, United States
J. Lewis Research Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States
Rochester Regional Health AIR

Rochester, New York, 14607, United States
Texas Children's Hospital - Feigin Center

Houston, Texas, 77030, United States
UCLA Pediatric Allergy & Immunology

Los Angeles, California, 90095, United States

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