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

NCT ID NCT07703982

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

32 people

The number who actually took part.

Started

Dec 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female children ages 7 through 17 years of age at the start of the Screening Period. * Participants with a known history of allergic reactions with an active prescription for epinephrine, and who (in the judgement of the investigator) are at high risk for serious allergic reactions (e.g., anaphylaxis). * Participant has a body weight ≥30 kg (66 lbs). * Participant is within the 5th and 95th percentiles, inclusive, for weight by age (according to CDC growth charts). Exclusion Criteria: * Any current or past medical conditions such as significant systemic diseases that, in the investigator's opinion, might significantly affect pharmacodynamic responses to DESF. * Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases. * Known intolerance or hypersensitivity to any component of DESF. * Participant has a disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of DESF. * Positive urine drug screen, saliva alcohol test, or urine cotinine test at Screening or prior to administration of DESF on Study Day 1. * Participant has participated in any clinical investigation within the 30 days prior to the planned administration of DESF on Study Day 1.

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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

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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