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No-Needle epinephrine: could a dissolving film replace the shot?

NCT ID NCT06527937

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 study tested a new dissolvable film called DESF that delivers epinephrine under the tongue. Thirty-six healthy adults with oral allergy syndrome received DESF and standard epinephrine injections to compare how quickly the drug enters the bloodstream. The goal is to see if this needle-free option can work as a fast and easy treatment for allergic reactions.

What this could mean

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

Active substance
DESF (sublingual epinephrine film)
What this could lead to
If successful, DESF could offer a needle-free way to quickly deliver epinephrine during allergic reactions, making treatment easier and faster.
What could go wrong
This is an early Phase 2 study with only 36 healthy adults, not people having severe reactions. It measures drug levels, not real-world outcomes, so results may not translate to emergency 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

36 people

The number who actually took part.

Started

Jul 2024

Finished

Oct 2024

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

18 to 55 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: * Willing and able to provide written informed consent and capable of following the protocol-required guidelines. * Healthy males and females 18 through 55 years of age. * Body weight ≥50 kg for males and ≥45 kg for females. * BMI ≥18 kg/m2 to ≤32 kg/m2. * Known history of oral allergy syndrome in response to exposure to any of the allergens (e.g., apple, cherry, mango, melon, kiwi, celery, banana and/or carrot). * Able to tolerate venipuncture. * Subject has not had exposure to antihistamines within 3 days prior to the Screening visit. Exclusion Criteria: * Any current 'clinically significant' medical condition(s) that, in the opinion of the investigator, could confound the assessment of safety or impact assessments of PK and/or PD parameters or the safety of the subjects in the trial such as significant systemic neurological, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, oncologic and/or metabolic disease. * Clinically significant laboratory results at Screening, including, but not limited to hemoglobin \<11.5 g/dL for males or \<10.5 g/dL for females. * Clinically significant 12-lead ECG findings (at any time). * Known history or presence of hypersensitivity or idiosyncratic reaction to DESF, epinephrine, or other drug substances with similar activity including intolerance or hypersensitivity to any component of DESF. * Known history or presence of any disorder of the sublingual mucosa or any disease or condition which affects the normal production of saliva (e.g., xerostomia, Ehlers-Danlos syndrome, or Sjögren's syndrome) which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. * Subject has a disorder of the sublingual mucosa that, in the opinion of the investigator, would impact or interfere with administration, retention or absorption of DESF.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Frontage Clinical Services, Inc.

    Secaucus, New Jersey, 07094, United States

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