A Phase 1 interventional study of DESF in Allergic Reaction, sponsored by Aquestive Therapeutics. Completed at 8 sites in 2 countries. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Aquestive Therapeutics · Phase 1, Interventional, and Treatment
Among 300 studies in Hypersensitivity with a site in United States — 32 open to participants now, 40 under way, 1 of them phase 3. Hypersensitivity · United States.
Among the 300 studies in Hypersensitivity with a site in United States, this one is the 150th largest by enrollment of the 220 interventional ones that give a count, is one of 4 that started in 2024, is one of 31 in phase 1, and was the 282nd registered.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
Browse Hypersensitivity studies →32 of the 300 studies in Hypersensitivity with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 12+
Lumicell, Inc. · Sites in United States
Ages 18+
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 12–50
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 12 mo–17 yrs
Qifeng Zhang · Sites in United States, China
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 100 Hypersensitivity studies recruiting now, 37 (37%) set no upper age limit and 51 (51%) stop at 75 or younger; 55 take children under 18; 36 take healthy volunteers.
This study: 7 Years to 17 Years · all sexes · no healthy volunteers.
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300 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 63 · Phase 3 41 · Phase 4 18
First in 1996; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Median enrollment 60 across the 220 interventional studies, 200 across the 76 observational. Of the 243 that completed or were terminated, 104 (43%) have results posted.
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117 of 300 have an industry lead sponsor. The 10 most frequent:
Aquestive Therapeutics is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Aquestive Therapeutics has 2 studies filed under Hypersensitivity — fewer than ten, so there is no comparison to draw.
11 of the studies in Hypersensitivity with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07003919Phase 3DBV TechnologiesSafety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) | 2026-11 |
| NCT05584488Columbia UniversityAllergy and Immunology Natural History Study | 2027-01 |
| NCT07447869National Institute of Allergy and Infectious Diseases (NIAID)LYmph Node eXamination in Cat Allergen Immunotherapy | 2027-01-27 |
| NCT03914664Vanderbilt University Medical CenterNeural Correlates of Sensory Phenomena in Tourette Syndrome | 2027-02-28 |
| NCT06834165ARS Pharmaceuticals, Inc.Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy | 2027-04 |
Add all 11 to your calendar (.ics) → With an account.
Among the 300 studies in Hypersensitivity with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
An open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of epinephrine administered as a single dose of DESF in pediatric subjects weighing ≥30 kg with a personal history of allergic reactions and are at high risk for serious allergic reactions. All treated participants will receive a single dose of DESF on Study Day 1. On Study Day 2, participants will return to the study site for an Oral Mucositis Assessment Scale (OMAS) assessment.
This is a Phase 1, multi-site, open-label, single treatment study conducted in male and female pediatric subjects (age 7-17 years) who have a have a personal history of allergic reactions and are at high risk for serious allergic reactions. This study is designed to evaluate the pharmacokinetics (PK) of epinephrine administered as a single dose of DESF.
Up to 24 DESF treated pediatric participants are expected to be enrolled. The study population will consist of healthy, non-smoking, pediatric male and female participants aged 7 through 17 with a known history of allergic reactions that the investigators believe continue to remain at high risk of serious allergic reactions (e.g., anaphylaxis).
All treated participants will be administered a single, 12 mg, dose of DESF on Study Day 1. No other investigational product will be administered.
The expected maximum duration of an individual's participation in this study will be, approximately, 32 days including a 30-day Screening Period, a 1-day Treatment Period (Study Day 1) and a 1-day (±1 day) Post-treatment Follow-up (Study Day 2).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single dose (12 mg) of DESF administered.
Drug: DESF
DESF administered in the sublingual space
Cmax
Baseline Corrected Maximum Epinephrine Plasma Concentration
Time frame: 0 to 240 minutes post-dose
AUC0-10
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 10 minutes
Time frame: 0 to 10 minutes
AUC0-20
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 20 minutes
Time frame: 0 to 20 minutes
AUC0-30
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 30 minutes
Time frame: 0 to 30 minutes
AUC0-45
Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 45 minutes
Time frame: 0 to 45 minutes
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2024 to primary completion in Mar 2025, 2 months.
Of 26 phase 1 interventional studies under Hypersensitivity, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Aquestive Therapeutics