ClinicalTrials.gg
RecruitingNCT06834165Updated Apr 21, 2026

Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy

A Phase 4 interventional study of Neffy and Adrenaline in Allergic Reactions, sponsored by ARS Pharmaceuticals, Inc.. Recruiting at 6 sites in United States. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by ARS Pharmaceuticals, Inc. · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
4 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

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.

Planned enrollment
18th of 220
600 · median 60
Started
2025
with 10 others
Phase 4
18 of 300
1 open now
Primary completion
2027-04
later than 13 of 38 live
Registered
284th of 300
by date

Among the 300 studies in Hypersensitivity with a site in United States, this one is the 18th largest by planned enrollment of the 220 interventional ones that give a count, is one of 11 that started in 2025, is one of 18 in phase 4, reaches primary completion later than 13 of the 38 other live ones, and was the 284th registered.

Hypersensitivity

1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.

Browse Hypersensitivity studies →

Open to participants now

32 of the 300 studies in Hypersensitivity with a site in United States are open now. Recruiting first, the newest first:

26 more — sign in →

All 32 open studies →

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 →

Who these studies take

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: 4 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.

03

Conditions studied

  • Allergic Reactions

Browse trials for

04

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Is a patient 4 years old or greater, inclusive, who are scheduled to undergo OFC, AIT, or other relevant allergy challenge.
  • Has body weight 15 kg or greater at the time of allergy challenge.
  • Is willing and able to provide written prior to participating in the study. In the case of minors (\<18 years old), assent can be obtained from his/her legal representative, and as much possible from the patient himself/herself.
  • Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin.

Exclusion criteria

Exclusion Criteria:

- Has any medical condition that precludes treatment with epinephrine as assessed by the Investigator.

Terms in these criteria, in plain language(2)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    Neffy

    Drug: Neffy

  • Active comparator
    IM adrenaline

    Drug: Adrenaline

Interventions

06

What researchers measure

Primary outcomes

  1. AEs after epinephrine treatment within 2 hours

    Time frame: 2 hours

07

Study locations

6 of 6 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2025 (actual). Primary completion is estimated for Apr 2027, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2025
First posted
Feb 19, 2025
StartActual
May 20, 2025
Primary completionEst.
Apr 2027
CompletionEst.
Jun 2027
Last update
Apr 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06834165
Lead sponsor
ARS Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Feb 19, 2025
Start date
May 20, 2025
Primary completion
Apr 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Apr 21, 2026

Study contacts

Osnat Ehrman, MSc.
Contact
osnate@pacificlinkconsulting.com
952.334.5797

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Epinephrine

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