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Nasal spray vs. needle: new study tests easier allergy rescue

NCT ID NCT06834165

Symptom relief Sponsor: ARS Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the safety of a nasal spray called neffy compared to a standard epinephrine shot for treating allergic reactions. It involves 600 people aged 4 and older who have an allergic reaction during a food challenge or allergy shot session. The goal is to see if the spray works as well and is as safe as the injection.

Why investors are watching

ARS Pharmaceuticals is running a phase IV trial of its epinephrine nasal spray, neffy, against injected adrenalin in 600 patients having allergic reactions during food challenges or immunotherapy. For a micro-cap company whose value rests almost entirely on neffy, this readout tests whether the spray works as a reliable rescue option in real-world allergy settings, which could broaden its use beyond current approvals.

If it works: A positive result could support wider adoption of neffy by doctors and patients, potentially expanding its market beyond the current approved uses. That could strengthen the company's commercial position and justify further investment in the product.

If it fails: If the trial fails or shows neffy is less safe or effective than the injection, the company could face regulatory setbacks and lose credibility with prescribers. Trials fail often, and for a company this small, a negative readout could be hard to recover from.

AI-written from the trial record. Speculative, and not investment advice.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

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

4 years and older

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: * 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 informed consent 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: \- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.

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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 reactions

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's National Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Endeavor Health

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Orso Health, Inc.

    RECRUITING

    La Jolla, California, 92037, United States

  • University Of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • Weill Cornell Medicine/NewYork Presbyterian Hospital

    RECRUITING

    New York, New York, 10021, United States

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