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Could a dissolving film calm agitated teens? new trial begins

NCT ID NCT05025605

Symptom relief Sponsor: BioXcel Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 12, 2026 · Updated 4 times

Summary

This early-stage trial tests BXCL501, a dissolving film placed under the tongue, to quickly reduce agitation in children and teens aged 10-17 with schizophrenia or bipolar disorder. About 140 participants will receive either the drug or a placebo. The study measures changes in agitation using a standard psychiatric scale.

What this could mean

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

Active substance
BXCL501 (dexmedetomidine sublingual film)
What this could lead to
If it works, this could offer a fast-acting, non-injectable option to calm agitation in children and teens with these conditions.
What could go wrong
This is a very early phase 1 study with only 140 participants, so results may not apply broadly. Side effects of dexmedetomidine include low blood pressure and drowsiness.
Why investors are watching

BioXcel Therapeutics is testing BXCL501, an experimental drug, in children and adolescents with acute agitation linked to schizophrenia or bipolar disorder. This is a small company, so this single trial's outcome carries outsized weight for its future. A successful readout would validate the drug's use in a younger patient group, while a failure would leave the company with few other options.

If it works: A positive result could expand the drug's approved use to a pediatric population, opening a new market for the company. It might also strengthen BioXcel's position with regulators and potential partners.

If it fails: A failed or delayed trial could set the company back significantly, as it has few other products in development. Trials in this area often fail, and a negative outcome would likely reduce the drug's commercial prospects.

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 1

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

Participants

About 140 people

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

Started

Aug 2021

Expected to finish

Dec 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

10 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: 1. Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria). 2. Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC). 3. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline. 4. Participants who agree to use a medically acceptable and effective birth control method Exclusion Criteria: 1. Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening. 2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment. 3. Patients who are judged to be at significant risk of suicide. 4. Patients with serious or unstable medical illnesses. 5. Patients who have received an investigational drug within 30 days prior to the current agitation episode. 6. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar I disorder bipolar II disorder Psychotic Disorders schizoaffective disorder schizophrenia schizophreniform disorder

As listed by the trial registrant

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

Bipolar disorder I Bipolar disorder ii Schizo affective disorder Schizophrenia Schizophreniform; schizophrenic

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • BioXcel Clinical Research Site

    RECRUITING

    Anaheim, California, 92805, United States

    Contact Email: •••••@•••••

  • BioXcel Clinical Research Site

    COMPLETED

    Atlanta, Georgia, 30331, United States

  • BioXcel Clinical Research Site

    RECRUITING

    DeSoto, Texas, 75115, United States

    Contact Email: •••••@•••••

  • Bioxcel Clinical Research Site

    RECRUITING

    Hialeah, Florida, 33016, United States

    Contact Email: •••••@•••••

  • Bioxcel Clinical Research Site

    RECRUITING

    Decatur, Georgia, 30030, United States

    Contact Email: •••••@•••••

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