New dissolving film could calm agitation in schizophrenia without needles

NCT ID NCT04268303

Completed Symptom relief Sponsor: BioXcel Therapeutics Inc Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This Phase 3 trial tested a sublingual film containing dexmedetomidine (BXCL501) to quickly reduce agitation in 380 adults with schizophrenia or related disorders. Participants received either the drug or a placebo film, and researchers measured changes in agitation symptoms over time. The goal is to offer a needle-free, fast-acting option for acute agitation episodes.

What this could mean

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

Active substance: dexmedetomidine (BXCL501) sublingual film
What this could lead to: If successful, this could provide a fast-acting, non-injectable option to calm agitation in people with schizophrenia, potentially reducing the need for emergency sedation.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. The effect may be modest, and side effects like low blood pressure or drowsiness are possible.

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Conditions

The condition(s) this trial relates to.

Psychomotor Agitation Psychotic Disorders schizoaffective disorder schizophrenia schizophreniform disorder

As listed by the trial registrant

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

AGITATION SCHIZO AFFECTIVE DISORDER SCHIZOAFFECTIVE DISORDER SCHIZOPHRENIA SCHIZOPHRENIFORM DISORDERS

Contacts and locations

Locations

BioXcel Clinical Research Site

Little Rock, Arkansas, 72211, United States
BioXcel Clinical Research Site

Cerritos, California, 78754, United States
BioXcel Clinical Research Site

Culver City, California, 90230, United States
BioXcel Clinical Research Site

Long Beach, California, 90806, United States
BioXcel Clinical Research Site

Orange, California, 92868, United States
BioXcel Clinical Research Site

Miami Lakes, Florida, 33016, United States
BioXcel Clinical Research Site

Chicago, Illinois, 60640, United States
BioXcel Clinical Research Site

Gaithersburg, Maryland, 20877, United States
BioXcel Clinical Research Site

Las Vegas, Nevada, 89102, United States
BioXcel Clinical Research Site

Berlin, New Jersey, 08009, United States
BioXcel Clinical Research Site

Marlton, New Jersey, 08053, United States
BioXcel Clinical Research Site

Charleston, South Carolina, 29407, United States
BioXcel Clinical Research Site

Austin, Texas, 78754, United States
BioXcel Clinical Research Site

DeSoto, Texas, 75115, United States
BioXcel Clinical Research Site

Richardson, Texas, 75080, United States

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