New dissolving film could calm agitation in schizophrenia without needles
NCT ID NCT04268303
First seen Jun 23, 2026 · Last updated Jun 23, 2026
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.
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This is a summary of
the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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BioXcel Clinical Research Site
Little Rock, Arkansas, 72211, United States
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BioXcel Clinical Research Site
Cerritos, California, 78754, United States
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BioXcel Clinical Research Site
Culver City, California, 90230, United States
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BioXcel Clinical Research Site
Long Beach, California, 90806, United States
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BioXcel Clinical Research Site
Orange, California, 92868, United States
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BioXcel Clinical Research Site
Miami Lakes, Florida, 33016, United States
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BioXcel Clinical Research Site
Chicago, Illinois, 60640, United States
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BioXcel Clinical Research Site
Gaithersburg, Maryland, 20877, United States
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BioXcel Clinical Research Site
Las Vegas, Nevada, 89102, United States
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BioXcel Clinical Research Site
Berlin, New Jersey, 08009, United States
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BioXcel Clinical Research Site
Marlton, New Jersey, 08053, United States
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BioXcel Clinical Research Site
Charleston, South Carolina, 29407, United States
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BioXcel Clinical Research Site
Austin, Texas, 78754, United States
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BioXcel Clinical Research Site
DeSoto, Texas, 75115, United States
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BioXcel Clinical Research Site
Richardson, Texas, 75080, United States
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.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.