New agitation drug igalmi tested for repeated use in mental health conditions
NCT ID NCT06041646
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This completed study tested Igalmi, a fast-dissolving film placed under the tongue, for managing frequent agitation in people with schizophrenia or bipolar disorder. 29 adults received the drug as needed for 7 days in a clinic. Researchers looked for signs that the drug might stop working over time (tolerance) or cause withdrawal symptoms when stopped. The goal was to understand how safe and effective repeated use is for calming agitation.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Igalmi (dexmedetomidine) sublingual film
What this could lead to
If successful, this could help doctors understand how to use Igalmi safely for repeated agitation episodes without losing effectiveness or causing withdrawal.
What could go wrong
This is a small, early-phase study with only 29 participants and no comparison group. Results may not apply to all patients, and side effects like rapid heart rate or nausea are possible.
Disclaimer
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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.
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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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.
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
Rogers, Arkansas, 72758, United States