New agitation drug igalmi tested for repeated use in mental health conditions

NCT ID NCT06041646

Disease control Sponsor: BioXcel Therapeutics Inc Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 4 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.

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

29 people

The number who actually took part.

Started

Oct 2023

Finished

Apr 2024

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

18 to 65 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 18 to 65 years, inclusive. 2. Subjects who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder or bipolar I or II disorder. 3. Subjects who are currently moderate to severely agitated at least 3 days a week. 4. Subjects who read, understand, and provide written informed consent. 5. Subjects who are in good general health prior to study participation as determined by a detailed medical history and in the opinion of the Principal Investigator. 6. Subjects who agree to use a medically acceptable and effective birth control method 7. Subjects must be willing to remain in-clinic for the duration of the study. Exclusion Criteria: 1. Subjects with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse during screening. 2. Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 6 hours before study treatment. 3. Subjects with congenital prolonged QT syndrome. 4. Prior treatment with Igalmi

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar I disorder bipolar II disorder 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,psychomotor Bipolar disorder Schizo affective disorder Schizophrenia Schizophreniform disorders

New agitation drug igalmi tested for repeated use in mental health conditions

What the study statuses mean