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Showing 1–22 of 22 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Sublingual Dexmedetomidine Clear all
Recruiting Phase 1 Interventional

Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

NCT05025605
View directory record Official record
Conditions
Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II
Interventions
BXCL501 80 Micrograms, Placebo Film, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
10 Years to 17 Years
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
5
States / cities
Anaheim, California • Hialeah, Florida • Atlanta, Georgia + 2 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Completed Phase 4 Interventional Results available

Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder

NCT06041646
View directory record Official record
Conditions
Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder, Schizophreniform Disorders
Interventions
Sublingual film containing Igalmi
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 65 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
2
States / cities
Little Rock, Arkansas • Rogers, Arkansas
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Completed Phase 2 Interventional

Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder

NCT07116694
View directory record Official record
Conditions
Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Psychomotor Agitation
Interventions
BXCL501 Sublingual Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
5
States / cities
Chino, California • Oceanside, California • Orange, California + 2 more
Source: ClinicalTrials.gov public record
Updated Aug 5, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Completed Phase 1 Interventional

BXCL501 for Agitation in Schizophrenia

NCT03708315
View directory record Official record
Conditions
Schizophrenia, Schizoaffective Disorder
Interventions
Dexmedetomidine Hydrochloride, Placebos
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years to 65 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Jul 22, 2025 · Synced Sep 19, 2026, 2:26 PM EDT
Completed Phase 1 Interventional

Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study

NCT04827056
View directory record Official record
Conditions
Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
Interventions
Placebo, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg, Ethanol Infusion, PTSD Reactivity Condition, Alcohol Cue Reactivity
Drug · Procedure · Behavioral
Lead sponsor
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Other
Eligibility
21 Years to 65 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
1
States / cities
West Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Oct 25, 2023 · Synced Sep 19, 2026, 2:26 PM EDT
Terminated Phase 3 Interventional

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

NCT05665088
View directory record Official record
Conditions
Agitation, Dementia
Interventions
BXCL501, Matching Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
7
States / cities
Los Alamitos, California • Daytona Beach, Florida • Maitland, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Dec 10, 2023 · Synced Sep 19, 2026, 2:26 PM EDT
Terminated Phase 2 Interventional Results available

An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia

NCT05276830
View directory record Official record
Conditions
Agitation, Dementia
Interventions
BXCL501, Placebo film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022
U.S. locations
3
States / cities
North Miami, Florida • Springfield, Massachusetts • Toms River, New Jersey
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Completed Phase 1 Interventional

Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia

NCT04010305
View directory record Official record
Conditions
Agitation, Schizophrenia
Interventions
Sublingual film containing BXCL501 (Dexmedetomidine), Placebo film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 65 Years
Enrollment
135 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
12
States / cities
Little Rock, Arkansas • Cerritos, California • Lemon Grove, California + 9 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Enrolling by invitation Phase 2 Interventional

Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia

NCT06148311
View directory record Official record
Conditions
Familial Dysautonomia
Interventions
Matching placebo, Dexmedetomidine
Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
16 Years to 80 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Apr 12, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Not yet recruiting Early Phase 1 Interventional Accepts healthy volunteers

Dexmedetomidine Trial for Effects on Rhythms, Sleep Architecture, and Biomarker Dynamics in Older Adults

NCT07800910
View directory record Official record
Conditions
Sleep, Circadian Rhythm
Interventions
Dexmedetomidine sublingual film, Placebo Sublingual Film
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
65 Years and older
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2028
U.S. locations
2
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 1, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Recruiting Phase 1 Interventional

Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study

NCT06335407
View directory record Official record
Conditions
Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
Interventions
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg
Drug
Lead sponsor
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Other
Eligibility
21 Years to 65 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
West Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Oct 26, 2025 · Synced Sep 19, 2026, 2:26 PM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Sublingual Dexmedetomidine for Treating Opioid Withdrawal

NCT05712707
View directory record Official record
Conditions
Opioid Use Disorder, Opioid Withdrawal
Interventions
BXCL501 (180 micrograms), BXCL501 (240 micrograms), Placebo, Lofexidine (Positive Control)
Drug · Other
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 60 Years
Enrollment
160 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
4
States / cities
New Haven, Connecticut • Eatontown, New Jersey • Marlton, New Jersey + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 13, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Recruiting Phase 3 Interventional

Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)

NCT06192615
View directory record Official record
Conditions
Delirium
Interventions
Intravenous Dexmedetomidine, Sublingual Dexmedetomidine, Intravenous Placebo, Sublingual Placebo
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
60 Years and older
Enrollment
1,800 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
14
States / cities
Los Angeles, California • San Francisco, California • Chicago, Illinois + 9 more
Source: ClinicalTrials.gov public record
Updated Sep 13, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Not listed Phase 4 Interventional

Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder

NCT06093451
View directory record Official record
Conditions
Schizophrenia Agitation, Schizo Affective Disorder, Bipolar Disorder, Dexmedetomidine
Interventions
Dexmedetomidine, Lorazepam 2 MG/ML
Drug
Lead sponsor
Temple University
Other
Eligibility
18 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 22, 2023 · Synced Sep 19, 2026, 2:26 PM EDT
Recruiting Phase 2 Interventional

BXCL501 After Stress to Increase Recovery Success

NCT06943404
View directory record Official record
Conditions
Acute Stress Reaction, Acute Stress Disorder, Post-traumatic Stress Disorder
Interventions
BXCL501 (dexmedetomidine HCl), Placebo
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
18 Years to 65 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026
U.S. locations
3
States / cities
Jacksonville, Florida • St Louis, Missouri • Charlottesville, Virginia
Source: ClinicalTrials.gov public record
Updated Apr 13, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Completed Phase 3 Interventional Results available

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

NCT04268303
View directory record Official record
Conditions
Agitation, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder, Schizophreniform Disorders
Interventions
Sublingual film containing dexmedetomidine (BXCL501), Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
15
States / cities
Little Rock, Arkansas • Cerritos, California • Culver City, California + 12 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Completed Phase 3 Interventional Results available

Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

NCT04276883
View directory record Official record
Conditions
Agitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder
Interventions
Sublingual film containing Dexmedetomidine (BXCL501), Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
15
States / cities
Little Rock, Arkansas • Cerritos, California • Culver City, California + 12 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Completed Phase 3 Interventional

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)

NCT05658510
View directory record Official record
Conditions
Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
Interventions
BXCL501, Matching Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 75 Years
Enrollment
452 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
24
States / cities
Bellflower, California • Cerritos, California • Culver City, California + 19 more
Source: ClinicalTrials.gov public record
Updated Aug 6, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

NCT04251910
View directory record Official record
Conditions
Agitation,Psychomotor, Dementia
Interventions
Sublingual film containing Dexmedetomidine, Sublingual Placebo Film
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
5
States / cities
Homestead, Florida • Miami Lakes, Florida • Springfield, Massachusetts + 2 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal

NCT04470050
View directory record Official record
Conditions
Opioid Withdrawal
Interventions
Dexmedetomidine, Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
18 Years to 65 Years
Enrollment
225 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
3
States / cities
Miami Lakes, Florida • Marlton, New Jersey • New York, New York
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Completed Phase 3 Interventional Results available

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)

NCT05271552
View directory record Official record
Conditions
Agitation, Dementia
Interventions
BXCL501, Matching Placebo
Drug
Lead sponsor
BioXcel Therapeutics Inc
Industry
Eligibility
65 Years and older
Enrollment
151 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
11
States / cities
Phoenix, Arizona • Long Beach, California • Daytona Beach, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 19, 2026, 2:26 PM EDT
Active, not recruiting Phase 2 Interventional

Pilot Study of Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia

NCT06128356
View directory record Official record
Conditions
Familial Dysautonomia
Interventions
Dexmedetomidine Sublingual
Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years to 80 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Mar 3, 2026 · Synced Sep 19, 2026, 2:26 PM EDT