5 completed, 2 terminated, 1 recruiting, 1 withdrawn. 5 Phase 2, 3 Phase 3, 2 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 2, Recruiting 1, Terminated 1, Withdrawn 1 |
| Phase 3 | 3 | Completed 2, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 4 | 1 | Completed 1 |
Follow BXCL501: new trials by email Literature Review of BXCL501 trials Research Report on BXCL501
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| BXCL501 After Stress to Increase Recovery Success BXCL501 (dexmedetomidine HCl), Placebo - Acute Stress Reaction, Acute Stress Disorder | Phase 2 | Recruiting | University of North Carolina, Chapel Hill | 100 | 2026-02-23 | 2026-04-14 |
| Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder Sublingual film containing Igalmi - Bipolar Disorder, Schizophrenia | Phase 4 | Completed | BioXcel Therapeutics Inc | 29 | 2023-10-02 | 2026-08-11 |
| Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III) BXCL501, Matching Placebo - Agitation, Dementia | Phase 3 | Terminated | BioXcel Therapeutics Inc | 13 | 2022-12-05 | 2026-10-01 |
| Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) BXCL501, Matching Placebo - Agitation,Psychomotor, Bipolar I Disorder | Phase 3 | Completed | BioXcel Therapeutics Inc | 452 | 2022-11-21 | 2026-08-07 |
| Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II) BXCL501, Matching Placebo - Agitation, Dementia | Phase 3 | Completed | BioXcel Therapeutics Inc | 151 | 2022-04-27 | 2026-08-11 |
| An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia BXCL501, Placebo film - Agitation, Dementia | Phase 2 | Terminated | BioXcel Therapeutics Inc | 5 | 2022-02-08 | 2026-08-11 |
| Study of BXCL501 In Agitation Associated With Delirium in ICU Patients BXCL501, Placebo film - Agitation, Delirium | Phase 2 | Withdrawn | BioXcel Therapeutics Inc | 2021-02-23 | 2026-08-11 | |
| Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal Dexmedetomidine, Placebo - Opioid Withdrawal | Phase 1 / Phase 2 | Completed | BioXcel Therapeutics Inc | 225 | 2020-06-09 | 2026-08-11 |
| Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia Sublingual film containing Dexmedetomidine, Sublingual Placebo Film - Agitation,Psychomotor, Dementia | Phase 1 / Phase 2 | Completed | BioXcel Therapeutics Inc | 100 | 2019-12-27 | 2026-08-11 |
Psychomotor Agitation (8) · Dementia (4) · Bipolar Disorder (2) · Psychotic Disorders (2) · Schizophrenia (2) · Delirium (1) · Morphine Dependence (1) · Opioid-Related Disorders (1) · Stress Disorders, Post-Traumatic (1) · Stress Disorders, Traumatic, Acute (1)
BioXcel Therapeutics Inc (8) · University of North Carolina, Chapel Hill (1)
United States (9)
BioXcel MM, MD (6) · BioXcel MM (1) · Robert Risinger, MD (1) · Samuel McLean, MD (1) · Stacey House, MD (1)