Floatz Rating
BB70/100
Confidence
Indicative
Sponsor
BioXcel Therapeutics Inc
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
74High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07116694CT.gov Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder | — | Completed | — | — | — |
NCT06041646CT.gov Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder | — | Completed | — | — | — |
NCT05974527CT.gov Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department | — | Withdrawn | — | — | — |
NCT06093451CT.gov Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder | — | Unknown | — | — | — |
NCT05658510CT.gov Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) | — | Completed | — | — | — |
NCT05025605CT.gov Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder | — | Recruiting | — | — | — |
NCT04268303CT.gov Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia | — | Completed | — | — | — |
NCT04010305CT.gov Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Schizophrenia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Dexmedetomidine (this asset) | BioXcel Therapeutics Inc | Approved | BB · 70 |
| Trospium | European Group for Research In Schizophrenia | P4 | BBB |
| Xanomeline | European Group for Research In Schizophrenia | P4 | BBB |
| Asenapine | Noven Pharmaceuticals, Inc. | P4 | BBB |
| Lurasidone | Aziende Chimiche Riunite Angelini Francesco S.p.A | P4 | BBB |
| Brexpiprazole | Humanis Saglık Anonim Sirketi | P4 | BBB |
| Bitopertin | Hoffmann-La Roche | P3 | BBB |
| Ulotaront | Otsuka Pharmaceutical Co., Ltd. | P3 | BBB |
| Pyridoxol | Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara | P4 | BBB |
+42 more in the Schizophrenia cohort
Other indications for Dexmedetomidine
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Schizophreniform Disorder | — | P4 | A · 80 |
| Schizoaffective Disorder | — | P4 | BBB · 77 |
| Neuralgia | — | P4 | BBB · 76 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Dexmedetomidine in Schizophrenia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/dexmedetomidine-schizophrenia
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