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BXCL501 Sublingual Film
BXCL501 Sublingual Film is a selective serotonin reuptake inhibitor (SSRI) Small molecule drug developed by BioXcel Therapeutics Inc. It is currently in Phase 2 development for Acute agitation associated with schizophrenia or bipolar I disorder. Also known as: Dexmedetomidine.
BXCL501 is a selective serotonin reuptake inhibitor (SSRI) that modulates serotonin levels in the brain to treat acute agitation.
BXCL501 is a selective serotonin reuptake inhibitor (SSRI) that modulates serotonin levels in the brain to treat acute agitation. Used for Acute agitation associated with schizophrenia or bipolar I disorder.
At a glance
| Generic name | BXCL501 Sublingual Film |
|---|---|
| Also known as | Dexmedetomidine |
| Sponsor | BioXcel Therapeutics Inc |
| Drug class | selective serotonin reuptake inhibitor (SSRI) |
| Target | serotonin transporter |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 2 |
Mechanism of action
BXCL501 works by selectively inhibiting the reuptake of serotonin into presynaptic neurons, thereby increasing the levels of serotonin in the synaptic cleft, which can help reduce symptoms of acute agitation associated with certain psychiatric disorders.
Approved indications
- Acute agitation associated with schizophrenia or bipolar I disorder
Common side effects
- somnolence
- dizziness
- headache
Key clinical trials
- BXCL501 After Stress to Increase Recovery Success (PHASE2)
- Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department (PHASE4)
- Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder (PHASE4)
- Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II) (PHASE3)
- Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study (PHASE1)
- Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) (PHASE3)
- Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder (PHASE2)
- BXCL501 for Agitation in Schizophrenia (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BXCL501 Sublingual Film CI brief — competitive landscape report
- BXCL501 Sublingual Film updates RSS · CI watch RSS
- BioXcel Therapeutics Inc portfolio CI
Frequently asked questions about BXCL501 Sublingual Film
What is BXCL501 Sublingual Film?
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Related
- Drug class: All selective serotonin reuptake inhibitor (SSRI) drugs
- Target: All drugs targeting serotonin transporter
- Manufacturer: BioXcel Therapeutics Inc — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Acute agitation associated with schizophrenia or bipolar I disorder
- Also known as: Dexmedetomidine
- Compare: BXCL501 Sublingual Film vs similar drugs
- Pricing: BXCL501 Sublingual Film cost, discount & access