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Sublingual Dexmedetomidine
Dexmedetomidine is an alpha-2 adrenergic agonist that acts as a sedative and anxiolytic.
Dexmedetomidine is an alpha-2 adrenergic agonist that acts as a sedative and anxiolytic. Used for Sedation for patients in intensive care units.
At a glance
| Generic name | Sublingual Dexmedetomidine |
|---|---|
| Also known as | Sublingual Precedex |
| Sponsor | Nourhan M.Aly |
| Drug class | Alpha-2 adrenergic agonist |
| Target | Alpha-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Anesthesiology |
| Phase | Phase 3 |
Mechanism of action
It works by stimulating alpha-2 adrenergic receptors in the brain, which leads to a decrease in the release of norepinephrine and a subsequent decrease in sympathetic nervous system activity. This results in sedation, anxiolysis, and a decrease in blood pressure and heart rate.
Approved indications
- Sedation for patients in intensive care units
Common side effects
- Dry mouth
- Hypotension
- Bradycardia
- Nausea
- Headache
Key clinical trials
- Pilot Study of Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia (PHASE2)
- 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)
- Sublingual Dexmedetomidine for Treating Opioid Withdrawal (PHASE1, PHASE2)
- 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)
- Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II) (PHASE3)
- Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study (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:
- Sublingual Dexmedetomidine CI brief — competitive landscape report
- Sublingual Dexmedetomidine updates RSS · CI watch RSS
- Nourhan M.Aly portfolio CI