DEXMEDETOMIDINE HYDROCHLORIDE

Post-LOE

dexmedetomidine hcl

Hikma

ANDAINJECTIONINJECTABLE

Approved

Apr 2017

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

2/8 — Basic

Drug data last refreshed 18h ago

Mechanism of Action

Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (2)

NCT06335407Phase 1Recruiting

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

Started Jul 2025

10 enrolled

Alcohol Use Disorder (AUD)Post Traumatic Stress Disorder (PTSD)

NCT04827056Phase 1Completed

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

Started Nov 2021

10 enrolled

Alcohol Use Disorder (AUD)Post Traumatic Stress Disorder (PTSD)

Company

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.