ANDAINJECTIONINJECTABLE
Approved
Oct 2016
Lifecycle
Post-LOE
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
DEXMEDETOMIDINE HYDROCHLORIDE (dexmedetomidine hydrochloride) by Teva is 2 -adrenergic agonist with sedative properties. First approved in 2016.
Drug data last refreshed 20h ago
Mechanism of Action
2 -adrenergic agonist with sedative properties. Alpha 2 selectivity is observed in animals following slow intravenous infusion of low and medium doses (10 to 300 mcg/kg). Both alpha 1 and alpha 2 activity is observed following slow intravenous infusion of high doses (≥1,000 mcg/kg) or with rapid…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
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)
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.