NDAINTRAVENOUSSOLUTION
Approved
Oct 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
DEXMEDETOMIDINE HYDROCHLORIDE (dexmedetomidine) by R-Pharm US is 2 -adrenergic agonist with sedative properties. First approved in 2015.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Dexmedetomidine is a selective alpha-2 adrenergic agonist administered intravenously as a solution for sedation in clinical settings. It works through alpha-2 receptor activation to produce sedative and analgesic effects, with dose-dependent engagement of alpha-1 receptors at higher doses. The drug is primarily used for procedural sedation and ICU sedation in hospital and perioperative environments.
Peak9.8 years to LOE
Product is at peak commercial maturity with established market penetration; team focus is likely on optimization and maintaining market position rather than growth initiatives.
Mechanism of Action
2 -adrenergic agonist with sedative properties. Alpha 2 selectivity was observed in animals following slow intravenous infusion of low and medium doses (10 mcg/kg to 300 mcg/kg). Both alpha 1 and alpha 2 activity is observed following slow intravenous infusion of high doses (greater than or equal…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Dexmedetomidine-esketamine and tDCS for Prevention of Neurocognitive Complications After Surgery
Started Jun 2026
1,160 enrolled
Older PatientsSurgeryDexmedetomidine+3 more
Long-term Follow-up of Dexmedetomidine-esketamine and tDCS for Neurocognitive Complications After Surgery
Started Jun 2026
1,160 enrolled
Older PatientsSurgeryDexmedetomidine+4 more
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)
Effect of Perioperative Dexmedetomidine on Chronic Post-Surgical Pain
Started Jul 2025
364 enrolled
Chronic Post-Surgical Pain
Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies
Started Oct 2024
200 enrolled
Breast Cancer
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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.