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 2h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Dexmedetomidine hydrochloride is an intravenous selective alpha-2 adrenergic agonist approved in 2015 for sedation in clinical settings. It works by binding to alpha-2 receptors to produce sedative and analgesic effects, with selectivity dependent on dose and infusion rate. The drug is used primarily in perioperative and critical care environments where controlled sedation is required.
Peak9.5 years to LOE
Product is at peak commercial maturity with established market presence; teams likely focused on optimizing market penetration and defending against generic entry.
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 Oct 2026
1,996 enrolled
Older PatientsSurgeryDexmedetomidine+3 more
Long-term Follow-up of Dexmedetomidine-esketamine and tDCS for Neurocognitive Complications After Surgery
Started Oct 2026
1,996 enrolled
Older PatientsSurgeryDexmedetomidine+4 more
Comparison of Analgesic Efficacy of Intrathecal Bupivacaine Versus Bupivacaine Plus Dexmedetomidine in Patients Undergoing Orthopedic Surgeries.
Started Aug 2026
80 enrolled
Postoperative PainPainOrthopaedic Surgery+1 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
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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.