NDAINJECTIONINJECTABLE
Approved
Dec 1999
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
4/8 — Partial
Drug Shortage Active
PRECEDEX is currently in shortage. Reason: Available. This may impact manufacturing, supply chain, and quality hiring at the manufacturer.
PRECEDEX (dexmedetomidine hydrochloride) by Pfizer is 2 -adrenergic agonist with sedative properties. First approved in 1999.
Drug data last refreshed 20h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRECEDEX (dexmedetomidine hydrochloride) is a selective alpha-2 adrenergic agonist approved for sedation in intensive care and procedural settings. It works by activating alpha-2 receptors in the central nervous system to produce dose-dependent sedative effects, with selectivity maintained at lower to medium doses. The drug has been a cornerstone of ICU sedation protocols for over two decades.
Peak5.8 years to LOE
PRECEDEX remains at peak commercial maturity as an established ICU standard, supporting stable brand and field teams focused on hospital/critical care channel management.
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 (10–300 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 (6)
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)
A Study to Learn About the Study Medicine - Precedex in Children From Japan.
Started Oct 2023
111 enrolled
Sedation
Precedex Special Investigation (in Pediatric Patients)
Started Jul 2019
111 enrolled
Sedation
Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients
Started Sep 2010
373 enrolled
Intensive Care Unit
Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Started Oct 2009
89 enrolled
Endotracheal IntubationContinuous IV SedationICP Monitoring
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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.