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 26m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRECEDEX (dexmedetomidine HCl) is a selective alpha-2 adrenergic agonist indicated for sedation in ICU and perioperative settings. It provides sedation with maintained airway reflexes and reduced opioid requirements through alpha-2 receptor activation in the central nervous system.
Peak5.7 years to LOE
Peak-stage product with established hospital ICU/perioperative penetration; stable team supporting mature indication portfolio with limited new revenue drivers.
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.