PRECEDEX

Peak

dexmedetomidine hydrochloride

NDAINJECTIONINJECTABLE
Approved
Dec 1999
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6

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…

Clinical Trials (5)

NCT06335407Phase 1Recruiting

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)
NCT06085573N/ACompleted

A Study to Learn About the Study Medicine - Precedex in Children From Japan.

Started Oct 2023
111 enrolled
Sedation
NCT04040439N/ACompleted

Precedex Special Investigation (in Pediatric Patients)

Started Jul 2019
111 enrolled
Sedation
NCT01169571N/ACompleted

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
NCT01169467Phase 3Completed

Cerebral Perfusion Pressure Using Precedex and Other Sedatives

Started Oct 2009
89 enrolled
Endotracheal IntubationContinuous IV SedationICP Monitoring

Loss of Exclusivity

LOE Date
Jul 4, 2032
77 months away
Patent Expiry
Jul 4, 2032

Patent Records (5)

Patent #ExpiryTypeUse Code
8648106
Jan 4, 2032
Product
8242158
Jan 4, 2032
Product
9320712
Jan 4, 2032
Product
8455527
Jan 4, 2032
U-421
9616049
Jan 4, 2032
Product