NDAINTRAVENOUSSOLUTION
Approved
Oct 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
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…
Clinical Trials (5)
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)
Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies
Started Oct 2024
200 enrolled
Breast Cancer
Postoperative Dexmedetomidine in Prevention of Postoperative Delirium
Started Nov 2023
287 enrolled
Delirium in Old AgeAnesthesia; Adverse Effect
Different Administration Routes of Dexmedetomidine on Postoperative Delirium
Started Aug 2023
120 enrolled
DexmedetomidinePostoperative DeliriumGeneral Anesthesia
Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study
Started Nov 2021
10 enrolled
Alcohol Use Disorder (AUD)Post Traumatic Stress Disorder (PTSD)
Loss of Exclusivity
LOE Date
Apr 20, 2036
123 months away
Patent Expiry
Apr 20, 2036
Company
R-Pharm US
NJ - Princeton