dexmedetomidine 0.25 µg/kg IV — Competitive Intelligence Brief

dexmedetomidine 0.25 µg/kg IV (dexmedetomidine 0.25 µg/kg IV) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Alpha-2 adrenergic receptor agonist. Area: Anesthesia and Sedation.

marketed Alpha-2 adrenergic receptor agonist Alpha-2 adrenergic receptor Anesthesia and Sedation Small molecule

Target snapshot

dexmedetomidine 0.25 µg/kg IV (dexmedetomidine 0.25 µg/kg IV) — American University of Beirut Medical Center. Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist that produces sedation, analgesia, and anxiolysis by activating presynaptic and postsynaptic alpha-2 receptors in the central nervous system.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
dexmedetomidine 0.25 µg/kg IV TARGET	dexmedetomidine 0.25 µg/kg IV	American University of Beirut Medical Center	marketed	Alpha-2 adrenergic receptor agonist	Alpha-2 adrenergic receptor
brimonidine topical gel 0.33% & SOC	brimonidine topical gel 0.33% & SOC	Wake Forest University Health Sciences	marketed	Alpha-2 adrenergic agonist	Alpha-2 adrenergic receptor
Dexmedetomidine Hydrochloride - Cycling	Dexmedetomidine Hydrochloride - Cycling	Vanderbilt University Medical Center	marketed	Alpha-2 adrenergic agonist	Alpha-2 adrenergic receptor
Brimonidine 0.33% gel (Br)	Brimonidine 0.33% gel (Br)	Galderma R&D	marketed	Alpha-2 adrenergic agonist	Alpha-2 adrenergic receptor
Preemptive Analgesia Of Dexmedetomidine	Preemptive Analgesia Of Dexmedetomidine	China International Neuroscience Institution	marketed	Alpha-2 adrenergic agonist	Alpha-2 adrenergic receptor
Randomization of Propofol or Dexmedetomidine	Randomization of Propofol or Dexmedetomidine	Children's Hospital Los Angeles	marketed	Sedative/Hypnotic agents	GABA-A receptor (propofol); Alpha-2 adrenergic receptor (dexmedetomidine)
dexmedetomidine-esketamine-ropivacaine combination 1	dexmedetomidine-esketamine-ropivacaine combination 1	Peking University First Hospital	marketed	Combination anesthetic/analgesic	Alpha-2 adrenergic receptor, NMDA receptor, voltage-gated sodium channels

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Alpha-2 adrenergic receptor agonist class)

1. Allergan · 3 drugs in this class
2. Eye & ENT Hospital of Fudan University · 2 drugs in this class
3. National Cancer Institute, Egypt · 2 drugs in this class
4. The University of Hong Kong · 2 drugs in this class
5. Sindh Institute of Urology and Transplantation · 2 drugs in this class
6. Fayoum University Hospital · 1 drug in this class
7. First Affiliated Hospital of Chongqing Medical University · 1 drug in this class
8. Guangzhou General Hospital of Guangzhou Military Command · 1 drug in this class
9. Icahn School of Medicine at Mount Sinai · 1 drug in this class
10. KAT General Hospital · 1 drug in this class