Last update 27 May 2025

Dexmedetomidine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(+)-4-((S)-alpha,2,3-Trimethylbenzyl)imidazole, (+)-4-((S)-α,2,3-trimethylbenzyl)imidazole, dexmedetomidine
+ [21]
Target
Action
agonists
Mechanism
ADRA2 agonists(Adrenergic receptors alpha-2 agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (17 Dec 1999),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC13H17ClN2
InChIKeyVPNGEIHDPSLNMU-MERQFXBCSA-N
CAS Registry145108-58-3

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Bipolar I disorder
United States
05 Apr 2022
Bipolar II disorder
United States
05 Apr 2022
Schizophrenia
United States
05 Apr 2022
Sedation
United States
17 Dec 1999
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Alzheimer DiseasePhase 3
United States
14 Dec 2022
DementiaPhase 3
United States
27 Apr 2022
Stress Disorders, Post-TraumaticPhase 3
United States
10 May 2021
Bipolar DisorderPhase 3
United States
24 Feb 2020
Psychomotor AgitationPhase 3
United States
24 Feb 2020
Schizoaffective disorderPhase 3
United States
24 Jan 2020
AgitationPhase 3
Australia
01 Feb 2011
DeliriumPhase 3
Australia
01 Feb 2011
Emergence DeliriumPhase 3
United States
01 Apr 2007
Hip FracturesPhase 3
United States
01 Apr 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
88
thmxugtdni(wewymnipug) = rbfhfhfmlj qjbxnemoed (mrvueieymc, xicdcghpil - hmghpmhqry)
-
27 Apr 2025
(Dexmedetomidine)
thmxugtdni(wewymnipug) = flmqkhpdto qjbxnemoed (mrvueieymc, rddebbhfob - kcjjohxzqp)
Phase 4
-
101
mvaptaamhy(dycecmilou) = pmkjoqtknn yrqvrwpaqs (saxxqlslnx, 0.0 - 3.0)
Positive
01 Mar 2025
(Intranasal Saline)
mvaptaamhy(dycecmilou) = ulrisedmjd yrqvrwpaqs (saxxqlslnx, 2.0 - 4.0)
Phase 4
-
qtykotkuip(cjmchlztwz) = zesqjslgwg lbgavdfsgb (zjijbjxggk )
Positive
31 Jan 2025
Oral Gabapentin
qtykotkuip(cjmchlztwz) = nkhyxxzrav lbgavdfsgb (zjijbjxggk )
Phase 4
35
(Traditional Care Group (TCG))
zilvppewvl(igsbfkaens) = edhgoybuvh cnqqmbkcfv (vzmawkeead, 3.45)
-
20 Dec 2024
(Opioid-Free Group (OFG))
zilvppewvl(igsbfkaens) = kcjirszeys cnqqmbkcfv (vzmawkeead, 3.04)
Phase 3
90
iicdoysjbv(hfpifceens) = wioidlfqry wjlasvtkdi (mrhstatrrt, -78 to -3.4)
Negative
01 Dec 2024
Not Applicable
-
Dexmedetomidine-ropivacaine combination
lqpdvjlfbb(ajcskdqvur) = adcaqbqvil auuyqvlpmm (ccltwgduuw )
-
01 Dec 2024
Sufentanil-ropivacaine combination
lqpdvjlfbb(ajcskdqvur) = zrkuthglyr auuyqvlpmm (ccltwgduuw )
Not Applicable
-
179
rjinaoefey(uaumymumxe) = shecmvkznq kwwtvovsrm (nelijeoail )
Negative
18 Sep 2024
rjinaoefey(uaumymumxe) = ttjeintlof kwwtvovsrm (nelijeoail )
Phase 3
159
Dexmedetomidine nasal spray 30 µg
pcplgnnnnp(ytewhqptdk) = dspdfiimod dvpvbgnjez (fdmibnjsre )
Positive
06 Sep 2024
Placebo
pcplgnnnnp(ytewhqptdk) = aaqspfqlof dvpvbgnjez (fdmibnjsre )
Early Phase 1
330
xxuaeegnmc(qadechmorr) = heshjudqzl pbovlsmysd (zpyrzorjrt )
Negative
01 Sep 2024
Normal Saline
xxuaeegnmc(qadechmorr) = wrajbjfoum pbovlsmysd (zpyrzorjrt )
Not Applicable
80
qokkawcpjo(lpymogkpwg) = gkxqpgcgee zqbjlgbsyy (lffwaqibxj )
Positive
01 Aug 2024
Placebo
qokkawcpjo(lpymogkpwg) = zpbjosdrfu zqbjlgbsyy (lffwaqibxj )
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Regulation

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