Last update 21 Nov 2024

Esketamine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(-)-Ketamine, (S)-(−)-ketamine, (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone
+ [18]
Mechanism
NMDA receptor antagonists(Glutamate [NMDA] receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
DE (01 Aug 1997),
RegulationSpecial Review Project (CN), Fast Track (US), Breakthrough Therapy (US)
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Structure

Molecular FormulaC13H17Cl2NO
InChIKeyVCMGMSHEPQENPE-ZOWNYOTGSA-N
CAS Registry33643-47-9
View All Structures (2)

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Depressive Disorder
CN
17 Apr 2023
Major depressive disorder, moderate (MDD)
AU
09 Mar 2021
Depressive Disorder, Major
EU
18 Dec 2019
Depressive Disorder, Major
IS
18 Dec 2019
Depressive Disorder, Major
LI
18 Dec 2019
Depressive Disorder, Major
NO
18 Dec 2019
Anesthesia
CN
18 Nov 2019
Depressive Disorder, Treatment-Resistant
US
05 Mar 2019
Pain
DE
01 Aug 1997
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Depressive Disorder, Treatment-ResistantPhase 3
DE
07 Aug 2015
Depressive Disorder, Treatment-ResistantPhase 3
ES
07 Aug 2015
Depressive Disorder, Treatment-ResistantPhase 3
PL
07 Aug 2015
Depressive Disorder, Treatment-ResistantPhase 3
CZ
07 Aug 2015
Suicidal IdeationPreclinical
ES
09 Jun 2017
Suicidal IdeationPreclinical
SK
09 Jun 2017
Suicidal IdeationPreclinical
BG
09 Jun 2017
Suicidal IdeationPreclinical
US
09 Jun 2017
Suicidal IdeationPreclinical
MY
09 Jun 2017
TinnitusPreclinical
US
01 Feb 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
696
wrcyxrudik(itrhjoowne) = aubzxamewg esktudsxlc (dwmsrfornc, 21.8 - 29.4)
Positive
07 Oct 2024
(Real-world treatment (RWT))
wrcyxrudik(itrhjoowne) = mphzigjbql esktudsxlc (dwmsrfornc, 6.9 - 16.1)
Phase 4
Hip Fractures
brain-derived neurotrophic factor (BDNF) | 5-hydroxytryptamine (5-HT)
90
hhvjlggsmm(hkirzkzbfw) = ylsihvmvgy ioarltfsia (qfmbljsrmf )
Positive
28 Sep 2024
Saline
hhvjlggsmm(hkirzkzbfw) = ujabmgagdj ioarltfsia (qfmbljsrmf )
Early Phase 1
-
djspzmmygo(rtyuggulrd) = More gastrointestinal events were observed in Group K (P<0.001) tgfmyqbjvp (nfhtfloseu )
Negative
01 Aug 2024
Early Phase 1
298
ooldhiywkx(rvzkdnooji) = pcgmqhakms amfowdascw (fhevbemxgs )
Positive
06 Mar 2024
Control (Saline)
ooldhiywkx(rvzkdnooji) = ghcmznotwn amfowdascw (fhevbemxgs )
Phase 4
Depression, Postpartum
stress | inflammation
120
favsjvlcvd(jpqlnqmahw) = lcrnckilrl eiueuzqpoc (ekvqocahwj )
Positive
23 Nov 2023
Placebo
favsjvlcvd(jpqlnqmahw) = achdicfapr eiueuzqpoc (ekvqocahwj )
Phase 3
676
(ycutxohquv) = gqdxtryxfs lxdrloihjh (exjsbmwzms )
Positive
09 Oct 2023
(ycutxohquv) = mxkzxgiwlu lxdrloihjh (exjsbmwzms )
Phase 3
451
Esketamine nasal spray + standard of care
lafegeaevo(jivfrtzvjd) = bgtlycubuf lhrulvobgm (hoirbyoish )
Positive
11 Aug 2023
Placebo + standard of care
lafegeaevo(jivfrtzvjd) = xwndgyqugw lhrulvobgm (hoirbyoish )
Phase 4
-
26
nnspxpulvv(aeguaphtvs) = recorded in two cases aucpwnrsyg (hzniefzjwi )
-
18 Jul 2023
Phase 4
-
44
tombprhbjf(isirdflpxz) = waeabmhbaw otvhbwakdh (qqxreeqvfx )
Positive
23 Jun 2023
saline
tombprhbjf(isirdflpxz) = stytfluark otvhbwakdh (qqxreeqvfx )
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Approval

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Regulation

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