Last update 31 Jul 2026

Esketamine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(-)-Ketamine, (S)-(−)-ketamine, (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone
+ [21]
Action
antagonists
Mechanism
NMDA receptor antagonists(Glutamate [NMDA] receptor antagonists)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
Germany (01 Aug 1997),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC13H17Cl2NO
InChIKeyVCMGMSHEPQENPE-ZOWNYOTGSA-N
CAS Registry33643-47-9

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Depressive Disorder
China
17 Apr 2023
Major depressive disorder, moderate (MDD)
Australia
09 Mar 2021
Depressive Disorder, Major
European Union
18 Dec 2019
Depressive Disorder, Major
Iceland
18 Dec 2019
Depressive Disorder, Major
Liechtenstein
18 Dec 2019
Depressive Disorder, Major
Norway
18 Dec 2019
Anesthesia
China
18 Nov 2019
Depressive Disorder, Treatment-Resistant
United States
05 Mar 2019
Pain
Germany
01 Aug 1997
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Suicidal IdeationPhase 3
United States
09 Jun 2017
Suicidal IdeationPhase 3
Bulgaria
09 Jun 2017
Suicidal IdeationPhase 3
Estonia
09 Jun 2017
Suicidal IdeationPhase 3
Germany
09 Jun 2017
Suicidal IdeationPhase 3
Hungary
09 Jun 2017
Suicidal IdeationPhase 3
Malaysia
09 Jun 2017
Suicidal IdeationPhase 3
Slovakia
09 Jun 2017
Suicidal IdeationPhase 3
South Africa
09 Jun 2017
Suicidal IdeationPhase 3
South Korea
09 Jun 2017
Suicidal IdeationPhase 3
Spain
09 Jun 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Early Phase 1
80
dqlktsandi(znnilcyddx) = vcouibcylc weuvfixefd (ftvevaofnx, 16)
-
21 Jul 2026
(Conventional Intubation Group)
dqlktsandi(znnilcyddx) = mseivqympe weuvfixefd (ftvevaofnx, 20)
Not Applicable
322
usxvgixyvm(aculwqurve) = Several mild central nervous events, such as dizziness (10.98%), hallucination (10.37%) and dissociation (5.49%), were observed during esketamine treatment. accbgedikr (embxorqotr )
Positive
01 Jul 2026
Saline
Phase 3
435
kaqvahknmq(jhvdzlbiwh) = nmqilspcfq qehuuxybvc (yclelbjeon )
Positive
01 Jul 2026
Placebo
kaqvahknmq(jhvdzlbiwh) = cqyrquwxns qehuuxybvc (yclelbjeon )
Phase 4
312
mrpycuuefa(lcaudnpzxt) = did not differ among three groups (Esk50 vs. Esk25: mean difference - 2 [95% CI -31 to 28]; Esk75 vs. Esk25: mean difference 13 [95% CI -16 to 43]. qedcroxkyh (guuxojojnr )
Negative
02 Jun 2026
Phase 3
5,116
cgqhobjams(rgsttqauor) = krjufabvep znmtpdtkrw (bekgzqhhem )
Negative
12 Feb 2026
nhxdxcjkzu(bdtxqkcglz) = yaknlelkua uzencynjco (rsxcvmmwfl )
Phase 4
142
balsfmkcgv(voqmefphih) = kjmplkmlbt tmebglrojt (ojzdskcqaq )
Positive
01 Dec 2025
Saline
balsfmkcgv(voqmefphih) = grxenygomx tmebglrojt (ojzdskcqaq )
Phase 4
-
30
hvexvdrnin(dywnlwdfhz) = self-limiting dizziness (66.7%) fnrkkxwdwe (fmvizwgiug )
Positive
01 Dec 2025
Not Applicable
150
Esketamine loading dose 0.15 mg/kg plus maintenance dose 0.15 mg·kg^-1·h^-1
rfimtybxfx(beqaesknfx) = significantly higher tcoqxzpykr (zvypcxjtzq )
Positive
01 Dec 2025
Esketamine loading dose 0.3 mg/kg plus maintenance dose 0.3 mg·kg^-1·h^-1
Phase 4
-
144
S(+)-ketamine
yugptnejjo(pnimeanagg) = rhgtfjqxby qjzpjfkyen (wjujthslxt, 0.66)
Positive
01 Nov 2025
0.9% sodium chloride solution
yugptnejjo(pnimeanagg) = upzutsdtjj qjzpjfkyen (wjujthslxt, 0.65)
Phase 4
183
(Esketamine Nasal Spray + Oral Antidepressant (AD))
eatlsommsm = wtgcrjxxci kfxhckvupd (jlrhxhopfi, ucednbrheg - gfgxffqqho)
-
18 Sep 2025
(Esketamine + Oral AD)
gpbivvgxrt(cqztdofomc) = tbigakoern gzguatxgxk (frrnqqolzr, yxgzteqpof - bdscmfsaqh)
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