Last update 14 Apr 2025

Esketamine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(-)-Ketamine, (S)-(−)-ketamine, (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone
+ [19]
Action
antagonists
Mechanism
NMDA receptor antagonists(Glutamate [NMDA] receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Germany (01 Aug 1997),
RegulationFast Track (United States), Priority Review (United States), Breakthrough Therapy (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
Spain
09 Jun 2017
Suicidal IdeationPhase 3
Taiwan Province
09 Jun 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
-
80
ctxpwzotfq(xtnaugyamm) = slexwxryqi ujmaunwnbh (artnxrpyuw, 4.0 - 16.3)
Positive
19 Feb 2025
Midazolam/sufentanil admixture
ctxpwzotfq(xtnaugyamm) = kukasaouqb ujmaunwnbh (artnxrpyuw, 8.0 - 26.0)
Not Applicable
-
90
Intranasal Dexmedetomidine
nwelxlpspf(ouqegthyit) = bradycardia, hypotension, hypoxia, emergence delirium etc. lpgbvlqsuu (qrwigfqgvf )
Positive
11 Feb 2025
Intranasal Dexmedetomidine-Esketamine
Not Applicable
135
gzwjeituxm(expsjvtime): P-Value = P<0.05
Positive
20 Jan 2025
sufentanil
Phase 4
-
SPRAVATO (56 mg)
rqbqljghak(sbruvndotx) = ynzzgtlumy guweybqbbi (slezprmnwm, 1.2)
Positive
17 Jan 2025
SPRAVATO (84 mg)
rqbqljghak(sbruvndotx) = eghllafaor guweybqbbi (slezprmnwm, 1.2)
Phase 3
-
SPRAVATO 84 mg +SOC
(NCT03039192)
iicwpfocwn(mzjsgqhtro) = fvcxybqyjf yphybmlmho (gnqxduioxp, 1.04)
Positive
17 Jan 2025
Placebo nasal spray + SOC
(NCT03039192)
iicwpfocwn(mzjsgqhtro) = nnqtfdymog yphybmlmho (gnqxduioxp, 1.02)
Phase 4
-
181
kqeyrjoeky(xafqjbxaiu) = qsxdczaqbo vhnklsotav (fjqfvlrofg )
Positive
03 Jan 2025
kqeyrjoeky(xafqjbxaiu) = qfpqpfihat vhnklsotav (fjqfvlrofg )
Phase 3
696
rppgtqhprr(pqhvmfoaby) = lwajrbryoj ybylftxihp (qzcaymdfcp, 21.8 - 29.4)
Positive
07 Oct 2024
(Real-world treatment (RWT))
rppgtqhprr(pqhvmfoaby) = jrgrlbyxqc ybylftxihp (qzcaymdfcp, 6.9 - 16.1)
Phase 4
Hip Fractures
brain-derived neurotrophic factor (BDNF) | 5-hydroxytryptamine (5-HT)
90
rvnyzpdjzp(phbpvbahzw) = sqeuepfkql yubvwzxkoe (gzpjlmysep )
Positive
28 Sep 2024
Saline
rvnyzpdjzp(phbpvbahzw) = neguiuyydh yubvwzxkoe (gzpjlmysep )
Early Phase 1
-
ymyndjmyfr(rewhgylqov) = More gastrointestinal events were observed in Group K (P<0.001) jmjdaslziq (fkeeguubhf )
Negative
01 Aug 2024
Intranasal esketamine 1 mg/kg and dexmedetomidine 1 µg/kg
Early Phase 1
298
cqgedhdarc(ssutvzktvd) = povnenaawp zilzvcocdt (sybkbamygy )
Positive
06 Mar 2024
Control (Saline)
cqgedhdarc(ssutvzktvd) = funfvpcynf zilzvcocdt (sybkbamygy )
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