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Drug ReportsEsketamine
Spravato(esketamine)
Spravato (esketamine) is a small molecule pharmaceutical. Esketamine was first approved as Spravato on 2019-03-05. It is used to treat treatment-resistant depressive disorder in the USA. It has been approved in Europe to treat depressive disorder.
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5D
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YTD
1Y
2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Spravato
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Esketamine hydrochloride
Tradename
Company
Number
Date
Products
SPRAVATOJohnson & JohnsonN-211243 RX2019-03-05
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ketalarNew Drug Application2025-10-17
ketamine hydrochlorideANDA2025-12-08
mkh dose packunapproved drug other2019-03-05
mko melt dose packunapproved drug other2019-03-04
spravatoNew Drug Application2025-08-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
treatment-resistant depressive disorder—D061218—
Agency Specific
FDA
EMA
Expiration
Code
ESKETAMINE HYDROCHLORIDE, SPRAVATO, JANSSEN PHARMS
2024-03-05NCE*
Patent Expiration
Patent
Expires
Flag
FDA Information
Esketamine Hydrochloride, Spravato, Janssen Pharms
118835262040-02-18U-3812, U-3813
108698442035-09-10U-3034, U-3035, U-3036
111731342035-09-10U-3257, U-3536
113115002035-09-10U-3034, U-3035, U-3036
114462602034-03-14U-3444, U-3445, U-3446
87855002033-03-05U-2502
95922072027-03-20U-2502
ATC Codes
N: Nervous system drugs
— N01: Anesthetics
— N01A: Anesthetics, general
— N01AX: Other general anesthetics in atc
— N01AX14: Esketamine
— N06: Psychoanaleptics
— N06A: Antidepressants
— N06AX: Other antidepressants in atc
— N06AX27: Esketamine
HCPCS
Code
Description
G2082
Office or other outpatient visit for the evaluation and management of an established patient that requires the supervision of a physician or other qualified health care professional and provision of up to 56 mg of esketamine nasal self-administration, includes 2 hours post-administration observation
G2083
Office or other outpatient visit for the evaluation and management of an established patient that requires the supervision of a physician or other qualified health care professional and provision of greater than 56 mg esketamine nasal self-administration, includes 2 hours post-administration observation
S0013
Esketamine, nasal spray, 1 mg
Clinical
Clinical Trials
723 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Treatment-resistant depressive disorderD061218——1281214
Depressive disorderD003866EFO_1002014F32.A2431212
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863—F33.9243—110
Major depressive disorderD003865EFO_0003761F22134—19
Suicidal ideationD059020EFO_0004320R45.851—21——3
SuicideD013405———21——3
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———18————18
SchizophreniaD012559EFO_0000692F202————2
Substance-related disordersD019966EFO_0003890F131————1
Liver diseasesD008107EFO_0001421K70-K771————1
Hepatic insufficiencyD048550——1————1
Renal insufficiencyD051437—N191————1
Allergic rhinitisD065631—J30.91————1
RhinitisD012220EFO_0008521J311————1
Perceptual disordersD010468—R41.41————1
ConfusionD003221—F44.891————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rumination syndromeD000079562——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEsketamine
INNesketamine
Description
Esketamine is the S- (more active) enantiomer of ketamine. It has a role as an analgesic, a NMDA receptor antagonist and an intravenous anaesthetic. It is an enantiomer of a (R)-ketamine.
Classification
Small molecule
Drug classNMDA receptor antagonists; Antidepressants; General anesthetics; Dissociative hallucinogens; Analgesics
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN[C@]1(c2ccccc2Cl)CCCCC1=O
Identifiers
PDB—
CAS-ID33643-46-8
RxCUI—
ChEMBL IDCHEMBL395091
ChEBI ID60799
PubChem CID182137
DrugBankDB01221
UNII ID50LFG02TXD (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Spravato – Johnson & Johnson
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 82,007 documents
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Safety
Black-box Warning
Black-box warning for: Spravato
Adverse Events
Top Adverse Reactions
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14,301 adverse events reported
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