Esketamine - PharmaKB

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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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

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 disorders	D001523

Trade Name

FDA

EMA

Spravato

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Esketamine hydrochloride

Tradename	Company	Number	Date	Products
SPRAVATO	Johnson & Johnson	N-211243 RX	2019-03-05	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
ketalar	New Drug Application	2025-01-27
ketamine hydrochloride	ANDA	2024-10-14
mkh dose pack	unapproved drug other	2019-03-05
mko melt dose pack	unapproved drug other	2019-03-04
spravato	New Drug Application	2025-01-27

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
treatment-resistant depressive disorder	—	D061218	—

Agency Specific

FDA

EMA

Expiration	Code
ESKETAMINE HYDROCHLORIDE, SPRAVATO, JANSSEN PHARMS
2024-03-05	NCE*

Patent Expiration

Patent	Expires	FDA Information
Esketamine Hydrochloride, Spravato, Janssen Pharms
11883526	2040-02-18	U-3812, U-3813
10869844	2035-09-10	U-3034, U-3035, U-3036
11173134	2035-09-10	U-3257, U-3536
11311500	2035-09-10	U-3034, U-3035, U-3036
11446260	2034-03-14	U-3444, U-3445, U-3446
8785500	2033-03-05	U-2502
9592207	2027-03-20	U-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

667 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Depressive disorder	D003866	EFO_1002014	F32.A	2	4	11	1	2	20
Treatment-resistant depressive disorder	D061218	—	—	1	2	8	1	2	14

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Depression	D003863	—	F33.9	2	4	9	—	1	16
Major depressive disorder	D003865	EFO_0003761	F22	1	3	3	—	1	8
Suicidal ideation	D059020	EFO_0004320	R45.851	—	2	2	—	—	4
Suicide	D013405	—	—	—	2	2	—	—	4
Recurrence	D012008	—	—	—	—	1	—	—	1

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
Schizophrenia	D012559	EFO_0000692	F20	2	—	—	—	—	2
Substance-related disorders	D019966	EFO_0003890	F13	1	—	—	—	—	1
Liver diseases	D008107	EFO_0001421	K70-K77	1	—	—	—	—	1
Hepatic insufficiency	D048550	—	—	1	—	—	—	—	1
Renal insufficiency	D051437	—	N19	1	—	—	—	—	1
Allergic rhinitis	D065631	—	J30.9	1	—	—	—	—	1
Rhinitis	D012220	EFO_0008521	J31	1	—	—	—	—	1
Perceptual disorders	D010468	—	R41.4	1	—	—	—	—	1
Confusion	D003221	—	F44.89	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Rumination syndrome	D000079562	—	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Esketamine
INN	esketamine
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 class	NMDA receptor antagonists; Antidepressants; General anesthetics; Dissociative hallucinogens; Analgesics
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CN[C@]1(c2ccccc2Cl)CCCCC1=O