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

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Variants

Financial

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YTD

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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	2024-10-14
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	2024-11-13

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

634 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Depression	D003863	—	F33.9	20	43	26	29	34	145
Depressive disorder	D003866	EFO_1002014	F32.A	21	39	24	31	31	140
Major depressive disorder	D003865	EFO_0003761	F22	10	20	11	14	19	71
Postoperative pain	D010149	—	G89.18	5	7	5	23	14	50
Treatment-resistant depressive disorder	D061218	—	—	2	16	15	4	11	46
Healthy volunteers/patients	—	—	—	24	2	—	3	2	30
Pain	D010146	EFO_0003843	R52	4	2	3	10	12	29
Anesthesia	D000758	—	—	2	2	1	11	9	25
Suicidal ideation	D059020	EFO_0004320	R45.851	1	9	7	4	3	22
Acute pain	D059787	—	R52	2	4	5	12	1	21

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cognitive dysfunction	D060825	HP_0001268	G31.84	—	2	1	—	4	7
Neoplasms	D009369	—	C80	2	5	2	—	—	7
Substance-related disorders	D019966	EFO_0003890	F13	1	4	1	—	1	6
Postoperative cognitive complications	D000079690	—	—	—	2	1	—	3	6
Opioid-related disorders	D009293	EFO_0005611	F11	1	3	1	—	—	5
Status epilepticus	D013226	EFO_0008526	G41	—	2	4	—	1	5
Epilepsy	D004827	EFO_0000474	G40.9	1	2	2	—	—	4
Septic shock	D012772	—	A48.3	—	—	3	—	1	4
Shock	D012769	—	R57.1	—	—	3	—	1	4
Consciousness disorders	D003244	—	—	—	1	1	—	3	4

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Obsessive-compulsive disorder	D009771	EFO_0004242	F42	2	7	—	—	4	11
Traumatic stress disorders	D040921	—	—	2	4	—	—	4	10
Compulsive personality disorder	D003193	—	F60.5	2	6	—	—	1	7
Autistic disorder	D001321	HP_0000717	F84.0	1	1	—	—	2	4
Autism spectrum disorder	D000067877	HP_0000729	F84.0	1	1	—	—	2	4
Alcoholism	D000437	EFO_0003829	F10.1	3	1	—	—	—	3
Pervasive child development disorders	D002659	EFO_0003756	F84	1	1	—	—	1	3
Complex regional pain syndromes	D020918	EFO_1001998	—	—	2	—	—	1	3
Reflex sympathetic dystrophy	D012019	EFO_1001147	G90.5	—	2	—	—	1	3
Cancer pain	D000072716	—	G89.3	1	2	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Fistula	D005402	—	—	1	—	—	—	1	2
Heart arrest	D006323	EFO_0009492	I46	1	—	—	—	1	2
Pancreatic neoplasms	D010190	EFO_0003860	C25	2	—	—	—	—	2
Abdominal neoplasms	D000008	—	—	1	—	—	—	1	2
Separation anxiety	D001010	EFO_1001916	—	1	—	—	—	—	1
Emotions	D004644	—	—	1	—	—	—	—	1
Liver diseases	D008107	HP_0002910	K70-K77	1	—	—	—	—	1
Hepatic insufficiency	D048550	—	—	1	—	—	—	—	1
Allergic rhinitis	D065631	—	J30.9	1	—	—	—	—	1
Rhinitis	D012220	EFO_0008521	J31	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Sleep wake disorders	D012893	—	G47	—	—	—	—	4	4
Dyssomnias	D020920	—	—	—	—	—	—	4	4
Parasomnias	D020447	—	G47.5	—	—	—	—	4	4
Somatoform disorders	D013001	—	F45	—	—	—	—	2	2
Parkinson disease	D010300	EFO_0002508	G20	—	—	—	—	2	2
Phimosis	D010688	EFO_1001104	N47.1	—	—	—	—	1	1
Fissure in ano	D005401	HP_0012390	K60.2	—	—	—	—	1	1
Rectal fistula	D012003	HP_0010447	K60.3	—	—	—	—	1	1
Parturition	D036801	—	—	—	—	—	—	1	1
Tibial fractures	D013978	EFO_0003944	S82.20	—	—	—	—	1	1

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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