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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| mental disorders | D001523 |
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 |
|---|---|---|---|---|
| SPRAVATO | Johnson & Johnson | N-211243 RX | 2019-03-05 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| spravato | New Drug Application | 2020-08-06 |
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* | ||
| 2023-07-31 | I-840 | ||
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
1100 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | G89.18 | 5 | 16 | 19 | 43 | 30 | 102 | |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 20 | 25 | 16 | 14 | 21 | 88 |
| Pain | D010146 | EFO_0003843 | R52 | 8 | 8 | 15 | 34 | 24 | 85 |
| Depression | D003863 | F33.9 | 18 | 23 | 9 | 15 | 13 | 71 | |
| Healthy volunteers/patients | — | 40 | 3 | 1 | 3 | 5 | 51 | ||
| Treatment-resistant depressive disorder | D061218 | 4 | 15 | 15 | 8 | 9 | 48 | ||
| Acute pain | D059787 | R52 | 2 | 7 | 8 | 18 | 15 | 45 | |
| Anesthesia | D000758 | 3 | 4 | 5 | 13 | 10 | 34 | ||
| Chronic pain | D059350 | HP_0012532 | 2 | 5 | 7 | 4 | 17 | 33 | |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 5 | 8 | 6 | 5 | 8 | 30 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 4 | 5 | 6 | — | 3 | 16 | |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 3 | 8 | 2 | — | 1 | 12 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | 2 | — | 3 | 5 | |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | 2 | 2 | — | — | 4 |
| Cognitive dysfunction | D060825 | G31.84 | 2 | 2 | 1 | — | — | 4 | |
| Cocaine-related disorders | D019970 | F14 | 1 | 3 | 1 | — | — | 4 | |
| Mucositis | D052016 | EFO_1001898 | — | 2 | 2 | — | — | 4 | |
| Postoperative complications | D011183 | — | 1 | 2 | — | 1 | 3 | ||
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | 1 | 2 | — | — | 3 |
| Tonsillectomy | D014068 | 1 | 1 | 1 | — | — | 2 |
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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 | 8 | — | — | 4 | 12 |
| Fatigue | D005221 | HP_0012378 | R53.83 | 3 | 3 | — | — | — | 4 |
| Head and neck neoplasms | D006258 | 2 | 3 | — | — | — | 4 | ||
| Complex regional pain syndromes | D020918 | EFO_1001998 | — | 2 | — | — | 1 | 3 | |
| Cancer pain | D000072716 | G89.3 | — | 2 | — | — | — | 2 | |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | — | — | 1 | 2 |
| Magnetic resonance imaging | D008279 | 1 | 1 | — | — | — | 2 | ||
| Autism spectrum disorder | D000067877 | F84.0 | 1 | 1 | — | — | — | 2 | |
| Covid-19 | D000086382 | U07.1 | — | 1 | — | — | 1 | 2 | |
| Neurologic manifestations | D009461 | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 2 | — | — | — | 1 | 3 |
| Brachial plexus block | D065527 | 1 | — | — | — | 2 | 3 | ||
| Emotions | D004644 | 1 | — | — | — | 1 | 2 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | 1 | — | — | — | 1 | 2 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | — | — | — | — | 2 |
| Separation anxiety | D001010 | EFO_1001916 | 1 | — | — | — | — | 1 | |
| Pulmonary atelectasis | D001261 | J98.1 | 1 | — | — | — | — | 1 | |
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 | ||
| Allergic rhinitis | D065631 | J30.9 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nociceptive pain | D059226 | — | — | — | — | 4 | 4 | ||
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | — | — | — | 2 | 2 |
| Colorectal neoplasms | D015179 | — | — | — | — | 2 | 2 | ||
| Electroencephalography | D004569 | — | — | — | — | 2 | 2 | ||
| Replacement arthroplasty hip | D019644 | — | — | — | — | 2 | 2 | ||
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 2 | 2 |
| Bariatric surgery | D050110 | — | — | — | — | 1 | 1 | ||
| Rhytidoplasty | D015361 | — | — | — | — | 1 | 1 | ||
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 1 | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | — | — | — | 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 |
Identifiers
| PDB | — |
| CAS-ID | 33643-46-8 |
| RxCUI | 2119365 |
| ChEMBL ID | CHEMBL395091 |
| ChEBI ID | 60799 |
| PubChem CID | 182137 |
| DrugBank | DB01221 |
| UNII ID | 50LFG02TXD (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Spravato - Johnson & Johnson
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,606 documents
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Safety
Black-box Warning
Black-box warning for: Spravato
Adverse Events
Top Adverse Reactions
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596 adverse events reported
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