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
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 |
|---|---|---|
| ketalar | New Drug Application | 2025-06-30 |
| ketamine hydrochloride | ANDA | 2025-04-23 |
| mkh dose pack | unapproved drug other | 2019-03-05 |
| mko melt dose pack | unapproved drug other | 2019-03-04 |
| spravato | New Drug Application | 2025-08-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| treatment-resistant depressive disorder | — | D061218 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ESKETAMINE HYDROCHLORIDE, SPRAVATO, JANSSEN PHARMS | |||
| 2024-03-05 | NCE* | ||
Patent Expiration
Patent | Expires | Flag | 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 | |
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
710 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 | 21 | 44 | 24 | 29 | 36 | 146 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 21 | 40 | 19 | 25 | 25 | 123 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 10 | 23 | 15 | 15 | 22 | 81 |
| Postoperative pain | D010149 | — | G89.18 | 5 | 7 | 5 | 25 | 17 | 55 |
| Treatment-resistant depressive disorder | D061218 | — | — | 4 | 16 | 16 | 5 | 13 | 52 |
| Pain | D010146 | EFO_0003843 | R52 | 6 | 3 | 5 | 10 | 14 | 35 |
| Healthy volunteers/patients | — | — | — | 24 | 2 | — | 3 | 3 | 31 |
| Anesthesia | D000758 | — | — | 3 | 2 | 1 | 11 | 11 | 28 |
| Chronic pain | D059350 | — | — | 5 | 8 | 5 | 4 | 7 | 24 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 2 | 5 | 6 | 4 | 8 | 23 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wounds and injuries | D014947 | — | T14.8 | 3 | — | 3 | — | 3 | 9 |
| Postoperative cognitive complications | D000079690 | — | — | — | 2 | 1 | — | 4 | 7 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | 4 | 1 | — | 1 | 6 |
| Neoplasms | D009369 | — | C80 | 2 | 4 | 1 | — | — | 6 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | 3 | 1 | — | — | 5 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | 2 | 3 | — | — | 5 |
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | 2 | 4 | — | 1 | 5 |
| Septic shock | D012772 | — | A48.3 | 1 | 1 | 3 | — | 1 | 5 |
| Consciousness disorders | D003244 | — | — | — | 1 | 1 | — | 3 | 4 |
| Procedural pain | D000073818 | — | — | 1 | — | 2 | — | — | 3 |
Show 64 more
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 | — | — | 5 | 12 |
| Traumatic stress disorders | D040921 | — | — | 4 | 6 | — | — | 4 | 12 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 2 | — | — | 4 | 6 |
| Compulsive personality disorder | D003193 | — | F60.5 | 2 | 4 | — | — | 1 | 5 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | 1 | 1 | — | — | 2 | 4 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | 1 | 1 | — | — | 2 | 4 |
| Autism spectrum disorder | D000067877 | — | F84.0 | 1 | 1 | — | — | 2 | 4 |
| Heart arrest | D006323 | EFO_0009492 | I46 | 1 | 1 | — | — | 1 | 3 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 3 | 1 | — | — | — | 3 |
| Complex regional pain syndromes | D020918 | EFO_1001998 | — | — | 2 | — | — | 1 | 3 |
Show 38 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain injuries | D001930 | — | S06.9 | 1 | — | — | — | 2 | 3 |
| Fistula | D005402 | — | — | 1 | — | — | — | 1 | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | — | — | — | — | 2 |
| Anhedonia | D059445 | — | R45.84 | 1 | — | — | — | 1 | 2 |
| Separation anxiety | D001010 | EFO_1001916 | — | 1 | — | — | — | — | 1 |
| Emotions | D004644 | — | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Allergic rhinitis | D065631 | — | J30.9 | 1 | — | — | — | — | 1 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 1 | — | — | — | — | 1 |
Show 32 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Somatoform disorders | D013001 | — | F45 | — | — | — | — | 2 | 2 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 2 | 2 |
| Thoracic surgical procedures | D019616 | — | — | — | — | — | — | 2 | 2 |
| Herpes zoster | D006562 | EFO_0006510 | B02 | — | — | — | — | 2 | 2 |
| Trigeminal neuralgia | D014277 | EFO_1001219 | G50.0 | — | — | — | — | 2 | 2 |
| Herpes simplex | D006561 | — | B00 | — | — | — | — | 2 | 2 |
| Phimosis | D010688 | EFO_1001104 | N47.1 | — | — | — | — | 1 | 1 |
| Fissure in ano | D005401 | — | K60.2 | — | — | — | — | 1 | 1 |
| Rectal fistula | D012003 | — | K60.3 | — | — | — | — | 1 | 1 |
| Parturition | D036801 | — | — | — | — | — | — | 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 | — |
| ChEMBL ID | CHEMBL395091 |
| ChEBI ID | 60799 |
| PubChem CID | 182137 |
| DrugBank | DB01221 |
| UNII ID | 50LFG02TXD (ChemIDplus, GSRS) |
Target
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Variants
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Spravato – Johnson & Johnson
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Trends
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Safety
Black-box Warning
Black-box warning for: Spravato
Adverse Events
Top Adverse Reactions
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14,120 adverse events reported
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