Esmirtazapine
Esmirtazapine is a small molecule pharmaceutical. It is currently being investigated in clinical studies.
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FDA approval date
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Study first post date
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Commercial
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FDA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mirtazapine | ANDA | 2024-10-15 |
| remeron | New Drug Application | 2024-04-04 |
| remeron remeronsoltab | New Drug Application | 2024-03-04 |
Indications
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Agency Specific
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Clinical
Clinical Trials
136 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 | 1 | 13 | 6 | 17 | 17 | 53 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 2 | 11 | 4 | 18 | 11 | 45 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 2 | 8 | 4 | 13 | 8 | 34 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | 2 | 1 | 7 | 1 | 1 | 12 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 1 | — | 4 | 1 | — | 6 |
| Vomiting | D014839 | HP_0002013 | R11.1 | 2 | 2 | — | 1 | 1 | 5 |
| Nausea | D009325 | HP_0002018 | R11.0 | 2 | 2 | — | 1 | 1 | 5 |
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | 1 | 1 | 1 | 3 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | — | — | 2 | 1 | 3 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | 2 | 1 | 3 |
Show 21 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anorexia | D000855 | HP_0002039 | R63.0 | — | 6 | 1 | — | 1 | 7 |
| Neoplasms | D009369 | — | C80 | 1 | 3 | 2 | — | — | 5 |
| Sleep wake disorders | D012893 | — | G47 | — | — | 5 | — | — | 5 |
| Cocaine-related disorders | D019970 | — | F14 | 1 | 4 | 1 | — | — | 4 |
| Parasomnias | D020447 | — | G47.5 | — | — | 4 | — | — | 4 |
| Dyssomnias | D020920 | — | — | — | — | 4 | — | — | 4 |
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | — | 1 | 1 | — | 1 | 3 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 2 | — | 1 | 3 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 1 | 1 | — | 1 | 3 |
| Wasting syndrome | D019282 | — | — | — | 3 | 1 | — | — | 3 |
Show 19 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | 2 | — | — | 2 | 4 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 4 | — | — | — | 4 |
| Body weight | D001835 | EFO_0004338 | — | — | 2 | — | — | 2 | 4 |
| Weight loss | D015431 | HP_0001824 | — | — | 2 | — | — | 2 | 4 |
| Alcohol drinking | D000428 | EFO_0004329 | — | — | 3 | — | — | — | 3 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 1 | — | — | 1 | 2 |
| Dysthymic disorder | D019263 | EFO_0008623 | F34.1 | — | 2 | — | — | — | 2 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | 1 | 1 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | 1 | 2 |
| Hyperemesis gravidarum | D006939 | EFO_1000971 | O21 | 1 | 2 | — | — | — | 2 |
Show 24 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | — | — | — | — | 7 |
| Cardiovascular abnormalities | D018376 | EFO_0003848 | — | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 1 | — | — | — | — | 1 |
| Apnea | D001049 | HP_0002104 | R06.81 | 1 | — | — | — | — | 1 |
| Stomach diseases | D013272 | — | — | 1 | — | — | — | — | 1 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | 1 | — | — | — | — | 1 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 2 | 2 |
| Pathologic constriction | D003251 | — | — | — | — | — | — | 1 | 1 |
| Spinal stenosis | D013130 | EFO_0007490 | M48.0 | — | — | — | — | 1 | 1 |
| Pharmacokinetics | D010599 | — | — | — | — | — | — | 1 | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 1 | 1 |
| Chronic disease | D002908 | — | — | — | — | — | — | 1 | 1 |
| Brain injuries | D001930 | — | S06.9 | — | — | — | — | 1 | 1 |
| Alcohol-related disorders | D019973 | — | F10 | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 1 | 1 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | — | 1 | 1 |
Show 11 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Esmirtazapine |
| INN | esmirtazapine |
| Description | Esmirtazapine (ORG-50,081) is a tetracyclic antidepressant drug that was under development by Organon for the treatment of insomnia and vasomotor symptoms (e.g., hot flashes) associated with menopause. Esmirtazapine is the (S)-(+)-enantiomer of mirtazapine and possesses similar overall pharmacology, including inverse agonist actions at H1 and 5-HT2 receptors and antagonist actions at α2-adrenergic receptors.
|
| Classification | Small molecule |
| Drug class | tricyclic compounds |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1CCN2c3ncccc3Cc3ccccc3[C@H]2C1 |
Identifiers
| PDB | — |
| CAS-ID | 61337-87-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1366933 |
| ChEBI ID | — |
| PubChem CID | 3085218 |
| DrugBank | DB06678 |
| UNII ID | 4685R51V7M (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Mirtazapine, Remeron, Remeron remeronsoltab
Adverse Events
0 adverse events reported
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