Saphris, Sycrest(asenapine)
Asenapine, Saphris, Secuado, Sycrest (asenapine) is a small molecule pharmaceutical. Asenapine was first approved as Saphris on 2009-08-13. It is used to treat bipolar disorder, schizophrenia, and schizophrenia spectrum and other psychotic disorders in the USA. It has been approved in Europe to treat bipolar disorder. The pharmaceutical is active against 5-hydroxytryptamine receptor 2A and D(2) dopamine receptor. In addition, it is known to target 5-hydroxytryptamine receptor 1B, 5-hydroxytryptamine receptor 1D, histamine H1 receptor, 5-hydroxytryptamine receptor 1E, and 5-hydroxytryptamine receptor 1A.
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Events Timeline
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1M
3M
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YTD
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2Y
5Y
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
Asenapine, Saphris, Secuado
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Asenapine maleate
Asenapine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SECUADO | Hisamitsu Pharmaceutical | N-212268 RX | 2019-10-11 | 3 products, RLD |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| schizophrenia | EFO_0000692 | D012559 | F20 |
| bipolar disorder | EFO_0000289 | D001714 | F30.9 |
| schizophrenia spectrum and other psychotic disorders | — | D019967 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Asenapine, Secuado, Hisamitsu | |||
| 11813364 | 2033-09-22 | DP | |
| 9687474 | 2033-07-25 | DP | |
| 10022445 | 2033-07-25 | DP | |
| 10583121 | 2033-07-25 | DP | U-2763 |
| 10814002 | 2033-07-25 | DP | U-2763 |
| 11123305 | 2033-07-25 | DP | |
| Asenapine Maleate, Saphris, Allergan | |||
| 7741358 | 2026-04-06 | DS, DP | U-1064, U-1893, U-1960, U-1961, U-1962, U-1963, U-1966 |
| 8022228 | 2026-04-06 | DS, DP | |
HCPCS
No data
Clinical
Clinical Trials
58 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 4 | 3 | 21 | 2 | 2 | 31 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 2 | 1 | 11 | 1 | 5 | 20 |
| Psychotic disorders | D011618 | — | F20.81 | — | 2 | 4 | 2 | — | 8 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | 1 | 2 | 1 | — | 4 |
| Depression | D003863 | — | F33.9 | — | 1 | — | 1 | — | 2 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | — | 1 | — | 2 |
| Weight gain | D015430 | HP_0004324 | — | — | — | — | 1 | — | 1 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | — | 1 | — | 1 |
| Schizophrenia spectrum and other psychotic disorders | D019967 | — | — | — | — | — | 1 | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Paranoid schizophrenia | D012563 | — | F20.0 | — | — | 2 | — | — | 2 |
| Disorganized schizophrenia | D012562 | — | F20.1 | — | — | 2 | — | — | 2 |
| Bipolar and related disorders | D000068105 | — | — | — | — | 1 | — | — | 1 |
| Stuttering | D013342 | — | F80.81 | — | — | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
| Treatment-resistant schizophrenia | D000090663 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Asenapine |
| INN | asenapine |
| Description | (S,S)-asenapine is a 5-chloro-2-methyl-2,3,3a,12b-tetrahydrodibenzo[2,3:6,7]oxepino[4,5-c]pyrrole in which both of the stereocentres have S configuration. It is a conjugate base of a (S,S)-asenapine(1+). It is an enantiomer of a (R,R)-asenapine. |
| Classification | Small molecule |
| Drug class | tricyclic compounds |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1 |
Identifiers
| PDB | — |
| CAS-ID | 65576-45-6 |
| RxCUI | 784649 |
| ChEMBL ID | CHEMBL3187365 |
| ChEBI ID | 71255 |
| PubChem CID | 163091 |
| DrugBank | DB06216 |
| UNII ID | JKZ19V908O (ChemIDplus, GSRS) |
Target
Agency Approved
HTR2A
HTR2A
DRD2
DRD2
Organism
Homo sapiens
Gene name
HTR2A
Gene synonyms
HTR2
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 2A
Protein synonyms
5-HT2 receptor, 5-hydroxytryptamine (serotonin) receptor 2A, G protein-coupled, serotonin 5-HT-2A receptor, Serotonin receptor 2A
Uniprot ID
Mouse ortholog
Htr2a (15558)
5-hydroxytryptamine receptor 2A (P35363)
Alternate
HTR1B
HTR1B
HTR1D
HTR1D
HRH1
HRH1
HTR1E
HTR1E
HTR1A
HTR1A
Organism
Homo sapiens
Gene name
HTR1B
Gene synonyms
HTR1DB
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 1B
Protein synonyms
5-HT-1D-beta, 5-hydroxytryptamine (serotonin) receptor 1B, G protein-coupled, S12, Serotonin 1D beta receptor, Serotonin receptor 1B
Uniprot ID
Mouse ortholog
Htr1b (15551)
5-hydroxytryptamine receptor 1B (P28334)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Saphris – Allergan
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Saphris – Warner Chilcott
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Tabular view
Estimated US medical usage
Asenapine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,712 documents
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Safety
Black-box Warning
Black-box warning for: Asenapine, Saphris, Secuado
Adverse Events
Top Adverse Reactions
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3,133 adverse events reported
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