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Saphris, Sycrest(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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Saphris, Secuado (generic drugs available since 2020-12-10)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Asenapine
Tradename
Company
Number
Date
Products
SECUADOHisamitsu PharmaceuticalN-212268 RX2019-10-11
3 products, RLD
Asenapine maleate
Tradename
Company
Number
Date
Products
SAPHRISAllerganN-022117 RX2009-08-13
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
saphrisNew Drug Application2017-02-17
secuadoNew Drug Application2020-02-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bipolar disorderEFO_0000289D001714F30.9
schizophreniaEFO_0000692D012559F20
schizophrenia spectrum and other psychotic disorders—D019967—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Asenapine, Secuado, Hisamitsu
96874742033-07-25DP
100224452033-07-25DP
105831212033-07-25DPU-2763
108140022033-07-25DPU-2763
111233052033-07-25DP
Asenapine Maleate, Saphris, Allergan
77413582026-04-06DS, DPU-1064, U-1893, U-1960, U-1961, U-1962, U-1963, U-1966
80222282026-04-06DS, DP
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05A: Antipsychotics
— N05AH: Diazepines, oxazepines, thiazepines and oxepines antipsychotic drugs
— N05AH05: Asenapine
HCPCS
No data
Clinical
Clinical Trials
49 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F2022191124
Bipolar disorderD001714EFO_0000289F30.921101216
Psychotic disordersD011618F20.81—231—6
Schizophrenia spectrum and other psychotic disordersD019967———1—1
Post-traumatic stress disordersD013313EFO_0001358F43.1———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Paranoid schizophreniaD012563F20.0——2——2
Disorganized schizophreniaD012562F20.1——2——2
StutteringD013342F80.81——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameASENAPINE
INNasenapine
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 classtricyclic compounds
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Identifiers
PDB—
CAS-ID65576-45-6
RxCUI784649
ChEMBL IDCHEMBL3187365
ChEBI ID71255
PubChem CID163091
DrugBankDB06216
UNII IDJKZ19V908O (ChemIDplus, GSRS)
Target
Agency Approved
HTR2A
HTR2A
DRD2
DRD2
Organism
Homo sapiens
Gene name
HTR2A
Gene synonyms
HTR2
NCBI Gene ID
3356
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
Q5T8C0
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
3351
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
Q4VAY7
Mouse ortholog
Htr1b (15551)
5-hydroxytryptamine receptor 1B (P28334)
Variants
Clinical Variant
No data
Financial
Saphris - Allergan
$
€
£
₣
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Saphris - Warner Chilcott
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,430 documents
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Safety
Black-box Warning
Black-box warning for: Saphris, Secuado
Adverse Events
Top Adverse Reactions
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37 adverse events reported
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