Asenapine - PharmaKB

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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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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)

Abbreviated New Drug Application (ANDA)

Asenapine

Tradename	Company	Number	Date	Products
SECUADO	Hisamitsu Pharmaceutical	N-212268 RX	2019-10-11	3 products, RLD

Asenapine maleate

Tradename	Company	Number	Date	Products
SAPHRIS	Allergan	N-022117 RX	2009-08-13	3 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
asenapine	ANDA	2025-02-25
saphris	New Drug Application	2025-01-31
secuado	New Drug Application	2025-01-30

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

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

58 clinical trials

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Indications Phases 4

No data

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Schizophrenia	D012559	EFO_0000692	F20	1	1	18	—	1	21
Bipolar disorder	D001714	EFO_0000289	F30.9	1	—	9	—	2	12
Psychotic disorders	D011618	—	F20.81	—	2	3	—	—	5
Paranoid schizophrenia	D012563	—	F20.0	—	—	2	—	—	2
Disorganized schizophrenia	D012562	—	F20.1	—	—	2	—	—	2
Mental disorders	D001523	EFO_0000677	F91.9	—	1	1	—	—	2
Bipolar and related disorders	D000068105	—	—	—	—	1	—	—	1
Treatment-resistant schizophrenia	D000090663	—	—	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Anhedonia	D059445	—	R45.84	—	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

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

HTR1D

HRH1

HTR1E

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

No data

Financial

Revenue by drug

€

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Saphris – Allergan

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Saphris – Warner Chilcott

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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 1,857 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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3,305 adverse events reported

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