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Solifenacin
Vesicare (solifenacin) is a small molecule pharmaceutical. Solifenacin was first approved as Vesicare on 2004-11-19. It is used to treat overactive urinary bladder and urge urinary incontinence in the USA. The pharmaceutical is active against muscarinic acetylcholine receptor M3 and muscarinic acetylcholine receptor M2. In addition, it is known to target muscarinic acetylcholine receptor M4, muscarinic acetylcholine receptor M5, and muscarinic acetylcholine receptor M1.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Vesicare (generic drugs available since 2014-04-02)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Solifenacin succinate
Tradename
Company
Number
Date
Products
VESICAREAstellas PharmaN-021518 RX2004-11-19
2 products, RLD, RS
VESICARE LSAstellas PharmaN-209529 RX2020-05-26
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
solifenacin succinateANDA2021-06-30
vesicareNew Drug Application2022-10-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
overactive urinary bladderEFO_1000781D053201N32.81
urge urinary incontinenceEFO_0006865D053202N39.41
Agency Specific
FDA
EMA
Expiration
Code
SOLIFENACIN SUCCINATE, VESICARE LS, ASTELLAS
2023-11-26PED
2023-05-26NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Solifenacin Succinate, Vesicare Ls, Astellas
99189702031-05-18DP
ATC Codes
G: Genito urinary system and sex hormones
— G04: Urologicals
— G04B: Urologicals
— G04BD: Drugs for urinary frequency and incontinence
— G04BD08: Solifenacin
— G04C: Drugs used in benign prostatic hypertrophy
— G04CA: Alpha-adrenoreceptor antagonists, benign prostatic hypertrophy
— G04CA53: Tamsulosin and solifenacin
HCPCS
No data
Clinical
Clinical Trials
130 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
Overactive urinary bladderD053201EFO_1000781N32.815620301878
Prostatic hyperplasiaD011470EFO_0000284N403144—12
Urge urinary incontinenceD053202EFO_0006865N39.412234110
Lower urinary tract symptomsD059411EFO_00080082232110
Urinary incontinenceD014549HP_0000020R32——1629
Multiple sclerosisD009103EFO_0003885G35———2—2
Neurogenic urinary bladderD001750HP_0000011N31———2—2
NocturiaD053158R35.1—111—2
Parkinson diseaseD010300EFO_0002508G20——11—2
CognitionD003071EFO_0003925———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary bladder diseasesD001745N32.9—14——5
Urologic diseasesD014570N39.9—12——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary bladder neck obstructionD001748EFO_1000840N32.0—1———1
Breast neoplasmsD001943EFO_0003869C50—1———1
Hot flashesD019584—1———1
Signs and symptomsD012816EFO_0003765R68—1———1
Urological manifestationsD020924—1———1
Alzheimer diseaseD000544EFO_0000249F03—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—9————9
PharmacokineticsD0105993————3
Drug interactionsD0043472————2
Biological availabilityD0016821————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cross-sectional studiesD003430————11
Underactive urinary bladderD000077295————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSOLIFENACIN
INNsolifenacin
Description
Solifenacin is a member of isoquinolines.
Classification
Small molecule
Drug classmuscarinic receptor antagonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Identifiers
PDB—
CAS-ID242478-37-1
RxCUI—
ChEMBL IDCHEMBL1734
ChEBI ID—
PubChem CID154059
DrugBankDB01591
UNII IDA8910SQJ1U (ChemIDplus, GSRS)
Target
Agency Approved
CHRM3
CHRM3
CHRM2
CHRM2
Organism
Homo sapiens
Gene name
CHRM3
Gene synonyms
NCBI Gene ID
1131
Protein name
muscarinic acetylcholine receptor M3
Protein synonyms
acetylcholine receptor, muscarinic 3, m3 muscarinic receptor
Uniprot ID
Q9HB60
Mouse ortholog
Chrm3 (12671)
muscarinic acetylcholine receptor M3 (Q9ERZ3)
Alternate
CHRM4
CHRM4
CHRM5
CHRM5
CHRM1
CHRM1
Organism
Homo sapiens
Gene name
CHRM4
Gene synonyms
NCBI Gene ID
1132
Protein name
muscarinic acetylcholine receptor M4
Protein synonyms
acetylcholine receptor, muscarinic 4
Uniprot ID
Q4VBK7
Mouse ortholog
Chrm4 (12672)
muscarinic acetylcholine receptor M4 (Q64056)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,556 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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64,569 adverse events reported
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