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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| signs and symptoms pathological conditions | D013568 |
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| solifenacin succinate | ANDA | 2021-06-30 |
| vesicare | New Drug Application | 2022-10-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| overactive urinary bladder | EFO_1000781 | D053201 | N32.81 |
| urge urinary incontinence | EFO_0006865 | D053202 | N39.41 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SOLIFENACIN SUCCINATE, VESICARE LS, ASTELLAS | |||
| 2023-11-26 | PED | ||
| 2023-05-26 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Solifenacin Succinate, Vesicare Ls, Astellas | |||
| 9918970 | 2031-05-18 | DP | |
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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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | 5 | 6 | 20 | 30 | 18 | 78 |
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | 3 | 1 | 4 | 4 | — | 12 |
| Urge urinary incontinence | D053202 | EFO_0006865 | N39.41 | 2 | 2 | 3 | 4 | 1 | 10 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | 2 | 2 | 3 | 2 | 1 | 10 | |
| Urinary incontinence | D014549 | HP_0000020 | R32 | — | — | 1 | 6 | 2 | 9 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | 2 | — | 2 |
| Neurogenic urinary bladder | D001750 | HP_0000011 | N31 | — | — | — | 2 | — | 2 |
| Nocturia | D053158 | R35.1 | — | 1 | 1 | 1 | — | 2 | |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | 1 | 1 | — | 2 |
| Cognition | D003071 | EFO_0003925 | — | — | — | 1 | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neck obstruction | D001748 | EFO_1000840 | N32.0 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Hot flashes | D019584 | — | 1 | — | — | — | 1 | ||
| Signs and symptoms | D012816 | EFO_0003765 | R68 | — | 1 | — | — | — | 1 |
| Urological manifestations | D020924 | — | 1 | — | — | — | 1 | ||
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cross-sectional studies | D003430 | — | — | — | — | 1 | 1 | ||
| Underactive urinary bladder | D000077295 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SOLIFENACIN |
| INN | solifenacin |
| Description | Solifenacin is a member of isoquinolines. |
| Classification | Small molecule |
| Drug class | muscarinic 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-ID | 242478-37-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1734 |
| ChEBI ID | — |
| PubChem CID | 154059 |
| DrugBank | DB01591 |
| UNII ID | A8910SQJ1U (ChemIDplus, GSRS) |
Target
Agency Approved
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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64,569 adverse events reported
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