Solifenacin
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 diseases | D000091642 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Solifenacin, Vesicare (discontinued: Solifenacin)
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 |
|---|---|---|---|---|
| VESICARE | Astellas Pharma | N-021518 RX | 2004-11-19 | 2 products, RLD, RS |
| VESICARE LS | Astellas Pharma | N-209529 RX | 2020-05-26 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| solifenacin | ANDA | 2022-11-12 |
| solifenacin succinate | ANDA | 2024-07-24 |
| solifenacin succinate solifenacin succinate | ANDA | 2021-11-22 |
| solifenacine succinate | ANDA | 2022-12-05 |
| 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
No data
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
157 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 | 6 | 8 | 25 | 38 | 30 | 104 |
| Urinary incontinence | D014549 | HP_0000020 | R32 | 3 | 5 | 7 | 10 | 9 | 29 |
| Enuresis | D004775 | — | R32 | 2 | 2 | 3 | 8 | 5 | 18 |
| Urge urinary incontinence | D053202 | EFO_0006865 | N39.41 | 2 | 3 | 5 | 5 | 3 | 15 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | 2 | 2 | 4 | 4 | 3 | 15 |
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | 3 | 1 | 4 | 4 | 1 | 13 |
| Hyperplasia | D006965 | EFO_0000536 | — | 3 | 1 | 4 | 4 | 1 | 13 |
| Syndrome | D013577 | — | — | — | — | 2 | 1 | 1 | 4 |
| Dementia | D003704 | EFO_0003862 | F03 | — | 2 | — | 1 | — | 3 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | 1 | 2 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urologic diseases | D014570 | — | N39.9 | — | 1 | 4 | — | 1 | 6 |
| Urinary bladder diseases | D001745 | — | N32.9 | — | 1 | 4 | — | 1 | 6 |
| Ureteroscopy | D018666 | — | — | — | — | 1 | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | — | — | 1 | — | — | 1 |
| Diurnal enuresis | D053207 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 2 | — | — | — | 2 |
| 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 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 13 | — | — | — | — | 13 |
| Pharmacokinetics | D010599 | — | — | 5 | — | — | — | — | 5 |
| Drug interactions | D004347 | — | — | 3 | — | — | — | — | 3 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cross-sectional studies | D003430 | — | — | — | — | — | — | 2 | 2 |
| Prostatectomy | D011468 | — | — | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Nocturnal enuresis | D053206 | — | N39.44 | — | — | — | — | 1 | 1 |
| Underactive urinary bladder | D000077295 | — | — | — | — | — | — | 1 | 1 |
| Hypokinesia | D018476 | — | — | — | — | — | — | 1 | 1 |
| Deprescriptions | D000069340 | — | — | — | — | — | — | 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
No data
Financial
Revenue by drug
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Estimated US medical usage
Solifenacin
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 1,844 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15,271 adverse events reported
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