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Drug ReportsTolterodine
Tolterodine
Detrol, Tolterodine (tolterodine) is a small molecule pharmaceutical. Tolterodine was first approved as Detrol on 1998-03-25. It is used to treat urinary bladder diseases and urinary incontinence in the USA. It is known to target muscarinic acetylcholine receptor M4, muscarinic acetylcholine receptor M3, muscarinic acetylcholine receptor M5, muscarinic acetylcholine receptor M2, and muscarinic acetylcholine receptor M1.
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Safety
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Detrol, Tolterodine (discontinued: Tolterodine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tolterodine tartrate
Tradename
Company
Number
Date
Products
DETROLUpjohnN-020771 RX1998-03-25
2 products, RLD, RS
DETROL LAUpjohnN-021228 RX2000-12-22
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
detrolNew Drug Application2023-02-15
detrol laNew Drug Application2023-03-15
tolterodine tartarate tolterodine tartrateANDA2023-03-23
tolterodine tartrateANDA2024-09-03
tolterodine tartrate extended releaseNDA authorized generic2018-08-22
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
G: Genito urinary system and sex hormones
— G04: Urologicals
— G04B: Urologicals
— G04BD: Drugs for urinary frequency and incontinence
— G04BD07: Tolterodine
HCPCS
No data
Clinical
Clinical Trials
104 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 bladderD053201EFO_1000781N32.8171021211471
Urinary incontinenceD014549HP_0000020R3222211320
EnuresisD004775—R32—1—7311
Urge urinary incontinenceD053202EFO_0006865N39.41—1—326
SyndromeD013577——1——315
Healthy volunteers/patients———2——2—4
Lower urinary tract symptomsD059411EFO_0008008——11113
Chronic painD059350HP_0012532————2—2
Prostatic hyperplasiaD011470EFO_0000284N40———2—2
HyperplasiaD006965EFO_0000536————2—2
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Low back painD017116HP_0003419M54.5——1——1
Back painD001416HP_0003418M54——1——1
PainD010146EFO_0003843R52——1——1
Nocturnal enuresisD053206—N39.44—11——1
Pelvic organ prolapseD056887EFO_0004710———1——1
ProlapseD011391————1——1
Interstitial cystitisD018856EFO_1000869N30.1——1——1
Pelvic painD017699————1——1
CystitisD003556EFO_1000025N30——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuralgiaD009437EFO_0009430—11———1
NocturiaD053158—R35.1—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
Vascular diseasesD014652EFO_0004264I77————11
Drug-related side effects and adverse reactionsD064420—T88.7————11
Drug interactionsD004347——————11
Urologic diseasesD014570—N39.9————11
Urinary bladder diseasesD001745—N32.9————11
ProstatitisD011472EFO_0003830N41————11
Cross-sectional studiesD003430——————11
DeprescriptionsD000069340——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTolterodine
INNtolterodine
Description
Tolterodine is a tertiary amine. It has a role as a muscarinic antagonist, a muscle relaxant and an antispasmodic drug. It is functionally related to a p-cresol.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1ccc(O)c([C@H](CCN(C(C)C)C(C)C)c2ccccc2)c1
Identifiers
PDB—
CAS-ID124937-51-5
RxCUI—
ChEMBL IDCHEMBL1382
ChEBI ID9622
PubChem CID443879
DrugBankDB01036
UNII IDWHE7A56U7K (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CHRM4
CHRM4
CHRM3
CHRM3
CHRM5
CHRM5
CHRM2
CHRM2
CHRM1
CHRM1
Organism
Homo sapiens
Gene name
CHRM4
Gene synonyms
NCBI Gene ID
Protein name
muscarinic acetylcholine receptor M4
Protein synonyms
acetylcholine receptor, muscarinic 4
Uniprot ID
Mouse ortholog
Chrm4 (12672)
muscarinic acetylcholine receptor M4 (Q64056)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Detrol – Pfizer
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Estimated US medical usage
Tolterodine
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,369 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,205 adverse events reported
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