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Drug ReportsMirabegron
Myrbetriq, Betmiga(mirabegron)
Betmiga, Mirabegron, Myrbetriq (mirabegron) is a small molecule pharmaceutical. Mirabegron was first approved as Myrbetriq on 2012-06-28. It is used to treat overactive urinary bladder and urge urinary incontinence in the USA. It has been approved in Europe to treat overactive urinary bladder. The pharmaceutical is active against beta-3 adrenergic receptor. In addition, it is known to target beta-2 adrenergic receptor and beta-1 adrenergic receptor.
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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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
urogenital diseasesD000091642
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Mirabegron, Myrbetriq, Myrbetriq granules (discontinued: Mirabegron)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mirabegron
Tradename
Company
Number
Date
Products
MYRBETRIQAstellas PharmaN-202611 RX2012-06-28
2 products, RLD, RS
MYRBETRIQ GRANULESAstellas PharmaN-213801 RX2021-03-25
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
mirabegronANDA2024-10-09
myrbetriqNew Drug Application2024-10-31
Agency Specific
FDA
EMA
Expiration
Code
MIRABEGRON, MYRBETRIQ, APGDI
2024-09-25PED
2024-03-25I-855
MIRABEGRON, MYRBETRIQ GRANULES, APGDI
2024-09-25PED
2024-03-25NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Mirabegron, Myrbetriq Granules, Apgdi
100585362036-03-31DPU-3108
Mirabegron, Myrbetriq, Apgdi
108427802029-09-28DPU-2996, U-3670
117074512029-09-28U-2996, U-3670
87723152028-10-30U-2300
ATC Codes
G: Genito urinary system and sex hormones
G04: Urologicals
G04B: Urologicals
G04BD: Drugs for urinary frequency and incontinence
G04BD12: Mirabegron
HCPCS
No data
Clinical
Clinical Trials
168 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_1000781N32.8181019292387
Healthy volunteers/patients251228
Urinary incontinenceD014549HP_0000020R323255114
SyndromeD013577136212
Urge urinary incontinenceD053202EFO_0006865N39.4126210
Lower urinary tract symptomsD059411EFO_000800821317
Prostatic hyperplasiaD011470EFO_0000284N4011316
EnuresisD004775R3211316
HyperplasiaD006965EFO_000053611215
ObesityD009765EFO_0001073E66.91225
Show 16 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urologic diseasesD014570N39.91427
Urinary bladder diseasesD001745N32.91427
Neurogenic urinary bladderD001750HP_0000011N311213
Heart failureD006333HP_0001635I50313
CystitisD003556EFO_1000025N3022
UreteroscopyD01866611
Pelvic painD01769911
Diurnal enuresisD05320711
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Wounds and injuriesD014947T14.8123
Spinal cord injuriesD013119EFO_1001919123
NeoplasmsD009369C80112
Erectile dysfunctionD007172EFO_0004234F52.21122
ThermogenesisD022722222
Myeloproliferative disordersD009196D47.111
Essential thrombocythemiaD013920D47.311
Polycythemia veraD011087D4511
Primary myelofibrosisD055728D47.411
ThrombocytosisD013922HP_0001894D75.8311
Show 30 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD01059966
Biological availabilityD00168222
Drug interactionsD00434722
Polycystic ovary syndromeD011085EFO_0000660E28.211
Metabolic syndromeD024821EFO_0000195E88.81011
Esophageal achalasiaD004931HP_0002571K22.011
MetabolismD008660GO_000815211
DiseaseD004194EFO_0000408R6911
Liver diseasesD008107HP_0002910K70-K7711
Intraocular pressureD00742911
Show 3 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 2 diabetes mellitusD003924EFO_0001360E1122
Sexual behaviorD01272511
Behavior therapyD00152111
RecurrenceD01200811
Cardiovascular diseasesD002318HP_000162611
Nocturnal enuresisD053206N39.4411
DeprescriptionsD00006934011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMirabegron
INNmirabegron
Description
Mirabegron is a monocarboxylic acid amide obtained by formal condensation of the carboxy group of 2-amino-1,3-thiazol-4-ylacetic acid with the anilino group of (1R)-2-{[2-(4-aminophenyl)ethyl]amino}-1-phenylethanol. Used for the treatment of overactive bladder syndrome. It has a role as a beta-adrenergic agonist. It is a member of 1,3-thiazoles, an aromatic amide, a member of ethanolamines and a monocarboxylic acid amide.
Classification
Small molecule
Drug classbeta3 adrenoreceptor agonists
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Nc1nc(CC(=O)Nc2ccc(CCNC[C@H](O)c3ccccc3)cc2)cs1
Identifiers
PDB
CAS-ID223673-61-8
RxCUI
ChEMBL IDCHEMBL2095212
ChEBI ID65349
PubChem CID9865528
DrugBankDB08893
UNII IDMVR3JL3B2V (ChemIDplus, GSRS)
Target
Agency Approved
ADRB3
ADRB3
Organism
Homo sapiens
Gene name
ADRB3
Gene synonyms
ADRB3R, B3AR
NCBI Gene ID
Protein name
beta-3 adrenergic receptor
Protein synonyms
adrenergic, beta-3-, receptor, Beta-3 adrenoceptor, Beta-3 adrenoreceptor
Uniprot ID
Mouse ortholog
Adrb3 (11556)
beta-3 adrenergic receptor (Q9QZ98)
Alternate
ADRB2
ADRB2
ADRB1
ADRB1
Organism
Homo sapiens
Gene name
ADRB2
Gene synonyms
ADRB2R, B2AR
NCBI Gene ID
Protein name
beta-2 adrenergic receptor
Protein synonyms
adrenergic, beta-2-, receptor, surface, adrenoceptor beta 2 surface, Beta-2 adrenoceptor, Beta-2 adrenoreceptor, catecholamine receptor
Uniprot ID
Mouse ortholog
Adrb2 (11555)
beta-2 adrenergic receptor (Q8BH38)
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Mirabegron
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,979 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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20,843 adverse events reported
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