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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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Clinical
Drug
Target
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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
mirabegronANDA2025-03-07
myrbetriqNew Drug Application2025-03-13
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
170 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_1000781N32.8145149536
Healthy volunteers/patients———22——2—24
Urge urinary incontinenceD053202EFO_0006865N39.41——2114
Prostatic hyperplasiaD011470EFO_0000284N40———2—2
Lower urinary tract symptomsD059411EFO_0008008——1—1—2
Interstitial cystitisD018856EFO_1000869N30.1——11—2
HyperplasiaD006965EFO_0000536————1—1
HypertrophyD006984EFO_0002460————1—1
Parkinson diseaseD010300EFO_0002508G20———1—1
Multiple sclerosisD009103EFO_0003885G35———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urologic diseasesD014570—N39.9—14—16
Urinary bladder diseasesD001745—N32.9—14—16
CystitisD003556EFO_1000025N30——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Wounds and injuriesD014947—T14.812———3
Spinal cord injuriesD013119EFO_1001919—12———3
NeoplasmsD009369—C80—1——12
Erectile dysfunctionD007172EFO_0004234F52.2112———2
ThermogenesisD022722——22———2
Myeloproliferative disordersD009196—D47.1—1———1
Essential thrombocythemiaD013920—D47.3—1———1
Polycythemia veraD011087—D45—1———1
Primary myelofibrosisD055728—D47.4—1———1
ThrombocytosisD013922—D75.83—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599——6————6
Biological availabilityD001682——2————2
Drug interactionsD004347——2————2
Polycystic ovary syndromeD011085EFO_0000660E28.21————1
Metabolic syndromeD024821EFO_0000195E88.8101————1
Esophageal achalasiaD004931—K22.01————1
MetabolismD008660GO_0008152—1————1
DiseaseD004194EFO_0000408R691————1
Liver diseasesD008107EFO_0001421K70-K771————1
Intraocular pressureD007429——1————1
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_0001360E11————22
Sexual behaviorD012725——————11
Behavior therapyD001521——————11
RecurrenceD012008——————11
Cardiovascular diseasesD002318EFO_0000319I98————11
Nocturnal enuresisD053206—N39.44————11
DeprescriptionsD000069340——————11
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
$
€
£
â‚£
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 2,177 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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23,693 adverse events reported
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