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Myrbetriq, Betmiga(mirabegron)
Betmiga, 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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Myrbetriq, Myrbetriq granules (generic drugs available since 2022-09-28)
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
myrbetriqNew Drug Application2022-12-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
overactive urinary bladderEFO_1000781D053201N32.81
urge urinary incontinenceEFO_0006865D053202N39.41
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
87723152028-10-30U-2300
RE448722023-11-04U-1527
73421172023-11-04DP
79820492023-11-04DP
88354742023-11-04U-1527
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
142 clinical trials
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Mock data
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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_1000781N32.814817231566
Healthy volunteers/patients231226
Urge urinary incontinenceD053202EFO_0006865N39.412417
Urinary incontinenceD014549HP_0000020R3211315
Prostatic hyperplasiaD011470EFO_0000284N401214
ObesityD009765EFO_0001073E66.9123
Parkinson diseaseD010300EFO_0002508G2033
NephrolithiasisD053040N20.0112
Interstitial cystitisD018856EFO_1000869N30.1112
NocturiaD053158R35.1112
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary bladder diseasesD001745N32.91427
Urologic diseasesD014570N39.91225
Neurogenic urinary bladderD001750HP_0000011N311213
Heart failureD006333EFO_0003144I50313
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Spinal cord injuriesD013119EFO_1001919123
Lower urinary tract symptomsD059411EFO_0008008213
Prediabetic stateD011236EFO_1001121R73.03112
Erectile dysfunctionD007172EFO_0004234F52.21122
Essential thrombocythemiaD013920D47.311
Polycythemia veraD011087D4511
Primary myelofibrosisD055728D47.411
Prostatic neoplasmsD011471C6111
Blood pressureD001794EFO_000432511
Autonomic dysreflexiaD020211EFO_1001762G90.411
Show 13 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_0000195E88.8111
Esophageal achalasiaD004931HP_0002571K22.011
MetabolismD008660GO_000815211
Intraocular pressureD00742911
Renal insufficiencyD051437HP_0000083N1911
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
Cardiovascular diseasesD002318EFO_0000319I9811
Nocturnal enuresisD053206N39.4411
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)
Structure (InChI/SMILES or Protein Sequence)
Nc1nc(CC(=O)Nc2ccc(CCNC[C@H](O)c3ccccc3)cc2)cs1
Identifiers
PDB
CAS-ID223673-61-8
RxCUI1300786
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,511 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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1,108 adverse events reported
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