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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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 diseases | D000091642 |
| signs and symptoms pathological conditions | D013568 |
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 |
|---|---|---|---|---|
| MYRBETRIQ | Astellas Pharma | N-202611 RX | 2012-06-28 | 2 products, RLD, RS |
| MYRBETRIQ GRANULES | Astellas Pharma | N-213801 RX | 2021-03-25 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mirabegron | ANDA | 2025-10-02 |
| myrbetriq | New Drug Application | 2025-07-07 |
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
Expiration | Code | ||
|---|---|---|---|
MIRABEGRON, MYRBETRIQ, APGDI | |||
| 2024-09-25 | PED | ||
| 2024-03-25 | I-855 | ||
MIRABEGRON, MYRBETRIQ GRANULES, APGDI | |||
| 2024-09-25 | PED | ||
| 2024-03-25 | NP | ||
HCPCS
No data
Clinical
Clinical Trials
177 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 | 5 | 5 | 13 | 9 | 5 | 36 |
| Healthy volunteers/patients | — | — | — | 22 | — | — | 2 | — | 24 |
| Urge urinary incontinence | D053202 | EFO_0006865 | N39.41 | — | 1 | 6 | 1 | 1 | 9 |
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | — | — | — | 2 | — | 2 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | — | 1 | — | 1 | — | 2 |
| Interstitial cystitis | D018856 | EFO_1000869 | N30.1 | — | — | 1 | 1 | — | 2 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | 1 | — | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | 1 | — | 1 |
| Sclerosis | D012598 | — | — | — | — | — | 1 | — | 1 |
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 |
| Urinary incontinence | D014549 | — | R32 | 1 | 2 | 4 | — | — | 6 |
| Cystitis | D003556 | EFO_1000025 | N30 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | 1 | — | — | — | 1 |
| Signs and symptoms | D012816 | EFO_0003765 | R68 | — | 1 | — | — | — | 1 |
| Urological manifestations | D020924 | — | — | — | 1 | — | — | — | 1 |
| Urinary bladder neck obstruction | D001748 | EFO_1000840 | N32.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 6 | — | — | — | — | 6 |
| Biological availability | D001682 | — | — | 2 | — | — | — | — | 2 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Esophageal achalasia | D004931 | — | K22.0 | 1 | — | — | — | — | 1 |
| Metabolism | D008660 | GO_0008152 | — | 1 | — | — | — | — | 1 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Intraocular pressure | D007429 | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mirabegron |
| INN | mirabegron |
| 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 class | beta3 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-ID | 223673-61-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2095212 |
| ChEBI ID | 65349 |
| PubChem CID | 9865528 |
| DrugBank | DB08893 |
| UNII ID | MVR3JL3B2V (ChemIDplus, GSRS) |
Target
Agency Approved
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 2,342 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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24,539 adverse events reported
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