Mirabegron

Generic Name
Mirabegron
Brand Names
Myrbetriq, Betmiga
Drug Type
Small Molecule
Chemical Formula
C21H24N4O2S
CAS Number
223673-61-8
Unique Ingredient Identifier
MVR3JL3B2V
Background

Mirabegron is a sympathomimetic beta-3 adrenergic receptor agonist used to relax the smooth muscle of the bladder in the treatment of urinary frequency and incontinence. It is unique amongst overactive bladder treatment options in that, unlike other treatments such as solifenacin and darifenacin, it lacks significant antimuscarinic activity, which is responsible both for the therapeutic effects of these medications and their broad range of adverse effects. Mirabegron has a comparatively favorable adverse effect profile as compared to other available treatment options, and its complementary mechanism to the antimuscarinics that came before it allows for its use alongside solifenacin in refractory cases.

Mirabegron first received FDA approval in 2012, under the brand name Myrbetriq, for the treatment of adults with overactive bladder. An extended-release granule formulation was subsequently granted approval in March 2021 for the treatment of pediatric patients with neurogenic detrusor overactivity. Mirabegron is also used in other jurisdictions across the globe, including Canada, the EU, and Japan.

Indication

Mirabegron is indicated for the treatment of overactive bladder (OAB) - with symptoms of urge urinary incontinence, urgency, and urinary frequency - either alone or in combination with solifenacin. It is also indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years of age and older and weighing 35kg or more.

Associated Conditions
Neurogenic Detrusor Overactivity, Overactive Bladder Syndrome (OABS)
Associated Therapies
-

Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine

First Posted Date
2013-10-17
Last Posted Date
2013-10-17
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
24
Registration Number
NCT01964183

Specified Drug Use-results Survey of Betanis Tablets

Completed
Conditions
Interventions
First Posted Date
2013-07-12
Last Posted Date
2018-02-05
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
300
Registration Number
NCT01898624

Beta 3 Agonist Treatment in Heart Failure

First Posted Date
2013-06-12
Last Posted Date
2020-10-19
Lead Sponsor
Henning Bundgaard
Target Recruit Count
70
Registration Number
NCT01876433
Locations
🇦🇺

Monash Center of Cardiovascular Research., Melbourne, Australia

🇩🇰

Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital., Copenhagen Ø, Denmark

🇦🇺

Department of Cardiology, Royal North Shore Hospital., Sydney, Australia

A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients

Phase 4
Completed
Conditions
Interventions
First Posted Date
2012-12-07
Last Posted Date
2018-02-28
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
223
Registration Number
NCT01745094

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

First Posted Date
2012-07-11
Last Posted Date
2024-11-21
Lead Sponsor
Astellas Pharma Europe Ltd.
Target Recruit Count
1887
Registration Number
NCT01638000
Locations
🇦🇲

Site: 37404, Yerevan, Armenia

🇦🇲

Site: 37402, Yerevan, Armenia

🇦🇹

Site: 43013, Linz, Austria

and more 214 locations

A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects

First Posted Date
2012-04-18
Last Posted Date
2013-09-05
Lead Sponsor
Astellas Pharma Europe B.V.
Target Recruit Count
32
Registration Number
NCT01579461
Locations
🇸🇰

FNsP Bratislava, nemocnica akad. L. Dérera; Klinika pracovného lekárstva a toxikológie, Bratislava, Slovakia

A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

First Posted Date
2011-12-12
Last Posted Date
2013-12-09
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
48
Registration Number
NCT01489696
Locations
🇬🇧

Covance CRU Ltd, Leeds, United Kingdom

To Compare Blood and Urine Concentrations of Mirabegron (YM178) in Healthy Poor or Extensive Metabolizers for CYP2D6 and to Assess the Effect of Mirabegron on the Metabolism of Metoprolol

First Posted Date
2011-11-23
Last Posted Date
2014-04-10
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
28
Registration Number
NCT01478490
Locations
🇳🇱

PRA International (former Pharma Bio-Research), Zuidlaren, Netherlands

A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation

First Posted Date
2011-11-23
Last Posted Date
2013-06-27
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
12
Registration Number
NCT01478529
Locations
🇳🇱

Pharma Bio Research, Zuidlaren, Netherlands

To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken Together

First Posted Date
2011-11-23
Last Posted Date
2014-04-10
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
28
Registration Number
NCT01478568
Locations
🇫🇷

SGS Aster, Paris, France

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