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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
-

Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers

Phase 1
Completed
Conditions
Pharmacokinetics of YM178
Interventions
First Posted Date
2008-10-21
Last Posted Date
2013-07-03
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
24
Registration Number
NCT00776516

Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Phase 3
Completed
Conditions
Urinary Bladder, Overactive
Interventions
First Posted Date
2008-06-03
Last Posted Date
2024-11-20
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
2792
Registration Number
NCT00688688

Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Phase 3
Completed
Conditions
Urinary Bladder, Overactive
Interventions
First Posted Date
2008-06-03
Last Posted Date
2024-11-20
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
2336
Registration Number
NCT00689104

A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Phase 3
Completed
Conditions
Urinary Bladder, Overactive
Interventions
Drug: Placebo
Drug: Mirabegron
First Posted Date
2008-04-21
Last Posted Date
2024-11-20
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
2149
Registration Number
NCT00662909

A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

Phase 2
Completed
Conditions
Lower Urinary Tract Symptoms
Bladder Outlet Obstruction
Interventions
Drug: Placebo
Drug: Mirabegron
First Posted Date
2006-12-13
Last Posted Date
2014-04-04
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
200
Registration Number
NCT00410514
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