Overview
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)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/08/13 | Phase 4 | Completed | |||
2014/08/08 | Phase 1 | Completed | |||
2014/06/23 | Phase 1 | Completed | |||
2014/05/15 | Phase 4 | Completed | |||
2014/04/30 | Phase 1 | Completed | |||
2014/03/26 | Phase 4 | Completed | |||
2014/03/20 | Phase 4 | Completed | Daniel Burdick, MD | ||
2014/03/13 | Phase 4 | Completed | Theodore R. Brown, MD MPH | ||
2014/01/27 | Phase 3 | Completed | |||
2014/01/24 | Phase 2 | Terminated |
FDA Drug Approvals
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