MedPath

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)

Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron in Sexually Active Men With OAB Symptoms

Not Applicable
Completed
Conditions
Sexual Activity
Behavior Therapy
Sexual Behavior
Urinary Bladder, Overactive
Sexual Function Disturbances
Interventions
Behavioral: Behavior therapy alone
First Posted Date
2020-06-09
Last Posted Date
2022-10-05
Lead Sponsor
Chang Gung Memorial Hospital
Target Recruit Count
150
Registration Number
NCT04420533
Locations
🇨🇳

Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan

Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms

Phase 3
Conditions
Ureteral Stent
Stent Related Symptoms
Interventions
First Posted Date
2020-03-30
Last Posted Date
2021-11-23
Lead Sponsor
Mansoura University
Target Recruit Count
240
Registration Number
NCT04325880
Locations
🇪🇬

Urology and Nephrology Center, Mansoura, DK, Egypt

Mirabegron And Ureteral Stent-related Pain (MAP) Trial

Phase 3
Conditions
Nephrolithiasis
Interventions
Drug: Placebo oral tablet
First Posted Date
2020-02-26
Last Posted Date
2020-02-26
Lead Sponsor
Unity Health Toronto
Target Recruit Count
142
Registration Number
NCT04286152
Locations
🇨🇦

St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada

Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

Phase 3
Recruiting
Conditions
Overactive Bladder Syndrome
Interventions
First Posted Date
2019-07-17
Last Posted Date
2023-09-15
Lead Sponsor
Far Eastern Memorial Hospital
Target Recruit Count
120
Registration Number
NCT04023253
Locations
🇨🇳

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan

Beta 3 Agonist Treatment in Heart Failure-2

Phase 2
Completed
Conditions
Heart Failure With Reduced Ejection Fraction NYHA Class III-IV
Interventions
First Posted Date
2019-04-24
Last Posted Date
2022-05-04
Lead Sponsor
Henning Bundgaard
Target Recruit Count
56
Registration Number
NCT03926754
Locations
🇩🇰

Rigshospitalet, Copenhagen, Denmark

Impact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome

Phase 4
Withdrawn
Conditions
Overactive Bladder Syndrome
Interventions
First Posted Date
2018-10-04
Last Posted Date
2019-03-07
Lead Sponsor
Far Eastern Memorial Hospital
Registration Number
NCT03695822
Locations
🇨🇳

Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan

Comparison of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After TURP

Phase 2
Conditions
Overactive Bladder Syndrome
Interventions
First Posted Date
2018-08-15
Last Posted Date
2018-08-24
Lead Sponsor
Buddhist Tzu Chi General Hospital
Target Recruit Count
130
Registration Number
NCT03632772
Locations
🇨🇳

Buddhist Tzu Chi General Hospital, Hualien city, Taiwan

Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: Anticholinergic Agent vs. Mirabegron

Early Phase 1
Completed
Conditions
Cognitive Change
Spinal Cord Injuries
Neurogenic Bladder
Interventions
First Posted Date
2018-08-02
Last Posted Date
2021-06-22
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
20
Registration Number
NCT03612401
Locations
🇺🇸

South Texas Veterans Health Care System, Audie L. Murphy Hospital, San Antonio, Texas, United States

Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania

First Posted Date
2018-07-27
Last Posted Date
2024-10-16
Lead Sponsor
Astellas Pharma Singapore Pte. Ltd.
Target Recruit Count
5589
Registration Number
NCT03602508
Locations
🇦🇺

Site AU10000, Sydney, Australia

🇰🇷

Site KR82001, Seoul, Korea, Republic of

Mirabegron for Treatment of Erectile Dysfunction in Patients With LUTS Secondry to BPH: A Randomized Study

Phase 2
Conditions
Erectile Abnormalities
Prostatic Neoplasms
BPH
Erectile Dysfunction
Prostate Hyperplasia
Interventions
Drug: placebo
First Posted Date
2018-07-26
Last Posted Date
2019-09-04
Lead Sponsor
Mansoura University
Target Recruit Count
50
Registration Number
NCT03600766
Locations
🇪🇬

Urology and nephrology center, Mansourah, Dakahlia, Egypt

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