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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)

A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China

Completed
Conditions
Overactive Bladder (OAB)
Interventions
First Posted Date
2018-06-28
Last Posted Date
2020-04-22
Lead Sponsor
Astellas Pharma Singapore Pte. Ltd.
Target Recruit Count
805
Registration Number
NCT03572231
Locations
🇰🇷

Site KR410008, Daejeon, Korea, Republic of

🇰🇷

Site KR410009, Incheon, Korea, Republic of

🇰🇷

Site KR410005, Kangam, Korea, Republic of

and more 12 locations

Efficacy and Safety of the Mirabegron Compared With Solifenacin in Treatment of Overactive Bladder

Phase 4
Completed
Conditions
Overactive Bladder
Interventions
First Posted Date
2018-06-15
Last Posted Date
2018-06-19
Lead Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Target Recruit Count
81
Registration Number
NCT03558919
Locations
🇧🇩

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease

Phase 4
Conditions
Overactive Bladder
Parkinson Disease
Interventions
Drug: Placebo
First Posted Date
2018-01-26
Last Posted Date
2018-01-30
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
144
Registration Number
NCT03412513
Locations
🇰🇷

Severance Hospital, Seoul, Korea, Republic of

🇰🇷

Hallym University Medical Center, Gyeonggi-do, Korea, Republic of

🇰🇷

Seoul National University Bundang Hospital, Gyeonggi-do, Korea, Republic of

and more 2 locations

Mirabegron in Achalasia: A Clinical and Manometric Proof of Concept Pilot Study

Early Phase 1
Terminated
Conditions
Achalasia
Interventions
First Posted Date
2018-01-26
Last Posted Date
2021-03-24
Lead Sponsor
Thomas Jefferson University
Target Recruit Count
5
Registration Number
NCT03411252
Locations
🇺🇸

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Mirabegron and Oxybutynin Safety and Efficacy Trial in Spinal Cord Injury

Phase 2
Conditions
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Interventions
First Posted Date
2017-06-15
Last Posted Date
2019-12-17
Lead Sponsor
Kessler Foundation
Target Recruit Count
62
Registration Number
NCT03187795
Locations
🇺🇸

Kessler Institute for Rehabilitation, West Orange, New Jersey, United States

Comparison of Electroacupuncture to Mirabegron for Treatment of Overactive Bladder

Not Applicable
Withdrawn
Conditions
Overactive Bladder
Interventions
Other: electroacupncture
First Posted Date
2017-03-22
Last Posted Date
2022-05-06
Lead Sponsor
University Hospitals Cleveland Medical Center
Registration Number
NCT03087578
Locations
🇺🇸

University Hospitals Case Medical Center, Cleveland, Ohio, United States

Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan

Phase 3
Completed
Conditions
Overactive Bladder Syndrome
Urinary Incontinence
Interventions
First Posted Date
2017-02-23
Last Posted Date
2017-02-23
Lead Sponsor
Buddhist Tzu Chi General Hospital
Target Recruit Count
168
Registration Number
NCT03059134

The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists

Phase 1
Recruiting
Conditions
Polycystic Ovary Syndrome
Interventions
Other: B Complex Plus Vitamin C Tablets
First Posted Date
2017-02-10
Last Posted Date
2025-05-20
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
100
Registration Number
NCT03049462
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Therapeutic Efficacy and Safety of Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan

Phase 3
Conditions
Overactive Bladder Syndrome
Interventions
First Posted Date
2017-02-07
Last Posted Date
2017-02-09
Lead Sponsor
Buddhist Tzu Chi General Hospital
Target Recruit Count
574
Registration Number
NCT03044912
Locations
🇨🇳

Buddhist Tzu Chi General Hospital, Hualien, Taiwan

Mirabegron and Brown Adipose Tissue

Phase 4
Conditions
Obesity
Interventions
Other: Short term mild cooling
Drug: Placebo Oral Capsule
First Posted Date
2017-01-06
Last Posted Date
2017-01-06
Lead Sponsor
Ingrid Jazet
Target Recruit Count
20
Registration Number
NCT03012113
Locations
🇳🇱

Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands

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