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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)

Activation of Brown Adipose Tissue Metabolism Using Mirabegron

Not Applicable
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2021-03-30
Last Posted Date
2024-12-09
Lead Sponsor
Université de Sherbrooke
Target Recruit Count
9
Registration Number
NCT04823442
Locations
🇨🇦

Centre de recherche du CHUS, Sherbrooke, Quebec, Canada

Mirabegron and Physiological Function in Cold Environments

Phase 1
Completed
Conditions
Thermogenesis
Resting Energy Expenditure
Brown Adipose Tissue
Interventions
Drug: Placebo
First Posted Date
2021-02-23
Last Posted Date
2024-07-12
Lead Sponsor
Indiana University
Target Recruit Count
30
Registration Number
NCT04766021
Locations
🇺🇸

Indiana University, Bloomington, Indiana, United States

Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and as a Urinary Biomarker

Conditions
Detrusor Overactivity
Overactive Bladder Syndrome
Interventions
First Posted Date
2021-01-05
Last Posted Date
2021-01-27
Lead Sponsor
Chang Gung Memorial Hospital
Target Recruit Count
400
Registration Number
NCT04693897

Mechanisms for Activation of Beige Adipose Tissue in Humans

Phase 2
Recruiting
Conditions
PreDiabetes
Interventions
Drug: Placebo
First Posted Date
2020-12-14
Last Posted Date
2025-01-20
Lead Sponsor
Philip Kern
Target Recruit Count
65
Registration Number
NCT04666636
Locations
🇺🇸

University of Kentucky, Lexington, Kentucky, United States

A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)

Phase 3
Terminated
Conditions
Pharmacokinetics of Mirabegron
Overactive Bladder (OAB)
Interventions
Drug: Placebo
First Posted Date
2020-11-24
Last Posted Date
2024-11-14
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
26
Registration Number
NCT04641975
Locations
🇹🇷

Site TR90001, Bursa, Turkey

🇫🇷

Site FR33001, Marseille, France

🇰🇷

Site KR82001, Seoul, Seoul Teugbyeolsi, Korea, Republic of

and more 12 locations

A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder

Phase 4
Completed
Conditions
Overactive Bladder (OAB)
Urge Incontinence
Interventions
First Posted Date
2020-09-24
Last Posted Date
2024-11-15
Lead Sponsor
Astellas Pharma China, Inc.
Target Recruit Count
249
Registration Number
NCT04562090
Locations
🇨🇳

Site CN86014, Beijing, China

🇨🇳

Site CN86010, Chengdu, China

🇨🇳

Site CN86009, Guangzhou, China

and more 12 locations

Predictors for Retreatement of OAB After DC Mirabegron

Completed
Conditions
Recurrence of Overactive Bladder Syndrome
Interventions
First Posted Date
2020-09-16
Last Posted Date
2020-09-16
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
120
Registration Number
NCT04550702
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

Impact of Mirabegron on Erectile Function in BPH Patients

Conditions
Males With Benign Prostatic Hyperplasia Symptoms
Interventions
Drug: Alpha Blockers
First Posted Date
2020-08-07
Last Posted Date
2020-08-10
Lead Sponsor
Kasr El Aini Hospital
Target Recruit Count
100
Registration Number
NCT04503850

A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants

Phase 4
Completed
Conditions
Pharmacokinetics of Mirabegron
Healthy Chinese Subjects
Food Effect
Interventions
First Posted Date
2020-08-06
Last Posted Date
2024-11-11
Lead Sponsor
Astellas Pharma China, Inc.
Target Recruit Count
24
Registration Number
NCT04501640
Locations
🇨🇳

Site CN86001, Shanghai, China

Bioequivalence Study of Mirabegron From Bladogra 25 mg Extended Release Tablets (Multi-Apex for Pharmaceutical Industries, Egypt) Versus Myrbetriq 25 mg Extended Release Tablets (Marketed by Astellas Pharma US, Inc, Product of Japan)

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2020-07-20
Last Posted Date
2020-07-21
Lead Sponsor
Genuine Research Center, Egypt
Target Recruit Count
29
Registration Number
NCT04476966
Locations
🇪🇬

Genuine Research Center GRC, Cairo, Egypt

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