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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)

Does Mirabegron Increase the Body Heat Generated by the Nervous System

Early Phase 1
Completed
Conditions
Thermoregulation
Interventions
First Posted Date
2023-08-25
Last Posted Date
2024-06-06
Lead Sponsor
Christopher Bell
Target Recruit Count
19
Registration Number
NCT06011265
Locations
🇺🇸

Colorado State University, Fort Collins, Colorado, United States

Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2023-08-15
Last Posted Date
2024-01-25
Lead Sponsor
Dong-A ST Co., Ltd.
Target Recruit Count
37
Registration Number
NCT05992428
Locations
🇰🇷

Seoul National University Hospital, Soeul, Korea, Republic of

MIrabegron and Physiological Function in Cold Environments

Phase 1
Completed
Conditions
Resting Energy Expenditure
Thermogenesis
Brown Adipose Tissue
Interventions
Drug: Placebo
First Posted Date
2023-08-14
Last Posted Date
2024-04-25
Lead Sponsor
Indiana University
Target Recruit Count
17
Registration Number
NCT05990387
Locations
🇺🇸

Indiana University, Bloomington, Indiana, United States

Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study

Phase 4
Recruiting
Conditions
Female Patients With Overactive Bladder Syndrome
Interventions
First Posted Date
2023-07-14
Last Posted Date
2023-09-13
Lead Sponsor
Far Eastern Memorial Hospital
Target Recruit Count
150
Registration Number
NCT05946902
Locations
🇨🇳

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

Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls

Early Phase 1
Recruiting
Conditions
Accidental Falls
Urinary Bladder, Overactive
Urinary Incontinence
Interventions
Behavioral: Pelvic Floor Muscle Training
First Posted Date
2023-05-30
Last Posted Date
2024-12-20
Lead Sponsor
The University of Texas Medical Branch, Galveston
Target Recruit Count
48
Registration Number
NCT05880862
Locations
🇺🇸

University of Texas Medical Branch at Galveston, Galveston, Texas, United States

Effect of Mirabegron on Promoting Brown Adipose Tissue Activation

Not Applicable
Recruiting
Conditions
Tumour
Interventions
First Posted Date
2023-03-22
Last Posted Date
2023-03-22
Lead Sponsor
Zhejiang Provincial People's Hospital
Target Recruit Count
20
Registration Number
NCT05779514
Locations
🇨🇳

Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China

Effect of Mirabegron on Bladder Compliance

Not Applicable
Active, not recruiting
Conditions
Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics
Interventions
First Posted Date
2023-02-27
Last Posted Date
2023-02-27
Lead Sponsor
Yonsei University
Target Recruit Count
15
Registration Number
NCT05745584
Locations
🇰🇷

Yonsei University Health System, Severance Hospital, Seoul, Korea, Republic of

Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity

Phase 2
Not yet recruiting
Conditions
Insulin Resistance
Obesity
Interventions
First Posted Date
2023-02-06
Last Posted Date
2025-05-21
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
60
Registration Number
NCT05713799
Locations
🇺🇸

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

ADRB3 Signaling Pathway in Human Adipose Tissue

Phase 1
Active, not recruiting
Conditions
Obesity, Prediabetes
Interventions
First Posted Date
2022-12-02
Last Posted Date
2024-10-11
Lead Sponsor
University of California, San Diego
Target Recruit Count
40
Registration Number
NCT05634174
Locations
🇺🇸

UC San Diego Altman Clinical & Translational Research Institute, La Jolla, California, United States

A Study to Learn How Effective and Safe the Drug 'Mirabegron' is and How Long it Stays in the Body of Children Aged 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity

Phase 3
Recruiting
Conditions
Neurogenic Detrusor Overactivity
Interventions
First Posted Date
2022-11-18
Last Posted Date
2025-05-06
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
10
Registration Number
NCT05621616
Locations
🇺🇸

Nemours Children's Clinic, Orlando, Florida, United States

🇺🇸

Intermountain Primary Children, Salt Lake City, Utah, United States

🇺🇸

Stanford Hospital, Palo Alto, California, United States

and more 8 locations
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