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)

Mirabegron 25 mg for Treatment of Primary Nocturnal Enuresis

Not Applicable
Recruiting
Conditions
Nocturnal Enuresis
Interventions
First Posted Date
2022-11-15
Last Posted Date
2023-08-03
Lead Sponsor
Benha University
Target Recruit Count
150
Registration Number
NCT05617664
Locations
🇪🇬

Benha University Hospitals, Banhā, Qaliopia, Egypt

Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women

Phase 4
Recruiting
Conditions
Nocturia
Urgency Urinary Incontinence
Interventions
Behavioral: Brief Behavioral Treatment for Insomnia
First Posted Date
2022-11-03
Last Posted Date
2025-05-13
Lead Sponsor
Shachi Tyagi
Target Recruit Count
120
Registration Number
NCT05604222
Locations
🇺🇸

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

Mirabegron Combined With Behavioral Intervention for Overactive Bladder:a Prospective Multicenter Randomized Controlled Clinical Study

Phase 4
Conditions
Overactive Bladder
Interventions
First Posted Date
2022-07-11
Last Posted Date
2022-07-11
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
600
Registration Number
NCT05452434

TReating Incontinence for Underlying Mental and Physical Health

Phase 4
Recruiting
Conditions
Urinary Incontinence, Urge
Overactive Bladder
Urinary Incontinence
Incontinence, Urge
Incontinence, Urinary
Incontinence
Interventions
First Posted Date
2022-05-05
Last Posted Date
2024-12-04
Lead Sponsor
University of California, San Francisco
Target Recruit Count
270
Registration Number
NCT05362292
Locations
🇺🇸

University of California San Francisco, San Francisco, California, United States

🇺🇸

Stanford University, Palo Alto, California, United States

Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome

Phase 4
Recruiting
Conditions
Overactive Bladder Syndrome
Interventions
First Posted Date
2022-02-02
Last Posted Date
2024-08-19
Lead Sponsor
Walter Reed National Military Medical Center
Target Recruit Count
152
Registration Number
NCT05221021
Locations
🇺🇸

Walter Reed National Military Medical Center, Bethesda, Maryland, United States

Sequencing and Combination of Mirabegron and TTNS in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial

Phase 4
Conditions
Overactive Bladder Syndrome
Interventions
Procedure: TTNS
First Posted Date
2022-01-12
Last Posted Date
2022-01-12
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
Target Recruit Count
180
Registration Number
NCT05188742
Locations
🇨🇳

Taipei Veterans General Hospital, Taipei City, Taiwan

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Phase 4
Recruiting
Conditions
Pre-diabetes
Obesity
Interventions
First Posted Date
2021-09-21
Last Posted Date
2025-01-20
Lead Sponsor
Philip Kern
Target Recruit Count
96
Registration Number
NCT05051436
Locations
🇺🇸

University of Kentucky, Lexington, Kentucky, United States

Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome

Recruiting
Conditions
Overactive Bladder Syndrome
Interventions
First Posted Date
2021-09-10
Last Posted Date
2023-03-29
Lead Sponsor
Far Eastern Memorial Hospital
Target Recruit Count
500
Registration Number
NCT05040984
Locations
🇨🇳

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

Beta-3 Agonist and Anti-muscarinic Agent for Sjogren's Syndrome With Overactive Bladder

Phase 4
Conditions
Sjogren's Syndrome
Overactive Bladder Syndrome
Interventions
First Posted Date
2021-06-01
Last Posted Date
2021-08-10
Lead Sponsor
China Medical University Hospital
Target Recruit Count
50
Registration Number
NCT04909255
Locations
🇨🇳

China Medical University Hospital, Taichung, Taiwan

Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)

Phase 4
Completed
Conditions
Overactive Bladder
Interventions
Device: Posterior Tibial Nerve Stimulation (PTNS)
First Posted Date
2021-05-28
Last Posted Date
2023-07-20
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
54
Registration Number
NCT04907032
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

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