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)

Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms

Phase 3
Not yet recruiting
Conditions
Ureteral Stent-Related Symptom
Interventions
First Posted Date
2025-01-31
Last Posted Date
2025-03-19
Lead Sponsor
Bir Hospital
Target Recruit Count
189
Registration Number
NCT06803030
Locations
🇳🇵

NAMS, Bir Hospital, Kathmandu, Bagmati, Nepal

Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)

Phase 3
Recruiting
Conditions
Urinary Incontinence in Children
Interventions
First Posted Date
2024-08-13
Last Posted Date
2025-01-14
Lead Sponsor
University of Aarhus
Target Recruit Count
236
Registration Number
NCT06551246
Locations
🇩🇰

Department of Pediatric and Adolescent Medicine, Aarhus University Hospital, Aarhus, Aarhus N, Denmark

🇩🇰

Department of Pediatric and Adolescent Medicine, Aalborg University Hospital, Aalborg, Denmark

🇩🇰

Department of Pediatric and Adolescent medicine, Esbjerg Hospital, Esbjerg, Denmark

and more 2 locations

Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder

Phase 4
Recruiting
Conditions
Urinary Bladder, Overactive
Effect of Drug
Interventions
Drug: Combined pharmacotherapy with Solifenacin and Mirabegron
First Posted Date
2024-06-28
Last Posted Date
2025-05-09
Lead Sponsor
Mackay Memorial Hospital
Target Recruit Count
300
Registration Number
NCT06479720
Locations
🇨🇳

Mackay Memorial Hospital, Taipei, Taiwan

Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)

Phase 4
Recruiting
Conditions
Urinary Incontinence in Children
Interventions
First Posted Date
2024-06-20
Last Posted Date
2025-01-14
Lead Sponsor
University of Aarhus
Target Recruit Count
216
Registration Number
NCT06465576
Locations
🇩🇰

Department of Pediatric and Adolescent Medicine, Aarhus University Hospital, Aarhus, Aarhus N, Denmark

🇩🇰

Department of Pediatric and Adolescent Medicine, Kolding Hospital, Kolding, Denmark

🇩🇰

Department of Pediatric and Adolescent Medicine, Aalborg University Hospital, Aalborg, Denmark

and more 2 locations

Management of OAB in Female Patients .

Not Applicable
Completed
Conditions
Overactive Bladder
Interventions
First Posted Date
2023-12-28
Last Posted Date
2024-04-02
Lead Sponsor
Elsayed Abdelhalim Elsayed
Target Recruit Count
300
Registration Number
NCT06184334
Locations
🇪🇬

Kafrelsheikh University hospital, Kafr Ash Shaykh, Egypt

Acupuncture Combined With Mirabegron in the Treatment of OAB

Phase 1
Active, not recruiting
Conditions
Overactive Bladder
Interventions
Combination Product: acupuncture combined with mirabegron.
First Posted Date
2023-12-26
Last Posted Date
2023-12-26
Lead Sponsor
The Affiliated Ganzhou Hospital of Nanchang University
Target Recruit Count
75
Registration Number
NCT06181019
Locations
🇨🇳

Ganzhou People's Hospital, Ganzhou, Jiangxi, China

A Trial Evaluating the Clinical Efficacy and Safety of Hibero SR (Mirabegron) 50 mg and Ditropan (Oxybutynin Chloride) 10 mg in Children Between 5 and 18 Years With Overactive Bladder (OAB)

Phase 2
Not yet recruiting
Conditions
Overactive Bladder
Interventions
First Posted Date
2023-12-26
Last Posted Date
2024-03-08
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
44
Registration Number
NCT06181591
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Using Mirabegron to Increase BP in Patients With POTS

Phase 2
Recruiting
Conditions
Postural Orthostatic Tachycardia Syndrome
Syncope
Chronic Orthostatic Intolerance
Interventions
First Posted Date
2023-11-15
Last Posted Date
2025-02-12
Lead Sponsor
Cedars-Sinai Medical Center
Target Recruit Count
20
Registration Number
NCT06133075
Locations
🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS

Phase 4
Completed
Conditions
Ureteral Stone
Ureteral Stenosis
Kidney Stones
Interventions
First Posted Date
2023-11-09
Last Posted Date
2023-11-13
Lead Sponsor
Hasanuddin University
Target Recruit Count
42
Registration Number
NCT06124066
Locations
🇮🇩

DR Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital, and Akademis Jaury Jusuf Putra Hospital., Makassar, South Sulawesi, Indonesia

Extracorporeal Magnetic Innervation in Combination With Mirabegron in the Treatment of Overactive Bladder

Not Applicable
Completed
Conditions
Overactive Bladder
Overactive Bladder Syndrome
Interventions
Device: Extracorporeal magnetic innervation (active treatment)
Device: Extracorporeal magnetic innervation (sham treatment)
First Posted Date
2023-11-08
Last Posted Date
2023-11-09
Lead Sponsor
Serdinsek Tamara
Target Recruit Count
56
Registration Number
NCT06123364
Locations
🇸🇮

University Medical Centre Maribor, Maribor, Slovenia

© Copyright 2025. All Rights Reserved by MedPath