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)
Associated Therapies
-

Mirabegron and Brown Adipose Tissue

Phase 4
Conditions
Obesity
Interventions
Other: Short term mild cooling
Drug: Placebo Oral Capsule
Drug: Mirabegron
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

Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women

Phase 4
Withdrawn
Conditions
Bladder Irritable
Bladder Pain Syndrome
Urinary Frequency/Urgency
Interventions
First Posted Date
2016-12-05
Last Posted Date
2020-10-22
Lead Sponsor
State University of New York at Buffalo
Registration Number
NCT02981459
Locations
🇺🇸

UBMD Obstetrics and Gynecology, Buffalo, New York, United States

Brown Fat Activation Study

Early Phase 1
Completed
Conditions
Obese
Metabolic Syndrome
Interventions
First Posted Date
2016-09-29
Last Posted Date
2020-02-07
Lead Sponsor
Philip Kern
Target Recruit Count
39
Registration Number
NCT02919176
Locations
🇺🇸

Center for Clinical and Translational Science, Lexington, Kentucky, United States

Mirabegron For Erectile Dysfunction

Phase 1
Completed
Conditions
Erectile Dysfunction
Overactive Bladder
Urinary Incontinence
Interventions
First Posted Date
2016-09-27
Last Posted Date
2021-01-05
Lead Sponsor
Johns Hopkins University
Target Recruit Count
20
Registration Number
NCT02916693
Locations
🇺🇸

Johns Hopkins Medical Institutions, Baltimore, Maryland, United States

The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury

Phase 2
Completed
Conditions
Autonomic Dysreflexia
Vagal Integrity
Hypotensive
Autonomic Integrity
Sympathetic Integrity
Spinal Cord Injury
Baroreceptor Integrity
Cognitive Function
Cerebral Blood Flow
Blood Pressure
Interventions
First Posted Date
2016-09-08
Last Posted Date
2024-09-30
Lead Sponsor
James J. Peters Veterans Affairs Medical Center
Target Recruit Count
21
Registration Number
NCT02893553
Locations
🇺🇸

James J Peters VAMC, Bronx, New York, United States

🇺🇸

Kessler Foundation Research Center, West Orange, New Jersey, United States

A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis

Phase 3
Terminated
Conditions
Cystitis, Interstitial
Interventions
Drug: Placebo
Drug: Mirabegron
First Posted Date
2016-06-01
Last Posted Date
2019-12-03
Lead Sponsor
Philadelphia Urosurgical Associates
Target Recruit Count
9
Registration Number
NCT02787083
Locations
🇺🇸

Philadelphia Urosurgical Associates, Philadelphia, Pennsylvania, United States

Beta3 Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure

Phase 2
Conditions
Pulmonary Hypertension
Mirabegron
Heart Failure
Pulmonary Vascular Resistance Abnormality
Interventions
Drug: Mirabegron
Drug: Placebo
First Posted Date
2016-05-17
Last Posted Date
2016-05-17
Lead Sponsor
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Target Recruit Count
80
Registration Number
NCT02775539

A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

Phase 4
Completed
Conditions
Benign Prostatic Hyperplasia
Overactive Bladder
Interventions
First Posted Date
2016-05-02
Last Posted Date
2024-11-11
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
715
Registration Number
NCT02757768
Locations
🇺🇸

Site US01009, Homewood, Alabama, United States

🇺🇸

Site US01005, Huntsville, Alabama, United States

🇺🇸

Site US01070, Hawaiian Gardens, California, United States

and more 76 locations

Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity

Phase 3
Completed
Conditions
Neurogenic Detrusor Overactivity
Interventions
First Posted Date
2016-04-26
Last Posted Date
2024-11-11
Lead Sponsor
Astellas Pharma Europe B.V.
Target Recruit Count
91
Registration Number
NCT02751931
Locations
🇷🇴

Site RO40001, Bucuresti, Romania

🇸🇰

Site SK42101, Bratislava, Slovakia

🇯🇴

Site JO96202, Amman, Jordan

and more 29 locations

Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain

Phase 2
Completed
Conditions
Flank Pain
Ureteral Obstruction
Interventions
Other: Placebo
Drug: Mirabegron
First Posted Date
2016-04-20
Last Posted Date
2022-04-26
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
33
Registration Number
NCT02744430
Locations
🇺🇸

Ben Taub General Hospital, Houston, Texas, United States

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