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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)

Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement

Phase 2
Terminated
Conditions
Urinary Bladder, Overactive
Pain
Lower Urinary Tract Symptoms
Interventions
Drug: Placebo
First Posted Date
2015-06-04
Last Posted Date
2023-06-13
Lead Sponsor
Southern Illinois University
Target Recruit Count
11
Registration Number
NCT02462837
Locations
🇺🇸

SIUSOM - Division of Urology, Springfield, Illinois, United States

Treatment of Incontinence Without Memory Problems

Phase 4
Completed
Conditions
Urinary Incontinence, Urge
Urge Incontinence
Interventions
First Posted Date
2015-05-07
Last Posted Date
2019-04-16
Lead Sponsor
University of California, San Francisco
Target Recruit Count
23
Registration Number
NCT02436889
Locations
🇺🇸

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

Myrbetriq™ (Mirabegron) to Improve Disordered Sleep in Subjects With Lower Urinary Tract Symptoms (LUTS)

Completed
Conditions
Nocturia
Lower Urinary Tract Symptoms
Interventions
First Posted Date
2015-04-07
Last Posted Date
2019-05-09
Lead Sponsor
Southern Illinois University
Target Recruit Count
34
Registration Number
NCT02410135
Locations
🇺🇸

SIUSOM - Division of Urology, Springfield, Illinois, United States

A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)

Completed
Conditions
Urinary Bladder Overactive
Overactive Bladder
Urinary Bladder Diseases
Urologic Diseases
Interventions
Drug: antimuscarinic medication
First Posted Date
2015-03-11
Last Posted Date
2024-10-16
Lead Sponsor
Astellas Scientific & Medical Affairs, Inc.
Target Recruit Count
1524
Registration Number
NCT02386072
Locations
🇨🇦

Site CA1025, Oshawa, Ontario, Canada

🇺🇸

Site US1060, Raleigh, North Carolina, United States

🇺🇸

Site US1067, Houston, Texas, United States

and more 89 locations

MIrabegron With oveRACtive bLadder Symptoms in mEn

Phase 4
Conditions
Overactive Bladder
Interventions
Drug: placebo
First Posted Date
2015-02-11
Last Posted Date
2015-02-11
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
462
Registration Number
NCT02361502
Locations
🇰🇷

Seoul National University Bundang Hospital, Seongnam, Gyeonggi, Korea, Republic of

🇰🇷

Korea University Ansan Hospital, Ansan, Korea, Republic of

🇰🇷

Pusan National University Hospital, Busan, Korea, Republic of

and more 11 locations

Efficacy of Pharmacological Stimulation of BAT and WAT in Lean and Obese Young Adults

Phase 2
Conditions
Brown Fat
Interventions
Other: Cold exposure
First Posted Date
2015-02-03
Last Posted Date
2017-05-10
Lead Sponsor
Otto Muzik
Target Recruit Count
20
Registration Number
NCT02354807
Locations
🇺🇸

Children's Hospital of Michigan, Detroit, Michigan, United States

A Prospective Non-interventional Study in Overactive Bladder (OAB) Patients Prescribed Betmiga® as Part of Routine Clinical Practice

Completed
Conditions
Urgency Incontinence
Urinary Bladder Overactive
Overactive Bladder
Urologic Diseases
Urinary Bladder Diseases
Interventions
First Posted Date
2014-12-19
Last Posted Date
2024-10-31
Lead Sponsor
Astellas Pharma Europe Ltd.
Target Recruit Count
863
Registration Number
NCT02320773
Locations
🇸🇰

Site SK42103 CMFF, sro, Vranov Nad Topľou, Slovakia

🇸🇰

Site SK42105 ProCare Ziar nad Hronom, Žiar Nad Hronom, Slovakia

🇬🇷

Site GR30012 Papageorgiou General Hospital of Thessaloniki, Thessaloniki, Greece

and more 57 locations

Sympathicomimetic Agonist in Patients With Myeloproliferative Neoplasms With JAK2-mutation

Phase 2
Completed
Conditions
Myeloproliferative Neoplasm
Primary Myelofibrosis
Essential Thrombocythemia
Polycythemia Vera
Interventions
First Posted Date
2014-12-08
Last Posted Date
2019-05-15
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
39
Registration Number
NCT02311569
Locations
🇨🇭

Universitaetsspital-Basel, Basel, Switzerland

🇨🇭

Inselspital Bern, Bern, Switzerland

🇨🇭

Hopitaux Universitaires de Geneve, Genève 14, Switzerland

and more 8 locations

Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.

First Posted Date
2014-11-19
Last Posted Date
2024-10-31
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
649
Registration Number
NCT02294396

Efficacy And Safety Of Combination Therapy For Treatment Of Overactive Bladder In Male Patients With Benign Prostatic Hyperplasia.

Phase 4
Conditions
Overactive Bladder
Benign Prostatic Hyperplasia
Interventions
First Posted Date
2014-10-31
Last Posted Date
2021-03-19
Lead Sponsor
St. Joseph's Healthcare Hamilton
Target Recruit Count
200
Registration Number
NCT02279615
Locations
🇨🇦

St. Joseph's Healthcare Hamilton - McMaster Institute of Urology, Hamilton, Ontario, Canada

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