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
- -
Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement
- Conditions
- Interventions
- 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
- Conditions
- 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)
- 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)
- 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
MIrabegron With oveRACtive bLadder Symptoms in mEn
- 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
Efficacy of Pharmacological Stimulation of BAT and WAT in Lean and Obese Young Adults
- 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
Sympathicomimetic Agonist in Patients With Myeloproliferative Neoplasms With JAK2-mutation
- Conditions
- 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
Efficacy And Safety Of Combination Therapy For Treatment Of Overactive Bladder In Male Patients With Benign Prostatic Hyperplasia.
- Conditions
- 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
Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
- First Posted Date
- 2014-08-13
- Last Posted Date
- 2024-11-22
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 888
- Registration Number
- NCT02216214
- Locations
- 🇺🇸
Site US00102, Norman, Oklahoma, United States
🇺🇸Site US00122, Greensboro, North Carolina, United States
🇺🇸Site US00112, Los Angeles, California, United States
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
- Conditions
- Interventions
- First Posted Date
- 2014-08-08
- Last Posted Date
- 2024-10-22
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 34
- Registration Number
- NCT02211846
- Locations
- 🇷🇸
Site RS38010 Mother and Child Health Care, Belgrade, Serbia
🇧🇪Site BE32009 Univ.Ziekenhuis Antwerpen, Edegem, Belgium
🇵🇱Site PL48001 Pomnik-Centrum Zdrowia Dziecka, Warsaw, Poland
Drug Development Updates
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