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

Overview

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.

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)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/01/31
Phase 3
Not yet recruiting
Bir Hospital
2024/08/13
Phase 3
Recruiting
2024/06/28
Phase 4
Recruiting
2024/06/20
Phase 4
Recruiting
2023/12/28
Not Applicable
Completed
Elsayed Abdelhalim Elsayed
2023/12/26
Phase 1
Active, not recruiting
The Affiliated Ganzhou Hospital of Nanchang University
2023/12/26
Phase 2
Not yet recruiting
2023/11/15
Phase 2
Recruiting
2023/11/09
Phase 4
Completed
Hasanuddin University
2023/11/08
Not Applicable
Completed
Serdinsek Tamara

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Astellas Pharma US, Inc.
0469-2602
ORAL
50 mg in 1 1
4/1/2021
Cardinal Health 107, LLC
55154-8712
ORAL
25 mg in 1 1
12/30/2018
REMEDYREPACK INC.
70518-2435
ORAL
50 mg in 1 1
2/29/2024
Zydus Pharmaceuticals (USA) Inc.
70710-1160
ORAL
50 mg in 1 1
2/29/2024
Zydus Lifesciences Limited
70771-1752
ORAL
25 mg in 1 1
3/6/2024
Zydus Pharmaceuticals (USA) Inc.
70710-1159
ORAL
25 mg in 1 1
2/29/2024
Zydus Lifesciences Limited
70771-1753
ORAL
50 mg in 1 1
3/6/2024
Astellas Pharma US, Inc.
0469-5020
ORAL
8 mg in 1 mL
4/1/2021
Cardinal Health 107, LLC
55154-8713
ORAL
50 mg in 1 1
12/30/2018
REMEDYREPACK INC.
70518-3158
ORAL
25 mg in 1 1
3/13/2024

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
BETMIGA ® PROLONGED-RELEASE TABLETS 50MG
SIN14623P
TABLET, FILM COATED, EXTENDED RELEASE
50 mg
9/15/2014
BETMIGA ® PROLONGED-RELEASE TABLETS 25MG
SIN14622P
TABLET, FILM COATED, EXTENDED RELEASE
25 mg
9/15/2014

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Mirabegron Sustained-release Tablets
国药准字H20253412
化学药品
片剂
2/20/2025
Mirabegron Sustained-release Tablets
国药准字H20243715
化学药品
片剂
5/15/2024
Mirabegron Sustained-release Tablets
国药准字H20253036
化学药品
片剂
1/2/2025
Mirabegron Sustained-release Tablets
国药准字H20253035
化学药品
片剂
1/2/2025
Mirabegron Sustained-release Tablets
国药准字H20243453
化学药品
片剂
4/7/2024
Mirabegron Sustained-release Tablets
国药准字H20223358
化学药品
片剂
5/31/2022
Mirabegron Sustained-release Tablets
国药准字H20253257
化学药品
片剂
1/24/2025
Mirabegron Sustained-release Tablets
国药准字H20253163
化学药品
片剂
1/14/2025
Mirabegron Sustained-release Tablets
国药准字HJ20171298
化学药品
片剂
3/15/2022
Mirabegron Sustained-release Tablets
国药准字HJ20171299
化学药品
片剂
3/15/2022

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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