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
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 12/20/2012 | ||
Authorised | 12/20/2012 |
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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
BETMIGA mirabegron 25 mg film-coated prolonged-release tablet blister pack | 199664 | Medicine | A | 10/17/2013 | |
BETMIGA mirabegron 50 mg film-coated prolonged-release tablet blister pack | 199668 | Medicine | A | 10/17/2013 |