Drug Type Small molecule drug |
Synonyms Betmiga PR, Mirabegron (USAN/JAN), Myrbetriq Granules + [8] |
Target |
Action agonists |
Mechanism β3-adrenergic receptor agonists(Beta-3 adrenergic receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (01 Jul 2011), |
RegulationPriority Review (China) |
Molecular FormulaC21H24N4O2S |
InChIKeyPBAPPPCECJKMCM-IBGZPJMESA-N |
CAS Registry223673-61-8 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D09535 | Mirabegron |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Neurogenic detrusor overactivity | European Union | 05 Sep 2024 | |
| Neurogenic detrusor overactivity | Iceland | 05 Sep 2024 | |
| Neurogenic detrusor overactivity | Liechtenstein | 05 Sep 2024 | |
| Neurogenic detrusor overactivity | Norway | 05 Sep 2024 | |
| Overactive bladder syndrome | European Union | 20 Dec 2012 | |
| Overactive bladder syndrome | Iceland | 20 Dec 2012 | |
| Overactive bladder syndrome | Liechtenstein | 20 Dec 2012 | |
| Overactive bladder syndrome | Norway | 20 Dec 2012 | |
| Urinary Bladder, Overactive | Japan | 01 Jul 2011 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Lower Urinary Tract Symptoms | Phase 3 | Greece | 20 Sep 2016 | |
| Urolithiasis | Phase 3 | Greece | 20 Sep 2016 | |
| Cystitis, Interstitial | Phase 3 | United States | 01 Aug 2016 | |
| Urinary Incontinence | Phase 3 | United States | 10 Jul 2013 | |
| Urinary Incontinence | Phase 3 | Armenia | 10 Jul 2013 | |
| Urinary Incontinence | Phase 3 | Australia | 10 Jul 2013 | |
| Urinary Incontinence | Phase 3 | Austria | 10 Jul 2013 | |
| Urinary Incontinence | Phase 3 | Belgium | 10 Jul 2013 | |
| Urinary Incontinence | Phase 3 | Canada | 10 Jul 2013 | |
| Urinary Incontinence | Phase 3 | Czechia | 10 Jul 2013 |
Phase 3 | 795 | Mirabegron/Tamsulosin Combination Therapy | ylbtxeakwx(kmddsocgdq) = loxiinlpcm krdfkgciko (mcvcmacfrt ) View more | Positive | 15 May 2026 | ||
ylbtxeakwx(kmddsocgdq) = ngsjlcoxdm krdfkgciko (mcvcmacfrt ) View more | |||||||
Phase 2 | 20 | (50 mg Group) | ytgvuvxrfh(zvlmioqnkn) = xkmucqwgag nlcbblruow (hbaomothuk, 7) View more | - | 08 Apr 2026 | ||
(25 mg Group) | ytgvuvxrfh(zvlmioqnkn) = fiwbmenajn nlcbblruow (hbaomothuk, 7) View more | ||||||
Phase 3 | 26 | Behavioral health consultation/therapy+heparin+gentamicin+sodium bicarb+Kenalog+Vaginal estrogen+Gabapentin+Oxybutynin+Detrol+Mirabegron+lidocaine+Amitriptyline+Trospium+Methenamine (Multimodal Care Bundle) | peqqrkhbku(jnexuqyotf) = zggrmbhiii zegimtwvtk (dslqavncsi, 7.11) View more | - | 01 Apr 2026 | ||
Usual Urogynecologic care (Usual Care) | peqqrkhbku(jnexuqyotf) = ilevbgdxpf zegimtwvtk (dslqavncsi, 7.34) View more | ||||||
Not Applicable | 88 | yzwlmkwpdk(yddyinzrjk) = wfwesoqvmq eubimqvolo (ogxmxwchdz ) View more | Positive | 01 Mar 2026 | |||
Placebo | yzwlmkwpdk(yddyinzrjk) = shttcbwhbg eubimqvolo (ogxmxwchdz ) View more | ||||||
Phase 1/2 | - | 17 | Placebo (Placebo) | hrvjamtshd(drudiigrde) = rjjiqhgyzw zswtbloqxc (rzgjuvrhaa, 5.67) View more | - | 03 Jul 2025 | |
(100 mg Mirabegron) | hrvjamtshd(drudiigrde) = zjaltsafcr zswtbloqxc (rzgjuvrhaa, 7.42) View more | ||||||
Not Applicable | 3 | uhwmqazkcs(gfxziblwec) = decreased in all patients, with an average reduction of 22.4% [range 9.9% - 35.9%] (p = 0.03). juovovrbjq (gmhokfdoyd ) | Positive | 04 May 2025 | |||
Phase 1/2 | - | 30 | Placebo (Placebo) | xnzfmcnmcm(hawjxspzks) = knfjerkzwi pndtsepqpl (dlonluuxfj, 67.8) View more | - | 12 Jul 2024 | |
(100 mg Mirabegron) | xnzfmcnmcm(hawjxspzks) = fiwroyznmg pndtsepqpl (dlonluuxfj, 75.7) View more | ||||||
Phase 2 | 57 | mxjfwyfnap(sdrxbjqqbu) = Baseline and follow-up data: placebo: 13 ± 7 to 13 ± 5; mirabegron: 12 ± 6 to 13 ± 8 yjrojzkqxr (saduofpeiu ) View more | Positive | 05 Mar 2024 | |||
Placebo | |||||||
Phase 3 | 26 | (Mirabegron (5 to < 12 Years)) | gaiesujvkh(tfhvnouovc) = drmiuhkjns tisgxkxhpt (dpsrsgalsq, 0.89) View more | - | 28 Dec 2023 | ||
Placebo (Placebo (5 to < 12 Years)) | gaiesujvkh(tfhvnouovc) = ypdlebszps tisgxkxhpt (dpsrsgalsq, 0.89) View more | ||||||
Phase 2 | 296 | Mirabegron 50 mg/d | eidsitqnul(ktmvywjufn) = jombcosqrr wssajxyfyw (lgnwmiigsu, -0.15 to 2.74) | Negative | 01 Nov 2023 |





