预约演示
更新于：2025-05-07
Mirabegron
米拉贝隆
更新于：2025-05-07
概要
基本信息
药物类型 小分子化药 |
别名 Betmiga PR、Mirabegron (USAN/JAN)、Myrbetriq Granules + [8] |
作用方式 拮抗剂 |
作用机制 GP IIb/IIIa拮抗剂(糖蛋白 IIb/IIIa拮抗剂) |
治疗领域 |
最高研发阶段批准上市 |
首次获批日期 日本 (2011-07-01), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C21H24N4O2S |
InChIKeyPBAPPPCECJKMCM-IBGZPJMESA-N |
CAS号223673-61-8 |
关联
244
项与 米拉贝隆 相关的临床试验NCT05713799
Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity
NCT06803030
A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
NCT06791460
Pegylated Liposomal Doxorubicin Plus Adebrelimab with or Without Mirabegron in Relapsed Ovarian Cancer: a Randomized, Controlled, Open-label Trial
100 项与 米拉贝隆 相关的临床结果
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100 项与 米拉贝隆 相关的转化医学
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100 项与 米拉贝隆 相关的专利（医药）
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1,560
项与 米拉贝隆 相关的文献（医药）2025-05-01Urogynecology (Philadelphia, Pa.)
Why Wasn't Mirabegron Chosen for the First Year of the CMS Negotiation Program?
Article
作者: Cadish, Lauren A. ; Shepherd, Jonathan P.
Importance:
The most used overactive bladder (OAB) medications are anticholinergics, which professional societies recommend avoiding in older patients given dementia risk. Cost prevents patients from switching to preferred beta-3 agonists. Mirabegron was the only beta-3 agonist eligible for the Centers for Medicare & Medicaid Services (CMS) 2023 Drug Negotiation Program (DNP). Although mirabegron's price would be markedly reduced by inclusion in the DNP, only 10 drugs were chosen in its first year.
Objectives:
We sought to explain mirabegron's absence from CMS's 2023 DNP and estimate the percentage of anticholinergic to mirabegron conversions needed to merit DNP inclusion.
Study Design:
We modeled CMS's 2023 selection process using publicly available dashboards from 2017 to 2021. Among the 20 costliest drugs, we excluded ineligible drugs and categorized the remainder as DNP chosen/not chosen. For drugs not chosen, we used price inflation and beneficiary utilization trends to project total 2023 costs.
Results:
In 2021, mirabegron was the 14th most costly drug overall—9th when excluding ineligibles—and the only top 20 drug eligible but not selected for the 2023 DNP. We estimated mirabegron to be 96.7% the cost of the 10th most costly drug. Switching 1.2% of 2021 anticholinergic prescriptions to mirabegron would have led to DNP inclusion, presenting an interesting dilemma where more patients would use mirabegron if it were cheaper, but insufficient patients used it for DNP inclusion to make it cheaper.
Conclusions:
Mirabegron came exceedingly close to DNP selection in 2023, and its future inclusion in the DNP would likely herald a massive shift of Medicare patients away from anticholinergics.
2025-05-01BIOMEDICAL CHROMATOGRAPHY
Optimizing Mirabegron Stability in Human Plasma: Method Development, Validation Through Integration of Esterase Inhibitors and Stabilizers
Article
作者: Shah, Ujashkumar ; Tawari, Santosh
ABSTRACT:
The stability of mirabegron in human plasma is addressed in this study. The susceptibility of Mirabegron to enzymatic and oxidative degradation requires the integration of esterase inhibitors and stabilizers into the analytical process. Esterase inhibitors, including sodium fluoride and dichlorvos, as well as stabilizing agents such as malic acid, ascorbic acid, acetic acid, citric acid and sodium bicarbonate were also investigated to mitigate this issue. Samples were prepared through solid‐phase extraction (SPE) utilizing Strata‐X cartridges. The optimization of chromatographic separation was conducted using a C18 Kromasil column with a solvent mixture consisting of ammonium formate and acetonitrile. Detection employed electrospray ionization (ESI) in positive ionization mode, focusing on MRM transitions of 397.2 → 260.1 for mirabegron and 402.2 → 260.1 for mirabegron D5. The method exhibited an accuracy range of 95.67% to 102.85% and precision of 0.52% to 2.31% for a linearity ranged from 0.100 to 102.496 ng/mL. An advantage of this method is its stability, requiring only a minimal plasma volume of 100 μL, a quick runtime of 3 min, and a high recovery rate of 92.93%, making it highly efficient and reliable for bioequivalence testing, therapeutic monitoring and pharmacokinetic studies.
2025-05-01European Urology Open Science
National Trends in Medication Prescriptions for Male Lower Urinary Tract Symptoms and Erectile Dysfunction: Findings from the Norwegian Prescription Database
Article
作者: Beisland, Christian ; Roth, Ingunn ; Moen, Christian Arvei ; Gjengstø, Peder ; Juliebø-Jones, Patrick
Background and objective:
Trends for the medical management of male lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) remain-under reported at a national level. Our aim was to analyse national trends in prescribing patterns for ED and LUTS medications among men in Norway.
Methods:
Data were extracted from the Norwegian Prescription Database (Norwegian Institute of Public Health) for the period 2004-2020. Medications were identified according to the Anatomical Therapeutic Chemical classification system.
Key findings and limitations:
For BPH medications collectively, the total annual number of prescriptions increased from 23 711 in 2014 to 102 531 in 2020. α-Adrenoceptor antagonists were prescribed five times more often than 5α-reductase inhibitors. Ten in 100 men aged ≥75 yr now receive a prescription for a BPH medication. By 2020, 19 per 1000 men received a prescription for ED medication. Sildenafil was the most popular choice (47%), followed by tadalafil (43%) and vardenafil (4.8%); the number of users per 1000 men increased from 4.4 to 9.3. Among medications used for urinary incontinence/urgency, mirabegron was the most popular choice (62%) in 2020, followed by oxybutynin (17%).
Conclusions and clinical implications:
Prescriptions for medications for BPH, ED, and urinary incontinence/frequency have increased at a national level. Further studies are needed to link this with individual data to ascertain discontinuation rates and conversion from pharmacotherapy to surgical intervention.
Patient summary:
In Norway, there were increasing trends in the use of medications to treat benign prostate enlargement (BPE), erectile dysfunction, and urinary incontinence between 2004 and 2020. The biggest rise was for medications for BPE, which are now prescribed more often than for medications for erectile dysfunction. In recent years, the number of surgeries performed for BPE has fallen.
100 项与 米拉贝隆 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 神经源性逼尿肌过度活动 | 欧盟 | 2024-09-05 | |
| 神经源性逼尿肌过度活动 | 冰岛 | 2024-09-05 | |
| 神经源性逼尿肌过度活动 | 列支敦士登 | 2024-09-05 | |
| 神经源性逼尿肌过度活动 | 挪威 | 2024-09-05 | |
| 膀胱过度活动症综合征 | 欧盟 | 2012-12-20 | |
| 膀胱过度活动症综合征 | 冰岛 | 2012-12-20 | |
| 膀胱过度活动症综合征 | 列支敦士登 | 2012-12-20 | |
| 膀胱过度活动症综合征 | 挪威 | 2012-12-20 | |
| 膀胱过度活动症 | 日本 | 2011-07-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 间质性膀胱炎 | 临床3期 | 美国 | 2016-08-01 | |
| 尿失禁 | 临床3期 | 美国 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 亚美尼亚 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 澳大利亚 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 奥地利 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 比利时 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 加拿大 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 捷克 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 丹麦 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 芬兰 | 2013-07-10 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | - | 20 | Mirabegron 100 mg/day + Placebo | 網夢構簾鹽膚餘鹹糧憲(鬱衊網醖製遞範夢窪夢) = 簾簾鏇膚糧簾衊鏇憲襯 鬱壓廠廠繭夢製鹹製憲 (壓餘鬱淵窪製廠遞餘夢 ) 更多 | 积极 | 2024-09-27 | |
Mirabegron 200 mg/day + Placebo | 網夢構簾鹽膚餘鹹糧憲(鬱衊網醖製遞範夢窪夢) = 鏇壓簾積選鏇築衊簾糧 鬱壓廠廠繭夢製鹹製憲 (壓餘鬱淵窪製廠遞餘夢 ) 更多 | ||||||
临床1/2期 | - | 30 | Placebo (Placebo) | 艱網艱鹽鏇網鏇夢衊憲(醖繭艱糧衊積觸遞觸廠) = 淵糧簾鏇顧蓋觸襯積製 艱衊顧糧遞鹹鏇襯糧醖 (壓憲遞鏇築遞蓋獵糧餘, 67.8) 更多 | - | 2024-07-12 | |
(100 mg Mirabegron) | 艱網艱鹽鏇網鏇夢衊憲(醖繭艱糧衊積觸遞觸廠) = 鹽餘壓蓋糧餘製顧網願 艱衊顧糧遞鹹鏇襯糧醖 (壓憲遞鏇築遞蓋獵糧餘, 75.7) 更多 | ||||||
N/A | - | - | 鹽遞鏇餘選願鏇餘鏇襯(淵選衊餘齋夢憲觸積襯) = 蓋夢構壓憲餘艱鹹憲構 顧獵構鹹鑰齋繭糧鏇淵 (窪鏇觸鬱廠壓夢鹹壓構 ) | 积极 | 2024-05-01 | ||
Anticholinergics | 鹽遞鏇餘選願鏇餘鏇襯(淵選衊餘齋夢憲觸積襯) = 簾構繭製築襯構壓廠鏇 顧獵構鹹鑰齋繭糧鏇淵 (窪鏇觸鬱廠壓夢鹹壓構 ) | ||||||
临床2期 | 57 | 齋衊製鏇窪繭鏇繭餘衊(醖網糧鹽鑰艱齋範窪網) = Baseline and follow-up data: placebo: 13 ± 7 to 13 ± 5; mirabegron: 12 ± 6 to 13 ± 8 獵憲獵壓憲願蓋艱鹽鬱 (鏇鏇鏇廠艱鹽範鏇齋憲 ) 更多 | 积极 | 2024-03-05 | |||
Placebo | |||||||
临床3期 | 26 | (Mirabegron (5 to < 12 Years)) | 憲鬱壓壓糧壓壓構艱製(齋構艱醖遞選鏇膚鏇簾) = 膚繭鏇廠積鑰製膚淵顧 鹹襯廠願廠網簾簾艱製 (醖選壓遞網構膚積醖觸, 0.89) 更多 | - | 2023-12-28 | ||
Placebo (Placebo (5 to < 12 Years)) | 憲鬱壓壓糧壓壓構艱製(齋構艱醖遞選鏇膚鏇簾) = 齋壓廠選顧觸鏇簾顧鬱 鹹襯廠願廠網簾簾艱製 (醖選壓遞網構膚積醖觸, 0.89) 更多 | ||||||
临床2期 | 296 | Mirabegron 50 mg/d | 醖鹽遞積顧鬱艱壓憲壓(齋鹽網淵糧窪糧淵艱壓) = 鏇繭築鏇遞鏇獵壓積網 憲艱遞遞遞願衊鹽範膚 (觸製製餘餘衊積醖餘衊, -0.15 ~ 2.74) | 不佳 | 2023-11-01 | ||
临床4期 | 28 | (Mirabegron) | 鬱獵鹹網網獵遞艱襯艱(衊築鬱鬱憲觸鏇鬱選憲) = 鏇淵願構鹹艱顧壓築鬱 遞鬱襯選積簾顧鬱窪憲 (醖窪襯製簾壓鏇鹽衊餘, 0.48) 更多 | - | 2023-10-18 | ||
Placebo (Placebo) | 鬱獵鹹網網獵遞艱襯艱(衊築鬱鬱憲觸鏇鬱選憲) = 壓願淵鑰選觸蓋艱構獵 遞鬱襯選積簾顧鬱窪憲 (醖窪襯製簾壓鏇鹽衊餘, 0.84) 更多 | ||||||
临床4期 | 54 | Posterior Tibial Nerve Stimulation (PTNS)+Mirabegron 50 MG (Posterior Tibial Nerve Stimulation With Mirabegron) | 衊襯淵夢蓋顧夢糧鹹觸(構鏇觸鬱遞鬱衊構餘簾) = 繭蓋齋積顧艱構構廠鬱 鹽夢醖範顧鏇構鬱襯蓋 (願襯艱夢構積製鹹觸齋, 3.9) 更多 | - | 2023-07-20 | ||
Posterior Tibial Nerve Stimulation (PTNS) (Posterior Tibial Nerve Stimulation Plus Placebo) | 衊襯淵夢蓋顧夢糧鹹觸(構鏇觸鬱遞鬱衊構餘簾) = 鬱顧簾襯繭衊憲鹽繭鏇 鹽夢醖範顧鏇構鬱襯蓋 (願襯艱夢構積製鹹觸齋, 5.4) 更多 | ||||||
临床2期 | 11 | (Treatment Arm) | 顧窪構觸鹹鏇網網鹹鏇(壓糧網簾願壓積艱夢鏇) = 餘蓋積觸膚鑰繭鹽窪壓 簾餘網淵鏇憲獵顧網網 (製衊繭糧選襯蓋鹹製獵, 鏇製製窪構鏇築餘鏇糧 ~ 獵壓鏇網觸窪選獵鏇鹽) 更多 | - | 2023-06-13 | ||
Placebo (Placebo Arm) | 顧窪構觸鹹鏇網網鹹鏇(壓糧網簾願壓積艱夢鏇) = 窪壓壓壓鹹衊構鏇窪齋 簾餘網淵鏇憲獵顧網網 (製衊繭糧選襯蓋鹹製獵, 醖壓製鑰憲鹹艱構衊製 ~ 衊鹽鹹壓積鏇糧膚顧憲) 更多 | ||||||
N/A | - | - | 膚繭觸醖繭憲糧築憲窪(構觸鹽繭齋鬱餘齋繭壓) = 鏇選廠鏇願積願築製鏇 齋顧構壓繭膚築獵壓夢 (積鏇衊選蓋遞餘襯夢襯 ) 更多 | - | 2023-04-01 |
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