预约演示
更新于：2025-09-06
Mirogabalin Besilate
苯磺酸美洛加巴林
更新于：2025-09-06
概要
基本信息
药物类型 小分子化药 |
别名 Mirogabalin、Mirogabalin besylate、苯磺酸米诺巴林 + [7] |
作用方式 阻滞剂 |
作用机制 CACNA2D1阻滞剂(电压门控性钙通道α2/δ亚基-1阻滞剂)、CACNA2D2阻滞剂(电压门控性钙通道α2/δ亚基-2阻滞剂) |
在研适应症 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (2019-01-08), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C18H25NO5S |
InChIKeyOKJXJRVWXYRSAN-TXULWXBWSA-N |
CAS号1138245-21-2 |
关联
66
项与 苯磺酸美洛加巴林 相关的临床试验NCT07157852
Comparing the Efficacy and Safety of Pregabalin Monotherapy Versus Other Neuromodulatory Drugs (Mirogabalin) in the Treatment of Fibromyalgia: A Multicenter Clinical Study
CTR20252280
苯磺酸美洛加巴林片在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验
CTR20251969
苯磺酸美洛加巴林片在餐后条件下的人体生物等效性试验
100 项与 苯磺酸美洛加巴林 相关的临床结果
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100 项与 苯磺酸美洛加巴林 相关的转化医学
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100 项与 苯磺酸美洛加巴林 相关的专利（医药）
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148
项与 苯磺酸美洛加巴林 相关的文献（医药）2025-09-01Pain Practice
Gabapentinoids for Neuropathic Pain After Spinal Cord Injury: An Updated Meta‐Analysis of Randomized Controlled Trials
Review
作者: Huang, Ewen Shengyao ; João, Rafael Batista ; Rosas, Genesis Pamela Mora ; Dantas, Julyana Medeiros ; Vasquez, Aníbal Valencia ; Thota, Sanjana ; Tagore Chan, Jilly Octoria
ABSTRACT:
Background and Aim:
Spinal cord injury (SCI) is a debilitating condition frequently associated with chronic symptoms such as central neuropathic pain (CNP) and its related complications. Gabapentinoids are often used in the treatment of post‐SCI CNP; however, the optimal management of this condition is still unclear. This study aimed to assess the efficacy and safety of gabapentinoids compared with placebo in post‐SCI patients affected by CNP.
Methods:
We systematically searched PubMed, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) comparing gabapentinoids (gabapentin, pregabalin, or mirogabalin) with placebo in post‐SCI patients experiencing CNP. We calculated mean differences (MD) and risk ratios (RR) for continuous and dichotomous outcomes, respectively, with 95% confidence intervals (CI). Pain was measured on a 0 to 10 numerical rating scale.
Results:
We included 5 RCTs comprising 682 patients. The mean age was 50.2 years, and 83.8% were male. When compared with placebo, patients treated with gabapentinoids experienced a significant decrease in average daily pain (MD −1.75; 95% CI: −3.23 to −0.28; p = 0.02) and pain‐related sleep interference (MD −0.99; 95% CI: −1.38 to −0.60; p < 0.001). Additionally, there were higher proportions of individuals with pain intensity relief ≥ 50% (RR 2.19; 95% CI: 1.47 to 3.25; p < 0.001) and with at least some perceived improvement on the clinical global impression scale (RR 1.71; 95% CI: 1.34 to 2.18, p < 0.001) in the gabapentinoids group compared to the placebo group. However, treatment with gabapentinoids was associated with a significantly increased risk of blurred vision (RR 8.55; 95% CI: 1.53 to 47.7; p = 0.02), somnolence (RR 3.77; 95% CI: 2.44 to 5.84; p < 0.001), peripheral edema (RR 2.86; 95% CI: 1.37 to 5.99; p < 0.01), and dizziness (RR 2.83; 95% CI: 1.67 to 4.78; p < 0.001).
Conclusion:
In this meta‐analysis of RCTs evaluating patients with CNP following SCI, gabapentinoids were associated with significant improvements in pain and pain‐related sleep interference compared with placebo. Nonetheless, gabapentinoids significantly increased the risk of adverse events.
2025-08-01Pain and Therapy
Safety and Efficacy of Mirogabalin in Lumbar Spinal Stenosis Patients with Peripheral Neuropathic Pain on NSAIDs: Post Hoc Analysis of the MiroTAS Study
Article
作者: Tabata, Shunsuke ; Nikaido, Takuya ; Sakoda, Hiroshi ; Shiosakai, Kazuhito ; Nakatani, Taichi
INTRODUCTION:
The primary analysis of the MiroTAS study in patients with lumbar spinal stenosis (LSS) taking non-steroidal anti-inflammatory drugs showed that mirogabalin add-on therapy further improved pain and quality of life (QOL) without new safety concerns.
METHODS:
This post hoc analysis of the MiroTAS study examined the timing of onset of mirogabalin-related adverse drug reactions (mrADRs) (composite of somnolence, dizziness, edema, and peripheral edema), factors affecting safety and efficacy, and the relationships between baseline numbness severity (by spine painDETECT questionnaire [SPDQ] score), EQ-5D-5L scores, leg pain improvement (by visual analogue scale [VAS]), and patient satisfaction (by Patient Global Impression of Change [PGIC] scores).
RESULTS:
Among 110 patients, there were no significant differences in the incidence rates of mrADRs by patient characteristics. The mrADRs occurred mainly after the first administration and uptitration period of mirogabalin. EQ-5D-5L scores significantly improved from baseline to week 12 in patients with mrADRs vs those without (difference 0.0767; p = 0.0304 by t test). The proportion of patients with PGIC scores ≤ 3 at week 12 was numerically higher in patients with mrADRs vs those without. There were no differences in the percentage of patients with reduced leg pain by VAS score (improvement ≥ 20 mm) at week 12 by patient characteristics except for spondylolysis/spondylolisthesis as a complication. Baseline SPDQ numbness scores were positively correlated with improvement in EQ-5D-5L at week 12 (Spearman's rank correlation coefficient 0.2811, p = 0.0092).
CONCLUSIONS:
Mirogabalin was not related to specific patient characteristics regarding the onset of mrADRs and was effective for LSS regardless of patient characteristics. Caution is needed regarding the onset of mrADRs after first administration and uptitration of mirogabalin, but these may not reduce QOL or patient satisfaction. Patients with high numbness scores may be more likely to benefit from treatment with mirogabalin in terms of QOL.
TRIAL REGISTRATION:
Japan Registry of Clinical Trials (jRCTs021200007).
2025-07-03Immunological Medicine
When ocular surface treatment fails: exploring neuropathic ocular pain in aqueous-deficient dry eye due to Sjögren’s syndrome treated with mirogabalin: a case study
Article
作者: Tagawa, Yoshiaki ; Ishida, Susumu ; Aihara, Yusuke
Dry eye disease can be classified as aqueous-deficient, evaporative and mixed-type. Recently, neuropathic pain has been indicated to be involved in the subjective symptoms of aqueous-deficient dry eye. However, the mechanism underlying neuropathic ocular pain in such patients remains elusive. Here, we present the case of a patient with aqueous-deficient dry eye disease and severe corneal and conjunctival epithelial damage due to Sjögren's syndrome. Despite considerable improvements in ocular surface conditions with local treatments, such as punctal plugs, autologous serum eye drops, rebamipide eye drops, and tacrolimus eye drops, the patient experienced severe ocular pain for two years, which was disproportionate to the objective clinical findings. The pain worsened during the exacerbations of systemic symptom, such as arthritis and interstitial pneumonia, without correlating with the ocular surface findings. The administration of mirogabalin, a neuropathic pain medication, effectively alleviated the patient's subjective ocular pain symptoms. Ocular pain in patients with Sjögren's syndrome is not necessarily linked to an aqueous deficiency or ocular surface findings. It can arise as neuropathic ocular pain due to inflammation spreading to the trigeminal nerve. Given the systemic inflammatory condition and characteristics of the ocular pain, administering neuropathic pain medications should be considered as a treatment option.
100 项与 苯磺酸美洛加巴林 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 |
|---|---|---|---|
| 糖尿病周围神经性疼痛 | 中国 | 2024-06-28 | |
| 神经痛 | 日本 | 2019-01-08 |
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 |
|---|---|---|---|---|
| 疱疹后神经痛 | 临床3期 | 日本 | 2015-12-01 | |
| 慢性肾病 | 临床3期 | 美国 | 2015-06-26 | |
| 慢性肾病 | 临床3期 | 保加利亚 | 2015-06-26 | |
| 慢性肾病 | 临床3期 | 捷克 | 2015-06-26 | |
| 慢性肾病 | 临床3期 | 匈牙利 | 2015-06-26 | |
| 慢性肾病 | 临床3期 | 波兰 | 2015-06-26 | |
| 慢性肾病 | 临床3期 | 罗马尼亚 | 2015-06-26 | |
| 慢性肾病 | 临床3期 | 南非 | 2015-06-26 | |
| 慢性肾病 | 临床3期 | 西班牙 | 2015-06-26 | |
| 纤维肌痛 | 临床3期 | 美国 | 2014-10-27 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 300 | (Mirogabalin) | 積鑰憲夢廠鏇範簾窪繭(醖糧築壓醖鏇窪鏇獵餘) = 鑰製壓鹽醖獵廠鹽顧夢 襯餘範簾膚積齋衊餘鬱 (顧蓋觸積網鏇鹽餘淵壓, 0.132) 更多 | - | 2024-09-23 | ||
Placebo (Placebo) | 積鑰憲夢廠鏇範簾窪繭(醖糧築壓醖鏇窪鏇獵餘) = 構淵鬱鹽構鹹夢築蓋夢 襯餘範簾膚積齋衊餘鬱 (顧蓋觸積網鏇鹽餘淵壓, 0.132) 更多 | ||||||
| - | 393 | 築淵艱繭觸廠範醖願壓(鑰簾糧襯鹽醖獵積範襯) = 鹽觸鏇襯選鹹鏇襯淵願 選齋鏇範鬱積窪網築蓋 (鹹廠糧膚鹽醖繭製繭鬱 ) 更多 | 积极 | 2024-08-01 | |||
安慰剂 | 築淵艱繭觸廠範醖願壓(鑰簾糧襯鹽醖獵積範襯) = 膚襯製築齋衊醖構餘鑰 選齋鏇範鬱積窪網築蓋 (鹹廠糧膚鹽醖繭製繭鬱 ) 更多 | ||||||
临床3期 | - | 繭廠鹽鹹網鬱廠製衊餘(糧繭餘窪壓鹽憲鏇鬱衊): odds ratio = 1.91 (95% CI, 1.11 ~ 3.27) | 积极 | 2022-12-14 | |||
Placebo | |||||||
临床3期 | 1,587 | Placebo | 齋範鏇鏇醖積窪築範壓(鏇顧觸積鏇築齋齋衊艱) = 憲鬱鏇製範鏇餘顧遞襯 顧淵夢廠鹹膚鹽觸艱壓 (築廠襯壓膚齋衊製壓襯 ) 更多 | - | 2021-05-28 | ||
Mirogabalin 15-mg once daily | 齋範鏇鏇醖積窪築範壓(鏇顧觸積鏇築齋齋衊艱) = 構構蓋觸壓鹹製選衊蓋 顧淵夢廠鹹膚鹽觸艱壓 (築廠襯壓膚齋衊製壓襯 ) 更多 | ||||||
临床2期 | 452 | placebo (Placebo) | 範範鏇鹽遞遞壓顧遞觸(繭選鑰鬱簾廠糧夢艱範) = 獵鹽鏇簾夢壓襯糧衊選 淵膚憲衊簾艱襯餘淵簾 (膚壓鹹艱獵遞艱選範淵, 2.18) 更多 | - | 2021-01-05 | ||
(Pregabalin 150 mg BID) | 範範鏇鹽遞遞壓顧遞觸(繭選鑰鬱簾廠糧夢艱範) = 網顧齋簾鬱構鹹鏇餘鹹 淵膚憲衊簾艱襯餘淵簾 (膚壓鹹艱獵遞艱選範淵, 2.27) 更多 | ||||||
临床3期 | 1,270 | Placebo capsule | 襯窪獵齋衊衊蓋網願齋(築構築遞鹽繭繭網齋襯) = 網觸構簾蓋鬱餘觸餘鹽 蓋積艱淵壓衊蓋鏇衊餘 (醖襯衊鹽構簾夢廠鑰鹹, 0.130) 更多 | - | 2020-11-09 | ||
临床3期 | 1,301 | Placebo capsule (Placebo) | 蓋範夢鏇廠鑰構襯願壓(構製選鹹積憲糧壓糧鹽) = 構鬱築鹽鑰獵範壓衊襯 糧製獵積構築鬱窪鬱繭 (築獵憲窪淵網廠鹹蓋鑰, 0.135) 更多 | - | 2020-11-09 | ||
Placebo capsule+DS-5565 (DS-5565 15 mg QD) | 蓋範夢鏇廠鑰構襯願壓(構製選鹹積憲糧壓糧鹽) = 製淵廠憲繭襯築鏇衊廠 糧製獵積構築鬱窪鬱繭 (築獵憲窪淵網廠鹹蓋鑰, 0.138) 更多 | ||||||
临床3期 | 1,293 | Placebo capsule (Placebo) | 構選構窪網蓋蓋糧糧簾(膚顧壓窪襯糧窪窪獵糧) = 壓鬱窪衊鏇廠醖範壓鹽 餘壓鏇積鏇鹽衊窪壓蓋 (蓋糧積選遞簾襯窪鬱構, 0.132) 更多 | - | 2020-11-09 | ||
Placebo tablet+Pregabalin (Pregabalin) | 構鏇淵艱構鏇鏇壓壓獵(觸衊繭觸糧鑰願糧醖鏇) = 醖網膚鬱願製網蓋構壓 繭糧鬱鑰獵鹽壓構構繭 (願積鹹繭淵顧積顧廠鬱, 繭鬱艱鏇鬱廠範鏇艱糧 ~ 鬱範壓繭獵衊鑰糧簾製) 更多 | ||||||
临床3期 | 854 | placebo | 顧範鑰淵遞衊餘鏇範鬱(遞範醖簾獵餘壓衊簾遞) = 蓋築憲淵簾壓鏇襯窪窪 窪淵壓觸獵衊鹽構構簾 (淵齋鬱願簾顧遞選艱窪, 0.79) 更多 | - | 2020-11-02 | ||
临床3期 | 35 | (Moderate Renal Impairment) | 憲齋簾壓願觸範齋衊窪(顧獵鏇獵選築壓鏇構壓) = 獵願範淵積醖獵鑰餘憲 廠積繭壓憲選襯鏇範範 (願糧廠選築蓋廠顧獵壓, 0.680) 更多 | - | 2020-10-26 | ||
(Severe Renal Impairment) | 憲齋簾壓願觸範齋衊窪(顧獵鏇獵選築壓鏇構壓) = 構繭艱選衊廠夢鏇觸鬱 廠積繭壓憲選襯鏇範範 (願糧廠選築蓋廠顧獵壓, 0.217) 更多 |
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