预约演示
更新于：2025-12-06
Rimegepant Sulfate
硫酸瑞美吉泮
更新于：2025-12-06
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2020-02-27), |
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C56H64F4N12O13S |
InChIKeySOGUOEZRYKUOHR-CQZKMDJHSA-N |
CAS号1374024-48-2 |
关联
48
项与 硫酸瑞美吉泮 相关的临床试验NCT06898047
CORRELATE-UK: COnsistency of Response With RimegEpant Oral Lyophilisate in Acute Treatment of migrainE in the United Kingdom
NCT06999252
The Combination of Rimegepant and PD-1 Inhibitor in the Treatment of Liver Metastasis Colorectal Cancer
NCT06985342
A Prospective, Open-Label Study Examining the Use of Rimegepant ODT 75 mg or Zavegepant Nasal Spray 10 mg for Acute Treatment of Migraine in the Emergency Department Setting
100 项与 硫酸瑞美吉泮 相关的临床结果
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100 项与 硫酸瑞美吉泮 相关的转化医学
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100 项与 硫酸瑞美吉泮 相关的专利（医药）
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254
项与 硫酸瑞美吉泮 相关的文献（医药）2025-12-01Advanced Science
Nociceptive Nerve‐Derived CGRP Exacerbates Uterine Fibrogenesis in Adenomyosis by Promoting CD140b
+
CD146
+
Fibroblast Differentiation
Article
作者: Wenchao Sun ; Xia Li ; Lie Ma ; Tiantian Li ; Anning Zhao ; Jianmin Chen ; Yangyang Dai ; Yanqing Hao ; Liaobing Xin ; Songying Zhang ; Dong Huang ; Zi Ye
Abstract:
Progressive dysmenorrhea and extensive fibrosis within the myometrium are hallmark features of adenomyosis (AM). Approximately 80% of patients with AM experience secondary dysmenorrhea, which occurs more frequently in AM than in other gynecological disorders. Because nociceptive nerves mediate dysmenorrhea, their contribution to AM‐associated fibrosis is investigated. These results demonstrate overexpression of calcitonin gene‐related peptide (CGRP)+ nociceptive nerves within fibrotic lesions in both AM patients and murine models; nociceptive nerve ablation reduces uterine fibrosis in mice with induced AM. CGRP, secreted by nociceptive nerves, drives receptor activity‐modifying protein 1 (RAMP1) high‐expressing (RAMP1
hi
) CD140b
+
CD146
+
fibroblasts in AM lesions toward an extracellular matrix deposition subtype through activation of the extracellular signal‐regulated kinase pathway. Treatment of mice with AM using rimegepant, a United States Food and Drug Administration‐approved drug that blocks CGRP/RAMP1 signaling, alleviated progression of AM‐associated fibrosis and promoted fertility restoration. This study identifies a previously unrecognized nerve‐fibroblast crosstalk mechanism and provides a potential nonhormonal therapeutic strategy for AM treatment, particularly in women of reproductive age.
2025-11-01CEPHALALGIA
A phase 4, randomized, double-blind, placebo-controlled trial evaluating the efficacy and tolerability of rimegepant for the prevention of episodic migraine in adults with a history of inadequate response to traditional oral preventive medications
Article
作者: Fountaine, Robert ; Lisewski, Pawel ; Abraham, Lucy ; Thiry, Alexandra ; Aslan, Ayşe Neslihan ; Pozo-Rosich, Patricia ; Ramirez, Luz M. ; Seehra, Harpreet ; López, José Antonio Gien ; Fullerton, Terence
Aim:
This study aimed to evaluate the efficacy and tolerability of rimegepant for the prevention of episodic migraine in participants with a documented history of inadequate response to 2–4 categories of traditional oral preventive medication (OPM).
Methods:
This multinational phase 4 trial consisted of an untreated 28-day observational phase (OP) and a 12-week double-blind treatment (DBT) phase. Participants with 4–14 monthly migraine days (MMDs), <15 monthly headache days (<7 non-migraine) and documented previous inadequate response to 2–4 traditional OPM categories were enrolled. Participants were randomized to rimegepant 75 mg orally disintegrating tablet (ODT) or placebo every other day (EOD). The primary endpoint was mean change from the OP in MMDs through the 12-week DBT phase. Key secondary endpoints were tested hierarchically to control type I errors. Tolerance and safety were assessed throughout the DBT phase.
Results:
In total, 328 participants received rimegepant and 324 received placebo. The most common OPM categories with prior inadequate response were anticonvulsants (61%), beta-blockers (56%) and amitriptyline (51%). The mean ± SD number of MMDs in the OP was 8.4 ± 2.4 and 8.3 ± 2.3, respectively, in the rimegepant (n = 324) and placebo (n = 319) groups. Across the DBT phase, participants who received rimegepant had a significantly larger mean change from the OP in MMDs than those who received placebo (−2.1 vs. −0.5 days; difference = −1.6 days; 95% confidence interval (CI) = −2.1 to −1.2;
p
< 0.0001). All key secondary endpoints favored rimegepant: (i) percentage of participants with ≥50% reduction from the OP in MMDs with moderate or severe pain intensity across the DBT phase (difference: 20.1%; 95% CI = 13.7 to 26.5;
p
< 0.0001); (ii) mean change from the OP in MMDs in the first month of the DBT phase (difference: −1.7 days; 95% CI = −2.3 to −1.2;
p
< 0.0001); (iii) mean change from the OP in MMDs in the last month of the DBT phase (difference: −1.4 days; 95% CI = −2.1 to −0.8;
p
< 0.0001); (iv) mean change from baseline in Migraine-Specific Quality-of-Life Questionnaire v2.1 Restrictive Role Function domain score at week 12 of the DBT phase (difference: 6.6 points; 95% CI = 3.6 to 9.5;
p
< 0.0001); and (v) mean change from baseline in Migraine Interictal Burden Scale score at week 12 of the DBT phase (difference: −0.9 points; 95% CI = −1.4 to −0.4;
p
= 0.0006). Rimegepant was well tolerated with a safety profile not notably different from placebo.
Conclusions:
Rimegepant 75 mg ODT EOD is efficacious and well tolerated for the prevention of episodic migraine in participants with a documented history of inadequate response to 2–4 categories of traditional OPM.
Trial Registration:
ClinicalTrials.gov, NCT05518123 (
https://clinicaltrials.gov/study/NCT05518123
).
2025-11-01HEADACHE
Efficacy and safety of rimegepant for the acute treatment of migraine in Japan: A dose‐ranging, double‐blind, randomized controlled trial
Article
作者: Tomofumi Ishikawa PhD ; Fumihiko Sakai MD ; Koichi Ikeda MD ; Robert Croop MD ; Yuko Hoshino PhD ; Akio Arakawa PhD ; Takao Takeshima MD ; Alexandra Thiry PhD ; Hiroki Yoshimatsu PhD ; Masako Kudo MD ; Terence Fullerton PharmD ; Yasuhiko Matsumori MD
Abstract:
Objective:
The objectives of this study were to compare the efficacy, including dose response, and safety of rimegepant, an orally administered small‐molecule calcitonin gene‐related peptide receptor antagonist, with placebo for the acute treatment of migraine in Japan.
Background:
There is a substantial unmet need for the acute treatment of migraine in Japan due to undesirable attributes of existing acute treatments.
Methods:
In this Phase 2/3, double‐blind, randomized trial, adults with a ≥1‐year history of migraine were recruited to 50 study centers in Japan. Participants were randomly assigned to receive rimegepant 25 mg, rimegepant 75 mg, or placebo and instructed to treat a single migraine attack of moderate or severe pain intensity. The randomization was stratified by preventive migraine medication use (yes or no). The primary endpoint was the proportion of participants with pain freedom at 2 h post‐dose. Formal hypothesis testing was conducted for rimegepant 75 mg versus placebo. Safety was assessed based on adverse events (AEs).
Results:
The study was conducted from August 9, 2022, through January 19, 2024. A total of 706 treated participants were evaluable for efficacy (rimegepant 25 mg,
n =
238; rimegepant 75 mg,
n =
238; placebo,
n =
230) and safety (rimegepant 25 mg,
n =
239; rimegepant 75 mg,
n =
238; placebo,
n =
229). Response rates for pain freedom at 2 h post‐dose were 21.0% (rimegepant 25 mg), 32.4% (rimegepant 75 mg), and 13.0% (placebo): percentage difference rimegepant 75 mg versus placebo was 19.4% (95% confidence interval 12.0–26.8%,
p
< 0.001). On‐treatment AEs were reported by 7.1% (rimegepant 25 mg), 9.2% (rimegepant 75 mg), and 6.6% (placebo) of treated participants; all were mild or moderate in intensity and most were not considered related to the study drug.
Conclusion:
Rimegepant 75 mg demonstrated efficacy superior to placebo for the acute treatment of migraine, with a favorable safety profile, in participants in Japan. A dose–response relationship was observed for rimegepant (NCT05399459).
Plain Language Summary:
This randomized trial was designed to test the effectiveness and safety of rimegepant for the acute treatment of migraine among adults in Japan. Results indicated that rimegepant was more effective than placebo, and the 75 mg dose was observed to be more effective than the 25 mg dose. These results are similar to previous findings from clinical studies in other countries, and suggest that rimegepant can help patients with migraine in Japan.
100 项与 硫酸瑞美吉泮 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 |
|---|---|---|---|
| 急性偏头痛 | 韩国 | 2025-03-24 | |
| 偏头痛 | 美国 | 2020-02-27 |
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 |
|---|---|---|---|---|
| 无先兆偏头痛 | 临床3期 | 美国 | 2025-03-11 | |
| 无先兆偏头痛 | 临床3期 | 中国 | 2025-03-11 | |
| 无先兆偏头痛 | 临床3期 | 日本 | 2025-03-11 | |
| 无先兆偏头痛 | 临床3期 | 阿根廷 | 2025-03-11 | |
| 无先兆偏头痛 | 临床3期 | 加拿大 | 2025-03-11 | |
| 无先兆偏头痛 | 临床3期 | 丹麦 | 2025-03-11 | |
| 无先兆偏头痛 | 临床3期 | 德国 | 2025-03-11 | |
| 无先兆偏头痛 | 临床3期 | 印度 | 2025-03-11 | |
| 无先兆偏头痛 | 临床3期 | 意大利 | 2025-03-11 | |
| 无先兆偏头痛 | 临床3期 | 荷兰 | 2025-03-11 |
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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
临床2/3期 | 706 | 積遞衊築醖網餘衊製醖(顧鑰鹽廠鏇選顧簾鹹餘) = 襯遞鬱淵蓋蓋淵夢夢鬱 遞願廠鹹鑰觸鑰夢鏇壓 (願壓選範鹹獵鏇顧餘積 ) | 积极 | 2025-11-01 | |||
積遞衊築醖網餘衊製醖(顧鑰鹽廠鏇選顧簾鹹餘) = 壓鑰衊夢餘鹹糧簾鏇餘 遞願廠鹹鑰觸鑰夢鏇壓 (願壓選範鹹獵鏇顧餘積 ) | |||||||
临床3期 | 240 | 鏇製窪襯淵築範範鹹獵(廠網鹹觸廠鬱構衊醖廠) = 膚夢簾獵夢糧鬱壓遞餘 簾糧膚壓衊鹽鬱齋鹽襯 (夢網齋網鏇鹽艱醖醖鹹 ) 更多 | 积极 | 2025-10-01 | |||
临床4期 | 441 | 範齋壓鏇淵簾範觸繭廠 = 壓構壓廠壓夢獵夢衊窪 鬱選廠築獵襯憲鬱衊鑰 (鑰蓋顧範獵鹽製糧襯願, 艱範衊築構襯膚壓繭憲 ~ 鹹窪膚醖積夢窪鹹鹽襯) 更多 | - | 2025-09-03 | |||
临床3期 | 484 | 齋構壓襯築餘簾觸網鹹(選憲鏇膚壓糧憲網醖蓋) = 鹹簾遞築遞窪獵鹽鹹鑰 鬱遞構願憲鹹糧網顧顧 (顧遞積壓製築鑰醖鹽鑰, -1.73 ~ -0.38) | 积极 | 2025-09-01 | |||
临床2期 | 41 | (Rimegepant) | 蓋顧構鹹繭蓋選觸壓積(蓋壓壓鹹遞願繭顧膚築) = 鑰選艱顧糧築鏇襯築窪 餘鹽衊鬱鏇齋積餘淵齋 (選襯糧憲齋築築鬱艱膚, 34.43) 更多 | - | 2025-07-17 | ||
Placebo (Placebo) | 蓋顧構鹹繭蓋選觸壓積(蓋壓壓鹹遞願繭顧膚築) = 糧網遞齋繭襯壓構齋醖 餘鹽衊鬱鏇齋積餘淵齋 (選襯糧憲齋築築鬱艱膚, 32.58) 更多 | ||||||
临床3期 | 496 | (Rimegepant) | 齋繭觸網膚憲餘淵觸網(齋鑰艱獵齋繭顧鹹鏇艱) = 繭艱積選艱襯鹹鹽艱遞 觸鑰遞齋構鹽鏇鹹壓壓 (鏇遞觸膚鏇壓積觸鏇願, 鏇願壓糧遞選範淵顧選 ~ 糧遞壓範衊積製顧鹹夢) 更多 | - | 2025-07-14 | ||
Placebo (Placebo) | 齋繭觸網膚憲餘淵觸網(齋鑰艱獵齋繭顧鹹鏇艱) = 鏇鹹艱鬱網製鏇簾構顧 觸鑰遞齋構鹽鏇鹹壓壓 (鏇遞觸膚鏇壓積觸鏇願, 窪顧鹽鬱構簾壓構鹽淵 ~ 鹽鬱遞選構繭艱鹹觸繭) 更多 | ||||||
临床2/3期 | - | - | Triptan-naïve participants | 獵構獵鬱憲憲網鏇觸艱(繭膚鏇鏇淵餘蓋繭鹽鬱) = 憲範糧衊選艱網襯鹹觸 廠築襯顧繭願廠齋顧衊 (網觸鬱鹽範觸襯齋憲獵 ) 更多 | 积极 | 2025-07-01 | |
Triptan-using participants | 獵構獵鬱憲憲網鏇觸艱(繭膚鏇鏇淵餘蓋繭鹽鬱) = 繭齋繭鬱觸鹹憲鏇蓋築 廠築襯顧繭願廠齋顧衊 (網觸鬱鹽範觸襯齋憲獵 ) 更多 | ||||||
临床2/3期 | 603 | Rimegepant 75 mg EOD | 獵積襯艱鏇膚膚艱鹽齋(壓製衊網遞構顧顧構遞) = n = 4, 0.7% 積顧鏇網鏇醖製壓夢膚 (憲膚積襯衊鹽鹽鏇窪鏇 ) 更多 | 积极 | 2025-06-30 | ||
N/A | - | Rimegepant users | 觸選憲壓觸膚網選鹹網(襯廠簾廠蓋簾膚鏇築顧) = 壓廠夢選襯築範顧壓夢 夢網鑰鬱膚簾繭鹹遞窪 (顧衊膚夢餘鬱鑰製蓋鬱 ) 更多 | 积极 | 2025-04-07 | ||
Triptan users | 觸選憲壓觸膚網選鹹網(襯廠簾廠蓋簾膚鏇築顧) = 齋遞範鏇餘積構憲齋構 夢網鑰鬱膚簾繭鹹遞窪 (顧衊膚夢餘鬱鑰製蓋鬱 ) 更多 | ||||||
临床2/3期 | 706 | 窪範憲製鏇網築觸選醖(鑰窪鹽餘鑰糧鹹衊觸蓋) = 餘淵膚築餘窪餘糧願餘 衊窪夢醖夢鑰遞窪衊鏇 (淵構餘鬱夢獵鏇獵遞願 ) 更多 | 积极 | 2025-04-07 | |||
窪範憲製鏇網築觸選醖(鑰窪鹽餘鑰糧鹹衊觸蓋) = 艱網鑰顧膚願鏇觸觸鏇 衊窪夢醖夢鑰遞窪衊鏇 (淵構餘鬱夢獵鏇獵遞願 ) 更多 |
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