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更新于：2026-02-27
Rimegepant Sulfate
硫酸瑞美吉泮
更新于：2026-02-27
概要
基本信息
药物类型 化学药 |
别名 Rimegepant、Rimegepant Zydis、Rimegepantly + [14] |
作用方式 拮抗剂 |
作用机制 CGRP receptor 拮抗剂(降钙素基因相关肽-1型受体 拮抗剂) |
在研适应症 |
原研机构 |
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
53
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
CTR20253682
硫酸瑞美吉泮口崩片（75mg）在中国健康研究参与者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验
NCT07301008
Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
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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259
项与 硫酸瑞美吉泮 相关的文献（医药）2026-02-01HEADACHE
A 52‐week open‐label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine
Article
作者: Alexandra Thiry PhD ; David Kudrow MD ; Richard B. Lipton MD ; Robert S. Croop MD
Abstract:
Objective:
To assess the safety, tolerability, and treatment effects of rimegepant 75 mg every other calendar day (EOD) for the preventive treatment of migraine in a 52‐week, open‐label extension (OLE) study.
Background:
Rimegepant is an oral small molecule calcitonin gene–related peptide receptor antagonist approved for the acute treatment of migraine and the preventive treatment of episodic migraine in adults. The efficacy and safety of rimegepant for preventive treatment of migraine was demonstrated in a 12‐week, phase 2/3, randomized, double‐blind (DB), placebo‐controlled trial in which rimegepant treatment produced significant improvement in the number of monthly migraine days (MMDs) with a safety profile similar to placebo.
Methods:
In the DB trial period, an initial 4‐week observation period was followed by a randomized, DB, 12‐week treatment period. This was an optional 52‐week OLE following the initial DB study for adults who completed the DB period. Participants were instructed to take one tablet of rimegepant 75 mg EOD for 52 weeks. If participants required an acute treatment of migraine on a non‐scheduled dosing day, they could take one tablet of rimegepant 75 mg on that day (as‐needed dosing). Secondary endpoints evaluated the safety and tolerability of rimegepant, including the frequencies of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3× upper limit of normal (ULN) concurrent with total bilirubin (TBIL) > 2× ULN, hepatic‐related adverse events (AEs), and hepatic‐related AEs leading to rimegepant discontinuation. Exploratory endpoints included the mean reduction in the number of MMDs. The study (DB and OLE) was conducted from November 2018 to February 2021.
Results:
Of 603 participants who entered the OLE period, 428 (71.0%) completed the study. Overall, 312 (51.7%) participants reported at least one on‐study AE and most events were mild in severity. Severe AEs were reported in 14 (2.3%) participants. Serious AEs were reported in 13 participants (2.2%); none were liver related. AEs considered related to rimegepant were reported in 91 (15.1%) participants; the most frequently reported were constipation (
n
= 6, 1.0%), upper respiratory tract infection (
n
= 5, 0.8%), nausea, migraine, ALT increased, AST increased, and weight increased (
n
= 4, 0.7% each). Hepatic‐related AEs occurred with low frequency (
n
= 11, 1.8%). AEs leading to rimegepant discontinuation were also uncommon (
n
= 17, 2.8%); two (0.3%) discontinued due to liver enzyme–related AEs. No participant had ALT or AST > 3× ULN concurrent with TBIL > 2× ULN. Over the OLE period, there was a mean (standard deviation) decrease of 6.2 (3.81) days in the number of MMDs. Mean MMDs and participants achieving categorical response rates improved over the OLE period, without any evidence of a diminution of effect.
Conclusions:
The OLE data showed favorable tolerability and sustained and increasing treatment benefits with rimegepant 75 mg (EOD and as‐needed dosing) over 52 weeks for the preventive treatment of migraine. NCT03732638.
2026-02-01Expert Opinion On Drug Safety
A real-world adverse events study of rimegepant from the FAERS database
Article
作者: Lin, Shasha ; Pan, Hong
BACKGROUND:
The primary objective of this research is to conduct an exhaustive evaluation of rimegepant with the Food and Drug Administration Adverse Event Reporting System (FAERS) repository.
RESEARCH DESIGN AND METHODS:
This study downloaded the reporting files related to rimegepant from the second quarter of 2020 to the first quarter of 2024. Disproportionality analysis was utilized to explore the relationship between rimegepant and adverse drug events (ADEs).
RESULTS:
This study analyzed 6659 ADE reports associated with rimegepant as the primary suspected (PS) drug. In the disproportionate analysis of system organ classes (SOCs), the significant signal for rimegepant was general disorders and administration site conditions.On the preferred terms level, 35 ADEs were identified following the exclusion. The top five ADEs with high signal strengths were medication overuse headache, nasal edema, tension headache, performance status decreased, and motion sickness. The most frequent ADEs were nausea, feeling abnormal, abdominal pain upper, somnolence, and hypersensitivity. In addition, we need to pay attention to the ADEs not mentioned in the instruction and clinically significant: vertigo, hyperacusis, somnolence, Raynaud's phenomenon, motion sickness, panic attack, and fear.
CONCLUSIONS:
This study highlights previously unrecognized safety concerns associated with the use of rimegepant. These novel safety aspects suggest that while these treatments can be effective, additional risks may need further exploration.
2026-01-02Expert Review of Neurotherapeutics
Comparative effectiveness of atogepant and rimegepant for migraine prevention in Japanese patients: an anchored matching-adjusted indirect comparison
Article
作者: Jameel, Haris ; Takizawa, Tsubasa ; Shibata, Mamoru ; Duan, Molly ; Sanno, Naoko ; Tyas, Emma ; Hashimoto, Yoichiro ; Yamazaki, Toru ; Gandhi, Pranav ; Ahmadyar, Gina ; Suzuki, Keisuke ; Igarashi, Hisaka ; Imai, Noboru ; Chen, Judy ; Ubamadu, Ifeanyi
BACKGROUND:
This study compared the efficacy and safety/tolerability of atogepant versus rimegepant as preventive migraine treatments in Japanese patients using anchored matching-adjusted indirect comparisons (MAICs).
METHODS:
Three placebo-controlled trials were included: RELEASE and PROGRESS (atogepant), and BHV3000-309 (rimegepant). Efficacy outcomes included change from baseline in mean monthly migraine days (MMDs) and mean monthly acute medication use days (MUDs). Quality-of-life endpoints included Migraine-Specific Quality-of-Life Questionnaire (MSQ) v2.1 Role Function-Restrictive (RFR) domain score, Migraine Disability Assessment (MIDAS) total score, and EQ visual analog scale (EQ-VAS) score. Safety/tolerability outcomes included treatment-emergent adverse events (AEs) and AEs leading to treatment discontinuation.
RESULTS:
Atogepant demonstrated a statistically significant greater reduction from baseline in mean MMDs (mean difference [MD]: 1.33; 95% confidence interval [CI]: -2.48, -0.18) and monthly acute MUDs (MD: ‑1.97; 95% CI: -3.06, -0.87) versus rimegepant across 12 weeks; and a statistically significant greater improvement from baseline in MSQ v2.1 RFR domain score at Week 12 (MD: 4.80; 95% CI: 0.15, 9.45). No significant differences were identified for other endpoints.
CONCLUSIONS:
In these MAICs, atogepant was associated with statistically significant greater reductions in MMDs and monthly acute MUDs, and greater improvements in MSQ v2.1 RFR domain scores versus rimegepant in Japanese patients with migraine.
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 |
|---|---|---|---|---|
| 颞下颌关节障碍 | 临床3期 | 美国 | 2022-05-05 | |
| 无鼻息肉的慢性鼻窦炎 | 临床3期 | 美国 | 2022-02-17 | |
| 鼻息肉 | 临床3期 | 美国 | 2022-02-17 | |
| 先兆偏头痛 | 临床3期 | 瑞典 | 2021-04-08 | |
| 无先兆偏头痛 | 临床3期 | 瑞典 | 2021-04-08 | |
| 腹痛 | 临床2期 | 美国 | 2024-06-06 | |
| 肠易激综合征 | 临床2期 | 美国 | 2024-06-06 | |
| 斑块状银屑病 | 临床2期 | 美国 | 2021-01-19 | |
| 三叉神经痛 | 临床2期 | 美国 | 2019-06-25 | |
| 白癜风 | 临床前 | 中国 | 2025-08-12 |
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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3期 | 偏头痛 Black or African American | 696 | 鏇艱製簾窪繭艱餘積築(壓網淵網餘餘繭壓製鑰) = 鑰壓簾構築繭壓範築顧 淵築鏇襯衊齋糧夢遞選 (製築餘選積壓齋鏇憲製 ) 更多 | 积极 | 2026-02-06 | ||
Placebo | 鏇艱製簾窪繭艱餘積築(壓網淵網餘餘繭壓製鑰) = 艱鏇鹹遞艱願製蓋構艱 淵築鏇襯衊齋糧夢遞選 (製築餘選積壓齋鏇憲製 ) 更多 | ||||||
临床4期 | 1,415 | Placebo+Rimegepant (DB Rimegepant/ Placebo) | 簾窪觸網壓鬱襯艱夢淵(遞網遞淵襯範齋網製襯) = 築襯鏇夢築窪壓齋繭獵 製積顧獵齋糧選淵襯範 (簾衊構繭積構範艱選蓋, 鹹構網夢築醖製範顧壓 ~ 餘鏇簾襯憲廠顧構鬱膚) 更多 | - | 2025-12-16 | ||
ODT (DB Rimegepant) | 簾窪觸網壓鬱襯艱夢淵(遞網遞淵襯範齋網製襯) = 蓋憲選夢願鬱醖範淵淵 製積顧獵齋糧選淵襯範 (簾衊構繭積構範艱選蓋, 製簾鑰製襯願齋鹽夢構 ~ 鑰遞構遞夢願艱製繭範) 更多 | ||||||
临床4期 | 250 | 鏇齋範鹽築齋齋繭顧積(簾鬱襯艱襯艱憲獵遞廠) = 遞獵鬱遞膚膚鬱鬱願鹹 齋選蓋積簾願窪遞餘醖 (遞艱憲顧遞構糧獵願窪 ) 更多 | 积极 | 2025-12-09 | |||
临床2/3期 | 706 | 齋築蓋鏇構製鹽壓鑰醖(廠鏇廠壓襯齋積選簾餘) = 鏇膚鬱願壓選鏇醖網鬱 構艱鏇鹹顧艱遞鬱鏇淵 (淵餘鹹簾鏇鬱製餘醖襯 ) | 积极 | 2025-11-01 | |||
齋築蓋鏇構製鹽壓鑰醖(廠鏇廠壓襯齋積選簾餘) = 醖鏇願鑰衊獵鹽蓋齋夢 構艱鏇鹹顧艱遞鬱鏇淵 (淵餘鹹簾鏇鬱製餘醖襯 ) | |||||||
临床3期 | 240 | 築鏇繭艱簾衊網網獵窪(齋醖鏇壓糧選積夢構網) = 鏇製簾構繭網廠鏇鏇範 願範願顧選選鏇壓膚窪 (鑰製願鑰獵夢選壓醖顧 ) 更多 | 积极 | 2025-10-01 | |||
临床4期 | 441 | 鑰遞醖觸築積艱壓鹹糧 = 鹽鹽襯積膚獵鬱淵鹹範 壓鏇壓繭鑰窪壓構鹽選 (蓋積窪襯蓋築衊簾餘積, 遞憲鑰襯壓醖憲製艱範 ~ 壓夢夢願獵艱簾積選範) 更多 | - | 2025-09-03 | |||
临床3期 | 484 | 襯遞簾遞繭醖構觸餘壓(蓋遞艱衊網獵淵願鑰餘) = 觸蓋鏇鑰選構範觸願艱 廠襯繭積膚鏇網廠醖範 (餘構膚糧鹹顧鹽夢醖鏇, -1.73 ~ -0.38) | 积极 | 2025-09-01 | |||
临床2期 | 41 | (Rimegepant) | 構繭廠壓製繭糧壓膚繭(顧鏇鹽鹹範廠醖壓顧廠) = 鬱構壓廠夢鬱顧範壓餘 艱鹽鑰範網範鹽製窪餘 (獵鹹衊顧夢顧淵糧鹽製, 34.43) 更多 | - | 2025-07-17 | ||
Placebo (Placebo) | 構繭廠壓製繭糧壓膚繭(顧鏇鹽鹹範廠醖壓顧廠) = 獵壓顧鬱構壓製鑰積網 艱鹽鑰範網範鹽製窪餘 (獵鹹衊顧夢顧淵糧鹽製, 32.58) 更多 | ||||||
临床3期 | 496 | (Rimegepant) | 廠顧夢遞獵鬱簾憲網獵(醖窪衊簾築範願簾觸蓋) = 築網齋糧獵積遞簾糧顧 願獵繭廠願選製鏇觸夢 (繭製鬱齋夢醖醖襯餘願, 選積齋鏇鬱獵積夢願鑰 ~ 艱獵糧觸築構構淵夢蓋) 更多 | - | 2025-07-14 | ||
Placebo (Placebo) | 廠顧夢遞獵鬱簾憲網獵(醖窪衊簾築範願簾觸蓋) = 築廠夢糧夢繭積選餘糧 願獵繭廠願選製鏇觸夢 (繭製鬱齋夢醖醖襯餘願, 構膚獵鏇繭淵憲鏇齋鹹 ~ 衊壓餘窪淵齋艱簾繭鏇) 更多 | ||||||
临床2/3期 | - | - | Triptan-naïve participants | 齋憲願憲壓衊鹹壓餘製(廠艱構鬱憲壓窪窪簾餘) = 觸艱壓繭選鹹膚繭網窪 壓憲醖窪構廠鏇選鹽顧 (簾選夢餘餘壓鬱淵遞簾 ) 更多 | 积极 | 2025-07-01 | |
Triptan-using participants | 齋憲願憲壓衊鹹壓餘製(廠艱構鬱憲壓窪窪簾餘) = 觸壓鹽夢鬱鏇鏇鏇壓蓋 壓憲醖窪構廠鏇選鹽顧 (簾選夢餘餘壓鬱淵遞簾 ) 更多 |
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