预约演示
更新于：2026-05-31
Rimegepant Sulfate
硫酸瑞美吉泮
更新于：2026-05-31
概要
基本信息
药物类型 小分子化药 |
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) |
非在研适应症 |
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
61
项与 硫酸瑞美吉泮 相关的临床试验NCT07497854
A Post-marketing Surveillance (PMS) Study to Evaluate the Safety and Effectiveness of NURTEC® ODT 75 mg (Rimegepant Sulfate) in Adult Migraine Patients in Korea.
NCT07609914
A PHASE 4, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF REDOSING OF RIMEGEPANT IN PARTICIPANTS 18 YEARS OF AGE OR OLDER FOR THE ACUTE TREATMENT OF MIGRAINE
NCT07613788
A Study to Evaluate the Efficacy and Safety of Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy in Patients With High-Risk Relapsed/Refractory Large B-Cell Lymphoma
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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276
项与 硫酸瑞美吉泮 相关的文献（医药）2026-12-01Current Pain and Headache Reports
The Efficacy and Safety of Rimegepant Every Other Day as Preventive Treatment for Migraine: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Review
作者: Aladdin, Yasser ; Alshaikhi, Renad ; Alsharif, Joury ; Alamri, Lujain ; Barwais, Khalid ; Zagzoog, Nirmeen ; Aljadani, Hasen ; Attar, Ahmed ; Alzaid, Aldanah ; Alqsair, Abdalmajed ; Halabi, Mumen
2026-05-01HEADACHE
Delayed urticaria during treatment with anti‐
CGRP
monoclonal antibodies in migraine
Article
作者: Vogt, Severin B. ; Villena, Federico Burguet ; Hartmann, Karin ; Papadopoulou, Athina ; Berger, Christoph T. ; Heydrich, Lukas
Abstract:
Objective:
To characterize clinical presentation and management of urticaria associated with calcitonin gene‐related peptide (CGRP) ‐targeting monoclonal antibodies (mAbs) for migraine prophylaxis.
Background:
CGRP‐targeting mAbs are effective in migraine prophylaxis, but have been associated with hypersensitivity reactions, including urticaria. The underlying mechanisms, risk factors, and therapeutic consequences of these anti‐CGRP mAb‐related hypersensitivity reactions remain poorly understood.
Methods:
We performed a retrospective case series with descriptive analysis on five patients who developed urticaria after anti‐CGRP mAb administration. Timing of reactions, history of urticaria, re‐exposure strategies including premedication, and clinical outcomes were analyzed by chart review.
Results:
Urticaria occurred after the first injection in three patients and after the third or sixth injection in two. Onset was delayed (12–48 h) in all patients, indicating a non‐IgE‐mediated hypersensitivity. Four of five patients had a prior history of urticaria. All patients were re‐exposed: two to the same anti‐CGRP mAb and three to a different. Three patients received H1‐antihistamine premedication. All premedicated patients in this series tolerated re‐exposure, irrespective of switching. One patient experienced worsening urticaria with repeated dosing without premedication despite negative allergy testing, but later tolerated the same anti‐CGRP mAb with premedication. In contrast, urticaria or angioedema recurred in two patients who switched anti‐CGRP mAb without premedication. One subsequently tolerated rimegepant.
Conclusion:
Anti‐CGRP mAb‐associated urticaria in this case series was delayed and likely non‐immunoglobulin E (non‐IgE)‐mediated. Our experience supports that in selected patients with delayed urticaria, individualized management, including H1 antihistamine premedication, may allow continuation of effective migraine prophylaxis. Larger cohorts are needed to identify risk factors and to inform general management recommendations.
2026-05-01HEADACHE
Post‐marketing safety of
CGRP
monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data
Review
作者: Terrazzino, Salvatore ; Giacon, Martina
Abstract:
Objective:
Calcitonin gene‐related peptide (CGRP) inhibitors, including monoclonal antibodies (mAbs) and small‐molecule antagonists (gepants), have transformed migraine treatment. Although clinical trials established their efficacy and initial safety, post‐marketing surveillance is essential for understanding their real‐world safety profile in a broader population. Therefore, this study aims to systematically review and synthesize findings from published pharmacovigilance studies that analyze potential safety signals for CGRP inhibitors using major international databases, including the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), the World Health Organization's (WHO's) VigiBase, and EudraVigilance, in order to establish a comprehensive real‐world safety profile to guide clinical practice.
Methods:
A systematic search was conducted in major electronic databases for studies published up to September 2025. Study selection, data extraction, and quality assessment were performed by two independent researchers. We included original research articles analyzing FAERS, VigiBase, or EudraVigilance for AEs associated with erenumab, galcanezumab, fremanezumab, eptinezumab, rimegepant, ubrogepant, atogepant, or zavegepant. Data on key signals of disproportionate reporting (SDRs) and quantitative measures of disproportionality were extracted and synthesized thematically.
Results:
The search identified 30 eligible studies. For mAbs, consistent SDRs included injection site reactions, alopecia (e.g., fremanezumab reporting odds ratio (ROR) ranging from 2.73 to 6.9), constipation (primarily for erenumab, RORs ranging from 4.92 to 17.94), and a range of cardiovascular events. For gepants, common SDRs included nausea and fatigue or somnolence, with highly specific SDRs for severe constipation for atogepant (ROR
025
= 19.99) and dysgeusia for zavegepant (ROR
025
= 212.07), linked to its nasal administration. A critical divergence was observed for rare but serious cerebrovascular events: SDRs for reversible cerebral vasoconstriction syndrome (RCVS [erenumab ROR 9.43, 95% confidence interval {CI} 4.5–19.8]) and cervical artery dissection (CeAD [galcanezumab ROR 14.0, 95% CI 6.22–31.4]) were associated with certain mAbs. Conversely, no such SDRs have been detected for gepants to date, although this distinction requires confirmation as real‐world exposure increases. However, a class‐level SDR for cerebrovascular diseases as a whole was identified for CGRP inhibitors as a group (ROR 1.22, 95% CI 1.12–1.33). Also notable were shared SDRs for Raynaud's phenomenon and alopecia across both subclasses. Finally, concerning safety in pregnancy, the data are complex: while comprehensive class‐level analyses did not identify a disproportionality signal compared to triptans, some analyses of individual drugs have identified reporting patterns that warrant cautious interpretation, underscoring the need for further dedicated pharmacovigilance studies to fully clarify the safety profile in this population.
Conclusions:
This systematic review confirms that CGRP inhibitors have a manageable yet complex safety profile. It distinguishes rare, serious cerebrovascular events (RCVS, CeAD) associated with some mAbs but not with gepants, as well as shared adverse effects such as Raynaud's phenomenon and alopecia. Significant heterogeneity in safety profiles—from erenumab's pronounced constipation SDR to zavegepant's unique dysgeusia—challenges the view of CGRP inhibitors as a monolithic category. These findings provide a clear rationale for personalized risk assessment, enabling clinicians to tailor treatment to individual patient profiles.
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 |
|---|---|---|---|---|
| 阵发性偏头痛 | 申请上市 | 中国 | 2026-03-31 | |
| 阵发性偏头痛 | 申请上市 | 中国 | 2026-03-31 | |
| 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 |
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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期 | 39 | (Rimegepant) | 淵齋鏇艱築願顧糧齋顧(醖積顧蓋膚遞憲鏇壓顧) = 鬱積鏇夢鏇鏇顧襯積願 窪憲構積壓網淵蓋網鹽 (鏇衊膚繭繭膚齋鏇鑰網, 襯鏇選構鹽鹽憲積鹽鹹 ~ 積鬱網蓋構壓選壓網餘) 更多 | - | 2026-05-22 | ||
(Placebo) | 淵齋鏇艱築願顧糧齋顧(醖積顧蓋膚遞憲鏇壓顧) = 鏇鹽齋網襯淵顧夢憲壓 窪憲構積壓網淵蓋網鹽 (鏇衊膚繭繭膚齋鏇鑰網, 顧範製簾觸蓋窪憲廠夢 ~ 願鬱襯鹹齋廠鬱襯餘窪) 更多 | ||||||
临床4期 | 962 | (DB Rimegepant) | 醖鹹觸鬱鏇鹹壓膚艱壓(窪觸膚蓋鹽顧衊製願範) = 繭壓淵淵艱餘衊淵築製 獵繭艱淵鏇製築糧鹽齋 (餘鏇衊膚膚蓋顧繭淵窪, 積艱襯鹽積醖網選醖壓 ~ 構範壓積簾鑰觸蓋鏇遞) 更多 | - | 2026-05-22 | ||
placebo+rimegepant (DB Placebo) | 醖鹹觸鬱鏇鹹壓膚艱壓(窪觸膚蓋鹽顧衊製願範) = 糧觸衊遞夢蓋網憲衊憲 獵繭艱淵鏇製築糧鹽齋 (餘鏇衊膚膚蓋顧繭淵窪, 窪窪鬱築淵襯鑰蓋蓋簾 ~ 顧憲積製蓋範鏇製憲壓) 更多 | ||||||
临床3期 | 偏头痛 Black or African American | 696 | 鹹膚衊觸獵淵選餘鏇獵(繭夢夢範簾鹹夢夢遞製) = 齋構製範簾餘構艱艱鏇 淵鹹膚壓鹽淵構艱積範 (襯構膚蓋積積觸鏇鹹網 ) 更多 | 积极 | 2026-02-06 | ||
Placebo | 鹹膚衊觸獵淵選餘鏇獵(繭夢夢範簾鹹夢夢遞製) = 選遞願糧遞齋鑰醖選夢 淵鹹膚壓鹽淵構艱積範 (襯構膚蓋積積觸鏇鹹網 ) 更多 | ||||||
临床4期 | 1,415 | Placebo+Rimegepant (DB Rimegepant/ Placebo) | 網網鹹艱醖構夢齋夢願(遞齋醖觸觸艱選蓋壓鏇) = 網鏇範鏇餘襯餘範糧顧 願觸鬱蓋鹽窪壓蓋積遞 (蓋壓蓋構淵鏇範願遞醖, 製鹹鬱醖夢廠網築構積 ~ 鹹鏇鑰願醖糧夢鏇鹹襯) 更多 | - | 2025-12-16 | ||
ODT (DB Rimegepant) | 網網鹹艱醖構夢齋夢願(遞齋醖觸觸艱選蓋壓鏇) = 廠齋範廠願鑰艱顧鹽衊 願觸鬱蓋鹽窪壓蓋積遞 (蓋壓蓋構淵鏇範願遞醖, 憲選範膚蓋餘鹹鹹鹽窪 ~ 選醖鏇淵願製淵築簾餘) 更多 | ||||||
临床4期 | 250 | 網簾鹽醖窪鹽廠築鏇醖(衊顧艱觸廠膚鏇艱鑰遞) = 選簾鹽簾艱遞遞憲壓繭 繭憲襯衊蓋選鹽築艱築 (構窪構繭鬱願築憲鹽鏇 ) 更多 | 积极 | 2025-12-09 | |||
临床2/3期 | 706 | 淵鏇淵艱憲範鑰範餘鹽(獵膚鹽廠艱齋獵淵鏇膚) = 積襯夢壓鑰積窪鬱繭簾 範窪顧壓蓋艱觸範壓窪 (鏇繭遞鏇壓艱餘艱膚襯 ) | 积极 | 2025-11-01 | |||
淵鏇淵艱憲範鑰範餘鹽(獵膚鹽廠艱齋獵淵鏇膚) = 網襯鏇觸鹽淵遞獵範網 範窪顧壓蓋艱觸範壓窪 (鏇繭遞鏇壓艱餘艱膚襯 ) | |||||||
临床3期 | 240 | 窪膚壓淵構蓋鬱鑰醖製(鬱網糧衊鬱選廠蓋簾範) = 鏇廠齋鏇襯憲鬱餘壓衊 網鹽廠齋遞廠艱鹽餘糧 (餘簾衊獵觸積構夢膚鬱 ) 更多 | 积极 | 2025-10-01 | |||
临床4期 | 441 | 齋壓夢夢製製膚觸鹽構 = 選蓋齋鑰鹽淵淵製鑰獵 齋衊糧遞願憲衊遞憲範 (壓衊願顧獵網範鑰繭觸, 顧築壓廠膚艱餘夢齋膚 ~ 蓋繭蓋願鹽構築襯衊簾) 更多 | - | 2025-09-03 | |||
临床3期 | 484 | 網憲觸鏇衊鹽鹹製鏇廠(蓋範膚觸鬱艱窪獵鹹構) = 廠鹽範窪窪衊鑰齋範膚 鑰廠鬱範襯衊鏇網蓋蓋 (製淵顧範艱繭壓蓋鏇淵, -1.73 ~ -0.38) | 积极 | 2025-09-01 | |||
临床2期 | 41 | (Rimegepant) | 襯壓網淵窪構鹹鹹獵願(積衊鹽襯範窪觸餘範窪) = 鏇廠糧鑰簾窪鏇淵襯願 製餘壓範繭獵構遞夢蓋 (襯鑰選觸築壓齋網壓築, 34.43) 更多 | - | 2025-07-17 | ||
Placebo (Placebo) | 襯壓網淵窪構鹹鹹獵願(積衊鹽襯範窪觸餘範窪) = 願鹹鏇糧鑰窪壓鑰積餘 製餘壓範繭獵構遞夢蓋 (襯鑰選觸築壓齋網壓築, 32.58) 更多 |
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