艾曲帕米(Etripamil) - 药物靶点：L-type calcium channel_在研适应症：阵发性室上性心动过速，心房颤动，室上性心动过速_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Etripamil (USAN/INN)、(-)-MSP-2017、MSP-2017

+ [6]

靶点

L-type calcium channel

作用方式

阻滞剂

作用机制

L-type calcium channel阻滞剂(L-型电压门控性钙通道家族阻滞剂)

治疗领域

心血管疾病

在研适应症

阵发性室上性心动过速心房颤动室上性心动过速

非在研适应症-

原研机构

Milestone Pharmaceuticals, Inc.

在研机构

Milestone Pharmaceuticals, Inc.

箕星药业科技（上海）有限公司Milestone Pharmaceuticals USA, Inc.

非在研机构-

权益机构

Milestone Pharmaceuticals, Inc.

云顶新耀有限公司

箕星药业科技（上海）有限公司

最高研发阶段批准上市

首次获批日期

美国 (2025-12-12),

阵发性室上性心动过速

最高研发阶段(中国)申请上市

特殊审评-

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结构/序列

分子式C27H36N2O4

InChIKeyVAZNEHLGJGSQEL-MHZLTWQESA-N

CAS号1593673-23-4

关联

11

项与艾曲帕米相关的临床试验

NCT06716021

/ Not yet recruiting临床3期

Multi-Center, Placebo-Controlled, Phase 3 Study of Etripamil Nasal Spray (NS) in Patients With Atrial Fibrillation and Rapid Ventricular Rate (RVR)

This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with atrial fibrillation (AF). This study includes Screening Visit, Randomization Visit, a Treatment Period with scheduled Follow-up Visits (Monthly Follow-up and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow up Visit.
Each patient will be randomized 1:1 to receive placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR with an initial dose of placebo or 70 mg etripamil NS, followed by an optional second dose of the same study drug 10 minutes after the first dose if the patient continues to experience symptoms. Patients may treat up to a maximum of 4 episodes in the study.
Informed consent will be obtained prior to any study procedures.

开始日期2027-01-01

申办/合作机构

Milestone Pharmaceuticals, Inc.

NCT05763953

/ Recruiting临床2期

The NODE-202 Study Multi-Center, Multi-National, Open-Label, Efficacy and Safety Study of Etripamil Nasal Spray in Pediatric Patients With Paroxysmal Supraventricular Tachycardia

NODE-202 is a Phase 2, multicenter, multinational, single dose, open-label, 2-part, sequential design study in pediatric patients with an established diagnosis of paroxysmal supraventricular tachycardia (PSVT) presenting with a symptomatic episode of PSVT.
In Part 1, at least 30 patients aged 12 to <18 years will be enrolled and treated with etripamil nasal spray (NS). Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of 70 mg etripamil NS (Part 1A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the Pharmacokinetic (PK) analysis and will undergo efficacy and safety/tolerability assessments (Part 1B).
In Part 2, at least 30 patients aged 6 to <12 years will be enrolled and treated with etripamil NS at a dose selected based on appropriate body size-based modeling, as well as efficacy, safety/tolerability, and PK data collected in Part 1. Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of etripamil NS (Part 2A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the PK analysis and will undergo efficacy and safety/tolerability assessments (Part 2B).
The study will include the following visits: A Screening Visit, A Treatment Visit, , and A Follow-Up/End of Study Visit.

开始日期2023-12-11

申办/合作机构

Milestone Pharmaceuticals, Inc.

NCT05511870

/ Completed临床1期

A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Etripamil in Healthy Chinese Subjects

The objectives of the study are as below:
Primary:
·To evaluate the pharmacokinetics (PK) of Etripamil in healthy adult Chinese subjects
Secondary:
* To evaluate the pharmacodynamics (PD) of Etripamil in healthy adult Chinese subjects
* To evaluate the safety and tolerability of Etripamil in healthy adult Chinese subjects
Exploratory:
·To evaluate the PK exposure-PD response relationship of etripamil in healthy adult Chinese subjects

开始日期2023-03-07

申办/合作机构

Milestone Pharmaceuticals, Inc.

100 项与艾曲帕米相关的临床结果

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100 项与艾曲帕米相关的转化医学

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100 项与艾曲帕米相关的专利（医药）

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37

项与艾曲帕米相关的文献（医药）

2026-04-01·JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY

Self‐Administered Etripamil Nasal Spray Slows Ventricular Rate in Patients With Atrial Fibrillation: A Post Hoc Analysis of the NODE‐303 Study

Article

作者: Sheikh, Muhammad ; Ip, James E. ; Stambler, Bruce S. ; Alings, Marco ; Piccini, Jonathan P. ; Bharucha, David B. ; Martinez, Felipe A. ; Dorian, Paul ; Coutu, Benoit ; Shardonofsky, Silvia ; Camm, A. John

ABSTRACT:

Introduction:

Currently, there are no available fast‐acting agents to control the ventricular rate (VR) during atrial fibrillation (AF) episodes that can be self‐administered by patients on an as‐needed basis without medical supervision. Here, we aim to evaluate the effect of intranasal etripamil on VR in patients treating presumed paroxysmal supraventricular tachycardia (PSVT) episodes later identified as AF.

Methods:

NODE‐303 is a phase 3, multicenter, open‐label study to evaluate the safety and efficacy of self‐administered intranasal etripamil. The study enrolled adult (≥ 18 years) patients with prior documented PSVT. Patients self‐administered 70 mg of intranasal etripamil after applying an ECG monitor and performing a vagal maneuver. An optional second 70 mg dose was permitted if symptoms persisted after 10 min. This post hoc analysis specifically focused on AF patients (those with presumed PSVT episodes subsequently identified as AF) and evaluated the change from baseline VR (beats per minute, bpm), calculated using patient ECG data that was recorded through 60 min after drug administration, during an etripamil‐treated AF episode.

Results:

Of 1116 total enrolled patients, 503 self‐administered ≥ 1 dose of etripamil for presumed PSVT, and 18 had ≥ 1 episode(s) later identified as AF with adequate ECG data. AF episode baseline median VR (range) was 127 bpm (79, 164), and the average maximum reduction in VR was 27.4 bpm ± 6.1 at 22 min. VR reduction was sustained for at least 30 to 60 min (median VR reduction −22 and −18 bpm, respectively). No serious adverse events or adverse events of special interest were observed, including bradyarrhythmias, AV block, or sinus pauses ≥ 3 s, and treatment‐emergent adverse events were mild to moderate, transient, and related to the nasal administration route.

Discussion:

In this post hoc subgroup analysis of the open‐label NODE‐303 trial, self‐administered etripamil nasal spray led to a clinically significant and sustained VR reduction in patients with symptomatic AF. Further studies are needed to confirm efficacy in a broader AF population.

Conclusion:

Self‐administered etripamil may help to acutely control symptomatic AF‐RVR episodes outside of the healthcare setting.

Clinical Trial Registration:

NCT04072835.

2026-03-01·Cardiac electrophysiology clinics

Advances in Antiarrhythmic Drug Therapy

Review

作者: Kamareddine, Mohammed ; Keramati, Ali R

Pharmacologic management remains indispensable in supraventricular tachycardia despite ablation's curative potential. In stable patients, vagal maneuvers precede drugs; adenosine's ultrashort action makes it first-line, with intravenous calcium-channel or β-blockers and procainamide selected by QRS morphology and accessory-pathway risk. Chronic suppression relies on atrioventricular-nodal agents or class IC/III drugs selected by cardiac substrate and comorbidities, while special populations demand dose and drug modifications. Emerging self-administered therapies-particularly intranasal etripamil and selective A1 agonists-promise convenient, rapid conversion outside hospital settings. An individualized, guideline-driven strategy balancing efficacy, safety, and patient preference remains central to optimal supraventricular tachycardia care.

2026-03-01·JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY

Methodological Considerations in the NODE‐303 Trial of Etripamil for PSVT

Letter

作者: Tahir, Okasha ; Gokhool, Mohammad Ameen Ismael ; Qazi, Muhammad Majid

263

项与艾曲帕米相关的新闻（医药）

2026-05-06

·BioSpace

Milestone Pharmaceuticals to Announce First Quarter 2026 Financial Results on May 13, 2026

MONTREAL and CHARLOTTE, May 06, 2026 (GLOBE NEWSWIRE) -- Milestone ® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will report financial results for the first quarter ended March 31, 2026, and provide a business update before the market open. The announcement will be followed by a conference call and webcast for investors at 8:30am ET. Conference Details: Conference Date: Wednesday, May 13, 2026 Conference Time: 8:30am ET Conference Dial-in: 1-877-407-0792 International Dial-in: 1-201-689-8263 Conference ID: 13760062 Webcast link: Click here . Participants can use Guest dial-in numbers above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. The Call me™ link will be made active 15 minutes prior to scheduled start time. A replay of the audio webcast of the call will be available under the News & Events section of Milestone's website, . About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST™ (etripamil) nasal spray, a novel calcium channel blocker, which is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in development for the control of symptomatic episodic attacks associated with AFib-RVR. Contact: Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com Media Relations Rebecca Novak, rnovak@milestonepharma.com

财报上市批准

2026-04-28

·凤凰网

【券商聚焦】方正证券维持云顶新耀(01952)“强烈推荐”评级指RNA平台进一步验证

金吾财讯 | 方正证券发布研报指，云顶新耀(01952)在AACR大会发布mRNA肿瘤疫苗EVM16首次人体数据，RNA平台进一步验证。截至2025年12月7日，共入组9例患者，EVM16未观察到剂量限制性毒性，所有相关不良事件均为2级及以下且可自行缓解；9例患者中8例诱导出强烈的新抗原特异性T细胞免疫反应。RNA平台中，现货型TAA mRNA疫苗EVM14实现中美新药临床IND双获批并完成首例患者入组给药；mRNA自体生成CAR-T项目EVM18完成非人灵长类动物概念验证并推进临床开发。自研方面，公司将于2026年上半年公布EVER001（BTK）的1b/2a期详细临床研究数据。商业化成果显著，2025年公司实现收入17.07亿元人民币，大幅增长141.51%。国际财务准则下亏损大幅收窄71%，非国际财务准则下首度实现扭亏为盈，净利润为1.87亿元人民币。耐赋康全年销售收入突破14亿元，同比增长超过300%；依嘉实现2.62亿元，院内销售同比增长44%。2026年2月，维适平获批治疗溃疡性结肠炎，计划于2026年下半年参加国家医保谈判。截至2025年12月31日，公司现金储备达27.31亿元人民币。深化BD布局，2025年12月与海森生物制药达成战略合作，进入心血管代谢疾病领域，包括CSO代理及授权引进PCSK9抑制剂乐瑞泊。公司通过战略投资新桥生物引进VIS-101拓展眼科领域；2026年初引进麦科奥特MT1013完善肾科布局；从箕星药业引进艾曲帕米鼻喷雾剂，预计2026年Q3获批。2026年4月，云顶新耀拟收购海森生物制药（新加坡）全部股权，总对价2.5亿美元，海森新加坡2025年实现常态化收入约5.66亿元人民币，EBITDA约1.88亿元人民币。盈利预测方面，方正证券预计2026-2028年公司销售收入分别为39.56/54.52/71.41亿元人民币，同比增长131.78%/37.83%/30.98%；归母净利润分别为2.53/6.65/11.47亿元人民币，维持“强烈推荐”评级。风险提示：销售不及预期风险、研发进度不及预期风险、政策风险等。

2026-04-28

·证券之星

【券商聚焦】方正证券维持云顶新耀(01952)“强烈推荐”评级

金吾财讯|方正证券发布研报指，云顶新耀(01952.HK)在AACR大会发布mRNA肿瘤疫苗EVM16首次人体数据，RNA平台进一步验证。截至2025年12月7日，共入组9例患者，EVM16未观察到剂量限制性毒性，所有相关不良事件均为2级及以下且可自行缓解；9例患者中8例诱导出强烈的新抗原特异性T细胞免疫反应。RNA平台中，现货型TAA mRNA疫苗EVM14实现中美新药临床IND双获批并完成首例患者入组给药；mRNA自体生成CAR-T项目EVM18完成非人灵长类动物概念验证并推进临床开发。自研方面，公司将于2026年上半年公布EVER001（BTK）的1b/2a期详细临床研究数据。商业化成果显著，2025年公司实现收入17.07亿元人民币，大幅增长141.51%。国际财务准则下亏损大幅收窄71%，非国际财务准则下首度实现扭亏为盈，净利润为1.87亿元人民币。耐赋康全年销售收入突破14亿元，同比增长超过300%；依嘉实现2.62亿元，院内销售同比增长44%。2026年2月，维适平获批治疗溃疡性结肠炎，计划于2026年下半年参加国家医保谈判。截至2025年12月31日，公司现金储备达27.31亿元人民币。深化BD布局，2025年12月与海森生物制药达成战略合作，进入心血管代谢疾病领域，包括CSO代理及授权引进PCSK9抑制剂乐瑞泊。公司通过战略投资新桥生物引进VIS-101拓展眼科领域；2026年初引进麦科奥特MT1013完善肾科布局；从箕星药业引进艾曲帕米鼻喷雾剂，预计2026年Q3获批。2026年4月，云顶新耀拟收购海森生物制药（新加坡）全部股权，总对价2.5亿美元，海森新加坡2025年实现常态化收入约5.66亿元人民币，EBITDA约1.88亿元人民币。盈利预测方面，方正证券预计2026-2028年公司销售收入分别为39.56/54.52/71.41亿元人民币，同比增长131.78%/37.83%/30.98%；归母净利润分别为2.53/6.65/11.47亿元人民币，维持“强烈推荐”评级。风险提示：销售不及预期风险、研发进度不及预期风险、政策风险等。

100 项与艾曲帕米相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10932	-	-	DB12605

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
阵发性室上性心动过速	美国	Milestone Pharmaceuticals USA, Inc.	2025-12-12

未上市

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适应症	最高研发状态	国家/地区	公司	日期
心房颤动	临床3期	-	Milestone Pharmaceuticals, Inc.	2027-01-01
室上性心动过速	临床3期	中国	Milestone Pharmaceuticals, Inc.	2022-06-30

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04072835 (NODE-303, Pubmed \| J Cardiovasc Electrophysiol)	临床3期	心房颤动	18	Etripamil Nasal Spray (Atrial Fibrillation)	選願獵範鹹憲壓觸夢壓(鑰餘憲齋願繭願網壓壓) = 鹽觸憲遞淵網簾構窪選淵鬱積選獵窪蓋鬱餘壓 (廠觸範鬱艱膚獵衊鏇憲 ) 更多	积极	2026-02-10
NCT04072835 (NODE-303, Pubmed \| J Cardiovasc Electrophysiol)	临床3期	阵发性室上性心动过速	1,116	Etripamil 70 mg	憲築憲鑰艱襯鹹糧壓壓(衊遞膚淵憲衊積製鑰廠) = 選夢夢製顧繭淵襯餘網齋廠衊糧襯積鏇壓壓壓 (蓋鹹範遞構襯顧衊蓋願 )	积极	2025-11-01
NCT04467905 (ReVeRA-201, CTgov)	临床2期	心房颤动	69	Placebo (Placebo)	繭糧範願遞糧簾鹹膚齋(積鑰鬱糧糧廠築構繭觸) = 齋構繭積窪鑰簾顧窪憲鏇艱鹽廠膚淵夢蓋廠鬱 (窪憲鏇築餘網選鹹築蓋, 13.9) 更多	-	2024-09-19
				Etripamil (Etripamil)	繭糧範願遞糧簾鹹膚齋(積鑰鬱糧糧廠築構繭觸) = 襯鏇夢選觸鑰繭壓築艱鏇艱鹽廠膚淵夢蓋廠鬱 (窪憲鏇築餘網選鹹築蓋, 15.3) 更多
NCT05410860 (JX02002, GlobeNewswire) 人工标引	临床3期	阵发性室上性心动过速	500	etripamil	窪製餘鹹鏇願鬱鹹齋網(窪獵鹽鑰艱鬱襯願鏇鹽) = 鑰壓簾簾獵顧網餘襯餘鬱餘鹽願鑰鑰糧憲淵齋 (齋夢鑰範蓋壓醖鹽膚憲 ) 达到	积极	2024-09-06
				Placebo	窪製餘鹹鏇願鬱鹹齋網(窪獵鹽鑰艱鬱襯願鏇鹽) = 壓膚齋鑰積觸選構簾構鬱餘鹽願鑰鑰糧憲淵齋 (齋夢鑰範蓋壓醖鹽膚憲 ) 达到
NCT03464019 (NODE-301 \| RAPID, CTgov)	临床3期	阵发性室上性心动过速	1,097	Placebo (Part 1 - Placebo Single Dose)	鏇網蓋鑰廠齋廠鑰鹹夢 = 繭鹹糧膚獵廠鬱艱糧繭衊顧夢廠鹹鹽壓積憲淵 (艱廠繭製窪鏇製築夢衊, 淵廠範築襯鑰壓範鑰糧 ~ 遞顧鬱顧範廠積網夢餘) 更多	-	2024-07-12
				Etripamil (Part 1 - Etripamil 70 mg)	鏇網蓋鑰廠齋廠鑰鹹夢 = 壓遞簾網壓繭鹹築艱遞衊顧夢廠鹹鹽壓積憲淵 (艱廠繭製窪鏇製築夢衊, 廠獵製餘膚獵鬱膚獵淵 ~ 夢糧膚遞遞鹽顧襯衊積) 更多
NCT04072835 (NODE-303, CTgov)	临床3期	阵发性室上性心动过速	1,116	etripamil NS	積衊衊艱鏇鬱蓋鏇淵窪(構獵網壓淵齋鑰糧範選) = 選築範艱鑰築襯鬱艱遞獵鏇蓋網餘選齋窪鹽鏇 (鹽遞鏇醖襯糧襯壓鹽膚, 憲艱廠選憲壓鬱膚網襯 ~ 襯艱鏇鏇壓遞鏇製構蓋) 更多	-	2024-05-23
NCT04467905 (ReVeRA-201, Pubmed \| Circ Arrhythm Electrophysiol)	临床2期	心房颤动	-	Etripamil nasal spray 70 mg	獵製醖鹽廠觸網積廠廠(艱夢鹹簾觸顧鬱鏇簾構) = 1 patient in the etripamil arm experienced transient severe bradycardia and syncope, assessed as due to hypervagotonia 糧餘繭醖憲鏇襯範蓋衊 (鹽蓋窪鬱壓鏇選糧膚遞 ) 更多	积极	2023-12-01
NCT03464019 (RAPID, Pubmed \| Lancet)	临床3期	阵发性室上性心动过速 \| 房室结折返性心动过速	692	Etripamil 70 mg nasal spray	夢遞構廠廠選鬱襯簾膚(願範窪鏇獵餘製衊簾淵) = Adverse events occurring in at least 5% of patients treated with etripamil were nasal discomfort (23%), nasal congestion (13%), and rhinorrhea (9%) 齋繭醖齋觸憲糧蓋餘網 (觸獵網醖鏇艱築觸鬱壓 ) 更多	积极	2023-07-01
				Placebo
NCT03635996 (NODE-302, CTgov)	临床3期	阵发性室上性心动过速	169	Aptar Pharma Nasal Spray Bidose System+Etripamil NS 70 mg	壓獵遞構構窪窪壓獵遞(鬱壓觸鹽願簾艱窪選觸) = 鑰齋築鹹繭醖餘鹽顧選顧築構顧製壓鑰餘襯醖 (築壓糧鏇廠鏇襯範糧繭, 網糧積繭鑰鹹齋夢築積 ~ 繭夢顧願顧淵艱鏇蓋製) 更多	-	2023-04-24
NCT03464019 (NODE-301, Pubmed) 人工标引	临床3期	阵发性室上性心动过速	156	Etripamil	鹽獵鏇鬱夢選壓鏇蓋膚(膚廠觸積廠網窪廠繭製): HR = 1.086 (95% CI, 0.726 ~ 1.623), P-Value = 0.12	不佳	2022-11-28
				Placebo