评价aficamten与安慰剂相比对受试者健康状况的影响。次要目的：评价aficamten与安慰剂相比对极量和亚极量运动能力的影响。评价aficamten与安慰剂相比对NYHA心功能分级的影响。评价aficamten与安慰剂相比对心室壁压力的生物标志物的影响。评价aficamten与安慰剂相比对用于表征心脏结构重构情况的超声心动图指标的影响。评价aficamten与安慰剂相比对心血管事件的影响。安全性目的：评价aficamten与安慰剂相比在nHCM受试者中的安全性和耐受性。

开始日期2024-07-01

申办/合作机构

箕星药业科技（上海）有限公司

[+2]

NCT06412666 / Recruiting临床2/3期

A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension Trial to Evaluate the Efficacy and Safety of Aficamten in a Pediatric Population With Symptomatic Obstructive Hypertrophic Cardiomyopathy

The purpose of this study is to evaluate the efficacy, safety and PK of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

开始日期2024-05-29

申办/合作机构

Cytokinetics, Inc.

CTR20240575 / Active, not recruiting临床3期

一项在症状性梗阻性肥厚型心肌病成人受试者中评价Aficamten与美托洛尔相比的有效性和安全性的3期、多中心、随机、双盲试验

主要目的：评价aficamten 与美托洛尔对症状性梗阻性肥厚性心肌病（oHCM）受试者运动能力的影响。次要目的：评价aficamten 与美托洛尔相比对纽约心脏病协会心功能分级的影响；评价aficamten 与美托洛尔相比对受试者健康状况的影响；评价aficamten 与美托洛尔相比对心脏结构重构的影响；评价aficamten 与美托洛尔相比对N 末端B 型利钠肽原水平的影响；评价aficamten 与美托洛尔相比对Valsalva动作后左室流出道压力阶差的影响。安全性目的：评价aficamten 与美托洛尔相比在oHCM受试者中的安全性和耐受性特征。

开始日期2024-03-21

申办/合作机构

箕星药业科技（上海）有限公司

[+2]

100 项与 Aficamten 相关的临床结果

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100 项与 Aficamten 相关的转化医学

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100 项与 Aficamten 相关的专利（医药）

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项与 Aficamten 相关的文献（医药）

2024-11-08·EUROPEAN HEART JOURNAL

Cardiac biomarkers and effects of aficamten in obstructive hypertrophic cardiomyopathy: the SEQUOIA-HCM trial

Article

Abstract:

Background and Aims:

The role of biomarker testing in the management of obstructive hypertrophic cardiomyopathy is not well defined. This pre-specified analysis of SEQUOIA-HCM (NCT05186818) sought to define the associations between clinical characteristics and baseline concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I (hs-cTnI), and to evaluate the effect of treatment with aficamten on biomarker concentrations.

Methods:

Cardiac biomarkers were measured at baseline and serially throughout the study. Regression analyses determined predictors of baseline NT-proBNP and hs-cTnI concentrations, and evaluated whether early changes in these biomarkers relate to later changes in left ventricular outflow tract gradient (LVOT-G), other echocardiographic measures, health status, and functional capacity.

Results:

Baseline concentration of NT-proBNP was associated with LVOT-G and measures of diastolic function, while hs-cTnI was associated with left ventricular thickness. Within 8 weeks of treatment with aficamten, NT-proBNP was reduced by 79% (95% confidence interval 76%–83%, P < .001) and hs-cTnI by 41% (95% confidence interval 32%–49%, P < .001); both biomarkers reverted to baseline after washout. Reductions in NT-proBNP and hs-cTnI by 24 weeks were strongly associated with a lowering of LVOT-G, improvement in health status, and increased peak oxygen uptake. N-Terminal pro-B-type natriuretic peptide reduction strongly correlated with the majority of improvements in exercise capacity. Furthermore, the change in NT-proBNP by Week 2 was associated with the 24-week change in key endpoints.

Conclusions:

N-Terminal pro-B-type natriuretic peptide and hs-cTnI concentrations are associated with key variables in obstructive hypertrophic cardiomyopathy. Serial measurement of NT-proBNP and hs-cTnI appears to reflect clinical response to aficamten therapy.

2024-11-01·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Effect of Aficamten on Health Status Outcomes in Obstructive Hypertrophic Cardiomyopathy

Article

作者: Butzner, Michael ; Coats, Caroline J ; Garcia-Pavia, Pablo ; Lewis, Gregory D ; Maron, Martin S. ; Claggett, Brian L ; Saberi, Sara ; Coats, Caroline J. ; Sherrod, Charles F. ; Meng, Lisa ; Malik, Fady I ; Sherrod, Charles F ; Spertus, John A ; Spertus, John A. ; Januzzi, James L ; Ma, Changsheng ; Heitner, Stephen B. ; Jacoby, Daniel L. ; Jacoby, Daniel L ; Nassif, Michael E. ; Januzzi, James L. ; Wohltman, Amy ; Claggett, Brian L. ; Miao, Zi Michael ; Malik, Fady I. ; Maron, Martin S ; Lewis, Gregory D. ; Heitner, Stephen B ; Kupfer, Stuart ; Olivotto, Iacopo ; Nassif, Michael E ; Veselka, Josef

BACKGROUND:

A primary goal in treating obstructive hypertrophic cardiomyopathy (oHCM) is to improve patients' health status: their symptoms, function, and quality of life. The health status benefits of aficamten, a novel cardiac myosin inhibitor, have not been comprehensively described.

OBJECTIVES:

This study sought to determine the effect of aficamten on patient-reported health status, including symptoms of fatigue, shortness of breath, chest pain, physical and social limitations, and quality of life.

METHODS:

SEQUOIA-HCM (Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM) randomized symptomatic adults with oHCM to 24 weeks of aficamten (n = 142) or placebo (n = 140), followed by a 4-week washout. The Kansas City Cardiomyopathy Questionnaire (KCCQ) and Seattle Angina Questionnaire 7-item (SAQ7) were serially administered. Changes in mean KCCQ-Overall Summary Score (KCCQ-OSS) and SAQ7-Summary Score (SAQ7-SS) from baseline to 24 weeks and following treatment withdrawal were compared using linear regression adjusted for baseline scores and randomization strata. Proportions of patients with clinically important changes were compared.

RESULTS:

Among 282 participants, the mean age was 59 ± 13 years, 115 (41%) were female, and 223 (79%) were White. Baseline KCCQ-OSS (69.3 ± 20.1 vs 67.3 ± 18.8) and SAQ7-SS (72.0 ± 21.0 vs 72.4 ± 18.3) were similar between aficamten and placebo groups. Treatment with aficamten, compared with placebo, improved both the mean KCCQ-OSS (13.3 ± 16.3 vs 6.1 ± 12.6; mean difference: 7.9; 95% CI: 4.8-11.0; P < 0.001) and SAQ7-SS (11.6 ± 17.4 vs 3.8 ± 14.4; mean difference: 7.8; 95% CI: 4.7-11.0; P < 0.001) at 24 weeks, with benefits emerging within 4 weeks. No heterogeneity in treatment effect was found across subgroups. A much larger proportion of participants experienced a very large health status improvement (≥20 points) with aficamten vs placebo (KCCQ-OSS: 29.7% vs 12.4%, number needed to treat: 5.8; SAQ7-SS: 31.2% vs 13.9%, number needed to treat: 5.8). Participants' health status worsened significantly more after withdrawal from aficamten than placebo (KCCQ-OSS: -16.2 ± 19.0 vs -3.0 ± 9.6; P < 0.001; SAQ7-SS: -17.4 ± 21.4 vs -2.5 ± 13.3), further confirming a causal effect of aficamten.

CONCLUSIONS:

In patients with symptomatic oHCM, treatment with aficamten resulted in markedly improved health status, including significant improvement in chest pain-related health status, than placebo. (Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM [SEQUOIA-HCM]; NCT05186818).

2024-11-01·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Standard-of-Care Medication Withdrawal in Patients With Obstructive Hypertrophic Cardiomyopathy Receiving Aficamten in FOREST-HCM

Article

作者: Elliott, Perry ; Tower-Rader, Albree ; Nagueh, Sherif F. ; Sherrid, Mark V. ; Barriales-Villa, Roberto ; Malik, Fady I ; Oreziak, Artur ; Garcia-Pavia, Pablo ; Nagueh, Sherif F ; Sherrid, Mark V ; Heitner, Stephen B. ; Jacoby, Daniel L. ; Jacoby, Daniel L ; Abraham, Theodore P. ; Masri, Ahmad ; Wei, Jenny ; Melloni, Chiara ; Owens, Anjali Tiku ; Meng, Lisa ; Choudhury, Lubna ; Malik, Fady I. ; Abraham, Theodore P ; Nassif, Michael E ; Saberi, Sara ; Heitner, Stephen B ; Olivotto, Iacopo ; Kupfer, Stuart ; Maron, Martin S ; Maron, Martin S. ; Wang, Andrew ; Rader, Florian ; Nassif, Michael E.

BACKGROUND:

Standard-of-care (SoC) medications for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) are recommended as first-line therapy despite the lack of evidence from controlled clinical trials and well known off-target side effects.

OBJECTIVES:

We describe the impact of SoC therapy downtitration and withdrawal in patients already receiving aficamten in FOREST-HCM (Follow-Up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in Hypertrophic Cardiomyopathy; NCT04848506).

METHODS:

Patients receiving SoC therapy (beta-blocker, nondihydropyridine calcium-channel blocker, and/or disopyramide) were eligible for protocol-guided SoC downtitration and withdrawal at the discretion of the investigator and after achieving a stable dose of aficamten for ≥4 weeks. Successful SoC withdrawal was defined as at least a 50% dose-reduction in ≥1 medication. Adverse events (AEs) were prospectively evaluated 1 to 2 weeks after any SoC withdrawal.

RESULTS:

Of 145 patients with oHCM who were followed for at least 24 weeks (mean age 60.5 ± 13.2 years; 44.8% female; 42% NYHA functional class III), 136 (93.8%) were receiving ≥1 SoC therapy; of those, 64 (47%) had an attempt at withdrawal, with 59 (92.2%) successful. Thirty-eight (64.4%) patients completely discontinued ≥1 medication, and 27 (45.8%) achieved aficamten monotherapy with 2 later restarting a SoC medication. There were no significant differences in baseline characteristics on day 1 in FOREST-HCM in those with a SoC-withdrawal vs no-withdrawal attempt. In patients who underwent successful SoC therapy withdrawal, NYHA functional class improved by ≥1 class in 79.2% from baseline, Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score improved to 83.0 ± 15.8 points, and resting and Valsalva left ventricular outflow tract gradient improved to 14.3 ± 10.9 and 32.9 ± 21.4 mm Hg, respectively. N-terminal pro-B-type natriuretic peptide levels improved to a median of 220.0 pg/mL (Q1-Q3: 102.0-554.0.0 pg/mL) and high-sensitivity troponin I improved to a median of 6.0 ng/L (Q1-Q3:3.5-10.7 ng/L). Downtitration and withdrawal of SoC therapy did not impact these results (all P values for change were >0.05), and these changes were similar in patients who did not undergo SoC therapy withdrawal. There were no serious AEs attributed to SoC withdrawal and treatment emergent AEs were similar between groups.

CONCLUSIONS:

In FOREST-HCM, one-half of the patients with oHCM attempted downtitration and withdrawal of SoC medications while receiving aficamten treatment, with infrequent instances of resumption of SoC. Stopping and dose reduction of SoC medications were well tolerated with no adverse consequences in clinical measures of efficacy (Follow-Up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in Hypertrophic Cardiomyopathy [FOREST-HCM]; NCT04848506).

236

项与 Aficamten 相关的新闻（医药）

2024-11-12

·GlobeNewswire-Health Care

Cytokinetics to Participate in the 2024 Jefferies London Healthcare Conference

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Company is scheduled to participate in a fireside chat at the 2024 Jefferies London Healthcare Conference on Tuesday, November 19, 2024 at 4:00 PM Greenwich Mean Time at The Waldorf Hilton Hotel in London, England. Interested parties may access the live webcast of the fireside chat by visiting the Investors & Media section of the Cytokinetics website at http://www.cytokinetics.com. The webcast replay will be archived on the Cytokinetics website for 90 days following the conclusion of the event. About Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial evaluating aficamten, a next-in-class cardiac myosin inhibitor, in obstructive hypertrophic cardiomyopathy (HCM), Cytokinetics submitted an NDA for aficamten to the U.S. Food & Drug Administration and is progressing regulatory submissions for aficamten for the treatment of obstructive HCM in Europe. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of heart failure with preserved ejection fraction (HFpEF), and CK-089, a fast skeletal muscle troponin activator (FSTA) with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities of Cytokinetics’ product candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics' business outlined in Cytokinetics' filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics' actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757

临床3期申请上市

2024-11-11

·精准药物

创本年度之最：115个品种未被CDE批准！

药智数据显示，10月未被CDE批准的品种高达115个之多，为本年度前10月中最多的一个月，同比增长64%。从ATC分类来看，主要集中于系统用抗感染药，消化道及代谢领域。 >01< 115个品种，未被批准 2024年10月份CDE完成审批960个品种（受理号1278个，包含体外诊断试剂），同比减少7%。其中化药624个品种，中药178个品种，生物制品156个品种。以审评任务类型统计，IND申请完成审批140个品种，NDA申请25个品种，ANDA申请231个品种，一致性评价品种72个品种。按药智数据审评结论统计，批准临床186个品种，批准生产201个品种，批准进口17个品种。未被批准数量来看，为本年度前10月之最，高达115个品种，同比增长64%，从ATC分类来看，主要集中于系统用抗感染药，消化道及代谢。图1 2024年5-10月注册审评结论品种情况以注册分类统计，1类创新型新药完成审批112个品种，同比减少4%，IND申请完成审批107个品种，批准率达100%；NDA申请5个品种，批准率达80%。2类改良型新药完成审批38个品种，IND申请完成审批27个品种，均已批准；NDA申请11个品种，2个品种未被批准。 3类化学仿制药完成审批91个品种，批准临床14个品种，批准生产59个品种，未被批准18个品种。4类化学仿制药ANDA申请完成审批145个品种。生物类似药完成审批10个品种，其中临床试验申请6个品种，批准率达100%；上市申请4个品种，批准率为75%。境外原研5.1类NDA申请完成审批5个品种，批准率达100%。5.2类NDA申请完成审批9个品种，3个品种未被批准。表1 2024年10月创新型、改良型新药上市情况注：数据统计至2024年11月10日 >02< 申报同比减少12% 2024年10月份CDE共受理新的药品注册申请以品种（按药品+企业维度）统计1035个（受理号1366个），同比减少12%。其中化药636个品种，中药237个品种，生物制品162个品种。图2 2024年5-10月注册受理药品类型品种情况以审评任务类型统计，受理新药临床试验申请（以下简称IND）164个品种；新药上市许可申请（以下简称NDA）35个品种；同名同方药、仿制药、生物类似药上市许可申请（以下简称ANDA）299个品种；仿制药质量和疗效一致性评价注册申请（该注册申请类别以下简称一致性评价申请）32个品种。图3 2024年5-10月注册受理任务类型品种情况以注册分类统计，1类创新药受理131个品种，同比减少10%。其中IND申请127个品种，NDA申请仅有4个品种。1类创新药NDA申请分别是江苏恒瑞医药的SHR2554片、Cytokinetics与箕星药业共同开发的Aficamten片、首药控股的康太替尼颗粒，以及四川科伦博泰生物的注射用芦康沙妥珠单抗。 2类改良型新药注册申请受理43个品种，同比减少17%。改良型化药申请32个品种，改良型生物制品申请11个品种，中药品种暂无申请。2类改良型新药IND申报品种最多的企业是江西施美药业，共计申报3个品种；NDA申报品种数最多的企业是荣昌生物，申报2个品种，分别是注射用泰它西普、注射用维迪西妥单抗。 3类化学仿制药注册申请受理134个品种，其中验证性临床申请12个品种，ANDA申请122个品种。4类化学仿制药受理172个品种。中药同名同方药受理1个品种，是神威药业申报上市的3.1类药品——桃红四物颗粒。生物类似药受理18个品种，其中预防用生物制品5个品种，治疗用生物制品13个品种。 5.1类境外原研NDA申请5个品种，5.2类NDA申请4个品种。表2 2024年10月创新药与改良型新药注册申请受理情况 >03< 纳入优先审评品种5个，突破性治疗5个 2024年10月份CDE共将5个品种纳入了优先审评名单，多数为国产品种。以药品类型统计，化药3个品种，生物制品2个品种，中药未有品种纳入优先审评。纳入优先审评理由分别有“纳入突破性治疗药物程序”“附条件批准”“其他优先审评审批情形”。突破性治疗品种名单同样有5个品种，全为生物制品，涉及乳腺癌、小细胞肺癌、乙肝等适应症。表3 2024年10月优先审评与突破性治疗品种名单注：数据按公示日期进行统计数据来源：药智数据企业版——药品注册与受理数据库声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

临床申请生物类似药一致性评价

2024-11-11

·赛柏蓝

115个品种，未被药品审评中心批准

编者按：本文来自药智网，作者宇舟；赛柏蓝授权转载，编辑yuki 数据显示，10月未被CDE批准的品种达到115个，同比增长64%，是今年截至目前未批准品种数量最多的一个月。从ATC分类来看，主要集中于系统用抗感染药、消化道及代谢领域。 01 115个品种，未被批准 2024年10月，CDE完成审批960个品种（受理号1278个，包含体外诊断试剂），同比减少7%。其中，化药624个品种，中药178个品种，生物制品156个品种。以审评任务类型统计，受理新药临床试验申请（以下简称IND）完成审批140个品种，新药上市许可申请（以下简称NDA）25个品种，同名同方药、仿制药、生物类似药上市许可申请（以下简称ANDA）231个品种，一致性评价品种72个品种。根据数据审评结论统计，批准临床186个品种，批准生产201个品种，批准进口17个品种。未被批准数量方面，为本年度前10个月之最，高达115个，同比增长64%，从ATC分类来看，主要集中于系统用抗感染药，消化道及代谢。图1 2024年5-10月注册审评结论品种情况以注册分类统计，1类创新型新药完成审批112个品种，同比减少4%，IND申请完成审批107个品种，批准率达100%；NDA申请5个品种，批准率达80%。2类改良型新药完成审批38个品种，IND申请完成审批27个品种，均已批准；NDA申请11个品种，2个品种未被批准。 3类化学仿制药完成审批91个品种，批准临床14个品种，批准生产59个品种，未被批准18个品种。4类化学仿制药ANDA申请完成审批145个品种。生物类似药完成审批10个品种，其中临床试验申请6个品种，批准率达100%；上市申请4个品种，批准率为75%。境外原研5.1类NDA申请完成审批5个品种，批准率达100%。5.2类NDA申请完成审批9个品种，3个品种未被批准。表1 2024年10月创新型、改良型新药上市申请审评结论情况注：数据统计至2024年11月10日 02 申报同比减少12% 2024年10月份CDE共受理新的药品注册申请以品种（按药品+企业维度）统计1035个（受理号1366个），同比减少12%。其中化药636个品种，中药237个品种，生物制品162个品种。图2 2024年5-10月注册受理药品类型品种情况以审评任务类型统计，IND申请164个品种；NDA申请35个品种；ANDA申请299个品种；一致性评价申请32个品种。图3 2024年5-10月注册受理任务类型品种情况以注册分类统计，1类创新药受理131个品种，同比减少10%。其中IND申请127个品种，NDA申请仅有4个品种。1类创新药NDA申请分别是江苏恒瑞的SHR2554片、Cytokinetics与箕星药业共同开发的Aficamten片、首药控股的康太替尼颗粒，以及科伦博泰生物的注射用芦康沙妥珠单抗。 2类改良型新药注册申请受理43个品种，同比减少17%。改良型化药申请32个品种，改良型生物制品申请11个品种，中药品种暂无申请。2类改良型新药IND申报品种最多的企业是江西施美药业，共计申报3个品种；NDA申报品种数最多的企业是荣昌生物，申报2个品种，分别是注射用泰它西普、注射用维迪西妥单抗。 3类化学仿制药注册申请受理134个品种，其中验证性临床申请12个品种，ANDA申请122个品种。4类化学仿制药受理172个品种。中药同名同方药受理1个品种，是神威药业申报上市的3.1类药品——桃红四物颗粒。生物类似药受理18个品种，其中预防用生物制品5个品种，治疗用生物制品13个品种。 5.1类境外原研NDA申请5个品种，5.2类NDA申请4个品种。表2 2024年10月创新药与改良型新药注册申请受理情况 03 纳入优先审评品种5个突破性治疗5个 2024年10月份CDE共将5个品种纳入了优先审评名单，多数为国产品种。以药品类型统计，化药3个品种，生物制品2个品种，中药未有品种纳入优先审评。纳入优先审评理由分别有“纳入突破性治疗药物程序”“附条件批准”“其他优先审评审批情形”。突破性治疗品种名单同样有5个品种，全为生物制品，涉及乳腺癌、小细胞肺癌、乙肝等适应症。表3 2024年10月优先审评与突破性治疗品种名单注：数据按公示日期进行统计 END 内容沟通：郑瑶（13810174402）左下角「关注账号」，右下角「在看」，防止失联

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100 项与 Aficamten 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
梗阻性肥厚型心肌病	申请上市	中国	Cytokinetics, Inc.	2024-10-15
非梗阻性肥厚型心肌病	临床3期	美国	Cytokinetics, Inc.	2023-08-30
非梗阻性肥厚型心肌病	临床3期	中国	Cytokinetics, Inc.	2023-08-30
非梗阻性肥厚型心肌病	临床3期	巴西	Cytokinetics, Inc.	2023-08-30
非梗阻性肥厚型心肌病	临床3期	法国	Cytokinetics, Inc.	2023-08-30
非梗阻性肥厚型心肌病	临床3期	德国	Cytokinetics, Inc.	2023-08-30
非梗阻性肥厚型心肌病	临床3期	匈牙利	Cytokinetics, Inc.	2023-08-30
非梗阻性肥厚型心肌病	临床3期	以色列	Cytokinetics, Inc.	2023-08-30
非梗阻性肥厚型心肌病	临床3期	意大利	Cytokinetics, Inc.	2023-08-30
非梗阻性肥厚型心肌病	临床3期	荷兰	Cytokinetics, Inc.	2023-08-30

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临床结果

适应症

分期

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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


NCT05186818 (SEQUOIA-HCM, Pubmed \| J Am Coll Cardiol)	临床3期	梗阻性肥厚型心肌病 N-terminal pro-B-type natriuretic peptide	-	Aficamten	夢淵廠築築艱網積觸餘(鑰壓鏇觸憲齋構壓廠遞) = 網鑰願夢襯構製艱醖鑰築積膚窪築壓選醖觸廠 (簾窪選壓夢齋糧齋網願 ) 更多	积极	2024-11-01
				Placebo	夢淵廠築築艱網積觸餘(鑰壓鏇觸憲齋構壓廠遞) = 獵壓廠餘襯夢簾衊願糧築積膚窪築壓選醖觸廠 (簾窪選壓夢齋糧齋網願 ) 更多
NCT05186818 (SEQUOIA-HCM, Pubmed \| J Am Coll Cardiol)	临床3期	梗阻性肥厚型心肌病 N-terminal pro-B-type natriuretic peptide (NT-proBNP)	282	Aficamten	築窪簾選夢顧窪廠夢醖(齋窪繭範壓選窪繭鏇鏇) = 製顧醖餘鑰鑰淵壓憲襯餘鏇窪顧構糧夢襯繭蓋 (艱窪廠構繭範顧鹹糧顧 ) 更多	积极	2024-11-01
NCT05186818 (SEQUOIA-HCM, Pubmed \| J Am Coll Cardiol)	临床3期	梗阻性肥厚型心肌病	282	Aficamten	築鏇齋衊餘構壓積襯遞(壓繭鏇衊選製糧憲構糧) = 鬱鹽構廠蓋鏇蓋願醖餘壓窪窪憲鏇壓積醖構鏇 (餘選餘積廠夢壓鬱遞壓, -25 ~ -6) 更多	积极	2024-11-01
NCT05186818 (SEQUOIA-HCM, GlobeNewswire) 人工标引	临床3期	肥大型心肌病	282	Aficamten	簾遞淵醖構鏇願繭觸廠(襯築廠簾夢淵鏇鹽願範): Difference = -12.2 (95% CI, -18.0 ~ -6.5), P-Value = <0.001 更多	积极	2024-09-01
				Placebo
NCT04219826 \| NCT04848506 \| NCT05186818 (FOREST-HCM, GlobeNewswire) 人工标引	N/A	肥大型心肌病	-	Aficamten (Cumulative aficamten-treated pool)	壓獵醖製膚襯膚壓膚膚(願艱製鹹顧蓋鏇繭願製) = 鹽鹹襯壓鏇鑰廠餘製鑰繭糧襯醖製淵積夢顧襯 (構憲鹹構蓋餘鏇鏇簾網 ) 更多	积极	2024-09-01
				Aficamten (Placebo-controlled pool)	壓獵醖製膚襯膚壓膚膚(願艱製鹹顧蓋鏇繭願製) = 網糧鬱廠獵製顧廠淵廠繭糧襯醖製淵積夢顧襯 (構憲鹹構蓋餘鏇鏇簾網 ) 更多
NCT05186818 (SEQUOIA-HCM, Pubmed) 人工标引	临床3期	梗阻性肥厚型心肌病	282	Aficamten	網糧餘壓壓廠膚鏇獵獵(遞鑰網範製鏇鑰襯艱淵) = 鹹鑰鹽鑰壓網壓鹽遞構網憲網窪築憲繭醖積膚 (顧製淵築構築顧壓獵遞, 1.2 ~ 2.3)	积极	2024-05-13
				Placebo	網糧餘壓壓廠膚鏇獵獵(遞鑰網範製鏇鑰襯艱淵) = 繭鬱廠遞遞襯淵獵繭網網憲網窪築憲繭醖積膚 (顧製淵築構築顧壓獵遞, -0.5 ~ 0.5)
NCT05186818 (SEQUOIA-HCM, Pubmed) 人工标引	临床3期	梗阻性肥厚型心肌病	282	aficamten	醖築觸遞築願鹽餘製鬱(鬱構遞憲醖鑰夢遞夢鏇) = 範製膚網襯廠觸廠鬱觸廠憲繭願鬱願憲糧鹽壓 (鑰窪鏇積夢鹽夢遞簾膚, 1.2 ~ 2.3) 达到更多	积极	2024-05-13
NCT04848506 (FOREST-HCM, Corporate Publications) 人工标引	临床2期	肥大型心肌病	46	Aficamten	鏇齋膚製遞鏇膚鏇遞製(簾製觸鑰構鹽繭製夢簾) = none 構鹽夢衊齋蓋鏇憲顧膚 (蓋衊淵積構製衊顧鹽願 ) 更多	积极	2024-04-05
NCT04219826 (REDWOOD-HCM, Pubmed) 人工标引	临床2期	非梗阻性肥厚型心肌病	41	Aficamten 5-15 mg	觸選簾積壓鏇鬱獵積襯(簾鏇艱鹽齋鬱夢築壓餘) = One patient with prior history of aborted sudden cardiac death experienced a fatal arrhythmia during the study 遞憲遞壓觸壓鹽壓壓網 (鹽鑰廠簾憲鹹顧壓衊願 ) 更多	积极	2024-03-15
NCT05186818 (SEQUOIA-HCM, Corporate Publications) 人工标引	临床3期	梗阻性肥厚型心肌病	-	Aficamten	艱糧襯艱構壓構窪範選(獵醖廠遞鹽獵壓顧衊觸): Difference(mL/kg/min) = 1.74 (95% CI, 1.04 ~ 2.44), P-Value = 0.000002 达到更多	积极	2023-12-27
				Placebo