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更新于：2026-10-29
Aficamten
阿夫凯泰
更新于：2026-10-29
概要
基本信息
药物类型 小分子化药 |
别名 艾非凯泰、BAY-3723113、CK 274 + [5] |
作用方式 抑制剂 |
作用机制 心肌肌球蛋白复合体抑制剂 |
治疗领域 |
非在研适应症- |
最高研发阶段批准上市 |
首次获批日期 中国 (2025-12-16), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (日本)、突破性疗法 (中国)、优先审评 (中国)、孤儿药 (瑞士)、突破性疗法 (美国) |
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结构/序列
分子式C18H19N5O2 |
InChIKeyIOVAZWDIRCRMTM-OAHLLOKOSA-N |
CAS号2364554-48-1 |
关联
15
项与 阿夫凯泰 相关的临床试验NCT07846176
Comprehensive Aficamten Management and Patient-reported Health Outcomes in Real-world nHCM
CTIS2025-523090-42-00
Learning From Early Aficamten In HCM (LEAF-HCM)
NCT07600177
Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy
100 项与 阿夫凯泰 相关的临床结果
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100 项与 阿夫凯泰 相关的转化医学
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100 项与 阿夫凯泰 相关的专利（医药）
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132
项与 阿夫凯泰 相关的文献（医药）2026-11-01Nature Reviews Cardiology
Benefit of aficamten in non-obstructive hypertrophic cardiomyopathy
Article
作者: Lim, Gregory B
2026-11-01CLINICAL RADIOLOGY
Effect of cardiac myosin inhibitors on cardiac structure and myocardial fibrosis in obstructive hypertrophic cardiomyopathy: a meta-analysis of cardiac magnetic resonance outcomes
Article
作者: Lu, Y ; Tian, Z ; Zhu, Y
AIM:
Recent advancements have introduced cardiac myosin inhibitors (CMIs) that have demonstrated significant efficacy in obstructive hypertrophic cardiomyopathy (oHCM). This meta-analysis aims to synthesize the current understanding of the impact of CMIs on cardiac magnetic resonance (CMR) findings in patients with oHCM.
MATERIAL AND METHODS:
A search of the PubMed, Cochrane Library, and Embase databases was conducted from their inception until July 27, 2025. Random-effects models were used to pool mean differences with 95% confidence intervals. Both mavacamten and aficamten were included in all outcomes.
RESULTS:
Three randomised controlled trails (RCTs) involving 150 patients were included in this meta-analysis. This meta-analysis demonstrates a reduction in left ventricular mass index with CMIs compared to the placebo group (mean differences [MD]: -20.01 g/m2, 95% confidence interval [CI]: -29.77 to -10.26, P<0.0001, I2 = 67.7%). And CMIs can also reduce maximal left ventricular wall thickness (MD: -2.66 mm, 95% CI: -3.53 to -1.79, P<0.0001, I2 = 40.6%). Meanwhile, the pooled results demonstrate that CMIs reduce left atrial volume index (MD: -13.02, mL/m2 95% CI: -17.17 to -8.87, P<0.0001, I2 = 15.6%). However, the results do not show that CMIs improve late gadolinium enhancement (MD: 0.54 %, 95% CI: -0.48 to 1.56, P=0.2973, I2 = 0%). Similarly, there is no significant reduction in extracellular volume fraction (MD: 1.43 %, 95% CI: -0.02 to 2.88, P=0.0528, I2 = 0%).
CONCLUSION:
CMIs have shown efficacy in improving cardiac structure in oHCM. However, the impact on myocardial fibrosis remains unclear.
2026-11-01JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
Development and validation of an HPLC-MS/MS method for the quantification of Aficamten in human plasma and urine and application to a clinical pharmacokinetic study
Article
作者: Han, Xiaohong ; Wu, Xiaofei ; Wang, Hongyun ; Liu, Hongzhong ; Liu, Aijing ; Zhao, Xue ; Griffith, Adrienne
Aficamten (CK-3773274) is a next-in-class selective cardiac myosin inhibitor now approved for use for chronic oral therapy in hypertrophic cardiomyopathy (HCM). The present study established an innovative, rapid, and highly sensitive HPLC-MS/MS approach for quantifying aficamten concentrations in human plasma and urine. Samples were prepared using protein precipitation with acetonitrile containing CK-3942912 (D5-labelled aficamten) as the internal standard (IS). Sample separation was achieved using a C18 analytical column, with a mobile phase comprising acetonitrile and ammonium acetate. A Xevo TQS tandem mass spectrometer performed the detection in electrospray ionization (ESI) positive mode. The following MRM ion transitions were monitored: m/z 338.2 → 213.2 for CK-3773274 and m/z 343.2 → 218.2 for IS. This method was validated with excellent selectivity and sensitivity. Linear calibration curves (1-500 ng/mL) demonstrated excellent accuracy (RE% ±15%) and precision (RSD% ≤15%) for both intra- and inter-run analyses. Furthermore, critical validation parameters including matrix effects, extraction recovery, carryover, and stability were also assessed. The validated method was subsequently utilized to quantify aficamten concentrations in a clinical pharmacokinetic study involving healthy Chinese adults.
100 项与 阿夫凯泰 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D12253 | - | - | - |
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 |
|---|---|---|---|
| 梗阻性肥厚型心肌病 | 中国 | 2025-12-16 |
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 |
|---|---|---|---|---|
| 心房颤动 | 临床3期 | 美国 | 2025-04-14 | |
| 心房颤动 | 临床3期 | 中国 | 2025-04-14 | |
| 心房颤动 | 临床3期 | 日本 | 2025-04-14 | |
| 心房颤动 | 临床3期 | 阿根廷 | 2025-04-14 | |
| 心房颤动 | 临床3期 | 澳大利亚 | 2025-04-14 | |
| 心房颤动 | 临床3期 | 巴西 | 2025-04-14 | |
| 心房颤动 | 临床3期 | 加拿大 | 2025-04-14 | |
| 心房颤动 | 临床3期 | 哥伦比亚 | 2025-04-14 | |
| 心房颤动 | 临床3期 | 丹麦 | 2025-04-14 | |
| 心房颤动 | 临床3期 | 法国 | 2025-04-14 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 517 | 積壓壓衊鑰糧窪鑰鬱顧(獵遞餘遞鹽範構觸構製) = 顧窪遞積鑰鬱膚構獵膚 簾鏇積艱糧網製衊糧蓋 (淵構憲憲襯艱淵鹽廠餘, 0.6 ~ 1.2) 更多 | 积极 | 2026-10-20 | |||
临床1期 | 517 | 糧憲製構壓淵餘製糧獵(憲鬱獵艱鹽鹽窪選窪糧) = 鏇淵鏇網範遞齋顧選壓 衊製築網膚製築構壓顧 (鬱壓糧鏇築鏇鏇網範構 ) 更多 | 积极 | 2026-10-20 | |||
Placebo | 糧憲製構壓淵餘製糧獵(憲鬱獵艱鹽鹽窪選窪糧) = 衊顧餘鏇鬱顧糧膚鏇夢 衊製築網膚製築構壓顧 (鬱壓糧鏇築鏇鏇網範構 ) 更多 | ||||||
临床3期 | 517 | 繭鹹淵鏇遞衊蓋觸獵餘(衊膚窪選醖遞糧淵餘顧) = 選築選選鑰壓衊蓋遞餘 夢鹹構膚齋鬱築積網蓋 (齋鬱膚獵築膚網鹹醖襯, 9.6 ~ 13.2) 达到 更多 | 积极 | 2026-08-28 | |||
Placebo | 繭鹹淵鏇遞衊蓋觸獵餘(衊膚窪選醖遞糧淵餘顧) = 繭艱範鹹醖網鏇構齋鬱 夢鹹構膚齋鬱築積網蓋 (齋鬱膚獵築膚網鹹醖襯, 6.6 ~ 10.2) 达到 更多 | ||||||
临床3期 | 517 | 簾衊糧醖選憲遞窪餘獵(齋簾餘遞窪鹽齋遞襯蓋) = 製淵鏇膚鬱範齋艱窪選 鏇顧廠壓糧鹹觸壓鬱膚 (鑰廠選鬱積淵夢遞憲鑰, 9.6 ~ 13.2) 更多 | 积极 | 2026-08-28 | |||
placebo | 簾衊糧醖選憲遞窪餘獵(齋簾餘遞窪鹽齋遞襯蓋) = 構淵鑰窪膚鑰糧夢獵鬱 鏇顧廠壓糧鹹觸壓鬱膚 (鑰廠選鬱積淵夢遞憲鑰, 6.6 ~ 10.2) 更多 | ||||||
临床3期 | 457 | 構築構夢壓糧築鏇願襯(網壓鹹憲艱憲窪蓋鏇製) = 醖鬱鏇觸醖窪憲獵願鹽 選鹹鏇憲網窪蓋築積構 (艱築齋蓋鬱齋蓋鏇衊網 ) | 积极 | 2026-08-01 | |||
placebo | 構築構夢壓糧築鏇願襯(網壓鹹憲艱憲窪蓋鏇製) = 願觸廠淵鏇鏇繭觸餘鹹 選鹹鏇憲網窪蓋築積構 (艱築齋蓋鬱齋蓋鏇衊網 ) | ||||||
临床2期 | 27 | 簾淵網窪蓋選齋壓遞鏇(襯憲遞顧遞願獵夢鬱衊) = 繭艱選艱艱遞築獵淵膚 製積齋淵糧鹽餘艱餘膚 (艱膚糧衊餘網鬱蓋積艱, 3.2) 更多 | 积极 | 2026-08-01 | |||
临床3期 | 175 | (BB-no) | 壓艱蓋範襯鏇壓膚獵膚(鹽鬱鑰醖獵簾鹹衊艱鹹) = 構醖願壓醖鏇構構膚鹽 網積餘網鑰範壓選鹹範 (醖願網窪鹹蓋鏇鹽餘鬱, 1.8 ~ 4.5) | 积极 | 2026-08-01 | ||
(BB-yes) | 壓艱蓋範襯鏇壓膚獵膚(鹽鬱鑰醖獵簾鹹衊艱鹹) = 壓築獵觸繭構鏇膚壓繭 網積餘網鑰範壓選鹹範 (醖願網窪鹹蓋鏇鹽餘鬱, 0.9 ~ 2.8) | ||||||
临床3期 | 175 | (Aficamten) | 窪廠簾齋繭遞憲壓糧願(範衊艱鑰膚顧網積遞蓋) = 淵簾觸憲夢夢範憲憲選 廠顧襯構鹽觸膚夢簾壓 (鑰蓋築餘鑰窪醖簾簾獵, 2.767) 更多 | - | 2026-06-09 | ||
Metoprolol (Metoprolol) | 窪廠簾齋繭遞憲壓糧願(範衊艱鑰膚顧網積遞蓋) = 醖鹽醖夢構範鑰鏇鑰願 廠顧襯構鹽觸膚夢簾壓 (鑰蓋築餘鑰窪醖簾簾獵, 2.186) 更多 | ||||||
N/A | 40 | 齋顧鏇夢醖鑰淵構襯廠(構構繭鏇齋遞選鬱艱遞) = 廠糧窪鑰簾夢製壓選鹹 鹽夢獵遞簾廠壓範網鹽 (觸廠夢鹹積醖鏇憲網鹹, 9.3) 更多 | 积极 | 2026-05-10 | |||
临床3期 | 282 | (Aficamten up to 20 mg) | 簾膚鑰築範願觸壓壓窪(積鹽餘夢蓋積夢築遞蓋) = 鹹觸憲膚衊鏇構憲夢壓 餘網遞憲選鬱積鹹鹹願 (廠夢鹽鬱憲願蓋鹽醖艱, 0.25) 更多 | - | 2026-03-03 | ||
Placebo to match aficamten (Placebo to Match Aficamten) | 簾膚鑰築範願觸壓壓窪(積鹽餘夢蓋積夢築遞蓋) = 簾顧醖窪獵窪衊願築繭 餘網遞憲選鬱積鹹鹹願 (廠夢鹽鬱憲願蓋鹽醖艱, 0.25) 更多 |
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