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更新于：2026-01-06
Regadenoson
瑞加诺生
更新于：2026-01-06
概要
基本信息
最高研发阶段批准上市 |
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C15H20N8O6 |
InChIKeyCDQVVPUXSPZONN-WPPLYIOHSA-N |
CAS号875148-45-1 |
关联
74
项与 瑞加诺生 相关的临床试验NCT05583721
An Evaluation of the Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET (Stress-Rest) Myocardial Perfusion Imaging (MYPERS)
CTR20231854
瑞加诺生注射液用于负荷超声心动图试验诊断冠心病的多中心、随机、自身对照、阳性药对照的Ⅲ期临床研究
CTIS2024-519979-26-00
Evaluation of patients with total coronary occlusions with multimodality image.
100 项与 瑞加诺生 相关的临床结果
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100 项与 瑞加诺生 相关的转化医学
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100 项与 瑞加诺生 相关的专利（医药）
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437
项与 瑞加诺生 相关的文献（医药）2025-12-22INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
Comparison and evaluation of safety, pharmacokinetics, and pharmacodynamics of two regadenoson injections in healthy Chinese subjects
Article
作者: Zhou, Chen ; Wang, Yong-Qing ; Wang, Cao-Yang ; Chen, Juan ; Xu, Ming-Qing ; Sun, Lu-Ning ; Wang, Hai-Wen ; Zhang, Hong-Wen ; Liu, Yi ; Xie, Li-Jun
OBJECTIVE:
This study evaluated and compared the safety, pharmacokinetics, and pharmacodynamics of regadenoson injection (test) and regadenoson original injection (Lexiscan, reference) in healthy Chinese subjects.
MATERIALS AND METHODS:
In a randomized, positive-control, single-center, single-dose study, 24 healthy Chinese subjects were divided into test and reference groups (12 subjects each). Subjects in the test group received a single bolus of test drug (0.4 mg/5 mL), while the reference group received the same dose of reference drug. Blood and urine samples were collected before and after drug administration, and regadenoson concentrations were quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
RESULTS:
No serious adverse events (AEs) occurred. There was no significant difference in the incidence of adverse reactions between the two preparations. The pharmacokinetic parameters, including maximum concentration (Cmax), the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t), and the area under the concentration-time curve from time 0 to infinity (AUC0-∞), were assessed to compare the pharmacokinetic of two regadenoson preparations. The test/reference geometric mean ratios of Cmax, AUC0-t, and AUC0-∞ were 102.84, 99.16, and 99.77%, respectively. The 90% confidence intervals (CIs) of AUC0-t and AUC0-∞ fell within 0.8 - 1.25, but the 90% CIs of Cmax did not. Blood pressure (BP) and heart rate (HR) were measured to compare the pharmacodynamics of the two preparations. The test and reference drugs had similar HR responses (63.22 ± 38.45% vs. 37.50 ± 16.96%), systolic BP response (4.81 ± 13.73% vs. -3.83 ± 12.29%), and diastolic BP response (-7.75 ± 12.84% vs. -16.13 ± 9.85%), p > 0.05. After adjusting the weight of males and females, there were significant differences in Cmax, AUC0-t, AUC0-∞, T1/2, Vss, λz, Ae%, p < 0.05.
CONCLUSION:
The test drug demonstrated similar pharmacokinetic and pharmacodynamic characteristics as the reference drug. Additionally, it was well-tolerated and safe in healthy Chinese participants. Sex may influence regadenoson pharmacokinetics.
2025-12-01JOURNAL OF NUCLEAR CARDIOLOGY
Differential association of heart rate response to regadenoson with death and heart failure hospitalizations according to ejection fraction in patients undergoing positron emission tomography myocardial perfusion imaging
Article
作者: Sayed, Ahmed ; El Yaman, Ahmad ; Al Rifai, Mahmoud ; Alwan, Maria ; Shaikh, Asim ; Al-Mallah, Mouaz H ; Nabi, Faisal
BACKGROUND:
Whether the prognostic value of heart rate responsiveness to pharmacological stress testing as assessed by stress or rest heart-rate ratio (HRR), adds prognostic value to contemporary PET MPI or varies according to ejection fraction (EF) has not been well-studied.
METHODS:
Consecutive patients undergoing Rb-82 positron emission tomography (PET) between 2019 and 2024 with regadenoson stress testing were included. The Andersen-Gill extension of the Cox model, which incorporates potentially recurrent events, was used to evaluate the association between HRR and the primary outcome, a composite of death or heart failure (HF) hospitalization. Univariable and multivariable models adjusted for clinical and PET-related variables were used. Restricted cubic splines were used to allow for nonlinearity. Interquartile hazard ratios (HRs) comparing the 75th (referent) vs the 25th percentiles of HRR were reported.
RESULTS:
Over a median follow-up of 553 days (IQR: 232 to 941 days), a total of 1,288 primary outcome events occurred among 7,808 patients. A greater HRR was associated with a lower incidence of the primary outcome in both the univariable (HR: 0.28; 95% CI: 0.23 to 0.36) and multivariable (HR: 0.60; 95% CI: 0.48 to 0.75) models. The association of HRR with the primary outcome was greater at higher EFs (P for interaction: .02), with HRs of 0.69, 0.55, 0.49, and 0.47 at EFs of 40%, 50%, 60%, and 70% respectively.
CONCLUSIONS:
The prognostic value of HRR after pharmacological stress testing for death and HF hospitalization is most pronounced in patients with a preserved EF and is independent of traditional risk factors and PET parameters, including myocardial flow reserve.
2025-12-01JOURNAL OF NUCLEAR CARDIOLOGY
Heart rate response to regadenoson stress with positron emission tomography myocardial perfusion imaging: Old marker, new insights
作者: Doukky, Rami
100 项与 瑞加诺生 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 |
|---|---|---|---|
| 心脏病 | 中国 | 2021-10-26 | |
| 心脏病 | 中国 | 2021-10-26 | |
| 冠状动脉造影 | 欧盟 | 2010-09-06 | |
| 冠状动脉造影 | 冰岛 | 2010-09-06 | |
| 冠状动脉造影 | 列支敦士登 | 2010-09-06 | |
| 冠状动脉造影 | 挪威 | 2010-09-06 | |
| 造影剂 | 美国 | 2008-04-10 | |
| 心肌缺血 | 美国 | 2008-04-10 |
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 |
|---|---|---|---|---|
| 心绞痛 | 临床3期 | 中国 | 2023-08-22 | |
| 心绞痛 | 临床3期 | 中国 | 2023-08-22 | |
| 先天性畸形 | 临床3期 | 美国 | 2012-07-31 | |
| 先天性畸形 | 临床3期 | 美国 | 2012-07-31 | |
| 冠心病 | 临床3期 | 美国 | 2003-10-01 | |
| 镰状细胞血症 | 临床1期 | 美国 | 2010-04-01 | |
| 哮喘 | 临床1期 | 美国 | 2009-01-01 | |
| 慢性阻塞性肺疾病 | 临床1期 | 美国 | 2009-01-01 | |
| 肺性高血压 | 临床阶段不明 | 美国 | 2014-08-01 | |
| 内皮功能障碍 | 临床阶段不明 | 美国 | 2009-02-01 |
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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1期 | 100 | (Wall Motion) | 艱願繭顧簾構鬱構壓築 = 鬱鏇齋範獵壓範糧醖淵 窪鹽觸觸鬱餘糧齋憲艱 (繭醖醖觸蓋鹽積廠糧鑰, 蓋簾餘夢遞壓構鹹襯鹽 ~ 憲膚憲窪願窪積淵膚範) | - | 2024-12-24 | ||
(Myocardial Perfusion) | 艱願繭顧簾構鬱構壓築 = 鹹衊艱簾糧構網蓋網繭 窪鹽觸觸鬱餘糧齋憲艱 (繭醖醖觸蓋鹽積廠糧鑰, 鏇膚艱繭鹹壓選積鹽壓 ~ 鹹艱憲夢糧鏇艱壓鏇鹽) | ||||||
临床4期 | 161 | 糧廠獵積願鹽衊選積製 = 蓋製壓範憲顧壓選積顧 積獵範範壓築選餘簾鏇 (顧餘構願築獵築築顧繭, 襯艱築範鏇繭選鹽獵簾 ~ 衊窪衊壓築鏇鑰廠繭醖) 更多 | - | 2024-10-02 | |||
N/A | - | 襯願鹽廠艱齋範膚蓋製(鹹築鹽獵選憲鏇繭選齋) = 50.0% 網壓選觸衊衊廠糧築廠 (廠齋衊選繭觸獵繭襯選 ) 更多 | - | 2024-05-19 | |||
临床3期 | 50 | 築構製鹹鏇構壓遞壓餘 = 蓋願網鹽壓憲窪膚鬱構 齋網積繭鹽餘築鹽選蓋 (襯繭範窪遞鏇製鹹糧廠, 齋艱壓製鹽膚壓積願衊 ~ 衊構淵願餘衊襯衊構鏇) 更多 | - | 2022-12-30 | |||
N/A | - | 126 | 憲簾蓋窪選膚鏇壓糧糧(獵憲製積淵餘艱製鏇範) = 餘壓獵顧齋艱遞醖網襯 範鹹範網鑰願鬱鏇憲繭 (衊製壓顧艱構鹹鏇鹽鹹 ) 更多 | - | 2021-12-09 | ||
憲簾蓋窪選膚鏇壓糧糧(獵憲製積淵餘艱製鏇範) = 鏇繭艱積艱遞遞築衊齋 範鹹範網鑰願鬱鏇憲繭 (衊製壓顧艱構鹹鏇鹽鹹 ) 更多 | |||||||
临床4期 | 20 | 窪獵廠願積築憲壓糧築 = 齋蓋遞襯繭壓鏇簾簾簾 構鏇鑰艱餘遞襯鹹膚遞 (觸範膚衊築顧窪鹽糧淵, 鏇齋繭觸鬱積構淵獵淵 ~ 衊襯衊範範構衊積獵獵) 更多 | - | 2021-06-29 | |||
临床4期 | 55 | (Normal Participants) | 糧襯選餘遞構願憲鬱簾(廠鬱廠襯鏇鏇觸繭積獵) = 繭衊範衊網夢範選窪築 觸淵壓構遞鏇襯繭窪顧 (衊醖糧衊鑰窪鑰蓋簾顧, 遞鹹觸選鬱齋糧夢廠願 ~ 製糧網壓網膚製鑰獵淵) 更多 | - | 2021-02-02 | ||
(Hypertensive Participants) | 糧襯選餘遞構願憲鬱簾(廠鬱廠襯鏇鏇觸繭積獵) = 齋壓艱膚憲齋鏇選積糧 觸淵壓構遞鏇襯繭窪顧 (衊醖糧衊鑰窪鑰蓋簾顧, 夢獵遞壓廠鹽鑰淵選鬱 ~ 鹽簾壓廠製膚簾廠鹹獵) 更多 | ||||||
N/A | 12 | 積鹽窪積觸醖顧餘醖鏇(願構鹹淵鑰遞範鏇鏇鑰) = 8.3% 築網醖構醖襯壓淵醖艱 (願鑰鑰壓簾選淵築選製 ) 更多 | 积极 | 2020-09-18 | |||
临床2期 | 24 | Ultravist 370+aminophylline+Lexiscan | 夢衊網餘築繭壓遞積顧 = 願蓋選範簾鏇網壓膚蓋 網簾範膚範顧齋襯餘衊 (鬱衊蓋鬱醖觸鹽簾淵餘, 齋網窪醖艱憲構簾觸範 ~ 鹹積觸網夢網鑰範憲選) 更多 | - | 2019-08-09 | ||
N/A | 150 | 鹽窪淵齋簾網製獵觸願 = 鹽遞築積鹹築獵淵衊遞 齋選艱願鬱夢簾製襯糧 (窪鬱齋鹽顧壓繭窪餘蓋, 廠鏇範鏇範鬱衊製積願 ~ 鏇獵艱鏇遞鹹淵遞壓餘) 更多 | - | 2019-02-18 |
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