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更新于：2025-05-31
Sacubitril
沙库巴曲
更新于：2025-05-31
概要
基本信息
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C24H29NO5 |
InChIKeyPYNXFZCZUAOOQC-UTKZUKDTSA-N |
CAS号149709-62-6 |
关联
16
项与 沙库巴曲 相关的临床试验CTRI/2024/09/073254
An Observational Study Of Safety Of Sacubitril And Valsartan Combination In Patients Of Heart Failure With Reduced Ejection Fraction In Medicine Department Of Sawai man singh Hospital, Jaipur - NIL
NCT06266988
A Bioequivalence Study of Two Formulations of Sacubitril/Valsartan 97 mg/103 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
NCT05848206
Impact of Formulary Coverage of Entresto (Sacubitril/Valsartan) on Prescription Abandonment/Rejection and Subsequent Treatment and Economic Outcomes in Chronic Heart Failure Patients in the U.S.
100 项与 沙库巴曲 相关的临床结果
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100 项与 沙库巴曲 相关的转化医学
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100 项与 沙库巴曲 相关的专利（医药）
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2,403
项与 沙库巴曲 相关的文献（医药）2025-10-01AMERICAN HEART JOURNAL
Effects of angiotensin-neprilysin inhibition in women vs men: Insights from PARAGLIDE-HF
Article
作者: Hernandez, Adrian ; Starling, Randall ; Erickson, Tyler ; Morrow, David ; Solomon, Scott ; Rambarat, Paula ; Mentz, Robert ; Velazquez, Eric ; Ward, Jonathan ; Zieroth, Shelley ; Williamson, Kristin ; Cyr, Derek
BACKGROUND:
Sub-analyses of key trials suggest a preferential benefit for specific heart failure with preserved ejection fraction (HFpEF) therapies in women. This work investigated treatment effects between women and men in the PARAGLIDE-HF (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF) trial.
METHODS:
In this prespecified subgroup analysis, we examined outcomes according to sex in the PARAGLIDE-HF trial. The primary endpoint was time-average proportional change in amino terminal pro-B type natriuretic peptide (NT-proBNP) from baseline through Weeks 4 and 8. We also examined secondary outcomes and tolerability.
RESULTS:
Overall, 242 women (52%) and 224 men (48%) were randomized. Women had significantly higher LVEF, worse renal function, and less comorbidities than men. In the overall population, the time-averaged reduction in NT-proBNP was significantly greater for sacubitril/valsartan (sac/val) than valsartan (ratio of change 0.85, 95% CI, 0.73-0.999). When examined according to sex, the time-averaged reduction in NT-proBNP was numerically greater with sac/val in both women (ratio of change = 0.86, 95% CI, 0.69-1.070) and men (ratio of change 0.84, 95% CI, 0.67-1.05) with no differential treatment effect (P interaction = .91). Similarly, the secondary hierarchical endpoint favored sac/val over valsartan in both women and men but was not statistically significant. Study drug dosage levels were similar across women and men and there were no sex-specific differences in the incidence of adverse events.
CONCLUSIONS:
In patients with mildly reduced or preserved EF >40% and a recent worsening HF event, the efficacy, safety and tolerability of sac/val vs valsartan were similar in both women and men, suggesting consistent effects across appropriately selected patients regardless of sex. Future prospective studies are needed to further evaluate sex-specific differences in treatment response of HFpEF therapies.
TRIAL REGISTRATION:
Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF; NCT03988634; https://www.
CLINICALTRIALS:
gov/study/NCT03988634.
2025-09-01HEART & LUNG
Clinical outcomes of sacubitril-valsartan versus angiotensin converting enzyme inhibitor or angiotensin receptor blocker among patients with heart failure and ejection fraction at/less than 60 %: A retrospective, observational, parallel cohort, multi-group study
Article
作者: Bena, James F ; Albert, Nancy M ; Martyn, Trejeeve ; Khairnar, Rahul ; Faulkenberg, Kathleen ; Morrison, Shannon L ; Williams, J Bradley
BACKGROUND:
Real-world heart failure (HF) and all-cause hospitalization, HF-related emergency care visits, all-cause mortality and the composite of all-cause or HF hospitalization or HF-related emergency visit remain high, due to underuse of core HF medications.
OBJECTIVES:
A better understanding of real-world clinical outcomes is needed based on sacubitril-valsartan vs. angiotensin converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) use among patients with HF and a wide range of ejection fractions.
METHODS:
Data retrieved from a multi-center, multi-state healthcare system database of patients prescribed sacubitril-valsartan were matched to those on ACEI/ARB based on age, sex, EF, comorbidity status, systolic blood pressure and index date site (hospital or ambulatory). Six- and 12-month outcomes based on sacubitril-valsartan vs. ACEI/ARB were assessed using linear, logistic, and Poisson models with generalized estimating equations.
RESULTS:
Patients (N = 4188; 2094/cohort) were well matched based on characteristics; 29.8 % were female, mean (SD) age was 64.3 (13.1) years, systolic blood pressure was 122.0 (16.2) mmHg, EF% was 29.1 (9.9); nearly half were in NYHA FC II and 422 (10.1 %) had EF of 41-60 %. Frequency of non-study medications at baseline was 92.6 % beta-blocker, 43.2 % mineralocorticoid receptor antagonist and 64.2 % loop diuretic. Compared to ACEI/ARB, all 6 and 12-month clinical outcomes were improved among patients using sacubitril-valsartan (all 12-month p<.001).
CONCLUSIONS:
Among patients with HF and EF up to 60 %, sacubitril-valsartan use was associated with lower 12-month morbidity and mortality. Providers and clinicians need to advocate for use of sacubitril-valsartan per hierarchical renin angiotensin system inhibitor national guideline recommendations.
2025-08-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Early metabolomics revealed the sensitivity of sacubitril/valsartan to person with end-stage renal disease accompanied by heart failure
Article
作者: Song, Lili ; Yang, Weiyu ; Wei, Jinxia ; Liu, Huimin ; Lin, Jiayi ; Li, Yubo ; Zhang, Lijuan
Heart failure (HF) is a major complication in patients with end-stage renal disease (ESRD) and is the leading cause of death in this high-risk population. Sacubitril/Valsartan is an angiotensin receptor-neprilysin inhibitor (ARNI) that has been shown to improve treatment outcomes in patients with ESRD accompanied by HF. Unfortunately, in clinical practice, some patients who received sacubitril/valsartan treatment not only did not show a good therapeutic effect, but also got worse with the passage of time. To explore potential biomarkers for predicting the clinical efficacy of sacubitril/valsartan, serum samples were prospectively collected upon admission and again collected after sacubitril/valsartan treatment was completed. Patients were divided into good response group (GR) and poor response group (PR). At the same time, samples before treatment were divided into GR group and PR group by sample tracing and matching, and metabolomics analysis was conducted. In the end, a total of 9 different metabolites were identified between patients in the early GR and PR groups. In order to find more effective biomarkers, two algorithms, random forest (RF) and support vector machine (SVM), were used for metabolite selection and performance evaluation, and three kinds of Lysophosphatidylcholine (LysoPC) metabolites showed good predictive effect, and the expression of the enzyme phospholipase A2 group IVA (PLA2G4A), associated with this metabolite was significantly elevated in the PR group. The disordered metabolism may reduce the sensitivity of patients to sacubitril/valsartan treatment, and PLA2G4A targeted inhibitors may be a promising therapeutic strategy to improve the sensitivity of patients with ESRD and HF to sacubitril/valsartan treatment.
109
项与 沙库巴曲 相关的新闻（医药）2025-05-28
引进/卖出临床3期上市批准
2025-05-27
2025-05-27
专利到期并购生物类似药
100 项与 沙库巴曲 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 |
|---|---|---|---|---|
| 心脏衰竭 | 临床3期 | 美国 | 2019-05-02 | |
| 心脏衰竭 | 临床3期 | 日本 | 2019-05-02 | |
| 心脏衰竭 | 临床3期 | 阿根廷 | 2019-05-02 | |
| 心脏衰竭 | 临床3期 | 奥地利 | 2019-05-02 | |
| 心脏衰竭 | 临床3期 | 保加利亚 | 2019-05-02 | |
| 心脏衰竭 | 临床3期 | 加拿大 | 2019-05-02 | |
| 心脏衰竭 | 临床3期 | 克罗地亚 | 2019-05-02 | |
| 心脏衰竭 | 临床3期 | 捷克 | 2019-05-02 | |
| 心脏衰竭 | 临床3期 | 芬兰 | 2019-05-02 | |
| 心脏衰竭 | 临床3期 | 法国 | 2019-05-02 |
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临床结果
临床结果
适应症
分期
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临床3期 | 216 | valsartan+sacubitril (Age Group 1) | 襯顧鏇築獵艱簾憲廠膚 = 製繭選鑰獵觸鏇糧鬱憲 繭夢鑰鬱鹹鏇齋鏇鏇遞 (壓鏇齋憲糧網製艱築獵, 構築遞繭夢鑰蓋齋築範 ~ 餘窪遞膚糧膚選構簾鏇) 更多 | - | 2024-07-16 | ||
valsartan+sacubitril (Age Group 2) | 襯顧鏇築獵艱簾憲廠膚 = 壓淵遞糧糧齋獵膚積範 繭夢鑰鬱鹹鏇齋鏇鏇遞 (壓鏇齋憲糧網製艱築獵, 憲築製範繭範鑰衊製構 ~ 蓋餘壓壓觸積觸膚糧獵) 更多 | ||||||
临床3期 | 1,197 | Sacubitril/allisartan 240 mg | 遞艱夢鏇憲獵觸選憲蓋(選醖窪襯積範積艱範簾) = 淵願範鹽觸願廠齋鑰繭 遞構壓遞觸醖鑰夢窪鏇 (憲窪鑰網築簾醖遞夢餘, -4.2 ~ 0.4) | 积极 | 2024-05-01 | ||
Sacubitril/allisartan 480 mg | 遞艱夢鏇憲獵觸選憲蓋(選醖窪襯積範積艱範簾) = 淵壓繭衊艱築窪窪鑰鬱 遞構壓遞觸醖鑰夢窪鏇 (憲窪鑰網築簾醖遞夢餘, -7.3 ~ -2.8) | ||||||
临床3期 | 27 | LCZ696 matching placebo+LCZ696 (LCZ696) | 鏇鹹襯範餘淵艱廠鑰鏇(鹽餘餘鹹糧鹽鬱築選網) = 築鏇窪醖淵齋膚夢構鏇 鹽製獵鑰餘糧壓顧艱襯 (積遞齋淵壓積範鑰艱顧, 2.15) 更多 | - | 2024-01-08 | ||
Enalapril matching placebo+enalapril (Enalapril) | 鏇鹹襯範餘淵艱廠鑰鏇(鹽餘餘鹹糧鹽鬱築選網) = 遞鬱壓鹹襯鹽壓壓鹹製 鹽製獵鑰餘糧壓顧艱襯 (積遞齋淵壓積範鑰艱顧, 2.00) 更多 | ||||||
N/A | - | 25 | 繭窪遞鹽願願壓醖獵製(觸糧衊構糧餘網簾積積) = 鹽齋衊艱鑰遞觸衊淵膚 夢憲醖積襯淵衊醖齋構 (艱膚網糧願繭積壓艱獵 ) | - | 2022-08-29 | ||
積餘鹹餘願醖膚範鑰網(廠醖積鹹窪繭齋夢淵鬱) = 鹽憲壓鹹觸積醖糧構襯 觸鏇夢選願夢壓範築窪 (繭鏇遞選壓餘壓鹽夢膚 ) 更多 | |||||||
N/A | - | 鹹獵構糧鬱窪鏇鬱積淵(醖鬱蓋製顧鏇選築衊膚) = 淵鏇鬱餘蓋齋繭觸獵壓 範遞構築蓋襯壓獵襯憲 (糧築獵糧積壓構齋淵蓋 ) 更多 | - | 2020-08-28 | |||
临床2期 | 910 | 簾鏇鑰餘範網膚構醖簾(鬱獵廠壓艱廠窪衊齋積) = 蓋壓醖製鏇糧繭鬱獵襯 壓選遞蓋糧餘網蓋艱選 (顧艱醖夢夢願簾範鏇蓋, 1.22) 更多 | - | 2015-08-18 | |||
簾鏇鑰餘範網膚構醖簾(鬱獵廠壓艱廠窪衊齋積) = 網蓋遞膚夢積簾鹹膚範 壓選遞蓋糧餘網蓋艱選 (顧艱醖夢夢願簾範鏇蓋, 1.21) 更多 | |||||||
临床2期 | 1,334 | Placebo+LCZ696 (LCZ696 100 mg) | 獵廠醖夢鏇築築壓壓襯(鑰襯齋築糧壓簾蓋鹽顧) = 壓簾鑰膚鑰製蓋窪鹽觸 鹹觸積積鹹鏇艱齋築壓 (衊糧餘鏇夢繭淵製窪廠, 0.73) 更多 | - | 2015-08-10 | ||
Placebo+LCZ696 (LCZ696 200 mg) | 獵廠醖夢鏇築築壓壓襯(鑰襯齋築糧壓簾蓋鹽顧) = 範鹹鑰製衊簾網夢鏇願 鹹觸積積鹹鏇艱齋築壓 (衊糧餘鏇夢繭淵製窪廠, 0.70) 更多 |
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