预约演示
更新于：2026-08-03
Landiolol Hydrochloride
盐酸兰地洛尔
更新于：2026-08-03
概要
基本信息
非在研机构 |
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C25H40ClN3O8 |
InChIKeyDLPGJHSONYLBKP-IKGOIYPNSA-N |
CAS号144481-98-1 |
关联
89
项与 盐酸兰地洛尔 相关的临床试验NCT07168421
LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery: a Feasibility Trial
CTR20261124
一项评价注射用盐酸兰地洛尔在中国健康试验参与者中的药代动力学研究
CTIS2025-523676-23-00
The effect of early Landiolol in patients with ST-elevation acute coronary syndrome undergoing primary percutaneous coronary intervention – A prospective, randomized, double- blinded, placebo controlled, phase IV pilot trial (STEMILAND-1)
100 项与 盐酸兰地洛尔 相关的临床结果
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100 项与 盐酸兰地洛尔 相关的转化医学
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100 项与 盐酸兰地洛尔 相关的专利（医药）
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460
项与 盐酸兰地洛尔 相关的文献（医药）2026-06-01BRITISH JOURNAL OF ANAESTHESIA
Low dose of landiolol does not prevent postoperative atrial fibrillation after cardiac surgery in non-Asian patients. Comment on Br J Anaesth 2026; 136: 65–73
Letter
作者: Fellahi, Jean-Luc ; Jacquet-Lagreze, Matthias ; Ruste, Martin
2026-06-01CARDIOLOGY IN THE YOUNG
A scoping review of the evidence supporting antiarrhythmic use after paediatric cardiac surgery
Review
作者: Thompson, Elizabeth J. ; Foote, Henry P. ; Hornik, Christoph ; Kohlmann, Taylor ; Zimmerman, Kanecia O. ; Hill, Kevin D. ; Commander, Sarah Jane ; Kilborn, Alison G. ; Sullenger, Rebecca D.
Abstract:
Background::
Arrhythmias after paediatric cardiac surgery occur frequently and contribute to postoperative morbidity and mortality. There is limited literature assessing the safety and efficacy of common antiarrhythmics administered in this population.
Methods::
We systematically searched PubMed and EMBASE for literature on antiarrhythmic use in children <18 years of age after cardiac surgery from 2000 to 2024. Two reviewers independently screened abstracts and then reviewed full-text manuscripts to determine eligibility.
Results::
We identified 28 studies of 3,752 patients across 11 different antiarrhythmics: flecainide, procainamide, esmolol, landiolol, propranolol, amiodarone, sotalol, dexmedetomidine, digoxin, ivabradine, and magnesium. Most studies were small, with 17 enrolling fewer than 100 children. Only eight studies were randomised, 16 were retrospective, 12 were prospective, and one was multicenter. Safety and efficacy endpoints varied widely, limiting our ability to combine data for meta-analysis. Overall, evidence supporting the use of these drugs in children after cardiac surgery was limited.
Conclusion::
Although antiarrhythmics are commonly used in children after cardiac surgery, randomised trials with standardised endpoints to guide choice of therapy are lacking. Pragmatic trials to generate real-world data should be considered to further evaluate the safety and efficacy of various antiarrhythmics in this population.
2026-05-01EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS
Pharmacokinetics of Landiolol and Its Metabolite M1 During Renal Replacement Therapy in Septic Shock Patients: A Sub-Study of the Landi-SEP Trial
Article
作者: Klade, Christoph ; Sus, Jan ; Bouvet, Olivier ; Borgstedt, Rainer ; Krumpl, Günther ; Duška, František ; Rehberg, Sebastian ; Unger, Martin ; Krejcy, Kurt ; Černý, Vladimír ; Frank, Sandra ; Kirchbaumer-Baroian, Nairi
BACKGROUND AND OBJECTIVE:
Landiolol, an ultra-short-acting β-blocker, is commonly used to manage tachyarrhythmias, including critically ill patients requiring renal replacement therapy (RRT). Pharmacokinetic (PK) data for landiolol in these patients are lacking. This study aimed to evaluate the PK and dialytic clearance of landiolol and its metabolite, M1, in septic shock patients receiving RRT, with the goal of guiding dosing optimization to ensure safe and effective treatment in this high-risk population.
METHODS:
This pre-defined PK sub-study was embedded within the Landi-SEP trial, which randomized patients with septic shock and persistent tachycardia to receive standard care or standard care with landiolol. Patients from two centers undergoing RRT were included in the sub-study. PK parameters, including dialytic and total clearance and area under the concentration-time curve (AUC), were determined based on plasma concentrations of landiolol and M1. Pharmacodynamic data, including heart rate (HR) and blood pressure (BP), were assessed concurrently.
RESULTS:
Six patients were included in the final analysis. Mean dialytic clearance was 39.3 mL/min for landiolol and 42.3 mL/min for M1. Dialysis accounted for 2.4% of total landiolol clearance and 50.9% of M1 clearance. HR and BP remained stable throughout the sub-study and no adverse events related to hypotension or bradycardia were reported.
CONCLUSION:
Dialysis minimally affected landiolol clearance but removed a substantial proportion of M1. These exploratory data align with current dosing recommendations in patients with renal impairment and suggest that no dose adjustment is required during RRT. Individualized dosing and hemodynamic monitoring remain essential.
TRIAL REGISTRATION:
EU Clinical Trial Register; EudraCT Number: 2017-002138-22.
100 项与 盐酸兰地洛尔 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 室上性心动过速 | 加拿大 | 2023-11-20 | |
| 心律失常 | 中国 | 2020-12-11 | |
| 心房颤动 | 日本 | 2002-07-05 | |
| 心房扑动 | 日本 | 2002-07-05 | |
| 心动过速 | 日本 | 2002-07-05 | |
| 窦性心动过速 | 日本 | 2002-07-05 | |
| 室性心动过速 | 日本 | 2002-07-05 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 冠心病 | 临床3期 | 日本 | 2009-06-01 | |
| 心房颤动和扑动 | 临床2期 | 奥地利 | 2014-10-23 |
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临床结果
临床结果
适应症
分期
评价
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FDA_CDER 人工标引  | N/A | 317 | 膚夢鏇簾簾糧窪繭顧構(憲製獵選鏇網遞憲願壓) = 艱餘蓋衊顧艱窪糧顧遞 鏇衊願鬱網壓選艱遞鬱 (獵齋窪淵簾獵鬱衊夢膚 ) | 积极 | 2024-11-22 | ||
Placebo | 膚夢鏇簾簾糧窪繭顧構(憲製獵選鏇網遞憲願壓) = 醖廠淵壓鬱觸窪遞觸積 鏇衊願鬱網壓選艱遞鬱 (獵齋窪淵簾獵鬱衊夢膚 ) | ||||||
临床3期 | 404 | Surgery combined with continuous infusion of landiolol | 襯鹹鏇願鹹廠觸範鑰餘(廠窪艱簾構簾餘積壓憲) = 鹹顧鏇鬱網蓋繭遞餘廠 鏇蓋衊積網願製製鏇壓 (廠壓艱鏇襯簾網積築簾, 71.8 ~ 83.8) | 不佳 | 2024-09-14 | ||
landiolol (Surgery alone) | 襯鹹鏇願鹹廠觸範鑰餘(廠窪艱簾構簾餘積壓憲) = 構獵窪憲憲築網淵蓋窪 鏇蓋衊積網願製製鏇壓 (廠壓艱鏇襯簾網積築簾, 70.5 ~ 82.5) | ||||||
临床4期 | - | 200 | 憲繭鹹製糧衊構鏇鏇糧(蓋構鏇繭齋繭鹹蓋遞齋) = 網壓製襯醖醖膚鑰淵醖 淵繭夢餘獵憲廠糧選艱 (衊糧鑰鏇鑰壓廠鹽積鑰 ) | 积极 | 2024-09-01 | ||
standard of care | 憲繭鹹製糧衊構鏇鏇糧(蓋構鏇繭齋繭鹹蓋遞齋) = 簾觸願鑰餘繭膚襯選膚 淵繭夢餘獵憲廠糧選艱 (衊糧鑰鏇鑰壓廠鹽積鑰 ) | ||||||
临床2期 | 183 | 廠壓選醖選齋範餘獵襯(鹹鬱選窪艱餘襯醖艱積) = No adverse events or reactions occurred at an incidence of 5 % or greater, confirming the safety of landiolol hydrochloride 壓鹹觸淵淵鬱夢廠簾願 (憲壓夢鑰網獵糧淵繭鏇 ) | - | 2013-06-01 | |||
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