(21174) Relative bioavailability study to investigate the pharmacokinetics of a single oral dose of asundexian administered as 50 mg pediatric formulation in comparison to 50 mg tablet (adult formulation) in fasted state and to investigate the effect of a high-fat, high-calorie meal on the 50 mg pediatric formulation in healthy adult participants

开始日期2026-04-29

申办/合作机构

Bayer AG

CTIS2023-509447-28-00

/ Not yet recruiting临床1期

A study to learn about the amount of asundexian in the blood when healthy participants take different types of asundexian tablets

开始日期2024-07-26

申办/合作机构

Bayer AG

CTIS2023-509488-26-00

/ Completed临床1期

A study to learn how asundexian affects the amount of metformin in the blood when healthy participants take them together

开始日期2024-07-18

申办/合作机构

Bayer AG

100 项与 Asundexian 相关的临床结果

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100 项与 Asundexian 相关的转化医学

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100 项与 Asundexian 相关的专利（医药）

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项与 Asundexian 相关的文献（医药）

2026-04-16·NEW ENGLAND JOURNAL OF MEDICINE

Asundexian for Secondary Stroke Prevention

Article

作者: Staikov, Ivan ; Hirano, Teruyuki ; Turuspekova, Saule T. ; Amaya, Pablo ; Eikelboom, John W. ; Saver, Jeffrey L. ; Sampaio Silva, Gisele ; Neumann, Christoph ; Keller, Lars ; Veltkamp, Roland ; Lemmens, Robin ; Mundl, Hardi ; Campbell, Bruce C.V. ; Tsivgoulis, Georgios ; Zini, Andrea ; Masjuan, Jaime ; Shoamanesh, Ashkan ; Sylaja, P.N. ; Demchuk, Andrew M. ; Bereczki, Daniel ; Coutinho, Jonathan M. ; Leker, Ronen R. ; Knoflach, Michael ; Mikulik, Robert ; Hoo, Fan Kee ; Smith, Eric E. ; Matijošaitis, Vaidas ; Robinson, Thompson ; Lindgren, Arne G. ; Ferro, José M. ; Sandset, Else Charlotte ; Muehlhofer, Eva ; Heenan, Laura ; Putaala, Jukka ; Kasner, Scott E. ; Miglane, Evija ; Christensen, Hanne ; Sheth, Kevin N. ; Colorado, Pablo ; Lee, I-Hui ; Sharma, Mukul ; Kovar, Martin ; Joundi, Raed A. ; De Marchis, Gian Marco ; Slowik, Agnieszka ; van der Worp, H. Bart ; Xu, Lizhen ; Amarenco, Pierre ; Dong, Qiang ; Cordonnier, Charlotte ; Ozturk, Serefnur ; Schulze, Karleen ; Bae, Hee-Joon ; Turcani, Peter

BACKGROUND:

Patients with noncardioembolic ischemic stroke or transient ischemic attack (TIA) are at risk for recurrent stroke. Low factor XI levels are associated with a reduced risk of ischemic stroke. Asundexian inhibits activated factor XI. Whether the addition of asundexian to antiplatelet therapy would be superior to antiplatelet therapy alone for the secondary prevention of ischemic stroke is unclear.

METHODS:

In this phase 3, double-blind trial, we randomly assigned patients within 72 hours after the onset of a noncardioembolic ischemic stroke or high-risk TIA to receive asundexian (50 mg once daily) or placebo, in addition to planned dual or single antiplatelet therapy. Patients had at least one of the following: a nonlacunar infarct on imaging, a history of atherosclerosis, or evidence of atherosclerotic plaque at any location on cerebrovascular imaging. The primary efficacy outcome was ischemic stroke. The composite of death from cardiovascular causes, myocardial infarction, or stroke was a key secondary outcome. The primary safety outcome was major bleeding.

RESULTS:

Among 12,327 patients who underwent randomization (6162 to the asundexian group and 6165 to the placebo group), the incidence of ischemic stroke was lower in the asundexian group than in the placebo group (6.2% vs. 8.4%; cause-specific hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.84; P<0.001). The incidence of the composite of death from cardiovascular causes, myocardial infarction, or stroke was lower in the asundexian group than in the placebo group. The incidence of major bleeding was similar in the asundexian group and the placebo group (1.9% and 1.7%, respectively; cause-specific hazard ratio, 1.10; 95% CI, 0.85 to 1.44). The incidence of adverse events was 69.3% in the asundexian group and 70.1% in the placebo group; the incidence of serious adverse events was 19.2% and 19.5%, respectively.

CONCLUSIONS:

Among patients with noncardioembolic ischemic stroke or high-risk TIA treated with antiplatelet therapy, asundexian at a daily dose of 50 mg resulted in lower risks of ischemic stroke and major cardiovascular events than placebo, without a higher risk of major bleeding. (Funded by Bayer; OCEANIC-STROKE ClinicalTrials.gov number, NCT05686070.).

2026-04-01·BIOORGANIC CHEMISTRY

Development of selective NBD-based fluorescent probes for in vitro detection of factor XIa and Thrombus imaging

Article

作者: Yang, Han ; Zou, Meijuan ; Li, Qing ; Zhou, Fengjiao ; Zhuang, Xinyu ; Zhao, Xingyu ; Li, Ruixing

Factor XIa (FXIa) is a promising target for safer anticoagulants. Herein, a series of NBD-based fluorescent probes (FNC2-FNC6) were developed by linking an FXIa inhibitor scaffold to an NBD fluorophore via alkyl chains of varying lengths. Molecular dynamics simulations revealed that shorter linkers, especially a two‑carbon chain, stabilize NBD binding in the FXIa pocket, enhancing fluorescence. Among these probes, FNC2 displayed potent FXIa inhibition (Ki = 14.2 nM) and selectivity over related proteases. It exhibited linear fluorescence increase upon FXIa binding (R² = 0.9952; LOD = 1.19 μg/mL), enabling accurate quantification in immunoglobulin products (recovery: 94.41%-103.76%; RSD < 2%). FNC2 visualized FXIa in human plasma clots with 2.7-fold higher signal than free NBD, suppressed dose-dependently by asundexian. This structure-guided approach yields selective probes for FXIa detection and thrombus imaging.

2026-02-01·CLINICAL CARDIOLOGY

Dose‐Response Efficacy and Safety of Factor XI/XIa Inhibitors in Atrial Fibrillation; a Systematic Review and Meta‐Analysis With Subgroup Exploration and Trial Sequential Validation

Review

作者: Ferrara, Victoria Zecchin ; Waqas, Saad Ahmad ; Ikram, Jibran ; Faizan, Muhammad Aqib ; Saeed, Fatima ; Menon, Jaivardhan A. ; Humayun, Zainab ; Aslam, Main Muhammad Salman ; Dandamudi, Mrunalini ; Cerna, Luis ; Espiche, Carlos ; Ahmad, Raheel ; Tanvir, Alina ; Kholeif, Zeyad ; Chaudhri, Moiuz ; Khalid, Ahmad Mustafa ; Rehman, Tooba

ABSTRACT:

Background:

Factor XI/XIa inhibitors are emerging anticoagulants with potential to reduce bleeding complications in atrial fibrillation (AF) patients. This meta‐analysis evaluated their efficacy and safety compared to direct oral anticoagulants (DOACs) and explored dose optimization.

Methods:

A systematic search of PubMed, Cochrane, and Embase was conducted through March 2025 following PRISMA guidelines. Randomized controlled trials (RCTs) comparing Factor XI/XIa inhibitors with DOACs in AF patients were included. Outcomes assessed were major bleeding, stroke, systemic embolism, all‐cause and cardiovascular mortality and serious adverse events. Risk ratios (RR) with 95% confidence intervals (CI) were pooled using a Mantel‐Haenszel random‐effects model. Heterogeneity was evaluated with the I² statistic, and evidence certainty assessed by the GRADE approach. Trial Sequential Analysis (TSA) was performed.

Results:

Three RCTs including 16,772 patients (mean age 73 years, CHA₂DS₂‐VASc 3.9–5) were analyzed. Factor XI/XIa inhibitors significantly reduced major bleeding (RR: 0.41, 95% CI: 0.36–0.46, I² = 0%) compared to DOACs. However, stroke risk was increased (RR: 3.42, 95% CI: 2.62–4.46), particularly with asundexian 50 mg (RR: 4.02). No significant differences were observed in all‐cause mortality (RR: 0.82) or cardiovascular death (RR: 1.05). Systemic embolism risk was higher (RR: 4.26), while serious adverse events were comparable (RR: 0.95). TSA indicated encouraging safety outcomes but highlighted the need for further large‐scale studies.

Conclusion:

Factor XI/XIa inhibitors lower major bleeding risk in AF patients but increase stroke and systemic embolism rates without impacting mortality.

250

项与 Asundexian 相关的新闻（医药）

2026-05-07

·拜耳中国

拜耳asundexian获国家药品监督管理局药品审评中心授予优先审评资格

拜耳宣布，国家药品监督管理局药品审评中心（CDE）授予asundexian（BAY 2433334片）优先审评资格。拜耳于近日递交了asundexian“用于降低缺血性卒中或短暂性脑缺血发作（TIA）成人患者的卒中（复发）风险，不包含心源性栓塞性卒中患者”的上市申请，并已获CDE正式受理。卒中是当前威胁国民健康最严重的疾病之一，具有‌高发病率、高致死率、高致残率和高复发率‌的特点。2010年至2021年间，中国缺血性脑卒中患病率增加了10%，患病人数达2080万例1。约五分之一的卒中幸存者在五年内会再次复发，而复发性缺血性卒中通常更具致残性，死亡风险也更高。2，3，4 李琦拜耳集团处方药事业部副总裁，北京研发中心和中国药政事务部负责人 “作为全新一代活化凝血因子XI（FXIa）抑制剂，asundexian展现了其在降低缺血性卒中复发风险方面‘安效双优’的临床获益。此次纳入优先审评，不仅是对该药物创新价值的高度认可，更彰显了监管部门对解决脑血管疾病未满足临床需求的坚定决心。拜耳将全力配合审评工作，让asundexian尽早惠及中国广大卒中患者。” 参考文献 National Program for Stroke Prevention and Million Disability Reduction Initiative Expert Committee. China Stroke Prevention and Control Report 2024: An executive summary. Brain Circ. 2025;11(4):251-260. Kolmos M, et al. Recurrent Ischemic Stroke - A Systematic Review and Meta-Analysis. Journal of Stroke and Cerebrovascular Diseases. 2021;30(8):105935. Feigin VL, et al. Pragmatic Solutions to Reduce Global Burden of Stroke. Lancet Neurol. 2023;22:1160–1206. Rochmah TN, et al. Economic Burden of Stroke Disease: A Systematic Review. Int J Environ Res Public Health. 2021;18(14):7552. 关于拜耳拜耳作为一家跨国企业，在生命科学领域的医疗健康与农业方面具有核心竞争力。秉承“共享健康，消除饥饿”的使命，公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2025财年，拜耳的员工人数约为88,000名，销售额为456亿欧元。不计特殊项目的研究开发投入为58亿欧元。更多信息请见www.bayer.com。前瞻性声明本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站www.bayer.com上公开的拜耳各项报告中。拜耳没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。拜耳是一家在全球范围内运营子公司的控股公司。本文中所提及的“拜耳”或“公司”可能根据具体语境指一个或多个子公司。

2026-05-06

·bayer.com

Bayer announces new late-breaking data from OCEANIC-STROKE trial of asundexian

Data evaluates the frequency, severity, and disability of ischemic strokes in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack KEY FINDINGS The Phase III OCEANIC-STROKE study, previously published in The New England Journal of Medicine, met the primary efficacy outcome of time to first occurrence of ischemic stroke and the primary safety outcome of time to ISTH (International Society on Thrombosis and Haemostasis) major bleeding New analyses from OCEANIC-STROKE trial evaluate stroke severity and disability in patients treated with investigational asundexian who experienced an ischemic stroke during the trial compared to placebo, both in combination with antiplatelet therapy In a new analysis, acute treatment with intravenous thrombolysis (IVT) / endovascular treatment (EVT) and fatality outcomes of incident ischemic strokes were examined in patients taking asundexian compared to placebo; the analysis provides interesting insights but was not designed to provide statistical confirmatory evidence LinkedIn Email Facebook X WHAT’S HAPPENING WHIPPANY, N.J., May 6, 2026 — Bayer today announced late-breaking data from new analyses of the landmark Phase III OCEANIC-STROKE study of asundexian compared to placebo, both in combination with antiplatelet therapy. The study, presented at the European Stroke Organisation Conference (ESOC) 2026 in Maastricht, the Netherlands, analyzed the frequency, severity, and disability of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. Among patients who experienced an ischemic stroke during the study: The proportion of patients with a National Institutes of Health Stroke Scale (NIHSS) score ≥8 was lower with asundexian than placebo (22.9% vs 30.3%; p=0.045). Patients taking asundexian had numerically fewer disabling strokes (2.1% vs 3.0%; csHR 0.69; 95% CI 0.55–0.87) compared to placebo. WHY THIS MATTERS Stroke is the fifth leading cause of death in the United States.1 Each year, approximately 795,000 people in the United States will experience a stroke. Of these, approximately 87% are ischemic and 23% are recurrent.2 Despite current guideline recommended treatment options for stroke prevention, a significant proportion of survivors experience another stroke.3,4 Approximately one in five stroke survivors will have another stroke within five years.4 OCEANIC-STROKE STUDY ANALYSES DESIGN In OCEANIC-STROKE, 902 incident ischemic strokes occurred during the study (asundexian, n=384 [6.2%]; placebo, n=518 [8.4%]) and were evaluated for stroke severity and whether they were classified as disabling / fatal. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS) during hospitalization and stratified by score (≤3, 4–7, and ≥8). Disabling stroke was defined as a modified Rankin Scale (mRS) ≥3 or a ≥1 point increase in mRS for patients with a baseline mRS ≥3. KEY FINDINGS OF NEW ANALYSES FROM OCEANIC-STROKE TRIAL Stroke severity: Among incident ischemic strokes, moderate-to-high severity strokes (NIHSS ≥8) occurred in 88 patients (22.9%) in the asundexian group and 157 patients (30.3%) in the placebo group. Disabling / fatal stroke risk: The occurrence of disabling stroke was 2.1% (n=128) in the asundexian group and 3.0% (n=185) in the placebo group (csHR, 0.69; 95% CI: 0.55–0.87). Acute intervention: Of the ischemic strokes that did occur, 40 patients (10.4%) required acute intervention (intravenous thrombolysis [IVT] and/or endovascular treatment [EVT]) in the asundexian group, and 82 patients (15.8%) required acute intervention (IVT and / or EVT) in the placebo group. Ischemic stroke treated with EVT use: In patients who experienced an incident ischemic stroke, 27 patients (0.4%) required EVT in the asundexian group and 44 patients (0.7%) required EVT in the placebo group (csHR, 0.61; 95% CI: 0.38–0.99). Ischemic stroke with fatal outcomes: In patients who experienced an incident ischemic stroke, 16 patients (0.3%) experienced fatal outcomes in the asundexian group, and 28 patients (0.5%) experienced fatal outcomes in the placebo group (csHR, 0.57; 95% CI: 0.31-1.06). BAYER EXECUTIVE COMMENT“Stroke is one of the most pressing global health challenges, with serious and lasting consequences for patients, families, and healthcare systems around the world,” said Sara Hegab, MD, VP, Stroke & Thrombosis, Specialty and Pipeline, U.S. Medical Affairs, Bayer. “OCEANIC-STROKE reflects the strength of Bayer’s capabilities to take on complex global health challenges like stroke and the impact we hope to offer to patients. The insights from this study will continue to contribute to a deeper understanding of secondary stroke and the outcomes associated with these events.” About OCEANIC-STROKE The Phase III OCEANIC-STROKE study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once-daily compared to placebo, both in combination with antiplatelet therapy, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that randomized 12,327 participants worldwide. The primary efficacy endpoint was time to first occurrence of ischemic stroke; the primary safety endpoint was time to ISTH major bleeding. About FXIaFactor XIa (FXIa) is a protein in the blood coagulation pathway, also known as the blood clotting process, with different roles in hemostasis (normal clotting to stop bleeding) and thrombosis (harmful clot formation that can block blood vessels). FXIa has a minor role in the formation of a hemostatic plug (a clot that seals a blood vessel injury) that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth (abnormal clot growth) and vessel blockage. About Bayer’s Commitment in Cardiovascular and Cerebrovascular MedicineBayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) and cerebrovascular diseases of high unmet medical need. We have set a clear focus on developing innovative therapies to treat such diseases (e.g., stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is our ambition to take a leading role in the care of patients with these diseases. Bayer is actively shaping the future of cardiology and neurology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.3 billion euros. R&D expenses amounted to 5.8 billion euros. Contact for U.S. media inquiries:Sarra Herzog, phone +1 862-460-8764Email: sarra.herzog@bayer.com Contact for investor inquiries:Bayer Investor Relations Team, phone +49 214 30-72704Email: ir@bayer.com www.bayer.com/en/investors/ir-team Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References: LinkedIn Email Facebook X

临床结果临床3期

2026-05-05

·信狐药迅

三款国产1类新药：先声乐德奇拜单抗、杭州晟斯培重组人凝血因子VIII-Fc融合蛋白和华道生物万基奥仑赛上市申请|新受理（4.27-5.5）

本周药品注册受理数据，分门别类呈现，一目了然。(4.27-5.5）新药上市申请药品名称企业注册分类受理号多西他赛注射液(白蛋白稳定型) 珠海贝海生物技术股份有限公司 5.1 CXHS2600061 乐德奇拜单抗注射液(皮下注射) 先声药业有限公司 1 CXSS2600076 乐德奇拜单抗注射液(皮下注射) 先声药业有限公司 1 CXSS2600075 注射用培重组人凝血因子VIII-Fc融合蛋白杭州晟斯生物制药有限公司 1 CXSS2600074 注射用培重组人凝血因子VIII-Fc融合蛋白杭州晟斯生物制药有限公司 1 CXSS2600073 万基奥仑赛注射液华道(上海)生物医药股份有限公司 1 CXSS2600077 新药临床申请药品名称企业注册分类受理号 SAL0167片深圳信立泰药业股份有限公司 1 CXHL2600519 SAL0167片深圳信立泰药业股份有限公司 1 CXHL2600518 SAL0167片深圳信立泰药业股份有限公司 1 CXHL2600517 BW-41012注射液上海舶望制药有限公司 1 CXHL2600524 GLR2038片甘李药业股份有限公司 1 CXHL2600522 GLR2038片甘李药业股份有限公司 1 CXHL2600521 ABP-671片杭州新元素药业股份有限公司 1 CXHL2600515 ABP-671片杭州新元素药业股份有限公司 1 CXHL2600514 HSK41959片海思科医药集团股份有限公司 1 CXHL2600511 TQB3126片正大天晴药业集团股份有限公司 1 CXHL2600510 TQB3126片正大天晴药业集团股份有限公司 1 CXHL2600509 LJR004片朗捷睿(苏州)生物科技有限公司 1 CXHL2600508 GFH276片劲方医药科技(上海)股份有限公司 1 CXHL2600507 JAR-2203注射液北京加科瑞康医药科技有限公司 1 CXHL2600505 CPD704吸入喷雾剂北京泰德制药股份有限公司 1 CXHL2600506 醋酸奥曲肽片三迭纪(上海)医药科技有限公司 2.2 CXHL2600525 GCF20216 广州绿十字制药股份有限公司 2.2 CXHL2600523 DYTH203 山西德元堂药业有限公司 2.2 CXHL2600520 YY2403口崩片药云(西安)医药技术有限公司 2.2 CXHL2600516 ADC119片江苏艾迪药业集团股份有限公司 2.3 CXHL2600512 氘恩扎鲁胺软胶囊海创药业股份有限公司 2.4 CXHL2600513 重组四价肠道病毒疫苗(汉逊酵母) 维尔泰克(北京)生物技术有限公司 1.4 CXSL2600457 SKB118注射液四川科伦博泰生物医药股份有限公司 1 CXSL2600463 RG002注射液仁景(苏州)生物科技有限公司 1 CXSL2600454 注射用BL-B01D1 成都百利多特生物药业有限责任公司 1 CXSL2600453 SPGL008注射液深圳赛保尔生物药业有限公司 1 CXSL2600452 GenSci155注射液长春金赛药业有限责任公司 1 CXSL2600461 GenSci155注射液长春金赛药业有限责任公司 1 CXSL2600462 GenSci155注射液长春金赛药业有限责任公司 1 CXSL2600460 GenSci155注射液长春金赛药业有限责任公司 1 CXSL2600459 JSKN016SC注射液江苏康宁杰瑞生物制药有限公司 1 CXSL2600458 GenSci164注射液长春金赛药业有限责任公司 1 CXSL2600449 9MW5211注射液迈威(上海)生物科技股份有限公司 1 CXSL2600448 CLD-423注射液江苏荃信生物医药股份有限公司 1 CXSL2600447 MRG007 乐普生物科技股份有限公司 1 CXSL2600446 IUAb190708注射液英诺欧奇生物医药(上海)有限公司 1 CXSL2600445 SSGJ-706注射液沈阳三生制药有限责任公司 1 CXSL2600451 仿制药申请药品名称企业注册分类受理号塞来昔布片浙江易泽达医药科技有限公司 3 CYHS2601010 右美沙芬安非他酮缓释片江苏恩华药业股份有限公司 3 CYHS2601007 硫酸特布他林口服溶液安徽杰玺医药有限公司 3 CYHS2601006 富马酸依美斯汀缓释胶囊福建大谱生物医药有限公司 3 CYHS2601004 依巴斯汀口服溶液江西盛翔制药有限公司 3 CYHS2601012 塞来昔布片浙江易泽达医药科技有限公司 3 CYHS2601011 利多卡因丙胺卡因气雾剂上海上药信谊药厂有限公司 3 CYHS2600999 碘化钾片北京紫萌医药科技有限公司 3 CYHS2601003 氨溴特罗口服溶液石家庄凯达生物工程有限公司 3 CYHS2601002 低钙腹膜透析液(乳酸盐-G2.55%) 成都青山利康药业股份有限公司 3 CYHS2600987 低钙腹膜透析液(乳酸盐-G1.76%) 成都青山利康药业股份有限公司 3 CYHS2600986 倍他米松磷酸钠注射液江西科为制药有限公司 3 CYHS2600995 辅酶Q10片海南赛立克药业有限公司 3 CYHS2600988 盐酸利多卡因凝胶江苏欣力元生物制药有限公司 3 CYHS2600969 盐酸利多卡因凝胶江苏欣力元生物制药有限公司 3 CYHS2600968 盐酸毛果芸香碱滴眼液北京福元医药股份有限公司 3 CYHS2600985 左氧氟沙星氯化钠注射液河南利欣制药股份有限公司 4 CYHS2601021 注射用两性霉素B脂质体四川汇宇制药股份有限公司 4 CYHS2601023 佩玛贝特片天方药业有限公司 4 CYHS2601005 美阿沙坦钾片江苏中邦制药有限公司 4 CYHS2601009 美阿沙坦钾片江苏中邦制药有限公司 4 CYHS2601008 夫西地酸乳膏浙江普利药业有限公司 4 CYHS2601022 注射用氟氧头孢钠海南全星制药有限公司 4 CYHS2601017 洛索洛芬钠贴剂北京京丰制药(山东)有限公司 4 CYHS2601015 洛索洛芬钠贴剂北京京丰制药(山东)有限公司 4 CYHS2601014 地氟烷福建海西联合药业有限公司 4 CYHS2601020 甲硝唑凝胶广州朗圣药业有限公司 4 CYHS2601018 富马酸福莫特罗吸入溶液北京韩美药品有限公司 4 CYHS2601013 硫酸氨基葡萄糖胶囊赫力昂(苏州)制药有限公司 4 CYHS2601016 多替拉韦钠片成都倍特药业股份有限公司 4 CYHS2601019 黄体酮软胶囊湖南醇健制药科技有限公司 4 CYHS2600997 瑞舒伐他汀依折麦布片(I) 江苏欧歌制药有限公司 4 CYHS2601001 恩他卡朋双多巴片(II) 山东京卫制药有限公司 4 CYHS2601000 黄体酮软胶囊湖南醇健制药科技有限公司 4 CYHS2600998 达格列净二甲双胍缓释片(III) 安徽佳和药业有限公司 4 CYHS2600978 达格列净二甲双胍缓释片(I) 安徽佳和药业有限公司 4 CYHS2600977 富马酸伏诺拉生片新乡市常乐制药有限责任公司 4 CYHS2600976 醋酸去氨加压素片苏州第三制药厂有限责任公司 4 CYHS2600975 醋酸去氨加压素片苏州第三制药厂有限责任公司 4 CYHS2600974 佩玛贝特片桂林南药股份有限公司 4 CYHS2600973 瑞维那新吸入溶液黑龙江显东药业有限公司 4 CYHS2600972 左奥硝唑氯化钠注射液浙江赛默制药有限公司 4 CYHS2600984 左奥硝唑氯化钠注射液浙江赛默制药有限公司 4 CYHS2600983 磷酸芦可替尼片南京海纳制药有限公司 4 CYHS2600982 腺苷注射液陕西博森生物制药股份集团有限公司 4 CYHS2600981 达格列净二甲双胍缓释片(Ⅰ) 天方药业有限公司 4 CYHS2600996 达格列净二甲双胍缓释片(Ⅳ) 天方药业有限公司 4 CYHS2600994 达格列净二甲双胍缓释片(Ⅰ) 天方药业有限公司 4 CYHS2600993 左乙拉西坦片北京百美特生物制药有限公司 4 CYHS2600992 左乙拉西坦片北京百美特生物制药有限公司 4 CYHS2600991 盐酸特比萘芬喷雾剂湖北康正药业有限公司 4 CYHS2600990 布洛芬缓释胶囊天津大家伙医药有限公司 4 CYHS2600989 洛索洛芬钠贴剂江苏万高药业股份有限公司 4 CYHS2600979 洛索洛芬钠贴剂江苏万高药业股份有限公司 4 CYHS2600980 兰索拉唑肠溶胶囊珠海润都制药股份有限公司 4 CYHS2600971 依达拉奉右莰醇注射用浓溶液黑龙江福和制药集团股份有限公司 4 CYHS2600970 贝美前列素滴眼液广州大光制药有限公司 4 CYHS2600967 静注人免疫球蛋白山东泰邦生物制品有限公司 3.2 CXSL2600450 司美格鲁肽注射液广州白云山拜迪生物医药有限公司 3.3 CXSL2600456 司美格鲁肽注射液广州白云山拜迪生物医药有限公司 3.3 CXSL2600455 进口申请药品名称企业注册分类受理号 BAY2433334片 Bayer AG 1 JXHS2600043 尼古丁贴剂 McNeil Sweden AB 5.1 JXHS2600048 尼古丁咀嚼胶 Kenvue Belgium NV 5.1 JXHS2600047 尼古丁贴剂 McNeil Sweden AB 5.1 JXHS2600046 尼古丁咀嚼胶 Kenvue Belgium NV 5.1 JXHS2600045 尼古丁贴剂 McNeil Sweden AB 5.1 JXHS2600044 RO7435846片 F. Hoffmann-La Roche Ltd. 1 JXHL2600138 RO7435846片 F. Hoffmann-La Roche Ltd. 1 JXHL2600137 RO7435846片 F. Hoffmann-La Roche Ltd. 1 JXHL2600136 RO7435846片 F. Hoffmann-La Roche Ltd. 1 JXHL2600135 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600134 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600133 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600132 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600131 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600130 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600129 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600128 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600127 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600126 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600125 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600124 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600123 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600122 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600121 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600120 Elecoglipron薄膜包衣片 AstraZeneca AB 1 JXHL2600119 盐酸阿曲生坦片 Novartis Pharma AG 2.4 JXHL2600139 ABBV-438注射用粉末 AbbVie Inc. 1 JXSL2600106 LY4298445注射液 Eli Lilly and Company 1 JXSL2600105 Trontinemab注射液 F. Hoffmann-La Roche Ltd. 1 JXSL2600104 PF-08046876 Pfizer Inc. 1 JXSL2600107 中药相关申请药品名称企业注册分类受理号柴葛退热口服液济川药业集团有限公司 1.1 CXZS2600023 芍药甘草颗粒吉林福康药业股份有限公司 3.1 CXZS2600024 天心解郁颗粒北京纽维珀奥医药科技有限公司 1.1 CXZL2600039 CS001 胶囊苏州重生医药科技有限公司 1.1 CXZL2600038 注：绿色字体部分为潜在首仿品种；咸达数据2026年1月每月药讯已出！关注“咸达数据”，微信关键词回复 ” 年+月，如202601” 获得最新药迅！不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市疫苗抗体药物偶联物

100 项与 Asundexian 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
缺血性卒中	申请上市	中国	Bayer AG	2026-04-30
急性缺血性卒中	临床3期	美国	Bayer AG	2023-01-26
急性缺血性卒中	临床3期	中国	Bayer AG	2023-01-26
急性缺血性卒中	临床3期	日本	Bayer AG	2023-01-26
急性缺血性卒中	临床3期	阿根廷	Bayer AG	2023-01-26
急性缺血性卒中	临床3期	澳大利亚	Bayer AG	2023-01-26
急性缺血性卒中	临床3期	奥地利	Bayer AG	2023-01-26
急性缺血性卒中	临床3期	比利时	Bayer AG	2023-01-26
急性缺血性卒中	临床3期	巴西	Bayer AG	2023-01-26
急性缺血性卒中	临床3期	保加利亚	Bayer AG	2023-01-26

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临床结果

适应症

分期

评价

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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


NCT05686070 (OCEANIC-STROKE, Company_Website) 人工标引	临床3期	短暂性脑缺血发作 \| 缺血性卒中	12,327	Asundexian	積製鹽壓構鹽鏇齋鹹膚(選壓窪構窪糧廠齋願糧) = 鬱願積構鹽顧蓋範積構繭膚窪獵鬱鑰觸齋築夢 (廠築構齋製築廠壓願憲 ) 更多	积极	2026-02-05
				placebo	積製鹽壓構鹽鏇齋鹹膚(選壓窪構窪糧廠齋願糧) = 築鬱鹽願鹹醖網鹽顧襯繭膚窪獵鬱鑰觸齋築夢 (廠築構齋製築廠壓願憲 ) 更多
NCT05686070 (OCEANIC-STROKE, Company_Website) 人工标引	临床3期	缺血性卒中	-	Asundexian	餘齋蓋製壓製鏇願選膚(膚築製夢齋願艱齋齋願) = Asundexian 50 mg once daily significantly reduced 糧鑰選窪壓範觸繭鹽範 (憲憲艱鏇衊鬱構壓鹹齋 ) 达到更多	积极	2025-11-23
				Placebo
NCT05643573 (OCEANIC-AF, Pubmed \| JAMA Cardiol)	临床3期	心房颤动	-	Asundexian	憲鏇窪製糧網蓋蓋廠襯(壓夢壓艱範選遞餘餘鬱) = 衊壓醖構艱衊網遞憲鏇鹽醖糧網蓋廠願糧鹹獵 (繭構憲獵築齋淵繭簾顧 )	积极	2025-06-01
				Apixaban	憲鏇窪製糧網蓋蓋廠襯(壓夢壓艱範選遞餘餘鬱) = 鹽衊夢選憲積鑰鏇餘糧鹽醖糧網蓋廠願糧鹹獵 (繭構憲獵築齋淵繭簾顧 )
NCT05643573 (OCEANIC-AF, CTgov)	临床3期	脑卒中 \| 心房颤动 \| 全身性栓塞	14,830	Apixaban matching placebo+Asundexian (BAY2433334) (Asundexian)	構衊鬱鬱夢繭餘壓憲構 = 壓顧膚齋蓋餘顧構醖築糧願鑰鬱糧淵齋憲遞網 (構淵鏇遞積選餘繭窪餘, 鑰鏇壓簾網觸衊膚繭顧 ~ 範齋鑰鏇網遞醖壓積鬱) 更多	-	2024-12-09
				Asundexian matching placebo+Apixaban (Apixaban)	構衊鬱鬱夢繭餘壓憲構 = 壓窪鏇製鹽觸鏇夢積窪糧願鑰鬱糧淵齋憲遞網 (構淵鏇遞積選餘繭窪餘, 顧壓鹹繭構鬱鹹鹽淵糧 ~ 衊構餘窪糧製構蓋壓衊) 更多
NCT05643573 (OCEANIC-AF, Pubmed \| N Engl J Med)	临床3期	心房颤动	-	Asundexian 50 mg once daily	網窪壓膚鹹簾願鬱憲網(鹹繭遞獵網夢醖艱衊淵) = 廠顧範範廠網醖鹽鑰鏇醖繭夢鏇繭鏇築願願齋 (範構膚鏇醖簾夢襯餘願 ) 更多	不佳	2024-09-01
				Apixaban	網窪壓膚鹹簾願鬱憲網(鹹繭遞獵網夢醖艱衊淵) = 願鹽築製鑰鹹製窪範築醖繭夢鏇繭鏇築願願齋 (範構膚鏇醖簾夢襯餘願 ) 更多
NCT05643573 (OCEANIC-AF, NEWS) 人工标引	临床3期	心房颤动	-	asundexian	鏇壓襯構憲積選鹽構壓(壓範願襯獵壓餘窪遞糧) = Bayer is stopping a pivotal clinical trial for its experimental treatment for atrial fibrillation at the recommendation of an independent committee that concluded the drug would not be more effective than a Bristol Myers Squibb and Pfizer product widely used to treat the heart condition. 糧遞範鏇蓋醖夢顧願鬱 (襯鹽蓋夢憲糧範構鑰膚 )	不佳	2023-11-20
				Eliquis
NCT04304508 (PACIFIC-STROKE, CTgov)	临床2期	血栓形成 \| 急性缺血性卒中	1,808	Asundexian (BAY2433334) (Asundexian 10 mg)	齋遞築窪壓艱簾艱廠網 = 壓鬱艱鏇鬱顧衊膚淵選網構壓衊顧鏇製襯選餘 (鏇糧繭築壓艱鏇鑰醖憲, 夢蓋繭選蓋遞醖築繭醖 ~ 鬱淵艱簾獵簾觸鑰觸鹹) 更多	-	2023-04-19
				Asundexian (BAY2433334) (Asundexian 20 mg)	齋遞築窪壓艱簾艱廠網 = 淵範糧願願憲齋顧艱鏇網構壓衊顧鏇製襯選餘 (鏇糧繭築壓艱鏇鑰醖憲, 觸壓艱鹹獵鬱築夢壓餘 ~ 窪遞製壓壓簾窪齋壓顧) 更多
NCT04304534 (PACIFIC-AMI, CTgov)	临床2期	急性心肌梗塞	1,601	Asundexian (BAY2433334) (Asundexian 10 mg)	壓鹹淵夢觸構衊廠鏇糧 = 廠艱製廠顧淵鑰餘膚鏇遞顧積鹽衊製夢鑰襯顧 (鹹鬱夢鑰願壓膚壓淵製, 糧願淵齋鬱觸鏇醖窪衊 ~ 範廠鏇顧築糧壓範鹹壓) 更多	-	2023-04-05
				Asundexian (BAY2433334) (Asundexian 20 mg)	壓鹹淵夢觸構衊廠鏇糧 = 鬱衊窪糧顧簾範壓顧餘遞顧積鹽衊製夢鑰襯顧 (鹹鬱夢鑰願壓膚壓淵製, 蓋鏇繭製鑰築衊齋糧鹹 ~ 鹹衊窪鹹鹹膚鬱夢廠衊) 更多
NCT04218266 (PACIFIC-AF, CTgov)	临床2期	并发症 \| 心房颤动	755	Apixaban+Asundexian (BAY2433334) (Asundexian 20 mg)	築獵築願憲廠網繭艱鹹 = 鏇窪廠醖艱範鹽簾鑰憲蓋築衊鹹艱範廠範積鑰 (襯夢範鹽構衊夢選餘鹽, 醖網構鏇網衊築網齋顧 ~ 製觸夢製窪齋獵繭壓廠) 更多	-	2022-10-27
				Apixaban+Asundexian (BAY2433334) (Asundexian 50 mg)	築獵築願憲廠網繭艱鹹 = 鹹築築構醖鹹構衊襯築蓋築衊鹹艱範廠範積鑰 (襯夢範鹽構衊夢選餘鹽, 顧範壓壓壓鹽鹽築衊鏇 ~ 觸製醖築廠齋艱廠簾鏇) 更多
NCT04304508 (PACIFIC-Stroke, Pubmed \| Lancet)	临床2期	急性缺血性卒中	1,808	Asundexian 10 mg	夢餘遞簾襯膚積糧齋衊(壓鬱糧糧夢遞網衊鑰觸) = 膚餘鬱製窪觸積遞選鑰遞積鹽蓋廠夢憲鏇製壓 (窪膚醖觸顧選鑰壓構積, 0.79 ~ 1.24) 更多	不佳	2022-09-02
				Asundexian 20 mg	夢餘遞簾襯膚積糧齋衊(壓鬱糧糧夢遞網衊鑰觸) = 繭憲襯獵壓簾網簾鬱憲遞積鹽蓋廠夢憲鏇製壓 (窪膚醖觸顧選鑰壓構積, 0.93 ~ 1.43) 更多