主要目的：在近期诊断为VTE的肿瘤患者中评估Abelacimab与阿哌沙班相比，在随机化后6个月内预防VTE复发方面是否具有非劣效性。如果证明了其具有非劣效性，则将评估优效性。次要目的：评估在随机化后6个月内，Abelacimab与阿哌沙班相比在预防大出血或CRNM出血复合终点事件方面是否具有优效性；Abelacimab与阿哌沙班相比在净临床获益（定义为无VTE复发或大出血或CRNM出血事件的生存期）方面是否具有优效性；Abelacimab与阿哌沙班相比在非死亡导致的永久终止治疗率方面是否具有优效性；Abelacimab与阿哌沙班相比在预防CRNM出血事件方面是否具有优效性; Abelacimab与阿哌沙班相比在预防大出血事件方面是否具有优效性; Abelacimab与阿哌沙班相比在预防GI大出血和GI CRNM出血复合终点事件方面是否具有优效性。评价Abelacimab与阿哌沙班相比在随机化后6个月内的安全性和耐受性，并在接受Abelacimab治疗的患者中评估注射部位反应、超敏反应和免疫原性的发生率。

开始日期2024-05-09

申办/合作机构

艾昆纬医药科技（上海）有限公司

[+2]

CTR20232698

/ Recruiting临床3期

一项评估 Abelacimab 在被认为不适合口服抗凝药物的高风险房颤患者中的疗效和安全性的 III 期、多中心、随机、双盲、安慰剂对照、平行组研究 (LILAC)

主要目的：评估 Abelacimab 在降低被认为不适合接受口服抗凝治疗的 AF 患者的缺血性卒中或全身性栓塞 (SE)风险方面是否优于安慰剂。次要目的：评估比较 Abelacimab 与安慰剂在缺血性卒中、SE、心机梗死（MI）、静脉血栓栓塞（VTE）或急性肢体缺血方面的复合终点。评估比较 Abelacimab 与安慰剂的净临床结局，定义为缺血性卒中、SE 或出血学术研究联合会 (BARC) 3c/5 型出血的复合终点。评估比较 Abelacimab 与安慰剂的心血管死亡率和全因死亡率。评估比较 Abelacimab 与安慰剂的净临床结局，定义为缺血性卒中、SE、MI、VTE、急性肢体缺血或国际血栓与止血学会 (ISTH) 大出血的复合终点。主要安全性目的：评估比较 Abelacimab 与安慰剂的出血风险。

开始日期2023-11-14

申办/合作机构

Anthos Therapeutics, Inc.初创企业

[+2]

NCT05712200

/ Recruiting临床3期

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to EvaLuate the EffIcacy and Safety of AbeLacimab in High-risk Patients with Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral AntiCoagulation (LILAC-TIMI 76)

A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.

开始日期2022-12-27

申办/合作机构

Anthos Therapeutics, Inc.初创企业

100 项与 Abelacimab 相关的临床结果

登录后查看更多信息

100 项与 Abelacimab 相关的转化医学

登录后查看更多信息

100 项与 Abelacimab 相关的专利（医药）

登录后查看更多信息

项与 Abelacimab 相关的文献（医药）

2025-01-23·NEW ENGLAND JOURNAL OF MEDICINE

Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation

Article

作者: Murphy, Sabina A ; Wojakowski, Wojciech ; Spinar, Jindrich ; Weitz, Jeffrey I ; Kuder, Julia F ; Giugliano, Robert P ; Bloomfield, Daniel ; Wiviott, Stephen D ; Patel, Siddharth M ; Sabatine, Marc S ; Parkar, Sanobar ; Kiss, Robert G ; Joung, Boyoung ; Chen, Shih-Ann ; Morrow, David A ; Goodman, Shaun G ; Goodrich, Erica L ; Hug, Bruce ; Ruff, Christian T

BACKGROUND:

Abelacimab is a fully human monoclonal antibody that binds to the inactive form of factor XI and blocks its activation. The safety of abelacimab as compared with a direct oral anticoagulant in patients with atrial fibrillation is unknown.

METHODS:

Patients with atrial fibrillation and a moderate-to-high risk of stroke were randomly assigned, in a 1:1:1 ratio, to receive subcutaneous injection of abelacimab (150 mg or 90 mg once monthly) administered in a blinded fashion or oral rivaroxaban (20 mg once daily) administered in an open-label fashion. The primary end point was major or clinically relevant nonmajor bleeding.

RESULTS:

A total of 1287 patients underwent randomization; the median age was 74 years, and 44% were women. At 3 months, the median reduction in free factor XI levels with abelacimab at a dose of 150 mg was 99% (interquartile range, 98 to 99) and with abelacimab at a dose of 90 mg was 97% (interquartile range, 51 to 99). The trial was stopped early on the recommendation of the independent data monitoring committee because of a greater-than-anticipated reduction in bleeding events with abelacimab. The incidence rate of major or clinically relevant nonmajor bleeding was 3.2 events per 100 person-years with 150-mg abelacimab and 2.6 events per 100 person-years with 90-mg abelacimab, as compared with 8.4 events per 100 person-years with rivaroxaban (hazard ratio for 150-mg abelacimab vs. rivaroxaban, 0.38 [95% confidence interval {CI}, 0.24 to 0.60]; hazard ratio for 90-mg abelacimab vs. rivaroxaban, 0.31 [95% CI, 0.19 to 0.51]; P<0.001 for both comparisons). The incidence and severity of adverse events appeared to be similar in the three groups.

CONCLUSIONS:

Among patients with atrial fibrillation who were at moderate-to-high risk for stroke, treatment with abelacimab resulted in markedly lower levels of free factor XI and fewer bleeding events than treatment with rivaroxaban. (Funded by Anthos Therapeutics; AZALEA-TIMI 71 ClinicalTrials.gov number, NCT04755283.).

2024-12-01·JOURNAL OF THROMBOSIS AND HAEMOSTASIS

New targets for antithrombotic medications: seeking to decouple thrombosis from hemostasis

Review

作者: Barnes, Geoffrey D

Arterial and venous thromboses are the leading causes of morbidity and mortality worldwide. Numerous antithrombotic agents are currently available with antiplatelet, thrombolytic/fibrinolytic, and anticoagulant activity. However, all the currently available antithrombotic agents carry a risk of bleeding that often prevents their use. This unfavorable risk-benefit profile is particularly challenging for patients with cancer-associated venous thromboembolism, patients with atrial fibrillation at a high risk of bleeding, and patients with end-stage renal disease. Patients with ischemic stroke and acute coronary syndromes have not yet found a favorable risk-benefit profile with anticoagulant therapy to help reduce the residual thromboembolic risk that remains after antiplatelet and lipid therapy. Two emerging classes of antithrombotic agents, factor (F)XI or activated factor Ⅺ (FⅪa) inhibitors and glycoprotein VI inhibitors, have shown promise in their ability to prevent pathologic thrombosis without increasing the risk of hemostatic-related bleeding in phase 2 studies. Among the FⅪ/FXIa inhibitors of coagulation, a parenterally administered monoclonal antibody (abelacimab) and 2 orally administered small molecule inhibitors (asundexian, milvexian) are collectively being studied in patients with atrial fibrillation, cancer-associated venous thromboembolism, acute coronary syndrome, and ischemic stroke. One parenterally administered glycoprotein VI antiplatelet agent (glenzocimab) is currently being studied in patients with ischemic stroke. If shown to be efficacious and safe in ongoing phase 3 studies, both classes of emerging antithrombotic agents have the potential to greatly improve outcomes for patients with challenging thrombotic conditions.

2024-09-01·JOURNAL OF THE NEUROLOGICAL SCIENCES

Factor XI inhibitors – Rising stars in anti-thrombotic therapy?

Review

作者: Nolte, Christian H

The "holy grail" of preventing and treating thrombosis and thromboembolism would be a drug that was highly effective (preventing clots) and at the same time had a low risk of bleeding. From a hemostasiological perspective, the inhibition of factor XI represents a promising target because a reduced level of factor XI protects against thrombosis without significantly increasing the risk of spontaneous bleeding. Currently, three different classes of drugs of factor XI-inhibition are tested. These are (1) monoclonal antibodies (mAbs), (2) so-called synthetic, small molecules and (3) antisense oligonucleotides (ASOs). This article provides a narrative overview of the current status of studies on all three classes of drugs. Tests with mAbs have been conducted primarily in DVT prevention after knee replacement surgery. One large phase 3 study is testing the mAbs Abelacimab in patients with atrial fibrillation. The synthetic, small molecules Asundexian and Milvexian are tested in several phase 3 trials, mainly in patients with non-cardioembolic ischemic stroke. Results can be expected in the coming years. Clinical testing of ASOs to inhibit factor XI are still in their infancies.

项与 Abelacimab 相关的新闻（医药）

2025-03-11

·PMLiVE

Novartis gains rights to Kyorin’s chronic spontaneous urticaria candidate in deal worth $830m

Novartis will be gaining global rights to Kyorin Pharmaceutical’s pre-clinical inflammatory disease drug in a deal worth over $830m. The agreement gives Novartis an exclusive worldwide licence to develop, manufacture and commercialise KRP-M223, an MRGPRX2 antagonist for chronic spontaneous urticaria (CSU) and other allergic and inflammatory diseases involving mast cells. Approximately 40 million people globally are affected by CSU, a common skin condition characterised by the sudden appearance of raised, itchy and sometimes painful hives (wheals) that last for at least six weeks. Alongside its physical symptoms, CSU can significantly impact well-being, with many patients experiencing sleep deprivation, as well as psychiatric disorders such as anxiety and depression. Under the terms of the agreement, Kyorin will receive $55m upfront and will be eligible for milestone payments of up to $777.5m, as well as tiered royalties on net sales. Kyorin will also have the option to commercialise KRP-M223 in Japan, with Novartis retaining its own option to co-promote the product in this market. Novartis has made a number of recent deals to expand its pipeline across multiple therapeutic areas. A few weeks ago, the company announced that it will be expanding its late-stage cardiovascular pipeline by acquiring Anthos Therapeutics for approximately $3.1bn. The acquisition will give Novartis access to abelacimab, which is currently in phase 3 development for the prevention of stroke and systemic embolism in patients with atrial fibrillation, the most common form of abnormal heart rhythm. Shreeram Aradhye, president, development and chief medical officer, Novartis, said at the time of the February announcement: “Welcoming Anthos Therapeutics strengthens our focus in the cardiovascular space and complements our portfolio of… treatments, comprehensive clinical programmes, and strategic collaborations that help thousands of patients with heart disease around the world.” Novartis also revealed in December that it would be gaining exclusive global rights to PTC Therapeutics’ mid-stage Huntington’s disease programme in a deal worth up to $2.9bn, and entered into a worldwide licence and collaboration agreement worth $745m with Ratio Therapeutic in November to advance a somatostatin receptor 2-targeting radiotherapeutic candidate for cancer.

并购引进/卖出临床3期上市批准

2025-03-04

·医学新视点

高血压手术降压效果怎么样？安全吗？一文解答6大问题

肾脏交感神经系统过度激活是导致高血压最重要的病理生理机制之一。基础和临床研究发现，阻断肾交感神经可以调节肾和中枢神经之间过度激活的交感神经信号，降低肾和全身交感神经活性，从而起到控制高血压发生、发展的作用。 ▲肾脏神经在高血压发生、发展中的作用（图片来源：参考文献[1]）目前，高血压治疗以生活方式干预和药物治疗为主，但高血压药物治疗的依从性并不乐观。尤其是服用多种降压药物的患者，其中大约一半的患者会在1年内因各种原因自行更改用药，甚至停止药物治疗。此外，大约10%~20%的高血压患者为难治性高血压。因此，为了降低血压持续升高给这些患者带来的心脑血管疾病的发生风险，亟待新的血压控制方法和手段，经皮去肾神经术（RDN）应运而生。 RDN降压效果如何？随着临床研究的开展，RDN的治疗技术平台也在不断更新和完善。目前，根据消融能量源的不同，RDN主要分为能量消融（射频消融、超声消融）、化学消融（如使用无水乙醇）及冷冻消融等。其中，射频消融是RDN疗法中应用最多的方式。在能量消融中，无论是射频消融还是超声消融，现有的临床研究数据均表明RDN治疗高血压是安全和有效的，其疗效和降压特征独立于服用的降压药物，可作为药物降压治疗的辅助治疗。 ▲部分RDN临床研究主要结果（上：24 h动态血压；下：诊室血压）（图片来源：参考文献[1]） RDN安全性如何？ RDN治疗可能带来的安全性问题包括：肾动脉损伤，如肾动脉痉挛、血栓、狭窄、夹层及穿孔等；血管穿刺部分并发症，如血肿、假性动脉瘤及动静脉瘘等；对比剂肾病及肾功能恶化等。随机对照研究、荟萃分析等一致表明，无论是术前还是术后，RDN治疗高血压具有良好的安全性。在临床研究中，假手术组和RDN组在安全性上无统计学差异，未见与设备相关的重大安全事件或手术相关安全事件。一项纳入48个RDN研究的荟萃分析显示，平均随访9.1个月，受试者估算肾小球滤过率（eGFR）较术前无显著变化（P=0.256）。 RDN适合中国人吗？有研究显示RDN在东亚人群中降压效果更佳。目前，中国已开展了多项RDN治疗高血压的临床研究，均为随机对照假手术的试验。在已结束的临床研究中，结果分析显示，随访6个月，与假手术组相比，RDN组在血压控制上表现更为优异且安全性良好。以Iberis-HTN研究为例，这项前瞻性、多中心、随机、双盲、假手术对照试验，评估了在三联抗高血压治疗背景下，高血压患者进行RDN治疗的效果。研究结果显示，与假手术组相比，RDN组的24小时收缩压降低显著（基线调整后的两组间差异为-9.4 mmHg，95%CI：-12.8~-5.9，P<0.001）。与假手术组相比，诊室收缩压和舒张压也分别降低了6.4 mmHg（95%CI：-10.5~-2.3，P=0.003）和5.1mmHg（95%CI：-8.2~-2.0，P=0.001）。 ▲Iberis-HTN研究主要结果（图片来源：参考文献[3]） RDN疗效能持续多久？ RDN治疗后降压疗效的持久性一直是临床关注的问题。从RDN相关临床研究公布的数据看，随访3年24 h动态血压和诊室血压均显著降低，且RDN降压效果持续存在并随着时间推移有增强趋势。 2023年发表于Journal of the American College of Cardiology的一项单中心、单臂、前瞻性的RDN10年随访结果表明，RDN的降压有效性可持续长达10年之久，术后1年、2年和10年的24 h动态血压较基线分别降低了12.2 mmHg、16.8 mmHg及16.2 mmHg。因此，RDN的临床应用有望对高血压患者的长期管理产生积极影响。 ▲RDN降压效果持久并随着时间推移有增强趋势（图片来源：参考文献[14]） RDN适合哪些高血压人群？基于RDN一系列临床研究结果展现出的治疗有效性和安全性，2023年11月美国FDA和2024年4月中国国家药品监督管理局（NMPA）相继批准了射频消融和超声消融的RDN作为高血压微创手术治疗的一种技术，用于经生活方式改善和降压药物治疗后，血压仍不能得到良好控制的高血压患者的辅助治疗。目前RDN治疗在高血压指南中的地位？ 2023年欧洲高血压学会（ESH）更新的高血压管理指南中对RDN治疗给予了肯定。《中国高血压防治指南（2024年修订版）》指出，现有研究结果证明了RDN治疗高血压的有效性和安全性。推荐在尊重患者意愿的前提下，排除继发性高血压，作为药物难以控制血压或药物依从性差的高血压患者的辅助治疗手段。指南同时也指出，RDN需要在丰富高血压诊治经验，能够进行继发性高血压病因鉴别的科室有序开展，并进行高血压诊治和操作技术培训。小结 RDN为高血压患者提供了一种新的、有效的治疗选择，虽然临床应用时间较短，但现有的数据表明RDN在降压治疗方面已经展现出良好的有效性和安全性。目前，全球高血压指南推荐，对于严格生活方式干预及降压药物治疗后，血压仍未能良好控制的高血压患者，在排除继发性因素后，可考虑行RDN治疗，以提高血压控制率，降低心脑血管事件风险。相信随着RDN治疗平台的发展，其在高血压管理中的地位会得到进一步提升。相关阅读全球13亿高血压患者新希望？新研究：降压潜在新选择，值得临床关注《柳叶刀》：仅需20分钟微创消融，有望同时治愈高血压和原酮症！不吃降压药，微创手术也能强效降压！符合这些条件的高血压患者，更能从中受益安贞医院周玉杰领衔：强效降压25.2 mmHg！微创手术有望为中国高血压患者带来新选择 JAHA：强化降压达到<140 mmHg，高血压患者就无需太担心中风风险欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料（可上下滑动查看） [1].Fisher NDL, Kirtane AJ. Renal denervation for hypertension. Nat Rev Cardiol. 2025 Jan 2. [2].Tajeu GS, Kent ST, Huang L, et al. Antihypertensive Medication Nonpersistence and Low Adherence for Adults <65 Years Initiating Treatment in 2007-2014. Hypertension. 2019 Jul;74(1):35-46. [3].Yoon M, You SC, Oh J, et al. Prevalence and prognosis of refractory hypertension diagnosed using ambulatory blood pressure measurements. Hypertens Res. 2022 Aug;45(8):1353-1362. [4].Townsend RR, Mahfoud F, Kandzari DE, et al; SPYRAL HTN-OFF MED trial investigators*. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-2170. [5].Kandzari DE, Böhm M, Mahfoud F, et al; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9; 391 (10137):2346-2355. [6].Azizi M, Schmieder RE, Mahfoud F, et al; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. [7].Böhm M, Kario K, Kandzari DE, et al; SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. [8].Azizi M, Sanghvi K, Saxena M, et al; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. [9].Kario K, Yokoi Y, Okamura K, et al. Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial. Hypertens Res. 2022 Feb;45(2):221-231. [10].Sanders MF, Reitsma JB, Morpey M, et al. Renal safety of catheter-based renal denervation: systematic review and meta-analysis. Nephrol Dial Transplant. 2017 Sep 1;32(9):1440-1447. [11].Lee CK, Wang TD, Lee YH, et al. Efficacy and Safety of Renal Denervation for Patients with Uncontrolled Hypertension in Taiwan: 3-Year Results From the Global SYMPLICITY Registry-Taiwan (GSR-Taiwan). Acta Cardiol Sin. 2019 Nov; 35(6):618-626. [12].Kim BK, Kim HS, Park SJ, et al. Long-term outcomes after renal denervation in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea). Hypertens Res. 2021 Sep;44(9):1099-1104. [13].Jiang X, Mahfoud F, Li W, et al. Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial. Circulation. 2024 Nov 12;150(20):1588-1598. [14].Al Ghorani H, Kulenthiran S, Recktenwald MJM, et al. 10-Year Outcomes of Catheter-Based Renal Denervation in Patients With Resistant Hypertension. J Am Coll Cardiol. 2023 Feb 7;81(5):517-519. [15].李月平,卢成志,蒋雄京,等. 经皮去肾神经术治疗高血压中国专家科学声明[J]. 中国介入心脏病学杂志,2023,31(12):881-893. [16].Cluett JL, Blazek O, Brown AL, et al; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; Council on the Kidney in Cardiovascular Disease; and Council on Peripheral Vascular Disease. Renal Denervation for the Treatment of Hypertension: A Scientific Statement From the American Heart Association. Hypertension. 2024 Oct;81(10):e135-e148. [17].Mancia G, Kreutz R, Brunström M, et al. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023 Dec 1;41(12):1874-2071. [18].中国高血压防治指南修订委员会,高血压联盟(中国),中国医疗保健国际交流促进会高血压分会,等. 中国高血压防治指南(2024年修订版)[J]. 中华高血压杂志,2024,32(7):603-700. 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。分享，点赞，在看，传递医学新知

临床研究临床结果疫苗

2025-03-04

·诺华集团

诺华收购Anthos Therapeutics公司以加强心血管产品研发管线

Anthos Therapeutics是一家聚焦药物临床研究阶段的生物制药公司，正在开发一种名为Abelacimab的药物，该药物可能将会成为靶向FXI的同类首创单克隆抗体疗法。 Abelacimab目前处于三期开发阶段，主要用于预防房颤患者的中风和全身性栓塞。此次收购将为诺华增添一项处于研发后期的项目，这款产品与诺华在心血管治疗领域的战略重点、优势和专业知识也高度契合。在满足惯例交割条件的前提下，交易预计将在2025年上半年完成。诺华日前宣布达成一项新的协议，将收购Anthos Therapeutics, Inc.，这是一家总部位于波士顿，聚焦药物临床研究阶段的私人生物制药公司。该公司正致力于开发一款用于房颤患者中风和全身性栓塞预防的晚期治疗药物Abelacimab。在满足惯例交割条件的前提下，此次交易完全符合诺华的增长战略和治疗领域重点，并将充分发挥诺华在心血管领域的优势和专业知识。 Anthos Therapeutics由黑石生命科学（Blackstone Life Sciences）和诺华于2019年创立，已根据诺华的许可推进Abelacimab的临床开发。Abelacimab是一种新型、高选择性、全人源单克隆抗体疗法，旨在通过抑制凝血因子XI实现有效的不影响止血功能的抗凝作用。二期数据显示，与使用标准治疗直接口服抗凝药的房颤患者相比，使用Abelacimab的房颤患者出血事件显著减少（AZALEA1,2）。目前正在进行三项针对动脉和静脉血栓风险患者的三期临床试验，其中一项针对房颤患者（LILAC-TIMI 763），另外两项针对癌症相关血栓（ASTER4）和（MAGNOLIA5）。诺华药品开发总裁兼首席医学官 Shreeram Aradhye博士非常高兴我们能携手推进Abelacimab的开发，这是一种潜在的同类首创治疗方法，对于预防房颤相关的中风和癌症相关的血栓形成将是一种更安全的疗法。欢迎Anthos Therapeutics的加入，这将强化我们重点关注的心血管领域，并将进一步丰富我们帮助患者改善生活质量的治疗方案，而全面的临床计划以及战略合作，都将帮助到全球成千上万的心血管疾病患者。 2022年7月，Abelacimab获得了美国食品药品监督管理局（FDA）授予的癌症相关血栓治疗的快速通道资格。2022年9月，Abelacimab也获得了针对房颤患者预防中风和全身性栓塞的快速通道资格。诺华心血管、肾脏和代谢药物开发全球负责人 David Soergel博士 Abelacimab是一种潜在的同类首创药物，或将有效且更安全地预防血栓和中风。我们为这款药物源自诺华感到自豪，并对Anthos Therapeutics团队的专业知识和奉献精神，以及他们在项目上取得的巨大进展印象深刻。现在是将Abelacimab重新纳入诺华CRM管线的恰当时机。 — 声明 — 1.本资料的目的在于传递医药前沿信息和研究进展，非广告用途。本资料中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。 2.本资料中涉及的药物Abelacimab尚未在中国大陆获批。 — 参考文献 — （滑动查看更多） 1. Samer Al Said, et al. Bleeding with the FXI Inhibitor Abelacimab compared with Rivaroxaban in Patients on Antiplatelet therapy: A Prespecified Analysis of the AZALEA-TIMI 71 Trial. Available from: https://timi.org/wp-content/uploads/2024/11/Samer-Al-Said-Bleeding-with-the-FXI-Inhibitor-Abelacimab-compared-with-Rivaroxaban-in-Patients-on-Antiplatelet-therapy-A-Prespecified-Analysis-of-the-AZALEA-TIMI-71-Trial-.pdf. Accessed February 2024. 2. Ruff C, Patel S, et al. Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation. N Engl J Med. 2025; 392 (4):361-371.doi:10.1056/NEJMoa2406674 3. ClinicalTrials.gov. NCT05712200. Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76) (LILAC-TIMI 76). Available from: https://clinicaltrials.gov/study/NCT05712200?term=NCT05712200&rank=1. Accessed February 2024. 4. ClinicalTrials.gov. NCT05171049. A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE. Available from: https://clinicaltrials.gov/study/NCT05171049. Accessed February 2024. 5. ClinicalTrials.gov. NCT05171075. A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/ Genitourinary Cancer and Associated VTE (MAGNOLIA). Available from: https://clinicaltrials.gov/study/NCT05171075. Accessed February 2024.

临床2期临床3期并购快速通道临床成功

100 项与 Abelacimab 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
全身性栓塞	临床3期	美国	Lonza AG	2022-12-27
全身性栓塞	临床3期	美国	Anthos Therapeutics, Inc.初创企业	2022-12-27
全身性栓塞	临床3期	日本	Anthos Therapeutics, Inc.初创企业	2022-12-27
全身性栓塞	临床3期	日本	Lonza AG	2022-12-27
全身性栓塞	临床3期	加拿大	Anthos Therapeutics, Inc.初创企业	2022-12-27
全身性栓塞	临床3期	加拿大	Lonza AG	2022-12-27
全身性栓塞	临床3期	以色列	Lonza AG	2022-12-27
全身性栓塞	临床3期	以色列	Anthos Therapeutics, Inc.初创企业	2022-12-27
心房颤动	临床3期	美国	Anthos Therapeutics, Inc.初创企业	2022-12-27
心房颤动	临床3期	美国	Lonza AG	2022-12-27

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04755283 (AZALEA-TIMI 71, Pubmed) 人工标引	临床2期	心房颤动	1,287	Abelacimab 150 mg	憲鹽積衊製觸窪壓遞構(衊範廠簾憲鏇鹽築製簾) = 夢繭夢廠壓遞繭繭選衊獵衊壓獵鹹糧願鹹顧壓 (範選艱鹹選糧艱築構蓋 )	积极	2025-01-23
				Abelacimab 90 mg	憲鹽積衊製觸窪壓遞構(衊範廠簾憲鏇鹽築製簾) = 繭構製齋鏇鏇窪醖壓鬱獵衊壓獵鹹糧願鹹顧壓 (範選艱鹹選糧艱築構蓋 )
NCT04755283 (AZALEA-TIMI 71, GlobeNewswire) 人工标引	临床2期	血栓形成	-	Abelacimab 150 mg	齋選憲鏇網鹹顧選膚壓(網壓淵簾遞鹽衊選願範) = 鏇膚衊壓鹹艱齋願願鬱製製壓簾蓋壓鏇鹹獵襯 (選繭簾網網廠構齋糧艱 )	积极	2024-11-16
				Rivaroxaban	齋選憲鏇網鹹顧選膚壓(網壓淵簾遞鹽衊選願範) = 憲簾鹽願膚膚壓艱窪網製製壓簾蓋壓鏇鹹獵襯 (選繭簾網網廠構齋糧艱 )
NCT04755283 (AZALEA-TIMI 71, PipelineReview) 人工标引	N/A	心房颤动	1,287	abelacimab 150 mg	觸觸衊構憲遞廠積夢製(艱憲糧範顧壓襯積廠餘) = 選網糧遞鹽獵獵鹽艱糧遞簾憲糧鬱鏇衊糧積襯 (積鏇範選壓遞範願膚壓 ) 更多	积极	2023-11-13
				rivaroxaban 20 mg	-
NCT04755283 (AZALEA-TIMI 71 , Corporate Publications) 人工标引	临床2期	心房颤动	1,287	Abelacimab 150 mg	夢衊壓願淵膚夢窪選膚(窪壓積鬱願鹹膚鹽構選) = 觸觸網鏇壓衊遞選艱糧網觸夢繭鹹顧蓋齋鹽衊 (構膚淵繭鹽鏇範鏇獵壓 ) 更多	优效	2023-11-12
				Rivaroxaban 20 mg	-
NCT04213807 (CTgov)	临床2期	心房颤动	28	Placebo	築餘艱獵醖構鑰壓蓋壓 = 窪糧夢蓋鏇齋鏇願選蓋襯窪淵壓範淵膚齋醖鹹 (窪鏇憲醖壓醖獵壓齋糧, 鹽襯鬱鹹鬱衊壓製蓋獵 ~ 鹽顧糧選顧選蓋壓廠襯) 更多	-	2021-12-07
EUCTR2019-003756-37-BG (ANT-005 TKA, ISTH2021 \| Company_Website) 人工标引	临床2期	静脉血栓栓塞	412	30mg abelacimab	壓淵獵壓齋襯襯選廠淵(鹹獵襯醖憲壓窪窪夢廠) = 顧膚繭膚鑰夢簾簾襯鹽窪選構衊壓簾築夢獵糧 (網糧構鏇壓選願艱蓋膚 ) 更多	积极	2021-07-17
				75mg abelacimab	壓淵獵壓齋襯襯選廠淵(鹹獵襯醖憲壓窪窪夢廠) = 選繭網壓衊鏇淵鑰簾窪窪選構衊壓簾築夢獵糧 (網糧構鏇壓選願艱蓋膚 ) 更多