A Phase 3 Prospective, Blinded, Randomized, Placebo Controlled, International Multicenter Study to Assess the Safety and Efficacy of a Single SQ Injection of Zalunfiban in Subjects With ST-elevation MI in the Pre-hospital Setting

This is a Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. These subjects will be evaluated by (para)medics who transport the subjects to the participating hospitals in Europe and North America. Hospitals and ambulance services with experience in ambulance studies will be selected. Each subject will receive a single subcutaneous injection containing either Disaggpro(tm) zalunfiban Dose 1 (0.110 mg/kg) or Disaggpro(tm) zalunfiban Dose 2 (0.130 mg/kg) or placebo

开始日期2021-04-24

申办/合作机构

CeleCor Therapeutics, Inc.

NCT04284995

/ Completed临床2期

A Phase 2 Open Label Study to Assess the PK and PD Properties of a Single Subcutaneous Injection of RUC-4 in Patients With a ST-elevation Myocardial Infarction Presenting to the Cardiac Catheterization Lab With Planned Primary Coronary Angioplasty

RUC-4 is a novel, promising and fast acting (5-15 minutes) αIIbβ3 receptor antagonist with a high-grade inhibition of platelet aggregation (≥80%) shortly after subcutaneous administration. This study is designed to extend the findings in CEL-01 to patients with ST-elevation myocardial Infarction (STEMI) presenting to the cardiac catheterization laboratory with planned coronary angioplasty.

开始日期2020-06-02

申办/合作机构

CeleCor Therapeutics, Inc.

[+2]

NCT03844191

/ Completed临床1期

A Randomized Phase 1 Dose-Escalation Study in Healthy Volunteers and Subjects on Aspirin With Stable Coronary Artery Disease to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RUC-4

This study is designed to assess tolerability of the weight-adjusted dose of RUC-4 (mg/kg) required to achieve 80% or more inhibition of the initial slope of platelet aggregation to 20 µM ADP by Light Transmission Aggregometry (LTA) within 15 minutes of SC administration of RUC-4 with return toward baseline values within 4 hours in healthy volunteers and subjects on aspirin with stable coronary artery disease (CAD). In the Dose Expansion Part, VerifyNow PRUTest will be used to measure platelet aggregation in addition to LTA.
Since the goal of RUC-4 therapy is to achieve maximal antiplatelet therapy as rapidly as possible, first the tolerability of the weight-adjusted dose (mg/kg) that inhibits ADP-induced platelet aggregation by 80% or more in 5 of 6 healthy volunteers will be identified. A similar dose escalation will be subsequently performed in subjects with CAD who are taking aspirin. To facilitate administration using a single weight-adjusted (mg/kg) dose for a defined group of subjects weighing between 55 and 120 kg, the study will also evaluate the safety and biologic effect on platelet aggregation of the weight adjusted (mg/kg) dose when administered to subjects with weights at either end of this range.

开始日期2019-02-18

申办/合作机构

CeleCor Therapeutics, Inc.

[+3]

100 项与 Zalunfiban 相关的临床结果

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100 项与 Zalunfiban 相关的转化医学

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100 项与 Zalunfiban 相关的专利（医药）

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项与 Zalunfiban 相关的文献（医药）

2025-12-23·NEJM evidence

Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction

Article

作者: Gosselink, M. ; Wittes, J. ; Gibson, C. M. ; Coller, B. S. ; Hermanides, R. ; ten Berg, J. M. ; Tolsma, R. ; Januzzi, J. L. ; van de Wetering, H. ; van Vliet, R. ; Jukema, J. W. ; Boomars, R. ; Welsh, R. C. ; Rasoul, S. ; Levy, M. ; Arslan, F. ; Ecollan, P. ; Arkenbout, K. E. ; Montalescot, G. ; Pisters, R. ; Hengstman, G. ; van Houwelingen, G. K. ; van Beurden, A. ; Chioncel, V. ; Giugliano, R. P. ; Verburg, A. ; van den Branden, B. J. L. ; Polad, J. ; Rikken, S. A. O. F. ; Vinereanu, D. ; Baron, N. ; Beelen, J. ; Ruiters, L. ; Vainer, J. ; Magro, M. ; Merkely, B. ; Durieux, M. ; van’t Hof, A. W. J. ; Lapostolle, F. ; Granger, C. B. ; Remkes, W. ; Kala, P. ; Arias-Mendoza, A. ; Cociorva, D. ; van de Hoef, T. P. ; Unger, E. F.

BACKGROUND:

Zalunfiban is a glycoprotein IIb/IIIa (integrin αIIbβ3) inhibitor designed for subcutaneous administration on first medical contact with patients with suspected ST-segment elevation myocardial infarction (STEMI).

METHODS:

An international, double-blind, placebo-controlled trial randomly assigned patients with STEMI in a 1:1:1 ratio to receive a single subcutaneous injection of zalunfiban (0.11 mg/kg or 0.13 mg/kg) or placebo. The primary efficacy end point was a hierarchical proportional odds model ranking seven end points from worst to best: all-cause death, stroke, recurrent myocardial infarction, acute stent thrombosis, new-onset or rehospitalization for heart failure, larger infarct size, or no end point through 30 days. The primary safety end point was the occurrence of severe or life-threatening bleeding as per the global use of strategies to open occluded coronary arteries (GUSTO) criteria.

RESULTS:

The trial randomly assigned 2467 patients (853 to zalunfiban 0.11 mg/kg, 818 to zalunfiban 0.13 mg/kg, and 796 to placebo). The primary efficacy end point was significantly improved by zalunfiban (adjusted odds ratio 0.79; 95% confidence interval, 0.65 to 0.98; P=0.028). GUSTO severe bleeding was similar between those who received zalunfiban versus placebo (1.2% vs. 0.8%; P=0.40), but GUSTO mild to moderate bleeding was increased (6.4% vs. 2.5%; P<0.001). Angiography showed faster coronary blood flow with zalunfiban versus placebo (corrected frame count of the infarct-related artery 109 [interquartile range 35 to 176] vs. 176 [interquartile range 40 to 176]; P=0.012).

CONCLUSIONS:

In patients with STEMI, zalunfiban administered at first medical contact significantly improved preintervention infarct-related patency and reduced the likelihood of a worse 30-day multicomponent hierarchical clinical end point. Zalunfiban was not associated with increased severe or life-threatening bleeding but was associated with increased mild to moderate bleeding. (Funded by CeleCor Therapeutics; CELEBRATE ClinicalTrials.gov number, NCT04825743.).

2024-11-01·Journal of Computational Biophysics and Chemistry

Molecular Docking, Quantum Mechanics and Molecular Dynamics Simulation of Anti-CAD Drugs Against High-Risk Xanthine Dehydrogenase Variants Associated with Oxidative Stress Pathways

作者: Sudhan, M. ; Ahmed, Shiek S. S. J. ; Emran, Talha Bin ; Attia, Sabry M. ; Ahmad, Sheikh F. ; Janakiraman, V.

Xanthine dehydrogenase (XDH) contributes significantly to generating reactive oxygen species in coronary artery disease (CAD). XDH has been proposed as a therapeutic target, but its genetic variants could affect protein structure and drug response. We aimed to assess protein structure modification occur due to genetic variants and to screen 215 CAD drugs for their utility in personalized CAD treatment against the XDH variants. A series of computational methods were implemented to identify pathogenic variants that cause XDH structure instability localized at the con served regions contributing to functional significance. Then, the XDH structures with the pathogenic variants were modeled using two different approaches to select the best models for docking with the CAD drugs. Finally, the stability of the docked complexes and their ability to transfer electrons were evaluated using molecular dynamics (MD) simulations and quantum mechanics/molecular mechanics (QM/MM) calculation. Among 751 variants examined; R149C and Q919R showed high pathogenicity, localized in conserved regions could alter protein structure and function. Further, docking of CAD drugs against XDH (native, R149C and Q919R) showed vericiguat with higher affinity, ranging from −7.95 kcal/mol to −10.41 kcal/mol, than the well-known XDH inhibitor (febuxostat, −5.73 kcal/mol to −8.35 kcal/mol). This indicates that vericiguat will be effective in CAD treatment, regardless of the XDH variants. Additionally, MD simulation and QM/MM confirmed vericiguat stability and electron transfer ability to form hydrogen bonds with the XDH protein. In conclusion, vericiguat will be beneficial for the personalized treatment of CAD by inhibiting XDH variants. Additional clinical studies are necessary to confirm our findings.

2023-12-19·Journal of the American Heart Association

Critical Analysis of Thrombocytopenia Associated With Glycoprotein IIb/IIIa Inhibitors and Potential Role of Zalunfiban, a Novel Small Molecule Glycoprotein Inhibitor, in Understanding the Mechanism(s)

Review

作者: Rikken, Sem A. O. F. ; Kereiakes, Dean J. ; Coller, Barry S. ; van 't Hof, Arnoud W. J. ; ten Berg, Jurriën M.

Thrombocytopenia is a rare but serious complication of the intravenous glycoprotein IIb/IIIa (GPIIb/IIIa; integrin αIIbβ3) receptor inhibitors (GPIs), abciximab, eptifibatide, and tirofiban. The thrombocytopenia ranges from mild (50 000–100 000 platelets/μL), to severe (20 000 to <50 000/μL), to profound (<20 000/μL). Profound thrombocytopenia appears to occur in <1% of patients receiving their first course of therapy. Thrombocytopenia can be either acute (<24 hours) or delayed (up to ~14 days). Both hemorrhagic and thrombotic complications have been reported in association with thrombocytopenia. Diagnosis requires exclusion of pseudothrombocytopenia and heparin‐induced thrombocytopenia. Therapy based on the severity of thrombocytopenia and symptoms may include drug withdrawals and treatment with steroids, intravenous IgG, and platelet transfusions. Abciximab‐associated thrombocytopenia is most common and due to either preformed antibodies or antibodies induced in response to abciximab (delayed). Readministration of abciximab is associated with increased risk of thrombocytopenia. Evidence also supports an immune basis for thrombocytopenia associated with the 2 small molecule GPIs. The latter bind αIIbβ3 like the natural ligands and thus induce the receptor to undergo major conformational changes that potentially create neoepitopes. Thrombocytopenia associated with these drugs is also immune‐mediated, with antibodies recognizing the αIIbβ3 receptor only in the presence of the drug. It is unclear whether the antibody binding depends on the conformational change and whether the drug contributes directly to the epitope. Zalunfiban, a second‐generation subcutaneous small molecule GPI, does not induce the conformational changes; therefore, data from studies of zalunfiban will provide information on the contribution of the conformational changes to the development of GPI‐associated thrombocytopenia.

项与 Zalunfiban 相关的新闻（医药）

2025-12-22

·NEJM医学前沿

NEJM及3本子刊2025最佳论文发榜

主编Eric Rubin致读者的信尊敬的读者：作为《新英格兰医学杂志》编辑的我们非常幸运，有机会审阅大量直接影响患者医疗的研究成果，并将其呈现给读者。这些研究涵盖高科技与低科技领域，从庞大的多国研究到单一病例研究皆有涉及。今年的重磅论文涵盖多种主题与研究方法，您可以从中一窥我们发表内容的多元性。细菌性阴道病会给女性带来诸多后果，包括增加复发风险、引发其他感染及影响分娩结局。众所周知该疾病难以根治，即使伴侣专一仍存在较高复发率。解决方案是什么？通过治疗配偶来预防细菌再定植。此类治疗可显著降低复发率，并大幅减少复诊需求。溶栓与取栓术对卒中的益处可否推广至更广泛人群？今年我们发表了多项卒中试验，但结果呈现明显分化。例如，两项研究表明，对于中等及更小的远端血管，相较于药物治疗，取栓术未能改善结局。另有多项研究提示，对于大血管卒中，溶栓联合取栓术优于单纯取栓术，这表明这些疗法或可推广至更广泛人群。对于像我这样在卒中溶栓治疗刚刚问世时接受培训的医师而言，能为患者提供更多治疗选择令人倍感欣慰。新型降压及降血脂疗法在降低心血管疾病和卒中风险方面前景广阔。新型治疗靶点与药物有望扩充高血压及高脂血症的治疗手段，其中包括醛固酮合成酶抑制剂（如baxdrostat）以及作用于脂蛋白合成与维持过程中关键蛋白（如脂蛋白[a]、PCSK9和ANGPTL3）的化合物——这些成果均于今年发表。这些新型药物与现有药物如何协同应用值得期待。总体而言，这些新疗法在治疗高血压和高脂血症，以及进一步降低心血管疾病发病率方面展现出良好前景。肿瘤学领域近期凭借多种新型药物取得重大进展。但并非所有突破都源于新药研发，部分进展反而体现了低科技含量策略。例如，运动对结肠癌患者的无病生存期具有深远影响。而在其他领域，有时“事半功倍”的理念同样奏效。对于淋巴结阳性但新辅助化疗效果良好的乳腺癌患者，淋巴结放疗并不能降低乳腺癌复发率或死亡率，反而会增加不良事件。当然，高科技疗法仍持续体现重要价值。现有证据进一步表明，错配修复缺陷肿瘤对阻断PD-1蛋白的免疫检查点抑制剂应答良好，患者往往可因此避免手术。 2型糖尿病和肥胖治疗因GLP-1受体及相关蛋白结合药物的研发而发生革命性变化。这些药物均为大型脂肽，生产成本高昂且通常需采用非消化道给药。但今年我们见证了一种口服小分子GLP-1受体激动剂进入3期临床试验。由于小分子药物的生产、储存和给药更为便捷，此类药物有望提升治疗可及性。许多疾病的治疗进展往往循序渐进。肺纤维化长期以来是一个难以攻克的领域。但在两项同步开展的试验中，磷酸二酯酶4B抑制剂nerandomilast展现出延缓用力肺活量下降速率的潜力。尽管尚未实现治愈或阻断疾病进展的目标，但更多手段的出现仍为这一艰难领域带来曙光。基因编辑技术正以多种形式展现其价值：在我们今年发表的研究中，通过69处基因组编辑构建的工程猪模型，成功将改造后的肾脏移植至人类受者体内，且未出现超急性排斥反应； CRISPR-Cas9基因编辑技术用于治疗婴儿期高致死率遗传病——氨甲酰磷酸合成酶1缺乏；以及CRISPR-Cas12b基因编辑结合慢病毒转导技术，实现异体胰岛细胞移植，且无需免疫抑制。该技术应用仍处于起步阶段，敬请持续关注! 最后谈谈我的专业领域——传染病学。伊维菌素用途广泛，最常见的是杀灭体外寄生虫。蚊虫本质上是比较大的体外寄生虫，同样可被伊维菌素消灭。一项大型整群随机研究显示，在肯尼亚儿童和青少年群体中，大规模使用伊维菌素相较另一种抗寄生虫药阿苯达唑显著降低了疟疾感染率。伊维菌素有望成为预防疟疾的可行方案。担任NEJM编辑的一大优势是有机会率先审阅具有重大影响力的研究。2026年刊物已蓄势待发，敬请期待精彩内容。此致 Eric J. Rubin, M.D., Ph.D. 《新英格兰医学杂志》主编 1 Endovascular Treatment for Stroke Due to Occlusion of Medium or Distal Vessels 中等血管或远端血管闭塞所致卒中的血管内治疗 DOI: 10.1056/NEJMoa2408954 在此项纳入543例中等血管或远端血管闭塞所致卒中患者的试验中，在发病后24小时内接受血管内治疗未能有效改善90天时的功能结局。 2 Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion 中等血管闭塞所致卒中的血管内治疗 DOI: 10.1056/NEJMoa2411668 在一项纳入中等血管闭塞所致缺血性卒中患者的试验中，在12小时内实施取栓术与常规治疗相比，未能改善90天时的功能结局和降低死亡率。 NEJM点评：无论从何种角度审视试验数据，两项试验无疑构成了当前关于中等或远端血管闭塞所致卒中患者取栓术的证据基准。试验数据明确显示，对于远端血管闭塞，取栓术不应被视为默认治疗方案。 3 Brief Report: Xenotransplantation of a Porcine Kidney for End-Stage Kidney Disease 异种移植猪肾治疗终末期肾病 DOI: 10.1056/NEJMoa2412747 一名长期患糖尿病、依赖血液透析，并且患晚期血管病变，在透析血管通路方面遇到巨大困难的男性移植了经过基因编辑的猪肾。 NEJM点评：迄今实施的每例异种器官移植手术都提供了大量宝贵的临床数据。后续病例以及当前正在进行的非人灵长类动物研究将提供关键数据，证明异种器官移植作为当前器官短缺问题的解决方案，是否具有安全性、有效性和可行性。 4 Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis 旨在预防女性细菌性阴道病复发的男性伴侣同治试验 DOI: 10.1056/NEJMoa2405404 在女性接受细菌性阴道病治疗的同时，男性伴侣接受口服和外用抗微生物剂联合治疗，与只有女性接受治疗相比，降低了12周内的阴道病复发率（参见《细菌性阴道病，夫妻同治复发率下降近半 | NEJM》）。 NEJM点评：本研究结果及时且重要，它提示细菌性阴道病治疗策略亟待调整。这不仅涉及如何向女性提供关于感染源的咨询，也强调男性伴侣在预防病原体传播和治疗疾病中的责任。男女双方共同参与治疗，有望降低细菌性阴道病复发率。 5 Lepodisiran — A Long-Duration Small Interfering RNA Targeting Lipoprotein(a) lepodisiran——靶向脂蛋白(a)的长效小干扰RNA DOI: 10.1056/NEJMoa2415818 lepodisiran是一种长效小干扰RNA，可降低脂蛋白(a)浓度升高者的脂蛋白(a)浓度。 NEJM点评：脂蛋白(a)的故事始于六十多年前的流行病学、生物化学和分子生理学研究，近年来随着遗传学和新型药物技术的加入，其发展进程显著加速。这一研究历程最终可能揭示动脉粥样硬化性心血管疾病的主要致病危险因素，并催生出高效精准的干预手段。整个心血管医学领域正翘首以待新篇章的开启，这很可能对未来数十年的临床实践产生深远影响。 6 Nonoperative Management of Mismatch Repair–Deficient Tumors 错配修复缺陷肿瘤的非手术治疗 DOI: 10.1056/NEJMoa2404512 PD-1抑制剂dostarlimab新辅助治疗帮助很高比例的早期错配修复缺陷肿瘤患者保留了器官，而且手术方案不受影响（参见《不用开刀了！NEJM发布dMMR肿瘤豁免手术研究》）。 NEJM点评：总体而言，本研究表明，抗PD-1疗法有可能成为帮助dMMR局部晚期直肠癌患者保留器官的潜在根治性方案，并对其他dMMR实体瘤患者展现出治疗前景。更长期随访数据和更多证据将决定该疗法能否更广泛地应用于各类实体瘤。 7 Patient-Specific In Vivo Gene Editing to Treat a Rare Genetic Disease 患者特异性体内基因编辑技术治疗罕见遗传病 DOI: 10.1056/NEJMoa2504747 研究者为一名患尿素循环障碍的婴儿定制了一种脂质纳米颗粒递送的碱基编辑疗法。患儿在大约7月龄和8月龄时接受了治疗。 NEJM点评：尽管目前结果尚处于早期阶段，但研究者针对CPS1缺乏（氨基甲酰磷酸合成酶1缺乏）所采取的基因缺陷治疗方案，展现了前沿科技与前瞻性监管策略相结合的巨大潜力——这种模式能够安全高效地加速研发进程，使挽救生命的药物更快面世。 8 Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis nerandomilast治疗特发性肺纤维化患者试验 DOI: 10.1056/NEJMoa2414108 在此项随机、3期试验中，与安慰剂相比，nerandomilast减缓了特发性肺纤维化患者的疾病进展速度（参见《特发性肺纤维化3期试验，10年首获阳性临床结局 | NEJM》）。 9 Nerandomilast in Patients with Progressive Pulmonary Fibrosis nerandomilast治疗进行性肺纤维化患者试验 DOI: 10.1056/NEJMoa2503643 在此项纳入进行性肺纤维化患者的随机试验中，在52周期间，与安慰剂相比，nerandomilast减小了用力肺活量下降幅度。 NEJM点评：临床试验为特发性肺纤维化（IPF）及非IPF的进行性间质性肺病（ILD）治疗格局带来了重大突破。我们必须持续努力为患者寻找更优疗法——这些疗法不仅要改变疾病进程，而且要提升罹患这些毁灭性疾病患者的生活质量。 10 Structured Exercise after Adjuvant Chemotherapy for Colon Cancer 结肠癌辅助化疗后的结构化运动试验 DOI: 10.1056/NEJMoa2502760 结肠癌辅助化疗后，与单纯健康宣教相比，为期3年的结构化运动计划提高了无病生存率、总生存率、身体功能和体能（参见《时隔近30年，运动抗癌研究再登NEJM》）。 NEJM点评：研究结果强调了将运动纳入癌症治疗的必要性。尽管仍需通过研究明确将运动纳入治疗的最佳策略，但我们不应等待。临床医师可将患者转介至社区运动项目，并利用或调整现有医疗服务（如心脏康复干预）。训练有素的运动顾问应进入肿瘤治疗团队，相关服务应纳入保险覆盖范围。随着肿瘤学不断进步，运动必须成为治疗方案的标准组成部分。 11 Omitting Regional Nodal Irradiation after Response to Neoadjuvant Chemotherapy 乳腺癌患者新辅助化疗缓解后豁免区域淋巴结放疗试验 DOI: 10.1056/NEJMoa2414859 在患淋巴结阳性乳腺癌，但经过新辅助治疗后淋巴结无病变的女性患者中，区域淋巴结放疗未能降低乳腺癌复发率或提高生存率。 12 Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes 口服小分子GLP-1受体激动剂orforglipron治疗早期2型糖尿病试验 DOI: 10.1056/NEJMoa2505669 在此项3期试验中，口服小分子GLP-1受体激动剂orforglipron在40周内显著降低了早期2型糖尿病成人患者的糖化血红蛋白水平。 NEJM点评：我们正迈入一个新时代：计算方法能够处理受体蛋白质在配体结合时产生的协同运动，这曾是极其困难且耗费精力的难题。orforglipron这类复杂结构曾因“不可成药”而遭弃用，但随着药物化学家不断开拓更复杂领域，此类错误将不再重演。药物终究要靠实际疗效说话。 13 Ivermectin to Control Malaria — A Cluster-Randomized Trial 应用伊维菌素控制疟疾的整群随机试验 DOI: 10.1056/NEJMoa2411262 伊维菌素是一种抗寄生虫药，可杀死在接受治疗者身上叮咬的蚊子。在肯尼亚进行的此项试验中，与阿苯达唑相比，连续3个月每月接受一次伊维菌素将疟疾感染率降低了26%。 NEJM点评：在当前形势下，我们应聚焦长效体内杀虫剂的基础研究，以及扩大伊维菌素投放规模的实施研究，同时探索其与其他新型阻断传播措施的联合应用潜力。若这些新策略兼具有效性、实用性和经济性，将显著提升未来疟疾防控方案的价值——尤其在34个最亟需干预的国家，这些方案能有效阻断疟疾传播、减少发病率并降低死亡率。 14 Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression 患者接受异体β细胞移植后，未使用免疫抑制剂情况下的细胞存活率 DOI: 10.1056/NEJMoa2503822 一名1型糖尿病患者移植了经过基因编辑的异体胰岛细胞，并且未使用免疫抑制剂。研究结果支持这些经过编辑的细胞具有免疫逃逸能力的概念。 NEJM点评：研究虽令人鼓舞，但仍处于初步阶段。为确立长期疗效与安全性，必须进行更深入且严谨的后续研究。患者的临床获益明显。当前胰岛分离与制备技术仍是主要限制因素。 15 Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension baxdrostat治疗未受控和顽固性高血压的疗效与安全性 DOI: 10.1056/NEJMoa2507109 在此项针对未受控或顽固性高血压患者的随机试验中，在背景治疗基础上加用baxdrostat较安慰剂降低了12周时的坐位收缩压。 NEJM点评：总体而言，试验在背景治疗基础上展现出baxdrostat对钠驱动型难治性高血压的明确疗效、可控安全性，以及机制合理性。后续工作将包括确定可能获得最佳疗效的患者群体，明确此类药物相较于盐皮质激素受体拮抗剂的用药场景，规范早期监测方案，以及提供关于疗效持久性和不良事件的长期数据。若取得成功，醛固酮合成酶抑制剂将从有前景的辅助疗法转变为难治性高血压治疗的核心支柱，从而推动利钠策略在降压领域迎来更广泛复兴。 16 NEJM EVIDENCE Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction 在ST段抬高型心肌梗死患者首次就诊时使用zalunfiban DOI: 10.1056/EVIDoa2500268 在ST段抬高型心肌梗死患者中，首次就诊时使用zalunfiban可显著改善介入治疗前的梗死血管通畅率，并降低30天内多组分分层临床终点恶化风险。zalunfiban未增加严重或危及生命的出血风险，但与轻度至中度出血风险增加相关。 NEJM EVIDENCE点评：本试验通过将院内静脉输注转化为具备理想药代动力学的皮下注射，重新启用了被搁置逾十年的治疗方案。若后续随机对照试验证实其对硬性临床结局的疗效，同类药物有望在权衡缺血获益与出血风险的前提下，使GPIIb/IIIa受体抑制剂重新确立为ST段抬高型心肌梗死患者的有效上游治疗手段。 17 NEJM AI Randomized Trial of a Generative AI Chatbot for Mental Health Treatment 生成式AI聊天机器人用于心理健康治疗的随机对照试验 DOI: 10.1056/AIoa2400802 这是首个证明生成式AI治疗聊天机器人对临床级心理健康症状有效的随机对照试验。该研究对抑郁症、焦虑症及慢性复发性抑郁症症状的治疗效果令人鼓舞。经过微调的生成式AI聊天机器人为大规模提供个性化心理健康干预提供了可行途径，但仍需更大规模的临床样本进行进一步研究，以验证其有效性和普适性。 18 NEJM CATALYST Using Mortality and Years-of-Life-Lost Metrics to Evaluate Health System Performance and Inform Health Care Policy 运用死亡率和损失生命年指标评估卫生系统性能并为卫生政策提供依据 DOI: 10.1056/CAT.25.0033 本研究提供了一项综合性结局指标，该指标可与凯泽永久（KP）长期追踪的大量疾病特异性性能指标形成互补。KP与健康指标与评估研究所（IHME）合作建立的死亡结局测量流程，可供美国其他医疗体系复制。此类分析有助于深入理解哪些组织设计和医疗服务措施与更好的健康结局相关。版权信息本文由《NEJM医学前沿》编辑部负责翻译、编写或约稿。对于源自NEJM集团旗下英文产品的翻译和编写文章，内容请以英文原版为准。中译全文以及所含图表等，由马萨诸塞州医学会NEJM集团独家授权。如需转载，请联系nejmqianyan@nejmqianyan.cn。未经授权的翻译是侵权行为，版权方保留追究法律责任的权利。点击下方名片，关注《NEJM医学前沿》

临床结果

2025-11-13

·PRNewswire

Support from Harrington Discovery Institute at University Hospitals Helped Advance Heart Attack Drug into Clinical Trials

Positive results of zalunfiban announced at AHA Scientific Sessions CLEVELAND, Nov. 13, 2025 /PRNewswire/ -- Promising results from a pivotal Phase 3 clinical trial of an investigational heart-attack drug were announced this week as part of the late-breaking sessions at the American Heart Association Scientific Sessions in New Orleans. The CeleBrate study of zalunfiban (Disaggpro™), from CeleCor Therapeutics, met its efficacy and safety endpoints in the treatment of STEMI (heart attack) patients. This achievement was reached, in part, with support from Harrington Discovery Institute at University Hospitals, a philanthropic organization with a mission to create new medicines for unmet need. Zalunfiban is a next-generation investigational GPIIb/IIIa inhibitor specifically designed for use by medical first responders and emergency room personnel. It acts on the platelet GPIIb/IIIa receptor to reduce clot formation or re-open the artery. The drug is administered subcutaneously, and its antiplatelet effects wear off in about two hours, to help avoid potential interference with subsequent interventional procedures. The vast majority of discoveries in academia fail to advance into new therapies. Barry Coller, MD, vice president for medical affairs, David Rockefeller Professor, head of the Allen and Frances Adler Laboratory of Blood and Vascular Biology, and physician-in-chief at The Rockefeller University, and co-founder of CeleCor, was the lead inventor of zalunfiban and needed support to take the investigational drug into clinical testing. Dr. Coller received Harrington's physician-scientist award in 2015, which helped advance the goal of developing and testing zalunfiban in the pre-hospital setting. Harrington Discovery Institute supports physician-scientists and scientists in advancing discoveries from academic labs into clinical practice by providing advanced drug and business development support, grant funding, and the opportunity to compete for acceleration funds and qualify for investment funds. Since its founding, Harrington has supported 217 drugs-in-the-making, 74 academic institutions, 43 company launches, 23 clinical candidates, and 15 licenses to pharma. "My therapeutics development advisory team at Harrington Discovery Institute played a crucial role in where we are today," said Dr. Coller. "They offered access to experts in multiple disciplines, which led us to reconsider the route of administration, and initiate much-needed reimbursement strategies. This positioning was instrumental in attracting new funding to advance the medication into clinical trials." "Harrington Discovery Institute was created to propel promising academic discoveries into medicines for patients," said Jonathan S. Stamler, MD, President and Co-Founder, Harrington Discovery Institute, Distinguished University Professor, Robert S. and Sylvia K. Reitman Family Foundation Chair of Cardiovascular Innovation, and Professor of Medicine and of Biochemistry at University Hospitals and Case Western Reserve University. "Dr. Coller's work is an excellent example of our mission being accomplished. We are privileged to have been able to contribute." CeleBrate was a pivotal Phase 3 prospective, blinded, randomized, placebo-controlled trial designed to assess the safety and efficacy of a single subcutaneous injection of zalunfiban in STEMI (heart attack) patients in the pre-hospital setting. It enrolled 2,467 patients at 45 sites in the United States, Canada, Mexico, and Europe. Eligible STEMI patients were enrolled in the ambulance or in a hospital emergency department. More information about the study results can be found here. SOURCE Harrington Discovery Institute 21% more press release views with Request a Demo

临床3期AHA会议临床结果

2025-11-11

·FierceBiotech

CeleCor Therapeutics tees up FDA filing with phase 3 win for rapid heart attack treatment

CeleCor Therapeutics is looking to file its heart attack med for FDA approval next year, the company said. \n With new phase 3 data backing the ability of its emergency use zalunfiban to fend off further heart damage, CeleCor Therapeutics is one step closer to bringing a speedy new weapon to the race against time that is medical care for heart attacks.CeleCor’s zalunfiban, an investigational antiplatelet therapy that blocks the glycoprotein IIb/IIIa receptor, is designed to be administered by first responders and emergency departments as the first point of medical contact for patients with suspected segment elevation myocardial infarction (STEMI) heart attacks. The subcutaneous injection has the potential to \"transform how we treat STEMI heart attacks,” principal trial investigator Arnoud WJ van \'t Hof, M.D., Ph.D., said in a Nov. 10 press release. The company assessed the drug in its CeleBrate study, details from which were reported in a late-breaking session at the American Heart Association’s annual scientific sessions in New Orleans. The results were also published in NEJM Evidence. When administrated at the first point of medical contact, zalunfiban prompted higher levels of blood flow to the heart and a 21% reduction in the risk of a larger heart attack or one that leads to death, stroke, heart failure or other risks compared to placebo, according to CeleCor. As well as succeeding on its efficacy endpoints, the drug also hit on safety, as it didn’t significantly increase major bleeding. With the CeleBrate data in hand, CeleCor looks to file its prospect for FDA approval in early 2026, the company said.About 750,000 people in the U.S. each year experience STEMI heart attacks, which are the most severe form of heart attack and are caused by blood clots that block blood flow to a portion of the heart. Typically, emergency care for this heart attack centers on opening the coronary artery as soon as possible to prevent death or irreversible heart damage.However, the urgency this procedure necessitates poses a problem for those who live in rural areas or otherwise don’t have a hospital with a percutaneous coronary intervention (PCI) nearby. Eighty-three percent of U.S. STEMI patients who are transferred to a PCI center from another hospital don’t arrive in time to receive effective treatment, making for a three- to fourfold higher death rate, according to CeleCor.Each minute that a coronary artery blood vessel remains closed heightens the risk of irreversible damage to the heart muscle, which can later result in heart failure. Zalunfiban, meanwhile, reaches its maximal effect within 15 minutes and wears off in about two hours. By the time the drug does wear off, it is “no longer needed, because by that time the cardiologists in the hospital have opened the artery and inserted a stent to keep the artery open,” Rockefeller University’s vice president for medical affairs Barry S. Coller, M.D., explained. Coller invented zalunfiban and co-founded CeleCor in 2017 with the sole purpose of improving the treatment of STEMI heart attacks.

AHA会议临床3期上市批准

100 项与 Zalunfiban 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
ST段抬高心肌梗死	临床3期	美国	CeleCor Therapeutics, Inc.	2021-04-24
ST段抬高心肌梗死	临床3期	加拿大	CeleCor Therapeutics, Inc.	2021-04-24
ST段抬高心肌梗死	临床3期	捷克	CeleCor Therapeutics, Inc.	2021-04-24
ST段抬高心肌梗死	临床3期	法国	CeleCor Therapeutics, Inc.	2021-04-24
ST段抬高心肌梗死	临床3期	匈牙利	CeleCor Therapeutics, Inc.	2021-04-24
ST段抬高心肌梗死	临床3期	墨西哥	CeleCor Therapeutics, Inc.	2021-04-24
ST段抬高心肌梗死	临床3期	荷兰	CeleCor Therapeutics, Inc.	2021-04-24
ST段抬高心肌梗死	临床3期	罗马尼亚	CeleCor Therapeutics, Inc.	2021-04-24
冠状动脉疾病	临床2期	荷兰	CeleCor Therapeutics, Inc.	2020-06-02
冠心病	临床1期	美国	CeleCor Therapeutics, Inc.	2019-02-18

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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


NCT04825743 (CELEBRATE, Pubmed \| NEJM Evid)	临床3期	ST段抬高心肌梗死	2,467	Zalunfiban 0.11 mg/kg	構鏇襯壓衊廠壓願製廠(襯選艱夢壓獵築顧壓襯) = 廠餘鹽膚窪鹽鏇衊選遞壓網鬱蓋膚鹹衊窪範鬱 (鑰壓範選衊醖壓衊獵夢 ) 更多	积极	2025-12-23
				Placebo	構鏇襯壓衊廠壓願製廠(襯選艱夢壓獵築顧壓襯) = 鬱鑰淵齋築築襯廠蓋積壓網鬱蓋膚鹹衊窪範鬱 (鑰壓範選衊醖壓衊獵夢 ) 更多
NCT04825743 (CeleBrate, PRNewswire) 人工标引	临床3期	ST段抬高心肌梗死	2,467	zalunfiban	製觸艱鏇齋鬱鹹醖襯膚(鑰蓋衊廠醖齋鑰獵壓壓) = positive 窪築鬱顧構鏇製簾鹽廠 (獵齋糧範糧蓋壓壓觸鏇 ) 更多	积极	2025-09-23
				Placebo
NCT04825743 (CELEBRATE, ESC2022)	临床2期	ST段抬高心肌梗死	27	Zalunfiban	觸範艱艱窪鹹觸獵壓製(鑰繭鹽積壓顧鏇觸繭願) = 範積獵築範遞積鑰窪襯製衊範醖憲構鬱製築積 (齋齋齋繭網顧積範醖鑰 )	-	2022-03-18
ISTH2021	临床1期	ST段抬高心肌梗死	-	RUC-4 (Zalunfiban)	簾糧積範壓繭積築醖構(鏇膚膚齋衊鬱鹹繭構築) = 廠鹽壓夢齋餘鬱膚願淵顧醖鹹構範壓鹽淵鬱糧 (獵製築鹹齋繭夢製蓋繭 )	-	2021-07-17