Portal hypertension (an increase in blood pressure in the portal vein that carries the blood from the intestine and spleen to the liver) underlies most of the serious complications of liver cirrhosis. This randomised placebo controlled study in people with liver cirrhosis evaluates the acute effects serelaxin (RLX030) infusion on portal hypertension and liver blood flow.

开始日期2017-10-18

申办/合作机构

The University of Edinburgh

[+2]

NCT02625922

/ Terminated临床2期

A Multicenter, Randomized, Double-blind, Crossover Placebo-controlled Phase II Study to Assess the Effect of Serelaxin Versus Placebo on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure After Exercise When Used in Addition to Standard of Care

This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.

开始日期2016-02-05

申办/合作机构

Novartis Pharmaceuticals Corp.

PER-023-15

/ Completed临床3期

A MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO- CONTROLLED PHASE IIIB STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SERELAXIN WHEN ADDED TO STANDARD THERAPY IN ACUTE HEART FAILURE PATIENTS

开始日期2015-10-22

申办/合作机构-

100 项与 Serelaxin 相关的临床结果

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100 项与 Serelaxin 相关的转化医学

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100 项与 Serelaxin 相关的专利（医药）

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项与 Serelaxin 相关的文献（医药）

2025-12-01·EUROPEAN JOURNAL OF HEART FAILURE

Clinical Profiles and Prognostic Impact of Residual Intravascular and Tissue Congestion in Acute Heart Failure

Article

作者: Davison, Beth A. ; Felker, G. Michael ; O'Conner, Christopher M. ; Cleland, John G.F. ; Greenberg, Barry ; Voors, Adriaan A. ; Givertz, Michael M. ; Voordes, Geert H.D. ; Pang, Peter S. ; Gimpelewicz, Claudio ; Teerlink, John R. ; Metra, Marco ; Filippatos, Gerasimos ; ter Maaten, Jozine M. ; Ceelen, Daan C.H. ; Cotter, Gad

Abstract:

Aims:

Residual congestion (RC) is common at discharge after acute decompensated heart failure (ADHF) and is associated with early mortality and rehospitalization. The prognostic value of distinct RC phenotypes (i.e. intravascular and tissue congestion) remains unclear. This analysis investigated RC phenotypes and their outcomes.

Methods and results:

Patients with congestion at admission from two large ADHF trials, PROTECT (rolofylline; index) and RELAX-AHF-2 (serelaxin; replication), were classified based on clinical signs at day 7/discharge as intravascular (jugular venous pressure) or tissue (pulmonary rales/peripheral oedema) congestion, each alone, combined or neither. Cox regression assessed 180-day mortality after adjusting for risk factors. Overall, 1557 patients with predominantly combined (i.e. tissue and intravascular) congestion at admission were included, with a median age of 72 years. By day 7 or discharge, 580 (37%) patients had RC. In these patients, intravascular congestion (n = 260; 45%) was most common, followed by combined (n = 185; 32%) and tissue (n = 135; 23%) congestion. During hospitalization, patients with solely intravascular RC had greater diuretic responses, shorter hospital stays and received lower doses of intravenous loop diuretics than those with tissue or combined congestion (all p < 0.05). Residual intravascular and tissue congestion were independently associated with increased 180-day mortality (hazard ratio [HR] 1.69, 95% confidence interval [CI] 1.15–2.49, and HR 2.07, 95% CI 1.25–3.41, respectively) compared to decongested patients. In the RELAX-AHF-2 substudy (n = 476), similar findings were observed.

Conclusions:

Patients with intravascular RC had better diuretic responses and shorter hospital stays than those with tissue/combined RC, but worse outcomes than decongested patients. This study highlights the importance of RC assessment to identify at-risk patients. Future studies should evaluate phenotype-guided treatments.

2025-10-01·JACC-Heart Failure

Clinical Presentation, Biomarker Trajectories, and Outcomes in Women and Men Hospitalized for Acute Heart Failure

Article

作者: Voors, Adriaan A ; Felker, G Michael ; Teerkink, John R ; Metra, Marco ; Qin, Hailun ; Gimpelewicz, Claudio ; Ravera, Alice ; Adamo, Marianna ; Ter Maaten, Jozine M ; Santema, Bernadet T ; Cotter, Gad ; Filippatos, Gerasimos S ; Ponikowski, Piotr ; Pang, Peter S ; Davison, Beth A ; Greenberg, Barry H ; Severin, Thomas

BACKGROUND:

Previous studies have shown important but sometimes heterogeneous differences between women and men with heart failure (HF).

OBJECTIVES:

This study aims to investigate sex differences in the phenotype and journey of men and women in a large contemporary acute heart failure (AHF) cohort.

METHODS:

The authors analyzed 6,545 AHF patients (40% women) enrolled in RELAX-AHF-2 (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF).

RESULTS:

Women were older (78 vs 72 years; P < 0.001) and had higher ejection fraction (45% vs 35%; P < 0.001). During hospitalization, women received lower diuretic doses (furosemide equivalent through day 5: 200 vs 240 mg intravenous; P < 0.001) and achieved lower weight loss (relative; P = 0.026), with slightly lower diuretic response (-0.33 vs -0.36 kg/40 mg furosemide at day 5; P = 0.011) and similar sign and symptom improvement by day 5 compared with men (all adjusted P > 0.05). More women experienced worsening renal function by day 5 (WRF; adjusted HR: 1.24 [95% CI: 1.06-1.46]; P = 0.009). Women experiencing WRF had increased risk of 180-day cardiovascular death and rehospitalizations for HF or renal failure (RF) and of rehospitalizations for HF/RF compared with men and women without WRF (adjusted P for interaction: P < 0.001). Incidence of other outcomes was similar in women and men (all P > 0.20).

CONCLUSIONS:

During an AHF hospitalization, women received lower doses of loop diuretic agents and achieved less weight loss with slightly lower diuretic response compared with men, despite similar symptom relief and postdischarge outcomes. Early incident WRF was more frequent in women and was associated with worse 180-day outcomes. (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF [RELAX-AHF-2]; NCT01870778).

2025-07-01·EUROPEAN JOURNAL OF HEART FAILURE

End-organ Protective Effect of Serelaxin in Patients Hospitalized for Heart Failure: Results of the Biomarker Substudy of Relaxin in Acute Heart Failure-2 (RELAX-AHF-2)

Article

作者: Voors, Adriaan A. ; Postmus, Douwe ; Davison, Beth A. ; Metra, Marco ; Gimpelewicz, Claudio ; Beldhuis, Iris E. ; Felker, G. Michael ; Cotter, Gadi ; Pang, Peter S. ; Teerlink, John R. ; Greenberg, Barry H. ; Ponikowski, Piotr ; Filippatos, Gerasimos

Abstract:

Aims:

Serelaxin is recombinant human relaxin-2, a hormone responsible for haemodynamic adaptations and organ protection in pregnancy. In the RELAX-AHF trial, serelaxin demonstrated reductions in cardiac, renal and hepatic damage. In RELAX-AHF-2, organ damage-related biomarkers were assessed in a biomarker substudy.

Methods and results:

Patients enrolled within 16 h of presentation for heart failure hospitalization were randomized to 48-h infusions of either serelaxin (30 μg/kg/day) or placebo, and plasma samples were obtained at baseline, 2, 5, and 14 days in patients participating in the biomarker substudy. Of the 6545 patients analysed in RELAX-AHF-2, 1020 (15.6%) patients (mean age 72 ± 12 years; 61% male) were enrolled in the biomarker substudy. Compared to placebo, serelaxin decreased percentage change from baseline in troponin T through day 14 (serelaxin +0.2% vs. placebo +40.3%; p = 0.042), as well as creatinine (−0.8% vs. +5.8%; p = 0.002), cystatin C (+3.8% vs. +8.3%; p = 0.016), and uric acid (+0.8% vs. +7.2%; p = 0.0014) at day 2. The decrease of N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to day 2 was greater in serelaxin-treated patients (−39.8% vs. −27.6%; p = 0.002). Early changes in NT-proBNP and troponin, but not creatinine, cystatin C and uric acid, were associated with 180-day mortality. In this substudy population, serelaxin did not reduce 180-day cardiovascular death (hazard ratio [HR] 0.78; 95% confidence interval [CI] 0.49–1.25; p = 0.30), but significantly reduced worsening heart failure through day 5 (HR 0.55; 95% CI 0.33–0.93; p = 0.027).

Conclusion:

In this substudy, serelaxin decreased plasma concentrations of cardiac, renal and hepatic injury markers. Changes of most of these markers were associated with cardiovascular mortality. In this pre-specified biomarker subgroup, serelaxin did not reduce 180-day cardiovascular mortality but significantly reduced worsening heart failure through day 5.

项与 Serelaxin 相关的新闻（医药）

2026-02-10

·FierceBiotech

AstraZeneca relaxed about relaxin drug\'s poor efficacy in phase 2 heart failure trial

AstraZeneca shared news it cut AZD3427 from its pipeline alongside the removal of two other new molecular entities.\n AstraZeneca executives have told Fierce Biotech they still see potential in harnessing the relaxin hormone to treat heart failure despite abandoning work on one of two clinical-stage candidates. As part of its full-year 2025 financial results (PDF), the U.K.-based Big Pharma revealed that it removed a long-acting relaxin-2 analog called AZD3427 from its pipeline, citing underwhelming efficacy in a phase 2 trial.There is a history of studying relaxin in cardiovascular settings—Novartis started a phase 3 heart failure trial of a recombinant relaxin-2 peptide in 2013—but preclinical evidence of the molecule’s vasodilatory, anti‐inflammatory and antifibrotic effects has yet to translate into clinical success.AstraZeneca identified the short half-lives of earlier candidates as a potential cause of the failures. To fix the problem, the company created a relaxin-2 mimic fusion protein and attached a fragment to create a candidate with a half-life measured in days rather than hours. However, AstraZeneca has now stopped development of AZD3427 after completing a phase 2 trial in 260 people with heart failure. While AZD3427 has been sunk by efficacy, the company is continuing to develop the oral relaxin drug candidate AZD5462. AstraZeneca has called (PDF) the candidate the first small molecule targeting relaxin biology to enter clinical trials. Data from a phase 2b trial of stable patients with chronic heart failure are due in the second half of 2026.During a press conference this morning, Sharon Barr, Ph.D., executive vice president of biopharmaceuticals R&D at AstraZeneca, told Fierce the company is moving forward with AZD5462 “because we think this is a potentially important molecule.”“One of the things that we have learned from competitor studies is that dosing matters,” Barr continued. “You really have to find that perfect space between efficacy and congestion, and we think we\'ve put in the hard yards to really understand the posology there, and we\'re moving forward with our existing program.”AstraZeneca CEO Pascal Soriot also told Fierce during the call that work on the relaxin program is a case study of “what is so exciting in this industry at this present time.”Soriot pointed to the likes of ACE inhibitors and SGLT2 drugs as examples of the progress made in recent years to treat specific groups of cardiovascular patients.“There\'s more and more of those technologies, and we need just to pick the right products to really help patients with heart disease,” the CEO added. AstraZeneca disclosed its discontinuation of AZD3427 alongside the removal of two other new molecular entities from the pipeline. The drugmaker confirmed the removal of AZD0233, a CX3CR1 modulator that was in development as a treatment for dilated cardiomyopathy. AstraZeneca terminated a phase 1 trial of the candidate last month over an adverse finding in a nonclinical, chronic toxicology study.The company also revealed it had axed a COVID-19 vaccine program. AstraZeneca moved the mRNA viruslike particle vaccine program into phase 1 in late 2023. Recently, the company reported that a vaccine candidate was well tolerated compared to Pfizer and BioNTech’s Comirnaty and generated similar immunogenicity at one-third of the dosage.

$AstraZeneca relaxed about relaxin drug\'s poor efficacy in phase 2 heart failure trial$

疫苗临床2期临床1期财报

2025-11-19

·thryvtrx.com

Amy Rudolph, PhD, Joins Thryv Therapeutics’ Board of Directors to Support Portfolio Progression into Heart Failure

Montreal, Quebec – November 19, 2025 – Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for inherited cardiac arrhythmias, cardiometabolic diseases, and cardiomyopathies, today announced that new preclinical data will be presented at the American Heart Association’s Scientific Sessions 2025, taking place November 8–10 in New Orleans, Louisiana. The American Heart Association’s Scientific Sessions bring together global experts to exchange the latest advancements in cardiovascular science, clinical care, and research. Thryv Therapeutics is honored to contribute to this important dialogue with its recent research highlighting the potential of SGK1 inhibition as a novel therapeutic strategy for cardiovascular disease, including heart failure. Dr. Rudolph currently serves as Head of Global Medical Affairs and Cross-TA Medical Affairs at Boehringer Ingelheim, where she leads a global transformation to build a market-leading Medical Affairs organization focused on external engagement, digital/AI integration, evidence generation, advanced analytics, and learning. “We are thrilled to welcome Amy Rudolph to our Board of Directors,” said Paul Truex, Chairman and CEO of Thryv Therapeutics. “Her extensive experience in medical affairs, evidence generation, and cross-functional drug development will be invaluable as we progress our SGK1 inhibitor pipeline toward late-stage clinical studies.” “We are also deeply grateful to Scott Weiner for his many contributions to the Board of Directors,” added Truex. “We’re pleased that he will remain closely involved with Thryv in an advisory capacity.” Prior to joining Boehringer Ingelheim, Dr. Rudolph held leadership roles at Novartis Pharmaceutical Corporation, where she served as Head of HCS (Healthcare Systems) Partnerships in Global Drug Development and Head of Evidence and Launch Excellence in Global Medical Affairs. Earlier in her career, she held key positions at Pfizer Inc., where she was responsible for the atherosclerosis and stroke platforms, early development, and licensing/technology evaluations, and began her scientific career with G.D. Searle/Pharmacia/Pfizer. Over the course of her career, Dr. Rudolph has played key roles in the development and launch of multiple cardiovascular therapies, including Inspra, Eliquis, Lipitor, Diovan, Diovan/HCT, Exforge, Tekturna, and Entresto, as well as in the development of Serelaxin and Amturnide. Dr. Rudolph earned her Ph.D. in Biochemistry and Molecular Biology from Washington University in St. Louis and is an inventor on 13 patents and numerous scientific publications spanning preclinical research, drug development, and real-world evidence. “I am honored to join Thryv Therapeutics’ Board of Directors,” said Amy Rudolph. “Thryv’s science and patient-centered mission resonate deeply with me, and I look forward to supporting the company’s continued progress in addressing serious cardiovascular conditions.” Dr. Rudolph joins the Board of Directors as Scott Weiner, who has served as a valued member since 2021, transitions to an observer role. Mr. Weiner will remain on the Board of Directors of the company’s subsidiary, Thryv Therapeutics USA, Inc., while also serving as an advisor to the company. About Thryv’s SGK1 Inhibitor Platform Thryv Therapeutics is advancing a portfolio of potent and selective SGK1 (serum and glucocorticoid-regulated kinase 1) inhibitors that target the fundamental mechanisms driving electrical and structural remodeling in the heart. THRV-1268, the company’s lead clinical candidate, is a best-in-class, highly selective SGK1 inhibitor with the potential to transform the treatment landscape for Long QT Syndrome (LQTS), heart failure (HF), and atrial fibrillation (AFib)—three serious cardiac conditions with urgent unmet medical needs. About Thryv Therapeutics Inc. Thryv Therapeutics Inc. is a privately owned company based in Montreal, Quebec, Canada. Thryv is pioneering a precision medicine approach to treat genetic channelopathies, cardiometabolic diseases, and cardiomyopathies with potent and highly selective inhibitors of serum glucocorticoid inducible kinase 1 (SGK1). For more information, please visit www.thryvtrx.com. Media Inquiries brittany@thryvtrx.com | 514 973 0915

高管变更AHA会议

2025-11-03

·大药时记

FDA一周回顾：FDA降低生物仿制药上市门槛等

美国卫生与公共服务部（HHS）近日批准包括默沙东、BMS等在内的八家制药企业，参与一项创新的340B药品折扣返利试点项目。340B Rebate Model Pilot Program（340B返利模式试点项目）于2025年7月底宣布推出。这是一个自愿性试点，旨在测试从传统的预付折扣（up-front discounts）模式向售后返利（post-sale rebates）模式的转变。该项目最初仅适用于CMS（医疗保险和医疗补助服务中心）Medicare药物价格谈判选定药物列表上的特定药品。试点旨在评估这种模式的优缺点，并解决合规问题，如重复折扣（duplicate discounts）和药品转移（diversion）。新试点转向售后返利（post-sale rebates）是合格实体先以全价（WAC）通过批发商账户购买药品，随后，在药品分发给合格患者后45天内提交索赔级数据（claim-level data，包括服务日期、处方号、NDC代码、数量等）。制造商在收到数据后10天内支付单位级返利，以实现等同于天花板价格的净效果。制造商需承担所有IT和行政成本，提供至少60天通知和技术支持，并通过HRSA批准的平台处理。双方需维护可审计记录，HRSA将进行审计以确保合规。 Kyverna的CD19靶向CAR-T免疫疗法KYV-101在全身性重症肌无力（gMG）临床2期试验中达到了100%的缓解率。此次公布的中期数据来自KYSA-6研究，该研究为一项单臂、开放标签的注册性临床试验，旨在评估KYV-101对患者日常生活能力的改善情况。截止目前，六名中重度全身性重症肌无力（gMG）患者已完成评估，且此前未对免疫抑制剂产生反应。根据Kyverna的说明，经过36周治疗，这六名患者的日常生活能力均实现了临床意义上的改善，相较于基线水平明显提升。所有患者都达到了疗效反应标准，定义为在两个疾病评分指标中至少减少3分。中期数据显示，KYV-101或能减轻患者的治疗负担。所有患者在24周后都可停止使用非甾体免疫抑制剂、高剂量激素及其他辅助药物。安全性方面，Kyverna报告称KYV-101耐受性良好，未出现高等级的细胞因子释放综合征（CRS）或免疫效应细胞相关神经毒性（ICANS）病例。不过有一名患者出现了4级（生命威胁性）中性粒细胞减少症。Kyverna认为这一不良反应是预期之中的，且该患者在数据截止时已改善至1级。公司计划将KYSA-6的三期临床试验纳入后续阶段，预计今年底开始患者招募。 Regenron计划在美国建立或扩建多个生产基地，以满足其创新药物和生物制剂的生产需求。 Tectonic Therapeutic公布了其长效Fc-relaxin融合蛋白TX45在HFrEF（射血分数减低型心力衰竭）伴肺动脉高压（PH-HFrEF）患者中的第二组1b临床试验的初步积极结果。数据显示，单次静脉注射TX45在该患者群体中具有良好的耐受性，并显著改善了左心功能和肺血流动力学指标。该试验特别关注联合前后毛细血管性肺动脉高压（CpcPH）且肺血管阻力（PVR）超过3 WU的患者，主要终点设在这一亚组。该开放标签的阶段b试验共纳入14名PH‑HFrEF患者，具体包括：7名符合CpcPH（PVR>3 WU）标准的患者，5名PVR>2 WU且<3 WU的患者，以及2名单纯的后毛细血管性肺动脉高压（IpcPH，PVR<2 WU）患者。血流动力学监测结果显示，TX45的给药在改善左心功能和肺血管状态方面均取得了显著成效，尤其是在严重病理状态的CpcPH患者中。肺毛细血管楔压（PCWP）平均下降29.2%，表明左心压力得到有效缓解；PVR（肺血管阻力）在PVR>3 WU的患者中下降了19.7%，在PVR>2 WU且<3 WU的患者中下降了10.3%，显示出明显的血管扩张作用；其他血流动力学指标如心排血量（CO）、总肺血阻力（TPR）和平均肺动脉压（mPAP）也呈现出改善趋势。 BridgeBio宣布其在治疗遗传性甲状腺疾病方面的最新临床数据表现优异，推动股价再上涨近8%。接受encaleret治疗的患者中，有76%在第24周达到了目标血钙水平，而对照组的患者仅有4%。这一结果远超市场预期，也优于第二期临床数据显示的69%的血钙控制率。结果显示，药物不仅达到了预期的血钙调节目标，还降低了尿钙排泄。在关键次要指标方面，有91%的患者在第24周实现了完整的内源性甲状腺激素（PTH）水平控制。Encaleret 是一种研究性药物，用于治疗常染色体显性低钙血症 1 型 (ADH1) 等疾病，其作用机制是作为钙敏感受体 (CaSR) 的选择性拮抗剂。 FDA正式拒绝Regeneron的高剂量Eylea预充填注射器的审批请求。主要原因是负责生产的第三方工厂存在合规问题，包括持续未解决的污染和预防措施不足。早在第二季度财报中Regeneron曾暗示其Eylea HD申请遇到问题，指出在由诺和诺德运营的某生产基地观察到异常情况。随后，公司披露FDA将这些审批决定推迟至第四季度。近日，诺和诺德通知Regeneron，该工厂已被FDA归类为“正式行动指示（Official Action Indicated）”，显示该工厂存在“不可接受的合规状态”，包括持续的污染和预防措施不足等问题。 Aldeyra宣布放弃RASP调节剂ADX-629的研发。该药曾被研究用于多种免疫介导疾病，包括哮喘、慢性咳嗽和特应性皮炎。然而，尽管在一项II期酒精相关肝炎研究中，ADX-629显示出改善肝功能和炎症指标的统计学意义，但公司决定终止其研发。公司同时公布了相关临床数据，显示药物在改善肝功能方面具有一定效果，且安全性良好，未出现严重不良反应。公司未明确说明终止ADX-629的具体原因，但资金压力可能是重要因素之一。与此同时，Aldeyra还宣布将推进两款新一代RASP调节剂，以替代现有的老一代分子。比如，在涉及肥胖和高甘油三酯血症的代谢性炎症领域，公司将重点开发ADX-248。在一项I期临床试验中，ADX-248表现出良好的药代动力学特性，药物在体内的暴露水平高，且每日口服剂量安全有效。这款新药将取代另一款候选药物ADX-743。默沙东的口服小分子HIF-2α抑制剂Welireg在两项针对早期肾癌患者的III期临床试验中取得主要终点。试验中，将Welireg作为辅助治疗加入Keytruda（帕博利单抗），手术切除后显著延长了患者的无疾病生存期（DFS），优于单独使用Keytruda。在另一项试验中，Welireg与卫材（Eisai）旗下的Lenvima（仑伐替尼）联合治疗复发患者，也优于Cabometyx（卡博替尼），在延缓疾病进展方面表现更佳。Welireg的建议零售价为每月3万美元，治疗周期54周。 FDA正式宣布暂停Intellia Therapeutics的两项III期临床试验，MAGNITUDE和MAGNITUDE-2研究。这两项试验正在评估由CRISPR基因编辑技术修饰的基因疗法nexiguran ziclumeran（nex-z）在治疗转甲状腺素淀粉样变（ATTR）伴心肌病（ATTR-CM）和多发性神经病（ATTR-PN）中的安全性和有效性。虽然FDA目前仅以口头通知暂停决定，但预计将在未来30天内发出正式书面通知。公司首次披露安全信号时称一名MAGNITUDE试验受试者出现转氨酶和胆红素水平升高，达到4级（即生命威胁级别），并于9月30日记录在案，患者随后住院接受治疗。在此之前，2022年8月，Intellia在一项早期临床试验中也曾报告过类似的肝酶升高事件，虽为无症状且在28天内自行缓解，但显示出nex-z在安全性方面存在一定风险。去年5月，公司还曾披露另一名患者出现4级肝酶升高反应，但当时未暂停试验，届时分析师对此普遍持较为轻松的态度。 FDA公布了一份关于生物仿制药的新草案指南。HHS表示，这一政策有望让仿制生物药在无需进行繁琐的人体试验的情况下上市，从而借助市场力量降低药品价格。FDA正考虑简化仿制药的审批流程，旨在推动药价下降，减少行政壁垒。官方指出，免除高昂的临床试验将有助于加快仿制药的研发和上市速度，为患者提供比品牌药更经济的治疗选择。新指南提出多项变革措施，旨在“简化生物相似性研究”，为那些与已获批准的参考药品高度相似、可互换的仿制药提供“更便捷的许可途径”。按照新框架，企业可能无需每次都进行大规模、高成本的人体试验，只要仿制药的效果和安全性与原研药相当。虽然申请仿制药上市的企业仍需证明其产品具备与原药的互换性，但在新指南中，FDA将决定是否需要进行比较疗效研究（CES），即比较两药在临床中的实际疗效。也可能认定，只需依靠临床前和生化数据的“比较分析”即可。指南建议，在仿制药与参考药品由克隆细胞生产、纯度高且可以通过临床前检测直接比对的情况下，可以采用更“简洁”的审批流程。不过FDA也明确表示，在某些特殊情况下，仍需进行人体试验，比如局部用药（如眼药）或以非临床终点评估疗效的药物。诺华发布的NEPTUNUS-1和NEPTUNUS-2两项III期临床试验数据显示，其全人源抗 BAFF-R 单克隆抗体ianalumab在干燥综合征患者中表现出显著的疗效，成功降低了疾病的活跃程度和患者的生活负担。干燥综合征是第二常见的风湿性自身免疫疾病，目前尚无专门的靶向治疗药物。Ianalumab具有双重作用机制：既能耗竭B细胞，又能靶向BAFF受体。这一假设得到了临床数据的验证。数据显示，到第16周时，ianalumab相较于安慰剂，显著改善了疾病活跃度，且这一效果持续至第52周，达到了欧洲风湿病联盟（EULAR）制定的疾病活动指数（ESSDAI）主要终点指标。同时，患者在干燥、疼痛和疲劳等主要症状方面也持续获益。 FDA正式批准了拜耳研发的全新非激素性药物Lynkuet，用于治疗绝经后女性的中重度热潮红。该药基于三项大规模临床试验，成功证明其能显著减少热潮红的频率和严重程度，改善患者的生活质量。血管运动症状主要在绝经期及其后出现，表现为热潮红、夜汗等不适。这些症状由雌激素水平下降引发，持续时间不一，严重影响女性的日常生活和工作效率。虽然激素替代疗法（HRT）曾是主流治疗手段，但并非所有女性都适用，部分人因潜在健康风险选择放弃。市场上另一款非激素药物Veozah由安斯泰来制药于2023年推出，但由于市场需求未达预期，加之出现肝损伤的安全警示，其商业表现受到影响。相比之下，Lynkuet的作用机制更为创新：它同时靶向调节体温的NK1和NK3两个神经激肽受体，而Veozah只作用于NK3。武田宣布已正式终止与阿斯利康合作开发的神经系统疾病项目，原因是相关疗法在二期临床试验中未达预期。该合作项目聚焦于针对α-突触核蛋白的单克隆抗体药物，名为TAK-341或MEDI1341。武田曾在全球范围内开展一项涉及159例多系统萎缩症（MSA）患者的临床试验。MSA是一种罕见的神经退行性疾病，主要由脑内神经细胞逐渐丧失引起。试验采用每四周静脉输注抗体或安慰剂的方案，旨在评估药物在52周内对患者的神经功能改善情况，主要通过修订版的多系统萎缩评分量表（Modified Unified MSA Rating Scale）衡量。该临床试验未能达到预设的主要和次要终点。最初，武田与阿斯利康的合作协议涵盖了TAK-341在多系统萎缩症和帕金森病（PD）等神经退行性疾病中的研发。然而，随着最新研发管线的调整，武田已不再列出任何帕金森相关的临床项目。尽管如此，阿斯利康的二期开发管线中仍将α-突触核蛋白单抗列为重点目标。武田还暂停了两个处于一期临床阶段的项目，其中包括GDX012（也称TAK-012-1501），这是一种由武田通过收购GammaDelta Therapeutics于2021年开发的异体γδT细胞免疫治疗药物。该药物曾在急性髓性白血病（AML）患者中进行一期/二期联合试验，但由于公司今年早些时候宣布将细胞免疫疗法作为次要方向，未来前景变得不明朗。近年来，武田对细胞免疫领域的投入明显减少。此外，武田还宣布终止用于嗜睡症的danavorexton（也称TAK-925）开发。该药物为催产素-2受体激动剂，目前仍在二期临床阶段，用于呼吸系统疾病的研究。公司表示，已停止在嗜睡症上的一期临床试验，原因是“战略考虑”。这一决定与一年前因招募缓慢而暂停danavorexton在阻塞性睡眠呼吸暂停症（OSA）等适应症的二期试验类似。 GSK宣布将放弃其在抗癌领域的CD226轴相关项目，撤回所有剩余的二期临床试验。多年来，GSK曾寄希望于利用CD226分子构建下一代抗癌药物平台。CD226主要表达在T细胞和自然杀伤（NK）细胞表面，能与肿瘤细胞表面的CD155和CD112结合，激活免疫反应。然而，免疫系统中的其他检查点如CD96、PVRIG和TIGIT会干扰这一激活过程，增加了开发难度。早在2022年，GSK便将CD226轴视为“未来免疫肿瘤学的重要潜力领域”，并启动了多项相关研发项目，试图开发针对这些免疫检查点的抑制剂，期望实现数十亿英镑的市场潜力。但今年早些时候，GSK在抗TIGIT抗体belrestotug的合作开发中遭遇重大挫折，公司不得不计提4.71亿英镑（约6.29亿美元）的资产减值。今日公布的财报显示，除了belrestotug外，其他与CD226轴相关的项目也已终止。其中包括由iTeos和23andMe合作开发的抗CD96抗体Nelistotug（GSK6097608）。GSK曾在一项针对360名复发或转移性、PD-L1阳性头颈癌患者的二期临床试验中评估该药物。该试验于2023年启动，旨在检测Nelistotug联合GSK自主研发的免疫药物Jemperli，以及已停产的抗TIGIT药物belrestotug的联合疗效。另一项被终止的项目是GSK的抗PVRIG抗体GSK4381562，该药由GSK从Surface Oncology授权获得，曾进入二期临床开发阶段。公司还在进行一项涉及141例晚期实体瘤患者的一期试验，评估GSK4381562单药及联合用药的效果。除了肿瘤学，GSK还暂停了多个传染病相关的二期临床项目。例如，面向A、B、C、W和Y血清型的第二代脑膜炎疫苗GSK4023393，主要在婴幼儿中进行评估。该决定是在公司获得FDA批准另一款针对青少年和成人的MenABCWY疫苗（商品名Penmenvy）八个月后作出的。Penmenvy目前适用于10至25岁的青少年和成人，而GSK4023393则主要针对婴幼儿。公司还终止了一款针对巨细胞病毒（CMV）感染的重组亚单位疫苗的二期开发，以及在乳糜泻研究结束后，停止了TG2抑制剂GSK3915393在肺纤维化治疗中的临床试验。在一阶段试验方面，GSK也撤回了一款名为GSK4172239的DNA甲基转移酶1抑制剂。 Edesa公布了其因商业原因中止的呼吸衰竭临床3期试验的部分关键数据。结果显示，其抗TLR4抗体在改善新冠引发的急性呼吸窘迫综合征（ARDS）患者的生存率和康复方面，具有一定的潜力。此次试验共招募约100名患者，均为因新冠导致的ARDS患者，且接受了侵入性机械通气治疗。在试验中止前，所有参与者都接受了单次静脉注射候选药物paridiprubart（也称EB05）或安慰剂。根据公布的数据，28天内，接受paridiprubart治疗的患者死亡风险为39%，而对照组为52%。在60天的随访中，paridiprubart组的死亡率为46%，对照组为59%。公司认为，这一结果达到了其主要临床终点。因安全性问题，Incyte宣布暂停BET抑制剂的研发计划。去年，诺华在一项涉及骨髓纤维化药物pelabresib的三期研究中发现，急性髓性白血病（AML）发病率出现失衡，引发了对BET抑制剂安全性的担忧。作为收购MorphoSys的一部分，诺华获得了pelabresib，但这一发现导致其推迟BET抑制剂的上市计划，并使公司面临8亿美元的减值损失。今年早些时候，FDA对Vyne Therapeutics的一款BET抑制剂进行了1b期银屑病（斑块型银屑病）临床试验的暂停，原因是在一项非临床犬只试验中观察到睾丸毒性反应。Incyte在宣布放弃INCB57643时，并未提及任何安全性担忧，而是将决定归因于“研发资源的优先调整”。亲爱的读者，如果您对生物医药的最新动态感兴趣，或希望了解更多前沿生物科技资讯，请关注公众号。您的每一次关注和转发，都是最大的支持和鼓励！ 👉 关注大药时记，掌握更多前沿生物科技！ 👉 分享文章，让更多人受益！

免疫疗法临床2期临床3期上市批准临床结果

100 项与 Serelaxin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10488	Serelaxin	C01DX21	DB05794

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
心脏衰竭	俄罗斯	-	2015-01-01

未上市

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
急性肾损伤	临床3期	荷兰	Novartis Pharmaceuticals Corp.	2010-10-05
急性失代偿性心力衰竭	临床3期	匈牙利	Novartis Pharmaceuticals Corp.	2008-02-26
肝硬化	临床2期	英国	Novartis Pharmaceuticals Corp.	2017-10-18
冠心病	临床2期	英国	Novartis Pharma Services AG	2013-09-26
食管胃静脉曲张	临床2期	英国	Novartis Pharmaceuticals Canada, Inc.	2013-04-01
代偿期肝硬化	临床2期	英国	Novartis Pharma AG	2012-11-06
纤维化	临床2期	英国	Novartis Pharma AG	2012-11-06
门静脉高血压	临床2期	英国	Novartis Pharma AG	2012-11-06
先兆子痫	临床2期	意大利	Novartis AG	2012-07-10
蛋白尿	临床2期	意大利	Novartis AG	2012-07-10

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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


NCT01979614 (Pubmed) 人工标引	临床2期	冠心病	51	serelaxin	鹹築製鹹構夢壓廠遞顧(鹽選構艱襯憲構廠蓋壓) = 範構鹽艱艱廠獵鏇構觸繭憲製膚繭齋廠鏇淵蓋 (鹹醖獵壓網憲餘鹽簾襯 ) 更多	积极	2021-01-01
				Placebo	鹹築製鹹構夢壓廠遞顧(鹽選構艱襯憲構廠蓋壓) = 憲鏇衊選築顧衊廠壓築繭憲製膚繭齋廠鏇淵蓋 (鹹醖獵壓網憲餘鹽簾襯 ) 更多
NCT02669875 (STOPP, Pubmed \| Trials)	临床2期	纤维化	15	Serelaxin	選憲膚鏇憲窪蓋鑰顧艱(範顧選艱廠夢願艱鏇選) = 顧遞積願觸糧繭鏇糧糧網憲繭鹽糧窪壓憲獵窪 (願簾鑰淵積鏇鹹網觸製, ±3.5)	-	2020-03-12
NCT01870778 (RELAX-AHF-2, Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	心脏衰竭	6,545	Serelaxin	艱鬱醖鏇鹹襯選糧觸簾(鏇鏇遞鑰淵淵構網艱餘) = 繭艱餘窪鬱襯廠鬱鹹網積鏇廠夢製鹹鑰構範齋 (網窪齋蓋襯簾構齋艱顧 ) 更多	不佳	2019-08-22
				Placebo	艱鬱醖鏇鹹襯選糧觸簾(鏇鏇遞鑰淵淵構網艱餘) = 鑰觸網鹹憲襯遞壓鑰築積鏇廠夢製鹹鑰構範齋 (網窪齋蓋襯簾構齋艱顧 ) 更多
NCT01979614 (CTgov)	临床2期	冠心病	58	Serelaxin (Serelaxin)	鹹艱齋構範襯衊築顧餘(願築築壓範構壓鏇選淵) = 淵鑰鏇範顧鏇製鬱廠遞齋製鹹襯壓製製壓積夢 (壓糧鏇淵鹽顧壓夢鹹獵, 範網網鹹艱憲鹽醖鑰遞 ~ 遞襯鹽範獵繭繭獵鹽醖) 更多	-	2019-07-01
				Placebo (Placebo)	鹹艱齋構範襯衊築顧餘(願築築壓範構壓鏇選淵) = 齋鹽襯膚觸簾淵夢淵積齋製鹹襯壓製製壓積夢 (壓糧鏇淵鹽顧壓夢鹹獵, 築築衊築齋築繭積鹹淵 ~ 築顧願鹹構願鏇製願鑰) 更多
NCT02151383 (RELAX-PEDS-PK, CTgov)	临床2期	心脏衰竭	12	Serelaxin (Serelaxin: Cohort 1)	鑰獵醖築鑰獵襯鬱製鏇 = 願遞衊選網憲築艱糧夢顧願鏇願範醖夢憲遞憲 (積製窪觸鬱齋膚鏇廠觸, 鹹顧餘範壓窪構鹽製鏇 ~ 憲蓋願遞鹽衊鬱淵繭網) 更多	-	2019-06-25
				Serelaxin (Serelaxin: Cohort 2)	鑰獵醖築鑰獵襯鬱製鏇 = 範選觸繭鹽襯衊網糧鹽顧願鏇願範醖夢憲遞憲 (積製窪觸鬱齋膚鏇廠觸, 襯襯積構觸鏇獵繭繭積 ~ 範衊壓壓襯範積糧積襯) 更多
NCT02064868 (RELAX-AHF-EU, CTgov)	临床3期	急性失代偿性心力衰竭	2,666	Standard of Care+Serelaxin (Serelaxin + Standard of Care)	鹽遞鹹簾顧窪積觸夢鹹 = 艱顧壓憲簾鬱壓衊襯鏇獵蓋齋遞積廠鹽艱顧襯 (齋製築醖網構範選簾糧, 獵選艱顧觸遞壓餘顧糧 ~ 簾衊範廠夢願餘蓋膚繭) 更多	-	2019-03-22
				Standard of Care (Standard of Care (SOC))	鹽遞鹹簾顧窪積觸夢鹹 = 簾積遞積廠遞觸鹹襯醖獵蓋齋遞積廠鹽艱顧襯 (齋製築醖網構範選簾糧, 獵衊糧醖選艱積蓋鹹糧 ~ 顧鬱憲鏇膚糧願積艱糧) 更多
NCT02064868 (RELAX-AHF-EU, Pubmed \| Eur J Heart Fail) 人工标引	临床3期	心脏衰竭	2,666	standard of care+serelaxin	蓋齋網窪簾蓋衊鹹網網(獵構蓋壓鹹衊繭夢簾壓) = 醖廠齋製鹹範鑰範蓋壓餘構築齋壓積夢鏇鬱鹽 (觸鬱餘襯鹽餘鏇襯淵蓋 )	积极	2019-03-01
				standard of care	蓋齋網窪簾蓋衊鹹網網(獵構蓋壓鹹衊繭夢簾壓) = 積鏇簾醖獵齋齋窪餘艱餘構築齋壓積夢鏇鬱鹽 (觸鬱餘襯鹽餘鏇襯淵蓋 )
NCT02625922 (RELAX-Cardio, CTgov)	临床2期	慢性心力衰竭	26	Serelaxin (Serelaxin)	鹹構夢製醖積構齋製獵(鹽窪蓋夢艱簾鹹餘憲壓) = 顧簾積築顧憲蓋積衊鹹積鹹觸艱窪艱築鬱鹹選 (窪憲積淵觸網夢壓構積, 0.64893) 更多	-	2018-09-21
				placebo (Placebo)	鹹構夢製醖積構齋製獵(鹽窪蓋夢艱簾鹹餘憲壓) = 膚糧簾廠顧遞積鏇壓廠積鹹觸艱窪艱築鬱鹹選 (窪憲積淵觸網夢壓構積, 0.60192) 更多
NCT01870778 (RELAX-AHF-2, CTgov)	临床3期	心脏衰竭	6,600	RLX030 (Serelaxin (RLX030))	廠製壓顧齋製醖蓋繭衊 = 襯膚餘繭鑰窪簾製願夢齋構鹽窪構選顧膚廠廠 (鹽壓蓋艱齋夢願鹹壓壓, 願壓鬱壓獵壓餘願遞繭 ~ 網壓範壓廠構網膚願鹹) 更多	-	2018-03-30
				Placebo (Placebo)	廠製壓顧齋製醖蓋繭衊 = 鹹夢築醖積糧窪築鑰鹽齋構鹽窪構選顧膚廠廠 (鹽壓蓋艱齋夢願鹹壓壓, 夢齋淵鏇夢蓋鏇鏇窪鏇 ~ 觸膚餘憲憲繭範網鬱鑰) 更多
NCT01979614 (ESC2017)	临床2期	冠心病	62	IV serelaxin (30 Î¼g/kg/24 h)	憲膚齋範獵積構夢鹹糧(選鹽簾淵願顧壓鬱築築) = 鑰憲鏇遞觸衊糧積醖壓壓艱簾憲蓋鏇鑰願鬱壓 (夢夢繭餘壓鏇鹽簾鹹蓋 ) 更多	不佳	2017-08-27
				Placebo	憲膚齋範獵積構夢鹹糧(選鹽簾淵願顧壓鬱築築) = 積鹹簾衊夢簾鏇壓鹹鹹壓艱簾憲蓋鏇鑰願鬱壓 (夢夢繭餘壓鏇鹽簾鹹蓋 ) 更多