RECOMPENSE: Right VEntricular COMPENsation with SotatercEpt: a Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is a progressive disease characterized by vascular remodelling resulting in elevated pressures in the pulmonary artery (PA). This elevated pressure ultimately leads to fulminant right heart failure. Current therapeutic options are limited and are centred around vasodilatory medications such as phosphodiesterase-5 inhibitors and prostacyclin. While these medications allow for the widening of blood vessels that are narrowed due to remodelling, they have no effect on the remodelling itself.
Sotatercept is a novel medication which targets the BMPR2/TGF-β pathway and restore a pro- and anti- proliferative balance to ultimately counteract vascular remodelling. Recent phase 2 and 3 trials showed that treatment with sotatercept led to lower resistance and pressure in the pulmonary vasculature and improved exercise tolerance. However, these results were not coupled with an increase in cardiac output, a change that is seen with other PAH-medications with a primarily vasodilatory effect. These results suggest that cardiac work is reduced and cardiac efficiency is improved in patients being treated with sotatercept, in contrast with conventional PAH therapies. This is a potentially beneficial effect that may result in improved disease control in the long-term. Our study aims to explore the effect of sotatercept on cardiac work and function. We hypothesize that the effects of sotatercept are more beneficial for cardiac function than that of traditional PAH medications.
All participants included in the trial will undergo a screening visit in which it will be checked that all inclusion criteria and no exclusion criteria are met. The screening visit involves a physical exam, blood draw, 6-minute walk test, right heart catheterization (RHC) and cardiac magnetic resonance imaging (cMRI) with contrast to assess fibrosis.
Upon inclusion, all participants will receive a subcutaneous injection of sotatercept starting at a dose of 0.3 mg/kg. Participants will return to the hospital every three weeks for a blood draw, physical examination and an adverse event review. If the laboratory values (specifically haemoglobin and platelet counts) stay stable after the first dose, the dosage will be escalated to 0.7 mg/kg. The dose will not be escalated beyond 0.7 mg/kg.
After 24 weeks of receiving sotatercept, there will be an end of treatment visit including a physical exam, 6-minute walk test, right heart catheterization (RHC) and cardiac magnetic resonance imaging (cMRI) with contrast material.

开始日期2025-01-01

申办/合作机构

Stichting Onderzoek Cancer Center Amsterdam

NCT06664801 / Recruiting临床2期

A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs.
The goal of the study is to learn:
* What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial.
* About the safety of sotatercept and if people tolerate it

开始日期2024-11-14

申办/合作机构

Merck Sharp & Dohme Corp.

NCT06409026 / Recruiting临床4期IIT

Effect of Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension

The purpose of this study is to see if the drug sotatercept given for 36 weeks improves the functioning of the heart and improves quality of life.

开始日期2024-07-05

申办/合作机构

Mayo Clinic

100 项与索特西普相关的临床结果

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100 项与索特西普相关的转化医学

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100 项与索特西普相关的专利（医药）

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148

项与索特西普相关的文献（医药）

2025-01-01·JOURNAL OF HEART AND LUNG TRANSPLANTATION

A new day has come: Sotatercept for the treatment of pulmonary arterial hypertension

Review

作者: Moles, Victor M ; Cascino, Thomas M ; Moles, Victor M. ; McLaughlin, Vallerie V ; Sahay, Sandeep ; Cascino, Thomas M. ; McLaughlin, Vallerie V.

Despite increasing therapeutic options and evolving treatment strategies, including targeting 3 therapeutic pathways, in the management of pulmonary arterial hypertension (PAH), morbidity and mortality have remained unacceptably high. Sotatercept is a first-in-class, novel activin signaling inhibitor approved for treating PAH based on evolving efficacy and safety evidence. This state-of-the-art review summarizes the current understanding of the mechanism of action, the impact on outcomes that improve how patients feel, function, and survive, and the safety and adverse event profile to inform readers of this breakthrough novel therapy.

2024-12-01·VASCULAR PHARMACOLOGY

Sotatercept: New drug on the horizon of pulmonary hypertension

Review

作者: Madonna, Rosalinda ; Biondi, Filippo

Sotatercept (brand name WINREVAIR, developed by Merck) is an activin receptor type IIA-Fc (ActRIIA-Fc), working by sequestering free activins. Sotatercept restores the balance between the activin proliferative pathway and the bone morphogenic protein (BMP) antiproliferative pathway in the pulmonary arterial cirulation. Sotatercept recently received approval in the USA and in Europe for the treatment of adults with pulmonary arterial hypertension (PAH) Group 1, on top of background PAH therapy to increase exercise capacity, improve WHO functional class and reduce the risk of clinical worsening events. Nevertheless, several studies are ongoing to investigate the potential adverse reactions of the drug especially at the haematological level. We provide an overview of the clinical and preclinical evidence of the targeting the activing pathway through sotatercept on the treatment of PAH. We also discuss what other possibilities there are for the application of sotatercept in the setting of pulmonary hypertension other than PAH Group 1.

2024-12-01·JOURNAL OF HEART AND LUNG TRANSPLANTATION

Efficacy and Safety of Sotatercept Across Ranges of Cardiac Index in Patients with Pulmonary Arterial Hypertension: A Pooled Analysis of PULSAR and STELLAR

Article

作者: Badesch, David B ; Souza, Rogerio ; Grünig, Ekkehard ; Gomberg-Maitland, Mardi ; Hoeper, Marius M ; Olsson, Karen M ; Kopeć, Grzegorz ; Ardeschir Ghofrani, H ; Waxman, Aaron B ; Perchenet, Loïc ; McLaughlin, Vallerie V ; Meyer, Gisela ; Cornell, Alexandra G ; Strait, James ; Preston, Ioana R ; Pena, Janethe de Oliveira ; Rosenkranz, Stephan ; Johnson-Levonas, Amy O ; Humbert, Marc ; Gibbs, J Simon R ; Xing, Aiwen

BACKGROUND:

This analysis compared effects of the activin signaling inhibitor, sotatercept, across pulmonary arterial hypertension (PAH) subgroups stratified by baseline cardiac index (CI).

METHODS:

Pooled data from PULSAR (N=106; NCT03496207) and STELLAR (N=323; NCT04576988) were analyzed using two different CI thresholds, < and ≥ 2.0 L/min/m² or 2.5 L/min/m². Median differences in change from baseline at week 24 were evaluated using Hodges-Lehmann (HL) estimator and mean differences by least squares (LS), with 95% confidence intervals and p-values; p=0.05 was significant. Categorial endpoints and time-to-clinical worsening were analyzed by Cochran-Mantel-Haenszel and Cox model (hazard ratio (HR), respectively, without multiplicity adjustment.

RESULTS:

Of 429 participants, 51 and 378 had CI <2.0 L/min/m² and ≥ 2.0 L/min/m², respectively, whereas 179 and 250 had CI <2.5 L/min/m² and ≥ 2.5 L/min/m², respectively. Across all CI subgroups, sotatercept vs placebo significantly improved median 6-minute walk distance (range: 33.9 to 63.7 m: p<0.001), pulmonary vascular resistance (range: -202.8 to -395.4 dyn•s•cm^-5; p≤0.002), and N-terminal pro-B-type natriuretic peptide (range: -317.3 to -1041.2 pg/mL; p<0.001). LS means showed reductions in pulmonary and right atrial pressures, decreased right ventricular size and enhanced tricuspid annular plane systolic excursion/ systolic pulmonary artery pressure in all subgroups. Sotatercept significantly delayed time to first occurrence of death or a worsening event in the subset of participants with CI ≥2.5 (HR 0.12; p<0.001), ≥2.0 (HR 0.13; p<0.001), and <2.5 (HR 0.21; p<0.001) L/min/m². Improvements in World Health Organization functional class (all p<0.050) and European Society of Cardiology/European Respiratory Society risk score (all p<0.001) were seen within each subgroup.

CONCLUSIONS:

Efficacy and safety were consistent across baseline CI subgroups, supporting use of sotatercept in PAH patients irrespective of baseline cardiac hemodynamics.

275

项与索特西普相关的新闻（医药）

2024-12-16

·BiG生物创新社

2024年FDA批准的重磅大分子药物

随着医学科技的迅猛发展和创新药物研发的不断深入，2024年再次见证了FDA在药物审批方面的重大进展。这一年，FDA批准了多种新药上市，这些药物不仅为患者带来了全新的治疗方案，更在疾病治疗领域取得了突破性进展。作者｜momo 相关阅读：2024年FDA批准的重磅小分子药物表1. FDA批准的17种大分子药物截至2024年12月16日，FDA已经批准44款新药上市，其中包括17款生物大分子药物（图1），在获批的生物大分子药物中，单抗药物依旧是创新主力，以59%（10款）的占比遥遥领先；其次是双抗，有3款（占比17%）；蛋白类药物2款（占比12%）；小核酸药物和甲状旁腺激素类似物各1款（分别占比6%）。图1. 2024 年 FDA 批准生物大分子药物类型本文将对2024年FDA批准上市的生物大分子药物进行详细介绍，探讨其在各自疾病领域的重要性及潜在影响。 1.Letybo（letibotulinumtoxinA-wlbg）适应症：中度至重度眉间纹的外观改善靶点：BoNT/A 批准日期：2024年2月29日企业：Hugel Inc. Letybo是一种乙酰胆碱释放抑制剂和神经肌肉阻滞剂，通过肌肉内注射，用于暂时改善成年患者与皱眉肌和/或降眉肌活动相关的中度至重度眉间纹外观。Letybo获得FDA的批准得到了三项已完成的3期试验的积极结果支持，这些试验在美国和欧洲招募了1000多名受试者。Letybo的临床试验结果证明了其在治疗眉间纹方面的有效性和安全性。 2.Tevimbra （tislelizumab-JSGR）适应症：不可切除、局部晚期或转移性食管鳞状细胞癌靶点：PD-1 批准日期：2024年3月13日企业：百济神州 Tevimbra是一款人源化IgG4抗PD-1单克隆抗体，设计目的旨在最大限度地减少与巨噬细胞中的Fcγ受体结合，帮助人体免疫细胞检测和对抗肿瘤细胞。用于治疗既往接受过全身化疗（不包括PD-1或PD-L1类疗法），患有不可切除或转移性食管鳞状细胞癌（ESCC）的成年患者。这是Tevimbra首次在美国获批。Tevimbra于2023年获得欧盟委员会批准用于治疗既往曾接受过化疗的晚期或转移性ESCC患者，并于2024年2月获得欧洲药品管理局（EMA）人用药品委员会的推荐，用于治疗非小细胞肺癌。在中国，该疗法已有12个适应症获得批准。 3.Winrevair （sotatercept-CSRK）适应症：肺动脉高压靶点：INHBA 批准日期：2024年3月26日企业：默克 Winrevair是一款“first-in-class”的IIA型激活素受体（ActRIIA）融合蛋白。它将ActRIIA经过改造的细胞外域与抗体的Fc端融合在一起。它可以阻断激活素与细胞膜上的受体结合，从而降低激活素介导的信号传导。用于治疗肺动脉高压（PAH）患者。Winrevair是默沙东于2021年以约115亿美元收购Acceleron Pharma公司获得的关键疗法。值得一提的是，这款疗法被行业媒体Evaluate评为2024年有望获批的潜在重磅疗法之一。 4.Anktiva （nogapendekin alfa inbakicept-pmln）适应症：膀胱癌靶点：IL-15R 批准日期：2024年4月22日企业：Altor Bioscience Corp. Anktiva是一款IL-15超级激动剂。IL-15通过影响自然杀伤（NK）细胞和免疫T细胞的发育、维持和功能，在免疫系统中发挥着至关重要的作用。Anktiva由与IL-15受体α/IgG1 Fc融合蛋白结合的IL-15突变体（IL-15N72D）组成。用于治疗对BCG无应答且伴有原位癌（CIS）的非肌层浸润性膀胱癌（NMIBC）成年患者。Anktiva在2019年获FDA授予突破性疗法认定，用于与BCG联合治疗此前对BCG应答不佳的非肌层浸润性原位膀胱癌患者。此外，行业媒体Evaluate在今年初将这款疗法列为今年有望获批的10款潜在重磅疗法之一。 5.Imdelltra （tarlatamab-dlle）适应症：广泛期小细胞肺癌靶点：CD3E、DLL3 批准日期：2024年5月16日企业：安进 Imdelltra是一款“first-in-class”双特异性抗体（bsAbs），通过结合肿瘤细胞上的 DLL3 蛋白和 T 细胞上的 CD3 抗原，激活人体的免疫细胞并诱导表达 DLL3 的癌细胞被破坏。用于治疗铂类化疗期间或之后疾病进展的广泛期小肺癌（SCLC）患者。Imdelltra在今年5月获FDA加速批准用于治疗ES-SCLC成人患者，他们在接受化疗时或之后出现疾病进展。值得一提的是，Imdelltra是首款用于治疗实体瘤的获批BiTE疗法。 6.Rytelo （imetelstat）适应症：低危骨髓增生异常综合征伴输血依赖性贫血靶点：Telomerase 批准日期：2024年6月6日企业：Geron Corp. Rytelo是一款“first-in-class”的寡核苷酸端粒酶抑制剂，通过抑制端粒酶活性，抑制癌变干细胞和祖细胞不可控制的增殖，导致癌变细胞的凋亡。用于治疗患有低风险至中等-1风险的骨髓增生异常综合征（MDS）成年患者。Rytelo是40年来首个获美国FDA批准的端粒酶靶向疗法。Rytelo被行业媒体Evaluate列为今年10大潜在重磅疗法之一。 7.Piasky （crovalimab-akkz）适应症：阵发性睡眠性血红蛋白尿症靶点：C5 批准日期：2024年6月20日企业：Sino-Foreign Pharmaceutical Co., Ltd. Piasky是一款靶向补体蛋白C5的可循环使用人源化单克隆抗体，能够阻止C5裂解为C5a和C5b，阻止终末补体通路，从而防止红细胞在阵发性睡眠性血红蛋白尿症（PNH）等疾病中的破坏。用以治疗阵发性睡眠性血红蛋白尿症（PNH）患者。Piasky是PNH的首个每月皮下注射治疗药物，且患者可以选择在受监督的医疗机构之外进行自我给药。 8.Kisunla（Donanemab-azbt）适应症：阿尔茨海默病靶点：pGlu3Aβ 批准日期：2024年7月2日企业：礼来 Kisunla是一款靶向β淀粉样蛋白（Aβ）的单克隆抗体，它能与N3pG的淀粉样蛋白亚型特异性结合，从而促进淀粉样斑块的清除。用于治疗出现早期症状的阿尔茨海默病（AD）的成年人。Kisunla是首个有证据表明在淀粉样斑块清除后可停止治疗的淀粉样斑块靶向疗法。2021年6月，Donanemab被FDA授予突破性疗法认定。 9.Yorvipath（palopegteriparatide）适应症：甲状旁腺功能亢进靶点：PTH1R 批准日期：2024年8月9日企业：Ascendis Pharma. Yorvipath是一种长效甲状旁腺激素（PTH）前药，旨在将甲状旁腺功能减退（HP）患者的PTH恢复至生理水平，以解决HP导致的血钙含量降低、血液磷酸盐水平升高等问题。用于治疗成人慢性甲状旁腺功能减退。该产品为甲状旁腺功能减退的首款激素替代疗法。 10.Nemluvio（nemolizumab-ilto）适应症：结节性痒疹靶点：IL-31 批准日期：2024年8月12日企业：Galderma Pharma. Nemluvio是一种”first-in-class”单克隆抗体，它通过与IL-31受体α相结合，可以阻断IL-31的信号通路，用于治疗成人结节性痒疹（prurigo nodularis）患者。Nemluvio是首款获得FDA批准用以抑制IL-31信号的单克隆抗体，它曾在2019年获得美国FDA授予突破性疗法认定，并在今年2月获得治疗结节性痒疹的优先审评资格。 11.Niktimvo（axatilimab-csfr）适应症：慢性移植物抗宿主病靶点：CSF-1R 批准日期：2024年8月14日企业：Incyte/Syndax制药 Niktimvo是一种靶向集落刺激因子-1受体（CSF-1R）的单克隆抗体，用于治疗慢性移植物抗宿主病（cGVHD）成人和体重40公斤以上的儿科患者。Niktimvo是全球首个获得批准用于治疗慢性移植物抗宿主病（GVHD）的CSF-1R单克隆抗体疗法。 12.Ebglyss（lebrikizumab-lbkz）适应症：中度至重度特应性皮炎靶点：IL-13 批准日期：2024年9月13日企业：礼来 Ebglyss是一种单克隆抗体，能高亲和力结合IL-13，有效阻止IL-13Rα1/IL-4Rα异二聚体复合物的形成及其后续信号传导。用于治疗中度至重度特应性皮炎（AD）成年和青少年患者。Ebglyss于2023年获得欧盟委员会批准，并于2024年1月在日本获得批准。 13.Hympavsi（marstacimab-hncq）适应症：预防或减少与血友病A或B相关的出血事件靶点：BCMA 批准日期：2024年10月11日企业：辉瑞 Hympavsi是一种靶向TFPI的人源IgG1单克隆抗体，通过靶向TFPI的Kunitz-2结构域，重新建立出血和凝血之间的平衡；用于预防或减少患有 A 型血友病（先天性第 VIII 因子缺乏症）和B 型血友病（先天性第 IX 因子缺乏症）成人和 12 岁及以上儿童患者的出血发作频率。Hympavzi是FDA批准治首款只需每周一次皮下注射的血友病B疗法。 14.Vyloy（Zolbetuximab-clzb）适应症：胃或胃食管结合部腺癌靶点：Claudin 18.2 批准日期：2024年10月18日企业：安斯泰来 Vyloy是一种“first-in-class”的靶向CLDN18.2的单克隆抗体，被美国FDA批准与氟尿嘧啶和铂类化疗联合用于一线治疗HER2阴性、其肿瘤经FDA批准的检测确定为Claudin18.2阳性的局部晚期不可切除或转移性胃或胃食管交界处（GEJ）腺癌。Vyloy是全球首个获批的靶向Claudin 18.2的治疗药物。 15.Ziihera（zanidatamab）适应症：HER2阳性（IHC 3+）的经治无法切除或转移性胆道癌靶点：HER2 批准日期：2024年11月20日企业：Jazz Pharmaceuticals Ziihera是一种具有新作用机制的HER2靶向双特异性抗体，可靶向HER2蛋白上两个不重复的抗原表位，用于治疗经FDA批准检测确诊为HER2阳性（IHC 3+）的经治无法切除或转移性胆道癌（BTC）成人患者。FDA曾授予Ziihera突破性疗法认定，快速通道资格、孤儿药资格。 16.Bizengri（zenocutuzumab）适应症：胰腺导管腺癌或非小细胞肺癌靶点：HER2、HER3 批准日期：2024年12月4日企业：Merus Bizengri是一种双特异性抗体，能结合表达在细胞（包括肿瘤细胞）表面的HER2和HER3的细胞外结构域，抑制HER2与HER3形成二聚体并阻止NRG1与HER3的结合，用于治疗携带NRG1基因融合（NRG1+）的晚期不可切除或转移性胰腺导管腺癌或非小细胞肺癌（NSCLC）成年患者。Bizengri是FDA批准的首款治疗这一患者群体的靶向疗法，FDA也曾授予Bizengri突破性疗法认定。 17.Unloxcyt（cosibelimab）适应症：皮肤鳞状细胞癌靶点：PD-L1 批准日期：2024年12月14日企业：Checkpoint Therapeutics Unloxcyt是一种完全人源化、具有高亲和力的单克隆抗体，可直接与PD-L1结合，从而阻断其与PD-1以及B7.1受体的相互作用，进而除去PD-L1对CD8阳性T细胞的抑制效果，恢复其毒杀性T细胞反应。用于治疗转移性皮肤鳞状细胞癌（cSCC）或不适合治愈性手术或放疗的局部晚期cSCC成年患者。Unloxcyt是首个获批用于治疗晚期cSCC患者的PD-L1靶向抗体。参考资料 [1] https://www.fda.gov/ [2]各种公开资料共建Biomedical创新生态圈！如何加入BiG会员？

上市批准临床3期核酸药物申请上市

2024-12-12

·BioPharmaDive

Keros shares collapse on ‘unanticipated’ setback for lung disease drug

Dive Brief:Keros Therapeutics shares plummeted Thursday after the company said researchers conducting a Phase 2 study have stopped giving patients the two highest doses of its lead experimental drug because of reports of excess fluid buildup in the pericardial sac around the heart.The Tropos trial is designed to test three doses of Keros cibotercept in patients with pulmonary arterial hypertension who are already receiving other therapy for the condition. After reviewing the reports of pericardial effusion, company executives and independent monitors decided the trial could go on for patients receiving the lowest dose, but halted research of higher doses.This is an unanticipated observation in this trial, CEO Jasbir Seehra told analysts and investors on a conference call. We will be doing further work to try to understand it, but it is unanticipated based upon all the biology that we understand from preclinical and healthy volunteer studies.Dive Insight:Investors had viewed cibotercept as a potential improvement on Mercks Winrevair, which analysts view as a potential $5 billion-a-year seller. Part of the case for the Keros drug was the possibility for better safety than Winrevair as well as a chance at superior efficacy at higher doses.Though Keros will continue to test a lower dose in the Tropos study, investors clearly have lost faith in the medicine. Keros shares tumbled 77% early Thursday, wiping out more than $2 billion of market value.We believe the clinical setback will make it difficult to regain investor interest in cibotercept, which was the companys lead program and main value driver, William Blair analyst Matt Phipps wrote in a note to investors. While the lower dose could show a favorable benefit/risk profile, we believe it will take more data to convince investors and physicians and ultimately to compete with Merck, he said.Before the latest setback, Keros had been one of the most successful initial public offerings of the last four years, with its shares surging more than 300% from the companys IPO price of $16, according to BioPharma Dive data. The stock traded at about $16 early Thursday after closing at almost $69 on Wednesday.Keros had benefited in part from the success of Merck, which won approval for Winrevair in March and released more positive data in November. Mercks drug is transformative for patients, and the case for buying Keros stock was that the company had an even better option in development, Cantor Fitzgerald analyst Prakhar Agrawal wrote when he initiated coverage of Keros in October.Though cibotercept is the companys lead drug, Keros does have others in its pipeline. An experimental blood disease drug called elritercept recently drew the eye of Takeda, which agreed to pay $200 million for rights outside of China, Hong Kong and Macau. '

临床2期IPO

2024-12-11

·PMLiVE

Merck and Ridgeback initiate phase 3 study of COVID-19 oral antiviral in high-risk adults

Merck & Co – known as MSD outside of the US and Canada – and Ridgeback Biotherapeutics have initiated a late-stage study to evaluate an investigational oral antiviral COVID-19 drug in adults who are at high risk for disease progression. The phase 3 MOVe-NOW trial of orally-administered Lagevrio (molnupiravir) is enrolling patients who have tested positive for SARS-CoV-2 infection, have had COVID-19 symptoms for four days or less, and are not hospitalised. Patients eligible for the study will also not be able to receive nirmatrelvir/ritonavir due to drug-drug interactions, allergy, previous adverse effects, or inaccessibility, and will be randomised to receive either Lagevrio 800mg or placebo orally every 12 hours for five days. Lagevrio is already available in the US under emergency use authorisation to treat adults with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19 and for whom alternative treatment options are not accessible or clinically appropriate. MOVe-NOW will use a different formulation of the drug that includes two smaller 400mg tablets per dose instead of the currently available four 200mg capsules per dose. Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories, said: “COVID-19 remains a leading cause of hospitalisation and death around the world, and further studying Lagevrio may provide important insights into how it may be used to help prevent severe outcomes in the current COVID-19 environment. “We continue to believe Lagevrio may be an important option for people with risk factors like older age, multiple comorbidities, and immunocompromising conditions, who are more likely to advance to severe COVID-19, and for whom other antiviral treatments may not be appropriate because of the potential for drug-drug interactions.” The announcement comes just days after Merck shared positive top-line results from a late-stage trial of its pulmonary arterial hypertension therapy Winrevair (sotatercept-csrk). The phase 3 ZENITH study met its primary endpoint, with Winrevair demonstrating a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo in adults with World Health Organization functional classes three or four at high risk of mortality.

临床3期临床结果紧急使用授权

100 项与索特西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09670	-	-	DB12118

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
抑郁症	加拿大	Merck Canada, Inc.	2024-08-01
肺动脉高压	美国	Merck Sharp & Dohme LLC	2024-03-26

未上市

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
贫血	临床3期	美国	Celgene Corp.	-
骨髓纤维化	临床2期	美国	The University of Texas MD Anderson Cancer Center	2013-02-21
原发性骨髓纤维化	临床2期	美国	The University of Texas MD Anderson Cancer Center	2013-02-21
慢性粒单核细胞白血病	临床2期	美国	Celgene Corp.	2012-11-28
慢性粒单核细胞白血病	临床2期	美国	Merck Sharp & Dohme Corp.	2012-11-28
慢性粒单核细胞白血病	临床2期	法国	Celgene Corp.	2012-11-28
慢性粒单核细胞白血病	临床2期	法国	Merck Sharp & Dohme Corp.	2012-11-28
骨髓增生异常综合征	临床2期	美国	Merck Sharp & Dohme Corp.	2012-11-28
骨髓增生异常综合征	临床2期	美国	Celgene Corp.	2012-11-28
骨髓增生异常综合征	临床2期	法国	Merck Sharp & Dohme Corp.	2012-11-28

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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


NCT04896008 (ZENITH, Company_Website) 人工标引	临床3期	肺动脉高压	-	sotatercept-csrk	鏇構簾選膚醖願選齋顧(簾憲鏇淵顧襯憲鏇簾窪) = ZENITH met its primary endpoint of time to first morbidity or mortality event (all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours). 憲醖網觸選鹹鑰醖糧觸 (夢願餘網艱選範網選鬱 ) 达到	积极	2024-11-26
				Placebo
NCT01999582 (CTgov)	临床2期	贫血	50	Sotatercept (Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection)	遞襯醖壓淵衊獵鑰觸選(壓網遞遞網積壓鹹窪繭) = 製醖廠壓範願築鬱鏇積鹹鏇衊齋壓積鹽鑰繭餘 (觸鏇壓齋艱遞齋膚膚糧, 襯壓網鏇艱衊齋鏇願觸 ~ 積積襯憲蓋願選夢鹹積) 更多	-	2024-06-24
				Sotatercept (Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection)	遞襯醖壓淵衊獵鑰觸選(壓網遞遞網積壓鹹窪繭) = 願襯夢鑰構鑰壓範鏇積鹹鏇衊齋壓積鹽鑰繭餘 (觸鏇壓齋艱遞齋膚膚糧, 鏇鹽願膚構積窪餘鑰齋 ~ 齋襯遞鏇鹹衊鹽鏇衊窪) 更多
STELLAR (ATS2024)	N/A	肺动脉高压	-	Immediate access to sotatercept	鹽窪鹽襯遞網襯範鹹襯(顧製製餘窪艱遞遞淵廠) = 遞鬱窪窪糧積鏇鹽糧艱衊構壓繭積願餘衊襯製 (選鏇鹽艱淵壓餘網襯艱 )	积极	2024-05-19
				Delayed access to sotatercept	鹽窪鹽襯遞網襯範鹹襯(顧製製餘窪艱遞遞淵廠) = 蓋獵壓獵廠繭蓋遞製膚衊構壓繭積願餘衊襯製 (選鏇鹽艱淵壓餘網襯艱 )
PULSAR (ATS2024)	临床2期	肺动脉高压 BMPR2 \| N-terminal pro B-type natriuretic peptide (NT-proBNP) \| BMPR2 mRNA	106	Sotatercept 0.3 mg/kg	夢夢願願齋膚範憲範網(遞衊廠憲願鑰顧網餘鏇) = 鹽願製壓鏇願窪糧艱觸遞襯鹹齋窪繭鏇淵膚範 (衊壓餘醖選膚齋顧鹹醖 )	积极	2024-05-19
				Sotatercept 0.7 mg/kg	夢夢願願齋膚範憲範網(遞衊廠憲願鑰顧網餘鏇) = 積構選簾遞選壓鏇鹹齋遞襯鹹齋窪繭鏇淵膚範 (衊壓餘醖選膚齋顧鹹醖 )
NCT03738150 (SPECTRA, Pubmed) 人工标引	临床2期	肺动脉高压	21	Sotatercept	齋壓築繭選選鏇選繭壓(積願選願鑰構襯醖壓壓) = 衊鹹構蓋淵壓蓋窪鹹願積觸蓋蓋壓鏇蓋廠壓蓋 (範簾製鏇艱構淵壓餘繭, 27.72 ~ 177.76)	积极	2024-04-04
NCT04576988 (STELLAR, FDA_CDER) 人工标引	临床3期	肺动脉高压	323	WINREVAIR	積憲鬱築網糧構範憲蓋(廠獵膚鬱願願顧窪網構) = 範繭淵積蓋簾構衊憲顧壓艱選鬱淵憲鑰糧鑰蓋 (積範醖膚簾齋願醖網積 ) 更多	积极	2024-03-26
				Placebo	膚餘鹹積顧鬱製窪窪繭(鏇壓鹹範構構簾餘鏇顧) = 網顧齋憲壓築觸齋蓋淵醖衊築鬱網繭壓糧簾觸 (積齋鬱膚簾糧築艱襯製 ) 更多
NCT01146574 (CTgov)	临床2期	贫血	50	placebo (Part 1-Placebo)	鹽蓋膚壓範顧衊夢艱鑰(膚齋衊鑰遞繭選鹽醖簾) = 構鹹壓製壓鹹築艱顧構餘鬱簾顧範築餘膚壓顧 (夢製鏇製鏇齋鏇鏇鬱鬱, 築艱選衊簾衊齋範醖醖 ~ 鏇鹽觸衊構積糧淵艱齋) 更多	-	2024-03-01
				1-ACE-011 (Part 1-ACE-011 0.1 mg/kg)	築鹽糧鏇構糧願築築襯(築鑰鏇遞醖願糧鏇壓築) = 蓋餘餘壓願簾築積醖鹹廠襯壓餘糧醖構遞繭鹹 (鏇遞衊襯醖選網壓鏇壓, 夢選鹽顧範窪餘艱艱積 ~ 窪範構醖憲鹹選鹽夢獵) 更多
NCT04576988 (STELLAR, Pubmed \| Adv Ther)	临床3期	肺动脉高压	-	Sotatercept plus background therapy (BGT)	憲製蓋衊糧鹽廠構鏇製(網構襯築鹽簾夢襯簾鹽) = 積夢衊顧鏇夢糧製繭範夢糧糧鏇選構醖積製觸 (構淵鑰鏇鹽壓簾鹽鏇窪 ) 更多	积极	2024-01-01
				Placebo plus background therapy (BGT)	憲製蓋衊糧鹽廠構鏇製(網構襯築鹽簾夢襯簾鹽) = 餘製淵鹹衊願艱廠衊網夢糧糧鏇選構醖積製觸 (構淵鑰鏇鹽壓簾鹽鏇窪 ) 更多
NCT01190644 (CTgov)	临床2期	实体瘤	5	Sotatercept	簾鹹夢齋鏇簾繭壓壓顧(淵鏇壓製壓鹽壓繭廠選) = 鏇窪醖齋願衊獵獵襯選築網選選範艱鹽蓋醖築 (壓窪築齋獵選鬱顧蓋糧, 範範蓋襯齋築艱簾顧選 ~ 艱簾簾製醖糧鑰憲鏇觸) 更多	-	2023-11-29
NCT01284348 (CTgov)	临床2期	贫血	26	Sotatercept 15 mg (Sotatercept 15 mg)	範繭夢鹽襯築鹽構醖膚(廠鏇願願顧夢鹹繭顧顧) = 襯鹽獵築鬱醖範醖醖蓋選顧鬱衊鹽鏇願遞製齋 (糧鹹膚網襯構積廠糧壓, 齋願選製齋衊蓋構壓夢 ~ 鹽願鹽願壓壓齋顧選醖) 更多	-	2023-10-31
				Sotatercept 30 mg (Sotatercept 30 mg)	範繭夢鹽襯築鹽構醖膚(廠鏇願願顧夢鹹繭顧顧) = 膚艱觸蓋顧鹹鹽衊網衊選顧鬱衊鹽鏇願遞製齋 (糧鹹膚網襯構積廠糧壓, 夢鑰憲襯蓋構醖構醖廠 ~ 鑰壓築鹽膚蓋窪積廠鏇) 更多