地塞米松磷酸钠(Dexamethasone Sodium Phosphate) - 药物靶点：GR_在研适应症：脑水肿，新型冠状病毒感染，急性呼吸窘迫综合征_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Dex 21-P、Dexamethasone 21-Phosphate、eDSP

+ [24]

靶点

GR

作用方式

激动剂

作用机制

GR激动剂(糖皮质激素受体激动剂)

治疗领域

肿瘤免疫系统疾病感染+ [10]

在研适应症

脑水肿新型冠状病毒感染急性呼吸窘迫综合征+ [38]

非在研适应症

过敏反应白内障干眼综合征+ [19]

原研机构

Merck & Co., Inc.

在研机构

Hameln pharma Gmbh.山德士有限公司Wockhardt UK Ltd.

+ [9]

非在研机构

Mercator MedSystems, Inc.

Aspen Global, Inc.

Kiora Pharmaceuticals, Inc.

+ [6]

权益机构

台湾微脂体股份有限公司

Bausch Health Cos., Inc.Valeant Pharmaceuticals Luxembourg SARL

+ [4]

最高研发阶段批准上市

首次获批日期

美国 (1959-08-26)

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)

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结构/序列

分子式C22H30FNa2O8P

InChIKeyODEOTKLZVXBMJD-FCJDYXGNSA-N

CAS号2392-39-4

关联

3,212

项与地塞米松磷酸钠相关的临床试验

NCT07605416

/ Recruiting临床2期IIT

Quadruplet Induction Followed by Teclistamab Consolidation and Doublet Maintenance in Patients With Primary Plasma Cell Leukemia: The QUANTUM Trial

This phase II trial compares standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone to consolidation with teclistamab following standard induction therapy and autologous hematopoietic stem cell transplant for improving overall survival of patients with plasma cell leukemia. Consolidation therapy is treatment given after initial therapy to kill any cancer cells that may remain in the body. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Carfilzomib inhibits protein complexes called proteasomes, which inhibits cancer cell growth and leads to cancer cell death. Lenalidomide may help kill cancer cells and prevents the growth of blood vessels that cancer cells need to survive. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Teclistamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving teclistamab as consolidation therapy after induction and autologous hematopoietic stem cell transplant may improve survival outcomes in patients with plasma cell leukemia, compared to standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone.

开始日期2027-04-20

申办/合作机构

National Cancer Institute

CTIS2026-527048-41-00

/ Not yet recruiting临床3期IIT

Finnish Dexamethasone Trial for Chronic Subdural Hematoma (FINDEX): A Multicenter, Double-Blind, Placebo-Controlled Randomized Controlled Trial

开始日期2027-04-01

申办/合作机构-

NCT07791264

/ Not yet recruiting临床1期IIT

A Phase 1 Study of the RAGE Inhibitor FPS-ZM1 for Controlling Post-Operative Cerebral Edema in Glioblastoma Patients

This phase I trial tests the safety, side effects, best dose and how well FPS-ZM1 works for controlling post operative cerebral edema in patients with glioblastoma. FPS-ZM1 works by blocking the pathway that controls inflammation. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving FPS-ZM1 with or without dexamethasone may be safe and/or effective in controlling post operative cerebral edema in patients with glioblastoma.

开始日期2027-02-17

申办/合作机构

City of Hope National Medical Center

[+1]

100 项与地塞米松磷酸钠相关的临床结果

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100 项与地塞米松磷酸钠相关的转化医学

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100 项与地塞米松磷酸钠相关的专利（医药）

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1,543

项与地塞米松磷酸钠相关的文献（医药）

2026-11-01·Contemporary Clinical Trials

Interpreting the totality of clinical study data: is there a better way? Statistical methodology for quantitatively interpreting clinical study data across efficacy endpoints

Article

作者: Horine, Sarah ; Gudin, Jeffrey ; Jaros, Mark ; Vought, Kip ; Dworkin, Robert H ; Lissin, Dmitri ; Meske, Diana S ; Vaughn, Benjamin

INTRODUCTION:

Interpretation of the efficacy of an intervention in clinical trials often relies on whether the p-value for the primary endpoint is <0.05, with less emphasis on the pattern of results across efficacy endpoints. When results across endpoints are consistent and strongly supportive (or unsupportive) interpretation is straightforward. When results vary among endpoints, p-values are nominally statistically significant or slightly greater than 0.05, the standardized effect size is low, or there are divergent results across studies, interpretation is more complicated and relies on individual interpretation, which can introduce bias. Statistical approaches are needed to help interpret the strength of the totality of efficacy results (within a study and across studies).

METHODS:

We investigated the properties of a non-parametric approach to testing individual endpoints and a method of combining the individual endpoints into a single test of the overall shift that was then compared to parametric approaches using results from a recent Phase 3 analgesic clinical trial (CLEAR-1 Trial that assessed the efficacy of SP-102 for the treatment of lumbosacral radicular pain).

RESULTS:

Results from these applied methods allowed us to (1) confirm that the observed statistical significance of the primary endpoint in the CLEAR-1 Trial was not driven by pre-defined model assumptions, (2) that a strongly statistically significant result was observed across all endpoints, and (3) that the methods do not simply inflate alpha.

CONCLUSION:

Statistical approaches such as these are needed to help interpret the strength of the totality of efficacy results quantitatively to support more consistent interpretation of results.

2026-10-01·Med

Pomalidomide plus bortezomib and dexamethasone for newly diagnosed multiple myeloma with renal impairment: Randomized phase II study (POM-MM-003)

Article

作者: Wang, Liru ; Dou, Xuelin ; Peng, Nan ; Liu, Yang ; Wang, Fang ; Li, Zhenyu ; Xiao, Fei ; Zhong, Yuping ; Hou, Jian ; Li, Fei ; Chang, Chunkang ; Wen, Lei ; Qu, Xiaoyan ; Lu, Jin

BACKGROUND:

POM-MM-003 study compared pomalidomide-bortezomib-dexamethasone (PVd) with Vd in newly diagnosed multiple myeloma (NDMM) patients with RI.

METHODS:

POM-MM-003 was open-label, randomized, phase II study done at eight centers in China (ClinicalTrials.gov: NCT05432414). Patients with symptomatic NDMM with RI (creatinine clearance ≥15 to <60 mL/min) were randomly 2:1 to PVd and Vd groups for two 21-day induction cycles, followed by additional 2-cycle same treatment when achieving minor response. Primary endpoint was very good partial response or better (≥VGPR) after 4-cycle induction.

FINDINGS:

Between January 18, 2023 and December 2, 2024, 82 patients were randomized to PVd (n = 58) and Vd (n = 24) groups. After 4-cycle induction, PVd resulted in a significantly higher ≥ VGPR rate (72.4% [42/58; 95% CI: 59.1-83.3] vs. 20.8% [5/24; 95% CI: 7.1-42.2]; p < 0.001) and renal response rate (75.9% [44/58; 95% CI: 62.8-86.1] vs. 45.8% [11/24; 95% CI: 25.6-67.2]; p = 0.009) versus Vd after 4-cycle induction. Median progression-free survival (PFS) and overall survival (OS) in both groups were not reached. Grade 3-4 treatment-related adverse events (TRAEs) occurred in 41.4% (24/58) of patients with PVd and 29.2% (7/24) with Vd. Only one case in the PVd group died of treatment-related ileus.

CONCLUSIONS:

PVd may represent a potential treatment option for this patient population.

FUNDING:

This trial was sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (2021072900001) and was funded by the National Natural Science Foundation of China (no. 82370203), the Beijing Natural Science Foundation (no. 7264339), and the Peking University People's Hospital Scientific Research Development Funds (RDJP2025-06).

2026-10-01·Lancet Child & Adolescent Health

Neurological effects of encapsulated dexamethasone sodium phosphate in children aged 6–9 years with ataxia telangiectasia (NEAT): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Article

作者: Pietrucha, Barbara ; Horn, Biljana ; Zielonka, Daniel ; Del Mar Garcia Romero, Maria ; Lederman, Howard ; Perlman, Susan ; Trischler, Jordis ; Koenig, Mary Kay ; Abolhassani, Hassan ; Zielen, Stefan ; Badolato, Raffaele ; Kern, Jan ; Lissauer, Samantha ; Russo, Sam ; Whitehouse, William P ; Smith, Alex ; Thye, Dirk ; Pisani, Francesco ; Prayle, Andrew ; Ip, Winnie ; Schaefer, Caralee ; Stray-Pedersen, Asbjørg ; Karampatsas, Konstantinos ; Kornmann, Oliver ; Wu, Steve ; Donath, Helena ; Gomez-Andres, David ; Børresen, Malene Landbo ; Roden, Maureen ; Pachlopnik-Schmid, Jana

BACKGROUND:

Ataxia telangiectasia is a rare, multisystem disorder with progressive cerebellar neurodegeneration and no approved treatments. The efficacy of corticosteroids, including erythrocyte encapsulated dexamethasone sodium phosphate (eDSP), which have been studied for two decades in this disease, has not yet been proven in randomised trials. We aimed to investigate the safety and efficacy of eDSP in children aged 6-9 years with ataxia telangiectasia.

METHODS:

NEAT was a multicentre, randomised, double-blind, placebo-controlled phase 3 study, conducted at 20 sites across nine countries (Denmark, Germany, Italy, Norway, Poland, Spain, Switzerland, UK, and USA). Eligible participants were children aged 6 years or older weighing at least 15 kg, with a genetic diagnosis of ataxia telangiectasia and presence of neurological symptoms. Participants were randomly assigned (1:1) to the eDSP or placebo group via an independent interactive web response system and were stratified by age (6-9 years or ≥10 years), sex, and region (USA vs other countries). All participants, investigators, sponsors, and raters were masked to treatment assignments. eDSP was given intravenously every 21-30 days for six doses. All randomly assigned participants were included in the intention-to-treat (ITT) and safety populations; the primary and secondary efficacy analyses were conducted in participants aged 6-9 years in the ITT population. The primary efficacy endpoint was the change in Rescored Modified International Cooperative Ataxia Rating Scale (RmICARS) score between baseline and month 6, and a mixed-model-repeated-measures analysis was used. The trial was registered at ClinicalTrials.gov, NCT06193200, and is completed.

FINDINGS:

Between June 24, 2024, and Dec 17, 2025, we screened 125 participants for eligibility, of whom 105 (84%) were randomly assigned to the eDSP group (n=51 [49%]) or the placebo group (n=54 [51%]) and received at least one dose of treatment. The mean age was 8·5 years (SD 1·9) in the eDSP group and 8·6 years (2·3) in the placebo group (overall age range 6-17 years). In the eDSP group, 24 (47%) of 51 participants were girls and 27 (53%) were boys and, in the placebo group, 26 (48%) of 54 were girls and 28 (52%) were boys. Of ITT participants aged 6-9 years, 38 (95%) of 40 in the eDSP group and 41 (95%) of 43 in the placebo group completed the study. Compared with the placebo group, no significant differences were identified in change in RmICARS score from baseline to 6 months in participants aged 6-9 years: least squares mean difference -1·30 (95% CI -2·77 to 0·18; p=0·085). Adverse events were reported in 47 (92%) of 51 participants in the eDSP group and in 50 (93%) of 54 participants in the placebo group. The most common treatment-emergent adverse events were vomiting, pyrexia, pruritus, nasopharyngitis, cough, headache, and fatigue. There were no reports of treatment-related serious adverse events or deaths. Safety laboratory parameters did not identify adverse effects on growth, metabolism, bone mineral density, or endocrine function in any of the treatment groups.

INTERPRETATION:

The primary efficacy endpoint was not achieved, because the effect of eDSP on neurological symptoms did not reach statistical significance. The favourable safety profile of eDSP, previously described in a large study of children with ataxia telangiectasia, was confirmed in this trial. The eDSP programme, comprising two randomised studies and treating the largest cohort of patients with ataxia telangiectasia to date, underscores the need for rigorously designed trials of sufficient duration to detect sustained clinical benefit.

FUNDING:

Quince Therapeutics.

652

项与地塞米松磷酸钠相关的新闻（医药）

2026-10-31

·今日头条

《Nature Reviews Rheumatology》综述：新兴的膝骨关节炎治疗方法

膝骨关节炎中靶向疼痛信号传导的新兴疗法膝关节是骨关节炎（OA）最常见的发病部位，膝骨关节炎也是全球慢性疼痛和残疾的主要原因之一。患者会出现功能受限、社会孤立和生活质量下降，该疾病还带来了巨大且持续增长的社会与经济成本。膝骨关节炎的全球疾病负担仍在不断上升，部分原因在于人口老龄化和肥胖患病率的日益增加；据预测，到2050年，受影响的个体将约为6.42亿。重要的是，膝骨关节炎并非仅仅是老年人的疾病，因为超过半数的患者在55岁之前就已发病，这凸显了预防策略和疾病修正干预措施的必要性。来自法国索邦大学的Alice Courties团队在《Nature Reviews Rheumatology》上综述了膝骨关节炎治疗方法。【关键点】（1）膝骨关节炎（OA）的药物研发始终将对症治疗与疾病修正型骨关节炎药物（DMOAD）区分开来，这反映了二者在生物学机制、临床目标和监管预期上的差异。（2）基于肠促胰素的疗法是目前最有前景的、针对肥胖相关膝骨关节炎管理的新兴方案之一，但其长期安全性和维持策略仍存在不确定性。（3）其他新兴的对症疗法包括缓释糖皮质激素、神经营养因子调节、甲氨蝶呤、润滑型注射剂以及影像引导下的神经血管干预。（4）候选的疾病修正型骨关节炎药物靶向软骨合成代谢、Wnt信号通路、免疫代谢、基质降解酶、软骨下骨重塑以及局部基因转移。（5）尽管间充质基质细胞疗法最初具有很强的生物学理论依据，但迄今其疗效表现不一，且尚未显示出令人信服的结构性获益。（6）未来膝骨关节炎的管理很可能有赖于基于机制的患者分层，以及整合代谢、炎症、骨软骨和伤害性感受通路的联合治疗策略。【核心内容】尽管目前的对症治疗只能提供有限且短暂的获益，但对OA疼痛机制认识的不断深入已推动了新型治疗方法的研发。本文综述了针对不同机制的新兴对症疗法，包括神经元信号传导、炎症、关节润滑、代谢功能障碍和神经血管通路。疼痛是膝骨关节炎的核心症状，如今被理解为涉及关节病理和神经系统的复杂多维过程。除炎症外，外周感觉神经元也积极参与疼痛的产生和持续。由离子通道功能异常和神经营养信号介导的伤害感受器兴奋性改变会放大疼痛信号的传递。这些研究进展使神经元通路成为OA的关键治疗靶点。由于炎症在OA疼痛中具有高度参与作用，一系列靶向膝骨关节炎炎症通路的疗法正在研发中，主要作为对症治疗。缓释关节腔内糖皮质激素的开发旨在相较于传统制剂提高镇痛效果的强度和持续时间。在2018年的一项III期研究中，FX006（一种曲安奈德缓释制剂）与安慰剂相比，在3个月内显示出持续的疼痛缓解。在过去4年中，脂质体地塞米松制剂TLC599和基于微球的制剂EP-104IAR也在II期研究中显示出适度的镇痛效果，且安全性良好。反复关节腔内注射糖皮质激素对软骨的潜在有害影响目前仍存在争议，而缓释制剂是否会改变这种影响尚不清楚。总体而言，靶向炎症仍是膝骨关节炎对症镇痛的一个相关策略。然而，除甲氨蝶呤在特定患者中可能显示出一定信号外，很少有新兴抗炎疗法能证明相对于现有糖皮质激素方案具有实质性优势。鉴于关节软骨固有的修复能力有限，且其在结构进展中发挥关键作用，靶向关节软骨仍是DMOAD研发的核心策略。从历史上看，相关方法要么侧重于抑制基质降解，要么侧重于促进软骨修复。然而，尽管生物学依据充分，临床转化却一直充满挑战。早期的广谱基质金属蛋白酶（MMP）抑制剂因肌肉骨骼毒性而被放弃，而其他合成代谢方法（如sprifermin）虽显示出结构性获益，但未能带来一致的症状改善，这凸显了结构改变与临床结局之间持续存在的脱节。软骨下骨重塑是OA病理生理学的一个关键特征，也是一个极具吸引力的治疗靶点。其中，骨髓病变（BML）一直与疼痛和结构进展相关，并可预测新发影像学OA。新证据表明，BML反映了骨重塑增加和微损伤的双重过程。与此同时，骨赘形成和骨形态的进行性改变会导致关节变形和结构性疾病的进展。因此，靶向骨重塑可能同时带来症状缓解和疾病改善两方面的获益。膝骨关节炎是一个重大且快速增长的全球公共卫生挑战，其驱动因素包括人口老龄化、肥胖患病率上升以及代谢功能障碍负担的不断增加。尽管疾病负担沉重，目前的治疗手段仍以缓解症状为主，这凸显了开发有效疾病改善策略的迫切需求。过去5年间，OA生物学领域的重要进展将治疗版图拓展到了传统镇痛药之外。新兴的症状性治疗靶向神经元、炎症、代谢和神经血管机制，而多种候选DMOAD正在临床开发中推进。尽管目前很少有候选药物能同时展现出令人信服的结构和临床疗效，但其中一些已产生令人鼓舞的信号，支持继续推进治疗开发。总体而言，OA越来越被视为一种异质性的全关节疾病，需要针对其多样化生物学机制的治疗手段。疾病生物学、转化研究和临床开发进展的持续整合，使人们对最终实现有效的疾病改善治疗抱有审慎乐观的态度。

细胞疗法

2026-10-29

·爱研守护

多发性骨髓瘤：菲泽妥单抗联合治疗，把中位PFS从10.4延长到18.9个月

深耕肿瘤医学科普，温暖陪伴抗癌之路解读前沿临床资讯，守护每一份生命希望温馨提醒：文章后面有抗CD38人源化单克隆抗体SG301的免费临床试验，复发/难治性多发性骨髓瘤患者可申请参加。近日，在《The Lancet Haematology》期刊上，发表了Felzartamab（菲泽妥单抗）联合来那度胺-地塞米松对比来那度胺-地塞米松治疗复发或难治性多发性骨髓瘤的一项平行对照III期试验数据[1]。 2019年3月27日至2021年10月20日期间，评估了390例既往接受过至少一线全身治疗且来那度胺非难治的复发或难治性多发性骨髓瘤成人患者，其中295例被纳入并随机分配至felzartamab联合来那度胺-地塞米松组（n=195）或来那度胺-地塞米松组（n=100）。在felzartamab联合来那度胺-地塞米松组中位随访34.5个月，来那度胺-地塞米松组中位随访28.7个月时，felzartamab联合来那度胺-地塞米松组的中位无进展生存期为18.9个月，而来那度胺-地塞米松组为10.4个月（风险比0.62）。 Felzartamab联合来那度胺-地塞米松与来那度胺-地塞米松单药相比显著延长了无进展生存期，支持felzartamab联合来那度胺-地塞米松作为中国复发或难治性多发性骨髓瘤患者潜在的新治疗选择。菲泽妥单抗产品介绍菲泽妥单抗是一款靶向CD38的人源单克隆抗体。2026年8月，国家药品监督管理局批准天境生物药业（杭州）股份有限公司申报的注射用菲泽妥单抗（商品名：境斐）上市，该品种联合来那度胺和地塞米松用于既往至少接受过一线治疗的多发性骨髓瘤成年患者[2]。目前，国内有其他多发性骨髓瘤临床试验进行中，例如：杭州尚健生物的抗CD38人源化单克隆抗体SG301。 01 SG301联合泊马度胺、地塞米松临床试验进行中在CDE官网显示[3]，一项评价SG301注射液联合泊马度胺和地塞米松对比安慰剂联合泊马度胺和地塞米松治疗复发/难治性多发性骨髓瘤有效性和安全性的随机、对照、双盲、多中心Ⅲ期临床试验正在进行中，复发/难治性多发性骨髓瘤患者可申请免费参加。 SG301单药临床数据在2024年美国血液学会（ASH）年会上，公布了SG301在复发/难治性多发性骨髓瘤患者的I期临床数据[4]。截至2024年3月7日，共有61例RRMM患者入组该试验，中位年龄为64岁。在13例可评估疗效的患者中，对于接受8mg/kg（推荐的II期剂量）SG301治疗的非髓外多发性骨髓瘤患者，客观缓解率（ORR）为30.8%，其中非常好的部分缓解率（VGPR）及以上缓解率为23.1%。初治患者，需要制定治疗方案；或经治患者病情变化，面临复发/难治/转移，需要更换治疗方案时，常规标准治疗之外，新药临床试验也是一种可能的选择，也正是参加临床试验的合适时机。想了解更多肿瘤临床试验，请咨询医学部老师。北京凯石国际医疗技术有限公司介绍北京凯石国际医疗技术有限公司，是专注于肿瘤临床试验咨询的正规医疗信息服务机构，深耕实体瘤与恶性血液肿瘤临床试验，依托专业医学团队，打造合规、专业、高效的肿瘤临床试验咨询服务体系，致力于为肿瘤患者和家属，提供客观、可落地的临床试验资讯服务，是国内值得信赖的肿瘤临床试验专业服务企业。公司核心业务聚焦全类型肿瘤临床试验咨询服务，覆盖全面的肿瘤病种，兼顾实体肿瘤与恶性血液肿瘤两大领域。目前有CAR-T、TIL等细胞疗法，PD-1/PD-L1等免疫治疗药物，小分子抑制剂、双抗、单抗、ADC等靶向药物的临床试验正在进行中。正在招募肺癌、食管癌、肝癌、胃癌、结直肠癌、宫颈癌、卵巢癌、乳腺癌、胆管癌、子宫内膜癌、黑色素瘤、肉瘤、恶性血液疾病、淋巴瘤等各种恶性肿瘤，想要了解或者参加临床试验项目，可以咨询我们医学部的老师。为了让更多人了解，恳请各位朋友花一两秒钟帮我们点亮文章底部右下方的【小手】和【爱心】，谢谢大家！参考文献： 1.Haiyan He，Jingjing Shang，Yafei Wang，et al.Felzartamab plus lenalidomide–dexamethasone versus lenalidomide–dexamethasone for relapsed or refractory multiple myeloma: an open-label, parallel-controlled, randomised, phase 3 trial [J].The Lancet Haematology Volume 13, Issue 10，E722-E736，October 2026. 2.国家药监局批准注射用菲泽妥单抗上市，2026-08-13. https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20260813143615187.html 3.国家药品监督管理局药品审评中心（CDE）官网. 4.Ying Tian,Keshu Zhou,Quande Lin 2,et al. SG301,a Novel Anti-CD38 Monoclonal Antibody, in Patients with Relapsed/Refractory Multiple Myeloma: A First-in-Human, Multicenter, Phase 1 Trial [J].2024年ASH.

2026-10-27

·Firstwordpharma

Pfizer's Elrexfio tops standard care in relapsed, refractory myeloma

Pfizer announced Tuesday that Elrexfio (elranatamab) outperformed standard regimens when used in patients with relapsed or refractory multiple myeloma (RRMM) who had received at least one prior line of treatment with an anti-CD38 therapy and lenalidomide, marking the second Phase III success for the BCMA/CD3-directed bispecific antibody this year."The treatment landscape for multiple myeloma continues to evolve as anti-CD38-based regimens and lenalidomide are increasingly used earlier in care," remarked Jeff Legos, Pfizer's chief oncology officer. "Yet many patients ultimately experience disease progression, with limited treatment options available following these commonly used therapies."The Phase III MagnetisMM-32 study enrolled 523 adults with RRMM who received at least one prior line of treatment with an anti-CD38 therapy — either Johnson & Johnson's Darzalex (daratumumab) or Sanofi's Sarclisa (isatuximab) — and lenalidomide. Participants were randomised to receive Elrexfio or investigator's choice among three standard-of-care regimens, consisting of: Bristol Myers Squibb's Empliciti (elotuzumab), pomalidomide and dexamethasone; pomalidomide, bortezomib and dexamethasone; or Amgen's Kyprolis (carfilzomib) and dexamethasone.Top-line results showed that Elrexfio demonstrated a statistically significant and clinically meaningful reduction in the risk of disease progression or death over standard regimens at the pre-specified interim analysis, meeting the trial's primary endpoint of progression-free survival (PFS). Pfizer said that over 75% of patients receiving Elrexfio had not experienced disease progression or death from any cause at the time of the analysis, with an estimated 68% PFS at 18 months. Data for overall survival, a key secondary goal of the study, are currently immature and follow-up will continue to the next pre-specified analysis. "These findings further strengthen the rationale for moving BCMA-directed therapy earlier in the treatment journey," Legos said. The findings are set to be shared with global health authorities and detailed results will be presented at a future medical meeting.Pfizer indicated that Elrexfio's safety profile in MagnetisMM-32 was consistent with its known profile and no new signals were identified. The company noted that infection prophylaxis measures were put in place from the beginning of the study. Grade ≥3 infections were observed in 27.5% of patients receiving Elrexfio versus 18.1% for the other arms, while grade 5 infections were observed at rates of 0.8% and 1.6%, respectively.Earlier this year, Pfizer reported that the MagnetisMM-5 study testing Elrexfio as monotherapy against the standard-of-care regimen including Darzalex plus pomalidomide and dexamethasone in RRMM patients who had received at least one prior line of treatment met its primary endpoint of PFS.Elrexfio gained accelerated approval in the US for use in adults with RRMM who have received at least four prior lines of therapy. In the EU, the off-the-shelf, fixed-dose monotherapy has conditional authorisation for adults with RRMM who have received at least three prior therapies and have demonstrated disease progression on the last therapy.For more on the evolving MM treatment landscape, see — KOL Views Q&A: AbbVie's etentamig may put J&J's Tecvayli, other BCMA bispecifics on notice in MM.

临床结果临床3期上市批准

100 项与地塞米松磷酸钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00975	地塞米松磷酸钠	D07AB19 H02AB02 D10AA03	DB01234

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
脑水肿	奥地利	Hameln pharma Gmbh.	2021-04-28
脑水肿	比利时	Hameln pharma Gmbh.	2021-04-28
脑水肿	保加利亚	Hameln pharma Gmbh.	2021-04-28
脑水肿	克罗地亚	Hameln pharma Gmbh.	2021-04-28
脑水肿	捷克	Hameln pharma Gmbh.	2021-04-28
脑水肿	丹麦	Hameln pharma Gmbh.	2021-04-28
脑水肿	芬兰	Hameln pharma Gmbh.	2021-04-28
脑水肿	德国	Hameln pharma Gmbh.	2021-04-28
脑水肿	匈牙利	Hameln pharma Gmbh.	2021-04-28
脑水肿	冰岛	Hameln pharma Gmbh.	2021-04-28
脑水肿	爱尔兰	Hameln pharma Gmbh.	2021-04-28
脑水肿	意大利	Hameln pharma Gmbh.	2021-04-28
脑水肿	荷兰	Hameln pharma Gmbh.	2021-04-28
脑水肿	挪威	Hameln pharma Gmbh.	2021-04-28
脑水肿	波兰	Hameln pharma Gmbh.	2021-04-28
脑水肿	葡萄牙	Hameln pharma Gmbh.	2021-04-28
脑水肿	罗马尼亚	Hameln pharma Gmbh.	2021-04-28
脑水肿	斯洛伐克	Hameln pharma Gmbh.	2021-04-28
脑水肿	斯洛文尼亚	Hameln pharma Gmbh.	2021-04-28
新型冠状病毒感染	奥地利	Hameln pharma Gmbh.	2021-04-28

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
膝关节炎	临床3期	美国	TLC BioSciences	2019-11-26
膝关节炎	临床3期	美国	台湾微脂体股份有限公司	2019-11-26
膝关节炎	临床3期	澳大利亚	TLC BioSciences	2019-11-26
膝关节炎	临床3期	澳大利亚	台湾微脂体股份有限公司	2019-11-26
根性疼痛	临床3期	美国	Scilex Pharmaceuticals, Inc.	2017-12-08
神经根病	临床3期	美国	Scilex Pharmaceuticals, Inc.	2017-12-08
共济失调毛细血管扩张	临床3期	美国	IRulya Therapeutics, Inc.	2017-03-02
共济失调毛细血管扩张	临床3期	澳大利亚	IRulya Therapeutics, Inc.	2017-03-02
共济失调毛细血管扩张	临床3期	比利时	IRulya Therapeutics, Inc.	2017-03-02
共济失调毛细血管扩张	临床3期	德国	IRulya Therapeutics, Inc.	2017-03-02

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临床结果

适应症

分期

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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


NCT05497804 (CTgov)	临床2期	多发性骨髓瘤的髓外病变 \| 多发性骨髓瘤	17	Multigated Acquisition Scan+Lenalidomide+carfilzomib+Daratumumab+Dexamethasone	壓壓選醖獵淵製鹹鑰繭 = 構窪觸選蓋襯獵憲構願觸壓遞憲簾鏇鹽鬱憲夢 (憲願鬱襯顧製繭築夢積, 淵鏇齋構獵齋鹹鑰蓋顧 ~ 願壓夢獵憲築廠觸餘簾) 更多	-	2026-11-02
NCT04826237 (CTgov)	临床4期	神经性听力损失	3	Statin+methylprednisolone+dexamethasone (Statin)	構鹽醖衊夢齋網鹹鑰艱(築淵遞鏇衊夢艱選觸繭) = 醖醖憲願範蓋鏇選網積觸鏇齋繭獵醖構選獵範 (顧築網範膚獵簾網構製, 夢獵構遞鹹鏇顧齋構夢 ~ 範構選醖網鹹網夢窪遞) 更多	-	2026-10-29
				Placebo+methylprednisolone+dexamethasone (Placebo)	選衊願鑰齋製餘鹽襯築(網糧餘壓壓鹹繭襯選鹽) = 鏇廠獵廠選壓鹽鑰鑰願願廠壓鹹糧鬱願衊壓衊 (築窪餘築鬱繭憲繭淵襯, 願窪選蓋顧醖願鑰選鬱 ~ 願糧膚襯顧鑰鏇遞製衊) 更多
ESMO2026	N/A	巨球蛋白血症一线	206	Dexamethasone-Rituximab-Cyclophosphamide (DRC)	餘積淵鹽構築蓋廠範憲(鬱簾鏇襯蓋獵鏇鏇築夢) = 選餘鹽壓觸糧鏇選憲夢鹽醖積構膚鏇淵壓醖構 (鑰選獵鹽餘觸衊廠襯鑰 ) 更多	积极	2026-10-23
				Dexamethasone-Rituximab-Cyclophosphamide (DRC) (POD24)	餘積淵鹽構築蓋廠範憲(鬱簾鏇襯蓋獵鏇鏇築夢) = 顧壓蓋範鑰壓糧築築襯鹽醖積構膚鏇淵壓醖構 (鑰選獵鹽餘觸衊廠襯鑰 )
NCT07537699 (ESMO2026)	临床2期	药物引起的恶心和呕吐	57	Dexamethasone (Auricular acupressure)	糧鏇糧衊淵範遞選鹽繭(鹽憲窪齋繭網窪鬱簾襯) = 艱膚窪製鏇糧窪淵築壓構鏇繭築膚構廠選窪憲 (鹹鏇網鏇壓簾膚鹹窪鹹 ) 更多	积极	2026-10-23
NCT05432414 (POM-MM-003, Pubmed \| Med)	临床2期	-	82	Pomalidomide + Bortezomib + Dexamethasone	簾網廠構鑰鬱構憲鬱顧(範積廠鬱衊淵願淵網遞) = 網範鬱鏇鹹鹹壓構齋構鬱鏇鑰築鑰範築願觸糧 (鏇製襯遞齋遞糧選衊醖, 59.1 ~ 83.3) 更多	积极	2026-10-01
				Bortezomib + Dexamethasone	簾網廠構鑰鬱構憲鬱顧(範積廠鬱衊淵願淵網遞) = 襯餘壓鹹憲網衊簾簾繭鬱鏇鑰築鑰範築願觸糧 (鏇製襯遞齋遞糧選衊醖, 7.1 ~ 42.2) 更多
NCT06604286 (Pubmed \| BMC Oral Health)	临床4期	-	20	dexamethasonedexamethasone (Intramasseteric dexamethasone injection)	廠餘觸鏇簾窪獵糧顧鑰(餘鏇窪餘鬱襯蓋衊窪範) = 衊餘窪鏇鏇鹽繭遞衊衊壓製顧醖餘獵鹽憲餘鬱 (憲襯醖製範選襯鏇願願, 2.8) 更多	积极	2026-09-26
				dexamethasonedexamethasone (Pterygomandibular space dexamethasone injection)	廠餘觸鏇簾窪獵糧顧鑰(餘鏇窪餘鬱襯蓋衊窪範) = 繭蓋鏇願鹽構窪範醖製壓製顧醖餘獵鹽憲餘鬱 (憲襯醖製範選襯鏇願願, 2.9) 更多
NCT04432259 (CTgov)	临床4期	恶心 \| 术后恶心呕吐 \| 膝关节炎 ... 更多	109	Dexamethasone (Group A (Dexamethasone))	襯鹹糧範簾獵憲窪膚簾(顧窪廠齋鬱鏇鹽艱網構) = 衊顧夢膚繭鏇膚範構獵窪築夢網夢鬱壓餘簾齋 (壓遞範衊鹽遞鏇選簾築, 1.99)	-	2026-09-25
				Placebo (Group B (Placebo))	襯鹹糧範簾獵憲窪膚簾(顧窪廠齋鬱鏇鹽艱網構) = 鏇壓衊鹽糧網遞製鹽顧窪築夢網夢鬱壓餘簾齋 (壓遞範衊鹽遞鏇選簾築, 1.99)
EANO2026	N/A	幕上肿瘤	50	DexmedetomidineRopivacaine + DexmedetomidineRopivacainedine	鹽膚選鹹蓋齋夢糧餘淵(鏇蓋醖壓鑰願齋鹹鏇獵) = 遞蓋選憲築蓋糧糧鹽齋獵艱襯夢簾顧構淵壓範 (願醖夢鏇艱壓糧鹽願鹽 ) 更多	积极	2026-09-24
				DexamethasoneRopivacaine + DexamethasoneRopivacainene	鹽膚選鹹蓋齋夢糧餘淵(鏇蓋醖壓鑰願齋鹹鏇獵) = 蓋糧膚夢遞壓遞鬱網鹽獵艱襯夢簾顧構淵壓範 (願醖夢鏇艱壓糧鹽願鹽 ) 更多
IMS2026	临床2期	多发性骨髓瘤一线	120	Ixazomib + Lenalidomide	範範餘選鹹壓願鏇襯顧(獵廠鹽遞顧顧選繭淵鏇) = 95% of the patients with sustained (two negative samples every 12 months) NGF-MRD negativity were progression-free at 2 years on maintenance. 廠餘齋遞觸選艱顧齋蓋 (淵願艱糧網繭積壓鑰構 ) 更多	积极	2026-09-23
				Lenalidomide
IMS2026	N/A	多发性骨髓瘤一线	62	D-BTd	糧醖憲觸艱選襯繭顧觸(製襯壓窪鹹憲鑰構鑰夢) = 蓋鑰餘襯鬱衊窪構鏇窪餘廠簾鑰製壓範齋網獵 (顧築簾構醖鏇廠夢鹽糧 ) 更多	积极	2026-09-23
				D-VRd	糧醖憲觸艱選襯繭顧觸(製襯壓窪鹹憲鑰構鑰夢) = 鬱獵膚鑰鏇顧艱範鹹齋餘廠簾鑰製壓範齋網獵 (顧築簾構醖鏇廠夢鹽糧 ) 更多