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更新于：2026-10-23

Dexamethasone Sodium Phosphate

地塞米松磷酸钠

更新于：2026-10-23

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

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+ [37]

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

IRulya Therapeutics, Inc.

Hameln pharma Gmbh.Wockhardt UK Ltd.

+ [9]

非在研机构

Semnur, Inc.

Scilex Pharmaceuticals, Inc.

Mercator MedSystems, 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

3,202

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

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]

NCT07097493

/ Not yet recruiting临床4期IIT

Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canal and iPACK Blocks in Patients Undergoing Primary Total Knee Arthroplasty

The purpose of this research study is to compare two different combinations of anesthetic medications to see which works the best in providing the longest lasting pain relief for total knee arthroplasty surgery. The drugs being used are liposomal bupivacaine compared to a combination of bupivacaine, clonidine, epinephrine, buprenorphine, and dexamethasone. Pain scores will be collected at different intervals during study participation.

开始日期2027-02-01

申办/合作机构

Wake Forest School of Medicine

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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1,475

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 ; Jaros, Mark ; Gudin, Jeffrey ; 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 ; Peng, Nan ; Dou, Xuelin ; 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 ; Del Mar Garcia Romero, Maria ; Zielonka, Daniel ; 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.

648

项与地塞米松磷酸钠相关的新闻（医药）

2026-10-22

·肽集圈

把“激素”做成 ADC：SAB05 用 CD40 把超强糖皮质激素送进致病免疫细胞，小鼠 CIA 里 Q14W 几乎清零、体重还涨

Santa Ana Bio 的 SAB05 不是“新靶点”，而是把老药重新架构： Fc-null 抗 CD40 抗体 + DAR4 超强糖皮质激素 payload = 阻断 CD40–CD40L 共刺激 + 只在 CD40⁺ 细胞里释放 GR 激动剂目标：保留激素的“镇压力”，扔掉全身激素的“满月脸/骨质疏松/感染/肾上腺抑制”。🎯 Key Takeaways 🎯 靶点/机制：抗 CD40（阻断 CD40L 信号）+ CD40 内吞后胞内释放糖皮质激素受体（GR）激动剂 🧪 分子形态：Fc-null ADC，DAR = 4 💥 Payload potency：约 dexamethasone 的 130 倍 🧬 选择性：GILZ / FKBP5 只在 CD40⁺ B 细胞诱导，CD40⁻ T 细胞不诱导 → cell-selective GC delivery 🐭 TDAR（KLH）：单剂 15.6–62.5 µg，day-28 抗 KLH IgG 抑制 98.5–100%，体重不受影响 🐭 治疗性 CIA：Q7D 最大临床评分 –83%、终末评分 –99%；Q14W 终末评分 0.0（–100%） ⚖️ 安全反差：游离 GC 组体重掉到 92.3%，vehicle 95.7%；Q14W ADC 组 106.0%，和抗 TNF 组（105.3%）相当 🧭 结论：疗效来自“payload 进 CD40⁺ 细胞”，不是单纯 CD40 阻断——单抗本身能保体重但控不住病 📅 节点：IND 申报计划 2027 H1，多适应症（RA / SLE / 移植 / 自免肾病等）🧬 SAB05 的工程逻辑（为什么不像传统 ADC）模块设计目的抗体抗 CD40，antagonist 阻断 B 细胞 / DC / 巨噬细胞的 CD40–CD40L 共刺激 Fc null / silenced 去掉 ADCC/CDC，别杀 CD40⁺ 细胞，只做“递送+阻断” Payload 高效 GR 激动剂（~130× dexa）低渗透、强抗炎、细胞内受体起效 Linker 细胞内酶切释放（具体未在公司稿披露） CD40 内吞 → 溶酶体/蛋白酶切 → 胞内 GC 释放 DAR 4 比肿瘤 ADC 常见 2–4 区间偏高，但自免场景看游离 payload 控制释放前提 CD40 表达 + 内吞炎症组织/次级淋巴器官/抗原呈递细胞优先吃到激素 💡 和 ABBV-154（抗 TNF-GR 偶联物）思路同源： “细胞因子阻断”不够，就把激素本地化。但 SAB05 选 CD40，打的是抗原呈递最上游——B 细胞、DC、活化巨噬细胞。🐭 临床前三件事很硬1️⃣ 体外：选择性不是嘴说抑 CD40L/IL-4 驱动的 B 细胞活化 + IL-6 抑 DC 成熟抑 MLR（T 细胞被别人激活的通路）抑 M1 巨噬细胞 IL-6 GILZ/FKBP5 只在 CD40⁺ 细胞起 → 证明 GC 不是全身跑，是抗体拖进去的2️⃣ TDAR：单针几乎灭掉抗体应答单 iv 15.6 / 31.25 / 62.5 µg → 28 天后抗 KLH IgG 剩 1.5% 以内单抗同剂量只 0–23% 波动 ADC 第 14 天就清掉了，但免疫抑制持续到 28 天 → “暴露短、效应长”，符合淋巴组织里长效重编程3️⃣ CIA：Q14W 把老鼠关节炎打到 0 组终末临床评分体重（起始=100%） Vehicle 15.9 → 高负荷 95.7% 游离 GC（等摩尔 QD） 0.2 ± 0.4 92.3%（掉秤）抗 CD40 单克隆 14.0 ± 3.0 ~100%（安全但无效）抗 TNF 12.0 ± 3.5 105.3% SAB05 Q7D 0.2 ± 0.6 — SAB05 Q14W 0.0 ± 0.0 106.0% → 这张表就是 SAB05 的全部卖点： “游离激素的疗效” + “生物制剂的安全曲线” + “双周一次还比每周更干净”。🥊 竞争/前车坐标资产靶向 Payload 状态看点 SAB05 CD40 超强 GC 临床前 / IND 2027H1 上游 APC 靶向 + 双机制 ABBV-154 TNF 高效 GC 曾进临床验证“免疫 ADC 送激素”可行，但未成大药 Telitacicept / atacicept BAFF+APRIL — 临床浆细胞/B 细胞轴，不是激素替代抗 CD40（iscalimab 等） CD40 — 临床阻断够，但没局部激素火力传统 GC 全身 GR 泼尼松/地塞米松 SOC 有效但长期毒性封顶 SAB05 的差异化 = “抗 CD40 的生物制剂” ∪ “局部激素”，不是 third cytokine blocker。🧭 Santa Ana Bio 的打法SAB01：KIT × Siglec-6 双抗 → 只删肥大细胞（荨麻疹/AD/食物过敏）SAB03：抗 PD-1（自免里抑致病 T 细胞）SAB05：CD40-GC ADC → 把激素“精准化”SAB06：TL1A × IL-23p19 × TNFα 多抗 → IBD / SSc-ILDSAB07：成纤维细胞轴 → 纤维化 Versant 出品、Peter Emtage（前 Kite/Cell Design Labs/MedImmune）+ Newman Yeilding（前 Janssen 自免 CMO）坐镇。打法是：多组学找致病细胞 → 用双抗/ADC/多抗把“广泛免疫抑制”拆成“细胞类型特异性免疫调节”。

2026-10-20

·BioSpace

101 Therapeutics to Present Phase 2/3 Data on Macrophage-Targeted, Steroid-Sparing Glucocorticoid 101-PGC-005 at ACR Convergence 2026

Poster 0122 on Sunday, November 8: CD206-targeted dexamethasone prodrug was superior to systemic dexamethasone in a 309-patient randomized trial (HR 2.31; p<0.0001), with no systemic steroid added in the '005 arm; abstract positions ' 005 as a potential steroid-sparing adjunct to biologic therapy, including in PMR, sJIA, GVHD and incomplete responses to single-cytokine biologics ENGLEWOOD, N.J.--(BUSINESS WIRE)--101 Therapeutics Ltd. (101TX), a clinical-stage biotechnology company developing macrophage-targeted therapeutics, today announced that an abstract on its lead investigational compound, 101-PGC-005 ('005; designated 101-PIF-GC-005 in the published abstract), a chemically synthesized small-molecule, CD206-targeted dexamethasone prodrug, has been accepted for poster presentation at ACR Convergence 2026, the annual meeting of the American College of Rheumatology (ACR), November 6–11 in Orlando, Florida. The abstract, now published in the ACR Convergence 2026 online program, reports that a three-day course of '005 was superior to systemic dexamethasone in a 309-patient randomized Phase II/III (Phase 2/3) trial, and sets out the rationale for '005 as a potential steroid-sparing adjunct to biologic therapy in rheumatology. Founder and Chief Scientific Officer Michael M. Goldberg, MD, will present the poster and is scheduling meetings with pharmaceutical and biotechnology business development, search-and-evaluation and life-science investment teams during the meeting. First scientific meeting presentation. ACR Convergence 2026 is the first scientific meeting at which 101 Therapeutics will present '005. The Phase II/III trial was run during the COVID-19 pandemic at six sites in India by an independently funded, privately held company, outside the rheumatology literature, and its results have not previously been presented at a scientific meeting. Poster 0122 is the first opportunity for rheumatologists, pharmaceutical partners and investors to review a targeted glucocorticoid that was compared head-to-head with dexamethasone in a randomized Phase 2/3 trial and was superior. Presentation details Title: CD206-Targeted Glucocorticoid Delivery as an Adjunct to Biologic Therapy in Macrophage-Driven Autoimmune Disease: Proof-of-Concept Clinical Evidence and a Mechanistic Rationale for Addressing the Residual Inflammatory Burden of Single-Pathway Cytokine Blockade Poster/Abstract: 0122 Session: Innate Immunity Poster A Date and time: Sunday, November 8, 2026, 10:30 a.m. to 12:30 p.m. ET Presenter: Michael M. Goldberg, MD, Founder and Chief Scientific Officer, 101 Therapeutics Location: ACR Convergence 2026, Orlando, Florida Abstract highlights '005 was evaluated in an adaptive Phase II/III randomized controlled trial in 309 hospitalized patients with moderate COVID-19 inflammatory disease at six GCP-compliant sites in India. Patients received '005 20 mg IV once daily for three days or dexamethasone 6 mg IV once daily for five to 10 days, each with standard of care. All 309 randomized patients completed the study. Primary endpoint, time to at least 2-point improvement on the WHO ordinal scale: HR 2.31 (95% CI 1.83–2.93; p<0.0001); median 3 vs 4 days. The Phase II effect was prospectively reproduced in Phase III across a later variant and vaccination landscape. Viral clearance: HR 1.47 (p=0.0001); median 3 vs 5 days. Day 5 discharge: 77.4% vs 29.0%. No patient in the '005 arm received an investigator-initiated systemic corticosteroid add-on despite protocol permission; cumulative exogenous corticosteroid exposure in the '005 arm was 0 mg. Treatment-emergent adverse events 54.8% vs 54.5%; no Grade 3 or higher events, serious adverse events, SUSARs, deaths or discontinuations in either arm. Human PK studies (completed Phase I, single and repeated dosing): intact prodrug circulation, rapid clearance, absent or very low free dexamethasone exposure, preserved cortisol/ACTH after repeated supratherapeutic dosing, and no glucose signal. Morning cortisol and ACTH remained within normal physiologic ranges after 30 mg IV '005 once daily for three consecutive days. In SARS-CoV-2-infected human macrophages, '005 suppressed inflammatory cytokine output, including IL-6 and TNF, while preserving CXCL10 antiviral signaling, a macrophage-targeted immune-modulating pro from broad systemic glucocorticoid immunosuppression. The abstract concludes that these data support a new steroid-sparing concept for rheumatology: retaining broad glucocorticoid-like efficacy while reducing toxicity. It identifies settings where glucocorticoids are used, or would be used, but are limited by toxicity, including polymyalgia rheumatica (PMR), systemic juvenile idiopathic arthritis (sJIA), graft-versus-host disease (GVHD) and incomplete responses to single-cytokine biologics. COVID-19 was the disease studied; efficacy in rheumatic diseases has not been established. The poster will present additional clinical, mechanistic and translational data. “Rheumatologists know exactly what glucocorticoids can do, and how often HPA-axis suppression, immunosuppression, hyperglycemia and cumulative toxicity force them to hold back,” said Dr. Goldberg. “Our Phase 2/3 data show that a CD206-targeted glucocorticoid achieved faster clinical improvement than 6 mg of systemic dexamethasone while preserving HPA-axis function. We believe that may be relevant wherever glucocorticoids are used but limited by toxicity, starting with a steroid-sparing adjunct to biologics. I invite rheumatologists, industry and investors to visit Poster 0122 on Sunday morning or to meet with us in Orlando.” To schedule a meeting at ACR Convergence 2026, contact michael@101therapeutics.com . Citation: Goldberg M. Arthritis Rheumatol. 2026;78(suppl 9). Abstract 0122. Published abstract: About 101 Therapeutics 101 Therapeutics Ltd. (101TX) is an independently funded, clinical-stage biopharmaceutical company developing macrophage-targeted therapeutics for diseases in which excessive or dysregulated macrophage activity contributes to tissue injury and persistent inflammation. Its lead investigational compound, 101-PGC-005 ('005), is a chemically synthesized small-molecule, CD206 (mannose receptor, MRC1)-targeted type 1a dexamethasone prodrug designed for short-course, episodic intracellular glucocorticoid delivery. The proposed mechanism involves modulation of activated inflammatory macrophages followed by apoptosis of excess pathogenic macrophages, without preventing recruitment and activation of new macrophages that can operate under physiological hypothalamic-pituitary-adrenal (HPA) axis and cortisol regulation. Development opportunities include rheumatology indications as an adjunct to biologics, rare inflammatory diseases, acute cytokine syndromes and immune-related complications of cancer immunotherapy, and host-directed anti-infective and medical-countermeasure applications in severe infectious hyperinflammation. The company has received FDA Rare Pediatric Disease designation for systemic juvenile idiopathic arthritis (sJIA), a designation relevant to potential Priority Review Voucher eligibility subject to statutory requirements; a study in sJIA is being planned. These applications remain investigational and require indication-specific studies. Patent publications include WO2022034582A1 and WO2023144815A1. 101 Therapeutics was founded by its Chief Scientific Officer, Michael M. Goldberg, MD, who as Chairman and CEO of Emisphere Technologies led development of the SNAC (salcaprozate sodium) oral absorption technology used in Novo Nordisk's oral semaglutide products, Rybelsus® for type 2 diabetes and the Wegovy® pill for chronic weight management. Investigational status and forward-looking statements 101-PGC-005 is investigational and has not been approved for any indication. The clinical study cited above involved COVID-19; clinical efficacy and safety in rheumatic diseases have not been established. Mechanistic hypotheses, potential complementary use with biologics, and future development plans are forward-looking and subject to further testing, regulatory review, and other uncertainties. Reference to ACR Convergence identifies the presentation venue and does not imply endorsement by the American College of Rheumatology. Contacts Media, partnering and investor inquiries: Michael M. Goldberg, MD | michael@101therapeutics.com |

临床结果临床2期

2026-10-19

·Medikabazaar

2026 CSCO指南：泊马度胺一线推荐用于骨髓瘤肾损伤

盈德健康(lndian-Med)是少数获得印度政府授权的印度本土正规跨境药房。盈德健康属于印度最大的医药供应链集团Medikabazaar，全球员工超1500人，全印度各地设有42个分公司。盈德健康为病友们提供印度老挝孟加拉等多国仿制药和原研药合法跨境购买咨询，所有药品均可提供印度源头采购文件，杜绝假药风险。盈德健康所有药品均通过印度药监局(CDSCO)认证，支持处方审核+跨境直邮，确保患者安全用药。中国人保产品责任险承保盈德健康跨境药房全线产品，央企为您的药品质量做全面保障，盈德健康药品质量值得信赖! 多发性骨髓瘤（MM）是血液系统常见的恶性肿瘤。由于病程较长且容易复发，患者长期面临生存挑战。自2025年《中国临床肿瘤学会（CSCO）浆细胞肿瘤诊疗指南》（以下简称“CSCO指南”）首次独立成册后，其在规范国内MM临床诊疗路径、改善患者长期预后方面的指导作用愈发突出。在近期召开的2026 CSCO指南会上，2026版《CSCO浆细胞肿瘤诊疗指南》正式发布。新版指南中的MM章节总体沿用2025版的基本框架，同时从结构、内容深度及治疗理念等多个维度进行了更新。值得关注的是，作为新一代免疫调节剂（IMiDs），泊马度胺凭借其在肾损伤患者治疗中的表现，被列入一线治疗Ⅰ级推荐，为肾功能不全MM患者提供了新的治疗选择。 1. 循证赋能，标准再进：2026版CSCO指南MM诊疗更新要点 2. 精准突围：泊马度胺攻克肾损伤难点，夯实全病程获益基石 3. 国产基石药物全矩阵布局，筑牢中国MM慢病管理愿景 4. 参考文献 01 一、循证赋能，标准再进：2026版CSCO指南MM诊疗更新要点《CSCO浆细胞肿瘤诊疗指南》自2025年从恶性血液病指南中独立成册以来，获得了广大医疗工作者的认可。新版指南的多发性骨髓瘤章节总体延续2025版基本框架，并在结构安排、内容深度和治疗理念上进一步完善。逻辑升级：新增讨论模块新版指南新增了“讨论模块”，对各项循证相关内容展开详细讨论与解析，并重点补充循证依据说明。这一变化使指南从单纯呈现“推荐什么”，进一步拓展至解释“为什么这样推荐”，强化了推荐意见背后的循证逻辑。适合移植NDMM：四药方案与肾损治疗双突破对于适合移植的新诊断多发性骨髓瘤（NDMM）患者，新版指南的核心治疗路径保持不变，仍采用诱导治疗、干细胞动员、自体移植、巩固治疗和维持治疗五步标准模式，但重点调整了诱导治疗与维持治疗部分。在诱导治疗方面，达雷妥尤单抗＋硼替佐米＋来那度胺＋地塞米松，以及艾沙妥昔单抗＋硼替佐米＋来那度胺＋地塞米松两种四药方案，均被纳入Ⅰ级推荐。针对肾功能不全患者，指南在Ⅰ级推荐中新增硼替佐米＋泊马度胺＋地塞米松方案，为此类患者提供了有效的治疗选择。 2026 CSCO浆细胞肿瘤诊疗指南推荐意见不适合移植NDMM：从“年龄”到“功能”的精准分层对于不适合移植的NDMM患者，新版指南不再仅以年龄作为分层依据，而是转向根据患者的真实体能状态和合并症负担进行精细化分层。经过调整后，患者分层更加细致，可供选择的治疗方案也更为丰富。复发难治MM：武器库不断丰富在复发难治MM领域，新版指南将CAR-T细胞治疗、双特异性抗体等免疫治疗，以及已经上市或即将上市的抗体偶联药物（ADC）纳入相应推荐，进一步丰富了挽救治疗手段。 02 二、精准突围：泊马度胺攻克肾损伤难点，夯实全病程获益基石肾功能损伤是MM最常见的合并症之一，给临床诊疗带来沉重负担。约有20%～40%的NDMM患者合并肾损伤，其中2%～4%需要接受肾脏替代治疗[1]。随着MM不断进展，确诊时已经出现肾功能损害的患者可能进一步恶化；而确诊时尚未发生肾功能损害的患者中，约有25%会在疾病晚期出现肾脏受累[2]。合并肾损伤的MM患者不仅生活质量明显下降，总生存期（OS）和无进展生存期（PFS）也会显著缩短，同时面临更高的早期死亡风险[2,3]。因此，肾损伤一直是MM临床治疗中的核心难题。长期以来，以蛋白酶体抑制剂（PI）和IMiDs为基础的方案是MM一线治疗的重要基石。然而，主流IMiDs药物主要经肾脏代谢，应用于肾损伤患者时，需要根据肌酐清除率调整剂量，可能影响治疗效果。随着临床研究持续推进，新一代PI和IMiDs药物为合并肾功能不全的MM患者提供了更多选择。泊马度胺属于第3代IMiD，其结构与沙利度胺、来那度胺相似，但抗MM活性更强，安全性相近。该药较少通过肾脏代谢，仅有2%的药物以原形经肾脏和粪便排泄[4]。研究显示，泊马度胺联合硼替佐米和地塞米松（PVd）作为一线方案治疗伴肾功能不全的MM患者，可取得显著疗效。中位随访3个月时，肾脏完全缓解（CR）率为29.5%，最佳肾脏客观缓解率（ORR）为78.7%；经二代流式细胞术（NGF）检测，微小残留病（MRD）阴性率达到85.7%。上述结果表明，PVd方案用于伴肾功能不全的MM患者时，可获得较高的肾脏缓解率和MRD阴性率[5]。 PVd方案治疗患者的肾脏缓解和血液学缓解率此外，国内研究者开展了一项前瞻性、多中心Ⅱ期临床研究[6]，分析SPVD方案，即塞利尼索、泊马度胺、硼替佐米和地塞米松，一线治疗伴肾损伤NDMM患者的疗效。研究结果显示，接受不少于3个疗程SVPD方案治疗的患者，3个月肾脏ORR为89.5%，血液学ORR为96.8%，为进一步优化伴肾功能不全MM患者的治疗路径提供了新的高质量证据。基于泊马度胺在临床研究中的表现，2024版指南已经推荐该药用于相关患者：肌酐清除率≥45 ml/min时为A级推荐，肌酐清除率＜30 ml/min时为B级推荐，并指出其无须根据肾功能调整剂量[1]。本次2026 CSCO指南进一步将泊马度胺列入肾功能不全MM的一线治疗推荐。这一更新丰富了肾损伤MM患者的治疗选择，并兼顾疗效、安全性和用药便利性，有助于患者接受更加规范、高效且稳妥的一线治疗。 03 三、国产基石药物全矩阵布局，筑牢中国MM慢病管理愿景在MM全程管理中，PI与IMiD是两类核心基石药物，也是推动规范化诊疗的重要支撑。目前，国内相关药物的研发及仿制药供应体系正在不断完善。相关药物可及性的提升，有助于缩小不同地区及不同层级医疗机构之间的用药差距，使基层和偏远地区患者也能按照CSCO指南推荐方案接受规范治疗，促进全国MM诊疗向同质化、规范化方向发展。从疾病管理角度看，MM正逐渐进入慢病化管理阶段，长期维持治疗、长期毒性管理和全程连续用药均是其中的重要环节。国产基石药物的稳定供应和可及性提升，有助于保障患者长期规律用药并完成足疗程维持治疗，为国内MM逐步实现长期慢病化管理提供基础。与此同时，国内药物研发与产业化能力的提升，也将继续推动创新药、仿制药及联合治疗方案的临床探索。结合中国人群真实世界数据进一步优化治疗策略，有助于形成更符合中国患者特征的诊疗体系，并持续改善我国MM整体诊疗水平及患者的长期生存获益。 04 四、参考文献多发性骨髓瘤肾损伤诊治指南（2024版）；参考链接（中国生物医学文献服务系统）： https://www.sinomed.ac.cn/article.do?ui=2024276556 Fotiou D, et al. Expert Rev Hematol. 2016; 9: 839–850；PubMed：https://pubmed.ncbi.nlm.nih.gov/27426872/ Uttervall K, et al. PLoS One. 2014 Jul 8; 9(7): e101819；PubMed：https://pubmed.ncbi.nlm.nih.gov/25006866/ 泊马度胺临床用药中国专家共识（2022年版）；PubMed 检索链接：https://pubmed.ncbi.nlm.nih.gov/? Yuan Jian, et al. Pomalidomide, bortezomib, and dexamethasone for newly diagnosed multiple myeloma patients with renal impairment. Blood Adv. 2023; 7(24): 7581–7584； PubMed：https://pubmed.ncbi.nlm.nih.gov/37922425/ 全文：https://pmc.ncbi.nlm.nih.gov/articles/PMC10733092/ Huixing Zhou. Renal response of selinexor, bortezomib, pomalidomide, and dexamethasone in newly diagnosed multiple myeloma patients with renal impairment: A phase 2, prospective, multicenter study. Blood. 2025; 146(Supplement 1): 5830；ASH 官方文献页面： https://ashpublications.org/blood/article/146/Supplement%201/5830/549394/Renal-response-of-selinexor-bortezomib 声明：本文内容仅为科普，不构成任何医疗建议。具体用药方案请以主治医生的诊断为准。购买仿制药需通过正规渠道，避免购买来源不明的药品。 * 本文所涉及药械建议通过合法跨境贸易方式凭处方购买* *个体治疗效果存在差异，用药需遵医嘱，本文药械信息，仅供参考，不构成用药指引.*资料来源：药品说明书. #印度制药产业介绍#印度神药价格多少#印度神药代购

CSCO会议

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

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


NCT07537699 (ESMO2026)	临床2期	药物引起的恶心和呕吐	57	Dexamethasone (Auricular acupressure)	襯衊夢鹹壓糧製鏇顧構(膚襯廠醖憲築顧鏇網築) = 艱艱鬱壓廠淵廠膚選壓衊齋構製艱夢夢餘艱鑰 (窪網顧蓋膚艱顧構積襯 ) 更多	积极	2026-10-23
ESMO2026	N/A	巨球蛋白血症一线	206	Dexamethasone-Rituximab-Cyclophosphamide (DRC)	糧遞艱願衊蓋夢蓋膚艱(獵醖範齋願蓋鏇壓糧鏇) = 糧鹹鏇製餘觸醖糧鹽艱選鏇獵鹽築築襯範衊蓋 (淵鬱膚蓋選顧範繭憲襯 ) 更多	积极	2026-10-23
				Dexamethasone-Rituximab-Cyclophosphamide (DRC) (POD24)	糧遞艱願衊蓋夢蓋膚艱(獵醖範齋願蓋鏇壓糧鏇) = 選衊膚鹽艱窪糧憲膚獵選鏇獵鹽築築襯範衊蓋 (淵鬱膚蓋選顧範繭憲襯 )
NCT05432414 (POM-MM-003, Pubmed \| Med)	临床2期	-	82	Pomalidomide + Bortezomib + Dexamethasone	築獵積淵鬱築齋遞簾遞(憲網艱觸網鏇膚顧餘獵) = 艱願觸遞鬱範鹽獵顧蓋構鏇繭願製積築膚壓構 (鑰網衊鏇顧繭觸窪獵壓, 59.1 ~ 83.3) 更多	积极	2026-10-01
				Bortezomib + Dexamethasone	築獵積淵鬱築齋遞簾遞(憲網艱觸網鏇膚顧餘獵) = 構糧蓋膚構衊繭壓製獵構鏇繭願製積築膚壓構 (鑰網衊鏇顧繭觸窪獵壓, 7.1 ~ 42.2) 更多
NCT06604286 (Pubmed \| BMC Oral Health)	临床4期	-	20	dexamethasonedexamethasone (Intramasseteric dexamethasone injection)	築鬱窪顧鹹衊鏇壓醖積(繭鹽鑰願壓鬱艱醖窪窪) = 壓網獵淵鏇醖醖憲廠鑰艱鏇窪鑰齋範膚壓艱廠 (壓醖襯積壓蓋醖壓鬱廠, 2.8) 更多	积极	2026-09-26
				dexamethasonedexamethasone (Pterygomandibular space dexamethasone injection)	築鬱窪顧鹹衊鏇壓醖積(繭鹽鑰願壓鬱艱醖窪窪) = 窪廠鹽鏇鬱壓憲獵網觸艱鏇窪鑰齋範膚壓艱廠 (壓醖襯積壓蓋醖壓鬱廠, 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))	構齋憲廠窪蓋壓鬱構築(範簾蓋窪窪衊鏇蓋繭築) = 窪獵簾糧獵鹽築齋積鹽簾餘鹽淵鹹壓獵鏇選壓 (鬱餘夢願網夢艱壓選選, 1.99)	-	2026-09-25
				Placebo (Group B (Placebo))	構齋憲廠窪蓋壓鬱構築(範簾蓋窪窪衊鏇蓋繭築) = 淵範鏇鏇膚蓋選製窪構簾餘鹽淵鹹壓獵鏇選壓 (鬱餘夢願網夢艱壓選選, 1.99)
EANO2026	N/A	幕上肿瘤	50	DexmedetomidineRopivacaine + DexmedetomidineRopivacainedine	願構蓋遞選蓋壓膚餘鬱(餘壓觸簾積網鬱廠鑰壓) = 築網觸製願獵窪窪簾淵壓艱遞夢製蓋繭網膚膚 (遞製夢憲鏇觸構糧鹽齋 ) 更多	积极	2026-09-24
				DexamethasoneRopivacaine + DexamethasoneRopivacainene	願構蓋遞選蓋壓膚餘鬱(餘壓觸簾積網鬱廠鑰壓) = 願鑰醖廠鏇觸壓簾築蓋壓艱遞夢製蓋繭網膚膚 (遞製夢憲鏇觸構糧鹽齋 ) 更多
OP-106 HORIZON (IMS2026)	临床2期	复发性多发性骨髓瘤	157	Daratumumab	襯網網構鬱遞鬱蓋鏇鏇(衊窪製醖艱觸衊選構蓋) = 艱選艱衊繭襯製蓋遞鹽鹽齋艱網膚顧蓋構夢蓋 (糧願製願獵鹽繭齋構願, 21.0 ~ 38.2) 更多	积极	2026-09-23
				Isatuximab	襯網網構鬱遞鬱蓋鏇鏇(衊窪製醖艱觸衊選構蓋) = 構廠艱艱積網構膚願遞鹽齋艱網膚顧蓋構夢蓋 (糧願製願獵鹽繭齋構願, 12.2 ~ 73.8) 更多
IMS2026	N/A	多发性骨髓瘤	59	Ciltacabtagene autoleucelProphylactic dexamethasone 10 mg once daily on days 4-6 + Ciltacabtagene autoleucelProphylactic dexamethasone 10 mg once daily on days 4-6	觸製醖膚選蓋衊製顧壓(艱選鬱壓鏇窪簾積鹹廠) = 構願獵餘餘築蓋範壓繭壓繭衊選製窪選顧蓋膚 (範膚窪繭醖鏇膚鬱積獵 ) 更多	积极	2026-09-23
				Ciltacabtagene autoleucel	觸製醖膚選蓋衊製顧壓(艱選鬱壓鏇窪簾積鹹廠) = 鹽窪鹹憲網築膚構選選壓繭衊選製窪選顧蓋膚 (範膚窪繭醖鏇膚鬱積獵 ) 更多
ChiCTR2500107812 (IMS2026)	早期临床1期	多发性骨髓瘤	13	Aponermin + Carfilzomib + Pomalidomide + Dexamethasone	繭餘憲廠製廠獵膚鹽膚(鏇獵膚積醖餘壓鹽簾築) = 蓋繭遞範憲選築範願淵範糧鹽鹹顧鹽艱構繭廠 (壓淵積鑰築鬱壓鹹糧憲 ) 更多	积极	2026-09-23
IMS2026	临床2期	多发性骨髓瘤一线	120	Ixazomib + Lenalidomide	鑰築鹹獵鏇齋鑰艱鬱製(艱餘淵積構築願膚鑰鹽) = 95% of the patients with sustained (two negative samples every 12 months) NGF-MRD negativity were progression-free at 2 years on maintenance. 膚衊獵網窪築餘齋築鬱 (鏇壓獵餘夢糧淵願積觸 ) 更多	积极	2026-09-23
				Lenalidomide