醋酸格拉默(Glatiramer Acetate) - 在研适应症：多发性硬化症，复发-缓解型多发性硬化，复发性多发性硬化_专利_临床

概要

基本信息

药物类型

聚合物

别名

(T,G)-A-L、COP 1、Copolymer 1

+ [15]

靶点-

作用机制

免疫调节剂

治疗领域

免疫系统疾病神经系统疾病其他疾病+ [1]

在研适应症

多发性硬化症复发-缓解型多发性硬化复发性多发性硬化+ [4]

非在研适应症

肌萎缩侧索硬化克罗恩病视神经炎

原研机构

Weizmann Institute of Science

在研机构

Mapi-Pharma Ltd.

Weizmann Institute of ScienceTeva-Handok Pharma Co., Ltd.

+ [6]

非在研机构

Teva Branded Pharmaceutical Products R&D, Inc.

Teva Pharmaceutical Industries Ltd.Teva Neuroscience, Inc.

最高研发阶段批准上市

首次获批日期

美国 (1996-12-20),

复发-缓解型多发性硬化

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (日本)、孤儿药 (韩国)

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结构/序列

分子式C25H45N5O13

InChIKeyFHEAIOHRHQGZPC-KIWGSFCNSA-N

CAS号147245-92-9

Sequence Code 321794895

关联

62

项与醋酸格拉默相关的临床试验

NCT05688436

/ RecruitingN/A

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.

开始日期2021-09-24

申办/合作机构

Biogen, Inc.

NCT04079088

/ Withdrawn临床2期

A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis

The primary objectives of the study are to evaluate the safety of BIIB061 versus placebo in participants with Relapsing Multiple Sclerosis (RMS), and to evaluate the efficacy of BIIB061 to improve disability outcome versus placebo in participants with RMS.
The secondary objectives of the study are to evaluate the effects of BIIB061 versus placebo on brain magnetic resonance imaging (MRI) markers of remyelination and axon preservation in chronic Multiple Sclerosis lesions and to evaluate the effects of BIIB061 versus placebo on additional measures of improved disability outcome.

开始日期2021-06-30

申办/合作机构

Biogen, Inc.

NCT06003972

/ Completed临床2期IIT

Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure

Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute decompensated heart failure.
Trial Design
An open-label, randomized, prospective trial of patients hospitalized due to acute decompensation of heart failure with reduced ejection fraction.
Patients will be enrolled within 24 hours from hospital admission.
Randomization and intervention will begin within 24 hours of enrollment (and at least 24 hours after admission).
Patients will be randomized in a 1:1 ratio either to receive guideline directed medical therapy (GDMT) or GDMT plus Copaxone.
Patients assigned to intervention group will receive daily SC Copaxone 20 mg for 14 days.
Patients will be assessed during 4 time points(screening/randomization, visit 3 day, visit 14 day, visit 30 day) as elaborated in article "monitoring".
Changes in inflammatory cytokines will be compared between control and intervention group throughout 3 time points.
The trial will be approved by the institutional view board and conducted in accordance with the principles or Good Clinical Practice guidelines and the Declaration of Helsinki.

开始日期2021-01-04

申办/合作机构

Hadassah University Hospital

[+1]

100 项与醋酸格拉默相关的临床结果

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100 项与醋酸格拉默相关的转化医学

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100 项与醋酸格拉默相关的专利（医药）

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11,528

项与醋酸格拉默相关的文献（医药）

2025-01-01·Multiple Sclerosis and Related Disorders

COVID-19 in patients with multiple sclerosis—A narrative review

Review

作者: Telagarapu, Venkata Madhavi Latha ; Karale, Smruti ; Sujakhu, Eru ; Shrestha, Bijay Kumar

BACKGROUND:

Multiple sclerosis (MS) is a complex neurodegenerative disease characterized by immune dysregulation, affecting over 2.5 million people worldwide. Interestingly, COVID-19 infection can cause neurodegeneration through demyelination similar to that of MS, and COVID-19 infection can lead to long-term neurological sequelae, post-COVID-19 neurological syndrome. These overlapping neurological mechanisms suggest that patients with MS (PwMS) may have a unique and potentially more complex relationship with COVID-19.

DISCUSSION AND CONCLUSION:

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) can enter the central nervous system via the olfactory nerve or through interactions with angiotensin-converting enzyme-2 receptors in the blood-brain barrier, potentially initiating or enhancing neurodegenerative processes through demyelination. The risk of SARS-CoV-2 infection among PwMS is similar to that of the general population; however, PwMS with higher Expanded Disability Status Scale scores, longer MS duration, or progressive forms of MS are at an increased risk for developing severe COVID-19 outcomes. Most disease-modifying therapies (DMT), such as interferon, glatiramer, teriflunomide, and cladribine, do not appear to affect the risk of COVID-19 infection, the severity of COVID-19 illness, or the response to COVID-19 vaccines. As a result, these therapies should be continued during COVID-19 infection in PwMS. Rituximab, however, has been shown to increase the risk of severe COVID-19 outcomes. For managing symptomatic COVID-19 infection in PwMS, remdesivir and neutralizing monoclonal antibodies are shown to be effective. COVID-19-associated cytokine release syndrome can be managed with corticosteroids. Importantly, COVID-19 infection does not increase susceptibility to MS relapses or exacerbate the progression of MS symptoms. Furthermore, COVID-19 vaccination is encouraged for all MS patients, particularly those at greater risk of severe outcomes, as it does not trigger relapses, exacerbate MS symptoms, or diminish the efficacy of DMT. Despite these findings, high-quality evidence remains lacking to fully establish the relationship between COVID-19 and MS, highlighting the need for further research in this area.

2025-01-01·BRAIN RESEARCH

Two-phase therapy for improving neuroprotection and neurogenesis: Preventive use of omega fatty acids plus Copolymer-1 immunization after stroke

Article

作者: Arias-Santiago, Stella ; Borlongan, Cesar V. ; Borlongan, Cesar V ; Cantú, Karla ; Gálvez-Susano, Vanessa ; Ojeda, Gerardo ; Ibarra-García, Andrea P. ; Antonio Vargas-Hernández, Marco ; Cruz-Martínez, Yolanda ; Carrasco-Vargas, Humberto ; Ibarra, Antonio ; Ibarra-García, Andrea P

Stroke is a major global health issue, ranking as the second leading cause of death and the primary cause of disability worldwide. However, current therapeutic options remain limited. Nutritional supplementation as a form of primary prevention stands as a potential stroke therapeutic. In particular, the intake of omega-3 fatty acids (omega-3FA) exerts anti-inflammatory and neuroprotective effects that help reduce the risk of stroke. In parallel, treatment with Copolymer-1 (COP-1), a peptide with immunomodulatory properties through Th1/Th2/Th3 phenotype switching, similarly affords neuroprotective and neurorestorative effects in stroke models. To investigate the combined effects of these treatments, we designed a two-phase therapy: the first phase involved preventive supplementation with omega-3FA, while the second phase included COP-1 immunization following stroke injury. Sprague-Dawley rats were randomly assigned to one of the four groups: 1) control, 2) omega-3FA, 3) COP-1, and 4) omega-3FA + COP-1. Omega-3FAs were administered for 28 days before inducing stroke. Thirty minutes after reperfusion, the respective groups were immunized with COP-1. Seven days post-stroke, neurological deficits were assessed using the Zea-Longa scale, infarct volumes with 2,3,5-triphenyltetrazolium chloride (TTC) staining, and levels of neurogenesis via immunofluorescence imaging. The results showed that the two-phase therapy produced significant synergistic effects, markedly reducing neurological deficits, and infarct volumes, while enhancing neurogenic activities in neurogenic niches. This combined approach underscores the potential of integrating nutritional and pharmacological strategies to enhance stroke recovery.

2025-01-01·SCANDINAVIAN JOURNAL OF IMMUNOLOGY

Expression of STAT‐ and T‐cell‐related genes in women with first‐line treatment of relapsing‐remitting multiple sclerosis

Article

作者: Zawadzka‐Więch, Urszula ; Karlińska, Anna ; Machcińska, Maja ; Donskow‐Łysoniewska, Katarzyna ; Kierasińska, Magdalena ; Maruszewska‐Cheruiyot, Marta ; Szewczak, Ludmiła ; Majewski, Paweł ; Rola, Rafał

Abstract:

Relapsing‐remitting multiple sclerosis is associated with changes in Jak/STAT pathways in immune cells, but the influence of disease‐modifying drugs on these pathways is poorly understood. The aim of this study was to evaluate the impact of first‐line disease‐modifying drugs used in treatment of RRMS on expression of the STAT pathway and T‐cell‐related genes in the blood and on serum concentrations of sgp130 and TGF‐β1 in women, as well as on the level of phosphorylated STAT3 and STAT5 proteins in T cells of untreated patients and heathy controls. Expression of STAT1, STAT3, STAT5A, STAT5B, SOCS1, SOCS3, FOXP3, IKZF2, RORC and ICOS genes in the blood of untreated RRMS patients, in the blood of patients treated with interferon‐β, glatiramer acetate, dimethyl fumarate or teriflunomide and in the blood of healthy controls was evaluated using droplet digital PCR. Serum concentrations of sgp130 and TGF‐β1 were evaluated by ELISA. Phosphorylated STAT3 and STAT5 protein levels in T cells were evaluated by flow cytometry. STAT3 gene expression was significantly higher in untreated patients than in healthy control, but the level of phosphorylated STAT3 in T cells was significantly lower. Patients treated with interferon‐β or dimethyl fumarate had significantly lower STAT3 gene expression. Patients treated with teriflunomide had higher STAT1 gene expression, than untreated patients. Patients treated with dimethyl fumarate also had significantly lower RORC gene expression than untreated patients. The study shows the impact of drugs used in first‐line treatment of relapsing‐remitting multiple sclerosis on expression of STAT and T‐cell‐related genes.

161

项与醋酸格拉默相关的新闻（医药）

2024-12-23

·药事纵横

复杂注射剂开发中的难点及相应对策探讨

一、概述在过去的几十年里，制药行业的无菌产品市场经历了快速增长，从而形成了多种剂型，如混悬剂、乳剂、脂质体、微球和纳米粒等，由于这些药品的设计和开发十分复杂，因此称之为“复杂注射剂”。美国FDA指出复杂注射剂主要包括复杂的活性成分（如醋酸格拉替雷注射液，美国梯瓦制药公司）或复杂制剂（如注射用醋酸奥曲肽微球，诺华制药公司），此外，还可能包括复杂的药物-器械组合，其中原料药预先装载在特定产品器械中（如肾上腺素预充式自动注射器， Mylan Specialty LP）。复杂注射剂的开发、可放大性以及表征均存在一定难度，现有的技术指导原则也很少涉及复杂注射剂，预测监管要求变得困难重重。故本文旨在探讨复杂注射剂的相关难点及对策，以期对业界提供一定参考。二、复杂注射剂分类及面临的挑战复杂注射剂包括复杂原料药、辅料、剂型、给药装置（如预充式注射器和注射笔）等，具体分类如下表所示：由于生产/操作复杂，需要高技能的人力资源和领域专家，资本投资高，从实验室到市场的转化活动耗时长，因此这些产品的开发和审批都具有挑战性。由于多单元操作/生产流程复杂，设备（如高压均质机、脂质挤压机等）不常用，因此放大过程十分繁琐。此外，由于质量属性特殊加上非常规的测试要求以及不明确的监管要求，导致复杂注射剂的审批周期长。由于复杂注射剂竞争少，持续占有市场的机会大，即使困难重重，业界对该领域仍然保有兴趣。常见的技术挑战如下表所示：要将这些产品从实验室顺利推向市场，就必须了解其开发、表征、放大和监管等各个阶段的障碍。接下来以案例分析的形式对复杂注射剂的研发挑战进行探讨，以期对大家有一定启示作用。三、结合案例分析探讨复杂注射剂的开发难点下面结合3个案例对复杂注射剂的研发难点进行分析，包括微球、脂质体及药械组合产品，这些产品因其复杂性，在国内的仿制药较少或无仿制药，下文的相关探讨希望对业界提供一定参考。注射用醋酸奥曲肽微球于1998年11月25日获FDA批准，由诺华制药有限公司持有，商品名为Sandostatin LAR®。2003年获批进口中国，目前国内仿制药仅有1家，即齐鲁制药有限公司。该产品是一种长效八肽，其药理性质与天然激素生长抑素相似。以聚乳酸乙二醇酯（PLGA）作为微球载体，由于辅料成分的复杂性及微球制备工艺的挑战性，使得本品的方法存在较大难度。FDA发布的个药指南中指出，仿制制剂需要与参比制剂进行单剂量、平行设计的体内生物等效性研究，同时要求处方中辅料种类（Q1）和用量（Q2）的一致性，同时仍需要关注本品的体外溶出行为。盐酸多柔比星化脂质体由杨森制药公司持有，商品名为Doxil®，该产品是FDA于1995年批准的首个纳米技术类产品。为了开发这种脂质体制剂的仿制药，FDA发布了盐酸多柔比星脂质体的个药指南，该个药指南提供了该类制剂成功上市及获批所需的体外、体内和理化性质信息。该个药指南中推荐的一些关键理化性质包括脂质体成分、包封药物的状态、内部环境、形态、脂质体片层数量、脂质双分子层相变、粒度分布、脂质体表面接枝的PEG、表面电位或电荷以及体外释放等情况。醋酸格拉替雷注射液由由Teva制药公司持有，商品名为Copaxone®，FDA于1996年批准本品上市，于2023年6月获批进口中国，目前国内无仿制药。其活性成分醋酸格拉替是一种合成多肽混合物，具有独特的抗炎和免疫调节活性。它是一种药械组合产品，为预充式注射器的成品。复杂的原料药、复杂的制备工艺及药械组合等使得Copaxone®成为一种复杂制剂。为了更好地明确和指导仿制药开发，FDA发布了本品的个药指南（PSG）。FDA在该指南中推荐了一些证明原料药相同性所需满足的标准，如基本反应方案的等效性、包括成分、聚合和解聚的结构特征在内的理化性质以及生物检测结果等。此外，相关物质的表征，如肽相关杂质分析、杂质的非临床免疫原性评估，以及包装成分的功能测试和其他常规测试等，均是格拉替雷预充式注射器成功仿制的必要条件。另一个与复杂注射剂生产有关的挑战是成品制剂的无菌性。处方中使用的聚合物、脂类、有机溶剂和水性缓冲剂等成分通过0.22-µm孔径的过滤器进行除菌过滤，然后在B＋A洁净区的工作站上利用这些成分制备药品。应严格监控无菌灌装的潜在污染源，如内包装材料、操作人员、环境空气污染和排水系统。考虑到生产复杂注射剂所涉及成分的独特化学成分和理化性质，常用的灭菌技术（如高压灭菌、γ-射线和电离辐射）可能会损害成品药物的稳定性。如产品对热不稳定，且粒径超过0.2µm，无法进行湿热灭菌也无法进行除菌过滤，在这种情况下，只能选择处方中各成分进行无菌处理，然后再无菌灌装。在无菌处理中，所有生产活动都是在无菌条件下进行的，包括制剂载体的搅拌/混合、减小粒径、配制、灌装和密封到内包装中，这些操作无疑增加了产品生产的复杂性。四、小结由于复杂注射剂竞争少，持续占有市场的机会大，即使研发、生产及审批等均困难重重，业界对该领域仍然十分关注。本文结合案例分析对复杂注射剂的研发难点及对策进行探讨，希望对业界同仁有一定的参考作用。五、参考文献 FDA各产品的个药指南药事纵横征稿启事

医药出海加速审批

2024-11-01

·Pharmaceutical Technology

EC fines Teva $502m over multiple sclerosis treatment Copaxone practices

Copaxone is used as standard-of-care treatment for multiple sclerosis. Credit: Pixel-Shot via Shutterstock. The European Commission (EC) has imposed a fine of €462.6m ($502m) on Teva Pharmaceuticals Industries after investigating the company’s practices regarding the standard-of-care multiple sclerosis treatment, Copaxone. The fine relates to the company’s attempts to delay the entry of competitors to Copaxone by artificially extending the therapy’s patent protection and disseminating misleading information about rival products. Teva held a basic patent for Copaxone’s active ingredient, glatiramer acetate, which expired in 2015. However, the commission found that Teva extended Copaxone’s exclusivity by misusing patent procedures and disseminating false information. The markets affected include Czechia, Belgium, Germany, Italy, the Netherlands, Poland, and Spain. The EC’s decision marks the first instance of imposing a fine for such dual practices, which together constitute a single, continuous infringement of Article 102 of the Treaty on the Functioning of the European Union. The fine was calculated following the commission’s 2006 guidelines on fines. Its investigation uncovered that Teva misused patent procedures by filing staggered divisional patent applications, creating a complex web of secondary patents around the multiple sclerosis therapy. This claimed to be a deliberate move to prolong legal uncertainty and potentially block the entry of cheaper alternatives. In addition, according to the EC, Teva orchestrated a systematic disparagement campaign to discredit a competing glatiramer acetate medicine, spreading false claims about its efficacy and safety despite health authorities’ approval. This campaign targeted doctors and national decision-makers, aiming to slow down or completely block the rival product’s market entry in various EU Member States. In response to the decision, Teva expressed deep disappointment stating that it has cooperated with the commission since 2019. The company disputes the legal theories applied by the EC, which it considers untested and factually unsupported. Teva expressed that it is prepared to defend its position on appeal and has reassured it will continue to support the multiple sclerosis community, which it has been part of since 1996, without distraction from providing access to Copaxone.

专利侵权

2024-10-31

·GlobeNewswire-Health Care

Teva Statement on European Commission Decision; Company to Appeal

Teva Pharmaceuticals disagrees with the European Commission decision, which is based on legal theories that the company believes are extreme, untested, and factually unsupportedThe company intends to appeal the outcome and is fully prepared to mount its defense Teva has supported the MS community since 1996 and will not be distracted from providing access to this important standard-of-care treatment Teva works to the highest ethical standards with all our external experts and do so in a highly regulated environment TEL AVIV, Israel, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals Industries Ltd. (NYSE: and TASE: TEVA) is responding to the European Decision following its investigation into the company’s practices regarding COPAXONE® -- the standard-of-care treatment for multiple sclerosis – and announcing its intention to appeal the judgement and fine imposed. The company is deeply disappointed by this decision and has been cooperating extensively with the EC since 2019. Teva disagrees with the Commission’s legal theories which are legally untested and, Teva believes, not supported by the facts. The company will vigorously defend its position on appeal and is well prepared financially to mount a defense. Teva conducts its business lawfully and ethically and has been a strong partner to Europe, its patients, economy and healthcare systems. This misguided decision will not distract Teva from its unwavering support for patients living with MS and their families. Media Contacts: Kelley Dougherty (973) 832-2810 Eden Klein +972 (3) 906 2645

100 项与醋酸格拉默相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04318	醋酸格拉默	L03AX13	DB05259

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
多发性硬化症	美国	Teva Pharmaceuticals USA, Inc.	2014-01-28
复发-缓解型多发性硬化	美国	Teva Pharmaceuticals USA, Inc.	1996-12-20

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
复发性多发性硬化	临床3期	美国	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	白俄罗斯	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	波斯尼亚和黑塞哥维那	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	保加利亚	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	爱沙尼亚	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	格鲁吉亚	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	以色列	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	摩尔多瓦	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	俄罗斯	Mapi-Pharma Ltd.	2019-09-19
复发性多发性硬化	临床3期	乌克兰	Mapi-Pharma Ltd.	2019-09-19

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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


GA Depot, Phase 3 (ACTRIMS2024)	临床3期	复发性多发性硬化	763	GA Depot	鏇構廠鏇壓製簾淵觸鹽(繭構遞製蓋餘製淵繭繭) = mean percent change 8.34 觸鑰鏇鹹選選選觸齋憲 (願願膚願壓築顧糧糧觸 )	积极	2024-02-29
Phase III Open Label period (ACTRIMS2024)	临床3期	-	821	Glatiramer Acetate Depot	積鏇淵醖壓繭壓鹹襯壓(壓選範壓積網壓積壓遞) = The most frequent TEAEs reported (≥5% of the subjects in any treatment group), irrespective of the relatedness, were ISRs, pyrexia, influenza-like illness, body temperature increase, and headache 齋膚餘窪遞壓範顧鏇鹽 (憲艱製窪願膚衊餘鬱鹽 ) 更多	积极	2024-02-29
				Placebo
ECTRIMS2023	临床3期	复发性多发性硬化	-	GA Depot	淵糧淵廠簾鑰艱鑰網鑰(壓網糧築廠鏇壓糧選構) = 廠鹹憲衊糧膚衊艱餘繭襯蓋齋齋襯餘艱壓齋艱 (鬱淵襯壓選範鏇衊憲齋 ) 更多	-	2023-09-30
				Copaxone®	淵糧淵廠簾鑰艱鑰網鑰(壓網糧築廠鏇壓糧選構) = 積鬱夢餘鹽鹽鏇淵遞廠襯蓋齋齋襯餘艱壓齋艱 (鬱淵襯壓選範鏇衊憲齋 ) 更多
MSBase registry (ECTRIMS2023)	N/A	多发性硬化症	-	Ocrelizumab	繭蓋憲顧窪廠製鏇廠鏇(觸網憲膚獵鑰鹽糧夢網): hazard ratio = 0.12 (95% CI, 0.05 ~ 0.26)	积极	2023-09-30
				Interferon/Glatiramer Acetate
AAN2023	临床3期	复发性多发性硬化	-	GA Depot 40mg	構範築積觸淵鹹窪範鬱(築選鹽鏇淵憲鑰齋齋繭) = 襯鹽鏇淵襯壓餘膚選獵淵願鏇醖觸遞範獵繭遞 (選淵獵淵網醖壓襯願獵 )	积极	2023-04-25
ACTRIMS2022	N/A	多发性硬化症	92	Glatiramer Acetate	積蓋願觸淵艱壓獵鑰齋(繭糧範觸蓋遞簾膚鬱願) = 鏇窪願淵糧鏇襯醖淵壓願鏇網鏇鹽範鏇衊憲遞 (獵蓋願構齋鹽膚鹽淵醖 ) 更多	积极	2022-05-16
				Dimethyl Fumarate	積蓋願觸淵艱壓獵鑰齋(繭糧範觸蓋遞簾膚鬱願) = 壓衊鏇蓋窪襯醖衊鹹艱願鏇網鏇鹽範鏇衊憲遞 (獵蓋願構齋鹽膚鹽淵醖 ) 更多
P5-4.010 (AAN2022)	临床2期	复发-缓解型多发性硬化 anti-GA antibodies	-	GA Depot 80mg	鹹醖鹹鹹觸觸餘選構夢(鑰衊築襯淵廠範鏇獵遞) = 網蓋顧襯範膚製艱鑰選觸鏇憲憲選鏇顧網窪範 (觸鹽艱夢鬱糧鏇積鏇鏇, +/ ~ 1.13) 更多	积极	2022-05-03
				GA Depot 40mg	鹹醖鹹鹹觸觸餘選構夢(鑰衊築襯淵廠範鏇獵遞) = 夢糧鹽鑰構襯艱艱築遞觸鏇憲憲選鏇顧網窪範 (觸鹽艱夢鬱糧鏇積鏇鏇, +/ ~ 1.25) 更多
NCT00176592 (BECOME, CTgov)	临床4期	多发性硬化症	75	Betaseron (Betaseron)	簾範願鹽夢廠製鏇餘願(遞網選壓蓋艱構壓膚齋) = 鏇築衊窪襯顧築簾觸襯鹹顧艱窪積獵築淵選壓 (醖構簾範願壓艱窪選憲, 簾築繭膚鏇鑰選繭簾積 ~ 鬱餘餘築願淵衊鹽積築) 更多	-	2021-11-16
				Copaxone (Copaxone)	簾範願鹽夢廠製鏇餘願(遞網選壓蓋艱構壓膚齋) = 積夢廠簾遞獵餘觸網淵鹹顧艱窪積獵築淵選壓 (醖構簾範願壓艱窪選憲, 壓鹽鏇廠窪繭餘願繭糧 ~ 廠夢鏇蓋鹹構築齋艱淵) 更多
NCT00326625 (CTgov)	临床2期	肌萎缩侧索硬化	366	Placebo	糧繭觸廠艱製衊壓範醖(衊襯鹹齋構築鬱蓋築鏇) = 餘鹽遞製製糧餘衊鏇範襯積衊夢製醖觸鹹衊構 (餘鬱積遞憲衊鹽艱構繭, 淵鑰壓觸構選築廠膚築 ~ 製窪衊餘膚觸膚選選壓) 更多	-	2021-10-20
ECTRIMS2021	N/A	多发性硬化症 Serum Neurofilament light chain (sNfL)	94	Glatiramer acetate (GA)	蓋襯網窪觸觸遞艱憲繭(憲餘網艱襯鹽範遞顧窪) = 齋網鏇夢製簾淵衊糧網壓鹽顧製蓋餘廠願齋壓 (繭壓簾繭膚壓憲顧壓鏇, 7.2 ~ 12.6)	-	2021-10-12
				Interferon beta (IFN)	蓋襯網窪觸觸遞艱憲繭(憲餘網艱襯鹽範遞顧窪) = 繭壓鏇獵窪鑰廠膚襯鹹壓鹽顧製蓋餘廠願齋壓 (繭壓簾繭膚壓憲顧壓鏇, 7.2 ~ 12.6)