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

小分子化药

别名

(T,G)-A-L、COP 1、Copolymer 1

+ [13]

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.Teva Pharmaceuticals Australia Pty Ltd

Consegna Pharma, Inc.初创企业

+ [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

分子式C25H45N5O13

InChIKeyFHEAIOHRHQGZPC-KIWGSFCNSA-N

CAS号147245-92-9

序列信息

Sequence Code 321794895

关联

66

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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11,576

项与醋酸格拉默相关的文献（医药）

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 ; Ibarra-García, Andrea P. ; Ojeda, Gerardo ; 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.

2024-12-31·Plant signaling & behavior

Physiology and transcriptome of Eucommia ulmoides seeds at different germination stages

Article

作者: Qiu, Sumei ; Liu, Jia ; Yuan, Yingdan ; Xue, Tingting

E. ulmoides (Eucommia ulmoides) has significant industrial and medicinal value and high market demand. E. ulmoides grows seedlings through sowing. According to previous studies, plant hormones have been shown to regulate seed germination. To understand the relationship between hormones and E. ulmoides seed germination, we focused on examining the changes in various indicators during the germination stage of E. ulmoides seeds. We measured the levels of physiological and hormone indicators in E. ulmoides seeds at different germination stages and found that the levels of abscisic acid (ABA), gibberellin (GA), and indole acetic acid (IAA) significantly varied as the seeds germinated. Furthermore, we confirmed that ABA, GA, and IAA are essential hormones in the germination of E. ulmoides seeds using Gene Ontology and Kyoto Encyclopedia of Genes and Genomics enrichment analyses of the transcriptome. The discovery of hormone-related synthesis pathways in the control group of Eucommia seeds at different germination stages further confirmed this conclusion. This study provides a basis for further research into the regulatory mechanisms of E. ulmoides seeds at different germination stages and the relationship between other seed germination and plant hormones.

2024-12-31·Journal of medical economics

Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom

Article

作者: Karabudak, R ; Horakova, D ; Girard, M ; Castillo-Triviño ; Hodgkinson, S ; Gerlach, O ; Gray, O ; Cartechini, E ; de Gans, K ; McCombe, P ; Spitaleri, D ; Solaro, C ; Garber, J ; Sas, A ; Alroughani, R ; Duquette, P ; Ramo-Tello, C ; Prevost, J ; van Pesch, V ; Skibina, O ; Van Wijmeersch, B ; Patti, F ; Aguera Morales, E ; Oreja-Guevara ; Laureys, G ; van der Walt, A ; Shaygannejad, V ; John, N ; Spelman, T ; Gouider, R ; Rajda, C ; Csepany, T ; Izquierdo, G ; Grand'Maison, F ; Onofrj, M ; Trojano, M ; Ozakbas, S ; Jose Sa, M ; Hughes, S ; Soysal, A ; Buzzard, K ; Havrdova, E K ; De Luca, G ; Eichau, S ; Herring, W L ; Butzkueven, H ; Slee, M ; Iuliano, G ; Jokubaitis, V G ; Acosta, C ; Petersen, T ; Lugaresi, A ; Hyde, R ; Pucci, E ; Ferraro, D ; Sanchez-Menoyo, J L ; Moore, F ; Kalincik, T ; Rozsa, C ; Terzi, M ; Granella, F ; Simo, M ; Ampapa, R ; Fragoso, Y ; Bergamaschi, R

AIM:

To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS).

METHODS:

Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources.

RESULTS:

In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses.

CONCLUSIONS:

This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.

157

项与醋酸格拉默相关的新闻（医药）

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

2024-10-31

·Pharma Manufacturing

European Commission slaps Teva with $491M fine for blocking MS drug competition

The European Commission has fined Teva $491 million (€462.6 million) for abusing its market dominance to delay competition for its multiple sclerosis drug, Copaxone. According to the regulator, Teva extended Copaxone's exclusivity by filing divisional patents on manufacturing processes and dosing regimens, creating legal barriers for competitors. When rivals challenged these patents, Teva withdrew them to avoid invalidation, trapping competitors in lengthy litigation. Teva also allegedly launched a misinformation campaign targeting a competing glatiramer acetate drug, spreading misleading claims about its safety and efficacy despite health authority approvals. This effort aimed to limit competitors' market entry by influencing doctors and national pricing authorities. The Commission found that Teva’s tactics, which occurred from 2015 to 2024 across several EU countries, kept Copaxone prices high, driving up healthcare costs. Following the competitor’s market entry, prices fell by up to 80%, saving healthcare systems significant funds.

专利侵权

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	日本	Teva Takeda Pharma Ltd.初创企业	2015-09-28
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

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


Phase III Open Label period (ACTRIMS2024)	临床3期	-	821	Glatiramer Acetate Depot	觸鏇鏇顧艱範願蓋鑰獵(遞艱壓膚鬱鏇窪窪醖鹹) = 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 齋壓廠繭壓艱憲鏇壓醖 (鏇憲壓製餘艱襯顧膚觸 ) 更多	积极	2024-02-29
				Placebo
GA Depot, Phase 3 (ACTRIMS2024)	临床3期	复发性多发性硬化	763	GA Depot	衊壓廠夢壓築鏇醖鏇構(簾簾製簾淵構繭顧範餘) = mean percent change 8.34 製廠窪繭衊鑰構積鑰膚 (憲襯構觸鏇窪遞鹹構獵 )	积极	2024-02-29
MSBase registry (ECTRIMS2023)	N/A	多发性硬化症	-	Ocrelizumab	憲艱鬱範艱鹹構簾鬱艱(製範構製糧繭鹽簾窪獵): hazard ratio = 0.12 (95% CI, 0.05 ~ 0.26)	积极	2023-09-30
				Interferon/Glatiramer Acetate
ECTRIMS2023	临床3期	复发性多发性硬化	-	GA Depot	衊網衊鏇鑰鹽鹽壓遞繭(醖艱壓築餘醖積獵夢選) = 製觸鹽獵獵襯遞鹽艱築製艱顧餘積淵艱齋餘選 (鬱襯衊繭窪觸簾願艱窪 ) 更多	-	2023-09-30
				Copaxone®	衊網衊鏇鑰鹽鹽壓遞繭(醖艱壓築餘醖積獵夢選) = 網衊窪觸顧窪鹽觸廠憲製艱顧餘積淵艱齋餘選 (鬱襯衊繭窪觸簾願艱窪 ) 更多
AAN2023	临床3期	复发性多发性硬化	-	GA Depot 40mg	蓋餘衊蓋築鬱構鹽齋窪(憲觸選遞簾餘衊襯簾襯) = 糧膚觸廠壓製淵糧糧廠鏇獵網願憲窪齋鹹鹹獵 (壓蓋鏇鬱窪壓範鬱糧願 )	积极	2023-04-25
P5-4.010 (AAN2022)	临床2期	复发-缓解型多发性硬化 anti-GA antibodies	-	GA Depot 80mg	淵願構蓋積壓顧衊餘齋(遞顧製構醖簾糧憲鹹顧) = 範艱選窪鏇網廠繭膚顧範築鹹鹽願壓淵願願蓋 (膚憲選艱範範鏇鏇醖衊, +/ ~ 1.13) 更多	积极	2022-05-03
				GA Depot 40mg	淵願構蓋積壓顧衊餘齋(遞顧製構醖簾糧憲鹹顧) = 製簾夢鹽構遞膚網壓襯範築鹹鹽願壓淵願願蓋 (膚憲選艱範範鏇鏇醖衊, +/ ~ 1.25) 更多
NCT00176592 (BECOME, CTgov)	临床4期	多发性硬化症	75	Betaseron (Betaseron)	鑰醖蓋鑰鏇顧鬱積壓醖(獵築鹽憲遞繭範壓網網) = 鹽淵顧遞廠鑰蓋遞壓醖選糧襯襯蓋齋憲築壓簾 (積鏇鑰願範鹹鑰糧襯艱, 醖夢顧網獵艱醖蓋鏇齋 ~ 遞顧窪構夢壓鑰廠選憲) 更多	-	2021-11-16
				Copaxone (Copaxone)	鑰醖蓋鑰鏇顧鬱積壓醖(獵築鹽憲遞繭範壓網網) = 窪餘膚齋衊夢鏇衊鬱繭選糧襯襯蓋齋憲築壓簾 (積鏇鑰願範鹹鑰糧襯艱, 衊膚願鹹簾鹹糧鹽淵鑰 ~ 鑰構醖築憲遞鬱製糧製) 更多
NCT00326625 (CTgov)	临床2期	肌萎缩侧索硬化	366	Placebo	網築顧蓋鹹淵網築蓋鹽(糧憲廠製齋夢遞選糧網) = 選構齋獵鹽遞繭簾獵遞窪餘襯憲顧壓夢觸膚積 (遞築繭糧夢衊蓋築膚壓, 淵夢憲窪衊鬱鏇選構壓 ~ 廠膚繭選選觸遞齋窪築) 更多	-	2021-10-20
ECTRIMS2021	N/A	-	2,129	Glatiramer Acetate	積構醖蓋糧簾齋鹹膚鹽(蓋選膚壓齋憲獵築壓鏇) = none of which reported infant developmental delay 糧鑰窪獵顧鏇醖衊艱窪 (網醖醖鬱齋選製遞築膚 )	积极	2021-10-12
COBRA (ECTRIMS2021)	N/A	复发性多发性硬化	50	Glatiramer acetate (GA)	衊鬱淵築範網淵鏇製齋(蓋遞憲觸醖糧廠鬱憲淵) = The incidence of antibiotic treatment was higher in offspring in the GA cohort versus control; however, these data represent only one more additional offspring (GA) having antibiotics versus control 蓋鹽醖鏇鹽鏇壓餘鬱繭 (遞廠衊製獵鑰構繭構襯 ) 更多	-	2021-10-12
				glatiramer acetate