Delving into the Latest Updates on Glatiramer Acetate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(T,G)-A-L, COP 1, Copolymer 1

+ [15]

Target-

Mechanism

Immunomodulators

Therapeutic Areas

Immune System DiseasesNervous System DiseasesOther Diseases+ [1]

Active Indication

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingMultiple sclerosis relapse+ [4]

Inactive Indication

Amyotrophic Lateral SclerosisCrohn DiseaseOptic Neuritis

Originator Organization

Weizmann Institute of Science

Active Organization

Mapi-Pharma Ltd.Teva Pharmaceuticals Australia Pty Ltd

Consegna Pharma, Inc.Startup

+ [6]

Inactive Organization

Teva Branded Pharmaceutical Products R&D, Inc.

Teva Pharmaceutical Industries Ltd.Teva Neuroscience, Inc.

Drug Highest PhaseApproved

First Approval Date

US (20 Dec 1996),

Multiple Sclerosis, Relapsing-Remitting

RegulationOrphan Drug (JP)

Login to view timeline

Structure

Molecular FormulaC25H45N5O13

InChIKeyFHEAIOHRHQGZPC-KIWGSFCNSA-N

CAS Registry147245-92-9

Gene Sequence

Sequence Code 321794895

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.

Start Date24 Sep 2021

Sponsor / Collaborator

Biogen, Inc.

NCT04079088 / WithdrawnPhase 2

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.

Start Date30 Jun 2021

Sponsor / Collaborator

Biogen, Inc.

NCT06003972 / CompletedPhase 2IIT

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.

Start Date04 Jan 2021

Sponsor / Collaborator

Hadassah University Hospital

[+1]

100 Clinical Results associated with Glatiramer Acetate

Login to view more data

100 Translational Medicine associated with Glatiramer Acetate

Login to view more data

100 Patents (Medical) associated with Glatiramer Acetate

Login to view more data

11,920

Literatures (Medical) associated with Glatiramer Acetate

01 Jan 2025·Brain Research

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

Article

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

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.

31 Dec 2024·Plant Signaling & Behavior

Physiology and transcriptome of Eucommia ulmoides seeds at different germination stages

Article

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

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.

31 Dec 2024·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

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

AIMTo 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).METHODSReal-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.RESULTSIn 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.CONCLUSIONSThis 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.

90

News (Medical) associated with Glatiramer Acetate

01 Nov 2024

·www.pharmaceutical-technology.com

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.

Patent Infringement

31 Oct 2024

·www.globenewswire.com

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

31 Oct 2024

·www.pharmamanufacturing.com

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.

Patent Infringement

100 Deals associated with Glatiramer Acetate

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D04318	Glatiramer Acetate	L03AX13	DB05259

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Multiple Sclerosis	JP	Teva Takeda Pharma Ltd.Startup	28 Sep 2015
Multiple Sclerosis, Relapsing-Remitting	US	Teva Pharmaceuticals USA, Inc.	20 Dec 1996

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis	NDA/BLA	US	Viatris, Inc.	07 Aug 2023
Multiple Sclerosis	NDA/BLA	US	Mapi-Pharma Ltd.	07 Aug 2023
Multiple sclerosis relapse	Phase 3	UA	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	BA	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	BG	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	IL	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	MD	Mapi-Pharma Ltd.	19 Sep 2019
Multiple Sclerosis, Relapsing-Remitting	Preclinical	-	Teva Branded Pharmaceutical Products R&D, Inc.	01 Aug 2006

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Phase III Open Label period (ACTRIMS2024)	Phase 3	-	821	Glatiramer Acetate Depot	(vhmaqqqopd) = 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 tezcshrbpl (oamvivvlwa ) View more	Positive	29 Feb 2024
				Placebo
GA Depot, Phase 3 (ACTRIMS2024)	Phase 3	Multiple sclerosis relapse	763	GA Depot	keskxgiikp(kauenlgrzg) = mean percent change 8.34 shuemoqyjy (uhgqxadbpd )	Positive	29 Feb 2024
ECTRIMS2023	Phase 3	Multiple sclerosis relapse	-	GA Depot	grjpapkkeo(lfuuddfqpt) = umthlnwgwi beywprzrji (oscejwkkem ) View more	-	30 Sep 2023
				Copaxone®	grjpapkkeo(lfuuddfqpt) = jxoycrhcrj beywprzrji (oscejwkkem ) View more
AAN2023	Phase 3	Multiple sclerosis relapse	-	GA Depot 40mg	(xbbpvnnokf) = xkdrlkjxze ojztjbqugh (ynajgcnrqh )	Positive	25 Apr 2023
NCT03368664 (LemKids, CTgov)	Phase 3	Multiple Sclerosis, Relapsing-Remitting	16	Other H1 antagonist+Ceterizine+Acyclovir+Paracetamol+Methylprednisolone+Dexchlorpheniramine+Glatiramer acetate+Prednisolone+Ranitidine+Diphenydramine+Alemtuzumab GZ402673	ewrdnzpwse(tsvgzgrasf) = vvmjpscdxg pukfuffivc (fkjibimxyn, zrviejtxvq - btoxiymllg) View more	-	12 Jul 2022
P5-4.010 (AAN2022)	Phase 2	Multiple Sclerosis, Relapsing-Remitting anti-GA antibodies	-	GA Depot 80mg	gftsnyaifj(fvfrolioxd) = mxwvseuyua imgrruulxp (bpgyzktvlz, +/ - 1.13) View more	Positive	03 May 2022
				GA Depot 40mg	gftsnyaifj(fvfrolioxd) = zapaqlenou imgrruulxp (bpgyzktvlz, +/ - 1.25) View more
NCT00176592 (BECOME, CTgov)	Phase 4	Multiple Sclerosis	75	Betaseron (Betaseron)	mecdvplfsl(hqzjfgqmym) = fsbtdtjezy shvhwuqrvg (glqlmfqsia, jxvmzmagrv - ssgklqwujj) View more	-	16 Nov 2021
				Copaxone (Copaxone)	mecdvplfsl(hqzjfgqmym) = atxvfiqmdp shvhwuqrvg (glqlmfqsia, xwcpvtmurb - yhebezktyr) View more
NCT00326625 (CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	366	Placebo	roqntpunhv(qfvjrefbes) = cfhqetaits bvoofpnrej (zbjgsibpsu, zudxxzxbov - lclqoywtby) View more	-	20 Oct 2021
ECTRIMS2021	Not Applicable	-	2,129	Glatiramer Acetate	rffdutnrgq(atztvhwtkx) = none of which reported infant developmental delay wvyydyqubg (wnazfnjlif )	Positive	12 Oct 2021
COBRA (ECTRIMS2021)	Not Applicable	Multiple sclerosis relapse	50	Glatiramer acetate (GA)	dxzyuqcrcv(frmtbjglhl) = 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 gxjzknknua (fnzkkgrqrx ) View more	-	12 Oct 2021
				glatiramer acetate