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Glatiramer

Generic Name
Glatiramer
Brand Names
Copaxone, Glatect, Glatopa
Drug Type
Biotech
CAS Number
28704-27-0
Unique Ingredient Identifier
U782C039QP
Background

Glatiramer acetate is a mix of synthetic polypeptides that includes L-glutamic acid, L-alanine, L-tyrosine, and L-lysine at an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. Since glatiramer acetate is a heterogeneous drug, there is limited information about its physicochemical properties. Originally, glatiramer acetate was designed as a stimulant of myelin basic protein (MBP), a myelin antigen involved in the development of multiple sclerosis (MS), to induce experimental autoimmune encephalitis (MS animal model). However, the opposite was observed. Glatiramer acetate exhibits several immunomodulatory effects and reduces the relapse rate of relapsing-remitting multiple sclerosis (RRMS) by 30%. Along with human interferon beta, teriflunomide, and dimethyl fumarate, glatiramer acetate is a first-line drug for patients with MS. It was approved by the FDA in 1996, and a generic version became available in 2017.

Indication

Glatiramer acetate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Associated Conditions
Clinically Isolated Syndrome (CIS), Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS)

An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

Phase 3
Terminated
Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
First Posted Date
2012-04-17
Last Posted Date
2014-04-02
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
178
Registration Number
NCT01578785
Locations
🇺🇸

Teva Investigational Site 10212, Raleigh, North Carolina, United States

🇧🇾

Teva Investigational Site 68004, Grodno, Belarus

🇧🇬

Teva Investigational Site 59027, Veliko Tarnovo, Bulgaria

and more 166 locations

Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate

Phase 2
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2012-04-03
Last Posted Date
2018-06-08
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
53
Registration Number
NCT01569451
Locations
🇺🇸

University of Colorado Hospital, Aurora, Colorado, United States

Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)

Phase 4
Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
Drug: Interferon beta - 1a (IFN)
First Posted Date
2012-02-16
Last Posted Date
2014-08-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
298
Registration Number
NCT01534182
Locations
🇷🇺

Novartis Investigative Site, Yaroslavl, Russian Federation

Efficacy and Safety of GTR in Comparison to Copaxone®

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2011-12-09
Last Posted Date
2016-12-29
Lead Sponsor
Synthon BV
Target Recruit Count
794
Registration Number
NCT01489254
Locations
🇨🇿

Synthon investigational site 215, Praha, Czech Republic

🇨🇿

Synthon investigational site 214, Teplice, Czech Republic

🇬🇪

Synthon investigational site 529, Tbilisi, Georgia

and more 130 locations

Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2010-07-22
Last Posted Date
2013-10-17
Lead Sponsor
Teva Neuroscience, Inc.
Target Recruit Count
148
Registration Number
NCT01167426

Treatment Interruption of Natalizumab

Phase 2
Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2010-02-19
Last Posted Date
2013-09-19
Lead Sponsor
Biogen
Target Recruit Count
175
Registration Number
NCT01071083
Locations
🇪🇸

Research Site, Valencia, Spain

A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo

Phase 3
Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2010-02-11
Last Posted Date
2021-12-09
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
1404
Registration Number
NCT01067521
Locations
🇨🇿

Teva Investigational Site 5432, Prague 10, Czechia

🇺🇸

Teva Investigational Site 1326, Fullerton, California, United States

🇺🇸

Teva Investigational Site 1349, Columbus, Ohio, United States

and more 173 locations

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

Phase 3
Terminated
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2010-01-28
Last Posted Date
2014-09-03
Lead Sponsor
Biogen
Target Recruit Count
84
Registration Number
NCT01058005
Locations
🇸🇪

Research Site, Molndal, Sweden

Safety of New Formulation of Glatiramer Acetate

Phase 3
Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2009-07-28
Last Posted Date
2017-03-14
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
147
Registration Number
NCT00947752

Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS)

Phase 4
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2009-06-01
Last Posted Date
2010-02-10
Lead Sponsor
Amphia Hospital
Target Recruit Count
60
Registration Number
NCT00910598
Locations
🇳🇱

Amphia Ziekenhuis, Breda, Netherlands

🇳🇱

Maasland Ziekenhuis, Sittard, Netherlands

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