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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)

Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS

Phase 4
Terminated
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2005-09-20
Last Posted Date
2010-10-18
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
91
Registration Number
NCT00202995

A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose

Phase 2
Completed
Conditions
Relapse-Remitting Multiple Sclerosis
Interventions
First Posted Date
2005-09-20
Last Posted Date
2010-01-14
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
90
Registration Number
NCT00202982
Locations
🇺🇸

The MS Center of Atlanta, Atlanta, Georgia, United States

🇺🇸

Michigan Institute of Neurological Disorders, Farmington Hills, Michigan, United States

🇺🇸

Center for Neurologic Study, La Jolla, California, United States

and more 17 locations

Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate

Phase 4
Terminated
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2005-09-20
Last Posted Date
2014-01-06
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
414
Registration Number
NCT00203047

Treatment of Multiple Sclerosis With Copaxone and Albuterol

Not Applicable
Completed
Conditions
Autoimmune Diseases
Multiple Sclerosis
Interventions
First Posted Date
2002-06-20
Last Posted Date
2016-09-22
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
40
Registration Number
NCT00039988
Locations
🇺🇸

Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts, United States

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis

Phase 3
Completed
Conditions
Multiple Sclerosis
First Posted Date
2000-02-25
Last Posted Date
2005-06-24
Lead Sponsor
National Center for Research Resources (NCRR)
Target Recruit Count
250
Registration Number
NCT00004814
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