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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)

Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).

Phase 3
Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2006-06-16
Last Posted Date
2011-10-10
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
1155
Registration Number
NCT00337779

Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate

Not Applicable
Conditions
Multiple Sclerosis
First Posted Date
2006-05-31
Last Posted Date
2006-07-07
Lead Sponsor
Sheba Medical Center
Target Recruit Count
20
Registration Number
NCT00331747
Locations
🇮🇱

Multiple Sclerosis Center, Sheba Medical Center, Tel Hashomer, Israel

FOCUS Fatigue Outcome in Copaxone USers

Phase 4
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2005-12-20
Last Posted Date
2009-12-07
Lead Sponsor
Sanofi
Target Recruit Count
111
Registration Number
NCT00267319
Locations
🇨🇿

Sanofi-Aventis, Praha, Czech Republic

A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®

Phase 4
Completed
Conditions
Multiple Sclerosis
Interventions
Procedure: Warm compress prior to injection of glatiramer acetate
First Posted Date
2005-10-17
Last Posted Date
2017-02-06
Lead Sponsor
Teva Neuroscience, Inc.
Target Recruit Count
50
Registration Number
NCT00239993
Locations
🇺🇸

Neurological Center of South Florida, Miami, Florida, United States

🇺🇸

Advanced Neurosciences Institute, Nashville, Tennessee, United States

🇺🇸

Multiple Sclerosis Care Center, Brooklyn, New York, United States

and more 3 locations

Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx

Phase 3
Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2005-09-21
Last Posted Date
2014-04-03
Lead Sponsor
Fred Lublin
Target Recruit Count
1008
Registration Number
NCT00211887
Locations
🇺🇸

MS Center of Atlanta, Atlanta, Georgia, United States

🇺🇸

Shepherd Center, Atlanta, Georgia, United States

🇺🇸

Northwest University, Chicago, Illinois, United States

and more 68 locations

Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine

Phase 2
Completed
Conditions
Relapse Remitting Multiple Sclerosis
Interventions
First Posted Date
2005-09-20
Last Posted Date
2012-05-14
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
18
Registration Number
NCT00203099

Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness

Phase 4
Completed
Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
First Posted Date
2005-09-20
Last Posted Date
2020-02-18
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
208
Registration Number
NCT00203021
Locations
🇺🇸

Teva Investigational Site 009, Los Angeles, California, United States

🇺🇸

Teva Investigational Site 004, Los Angeles, California, United States

🇺🇸

Teva Investigational Site 008, New Haven, Connecticut, United States

and more 8 locations

A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.

Phase 2
Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2005-09-20
Last Posted Date
2011-04-14
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
40
Registration Number
NCT00203073

Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

Phase 2
Completed
Conditions
Relapse Remitting Multiple Sclerosis
Interventions
First Posted Date
2005-09-20
Last Posted Date
2011-04-12
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
44
Registration Number
NCT00203112
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