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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)

A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

First Posted Date
2023-01-18
Last Posted Date
2025-01-30
Lead Sponsor
Biogen
Target Recruit Count
1178
Registration Number
NCT05688436
Locations
🇺🇸

OptumInsight, Eden Prairie, Minnesota, United States

Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran

Completed
Conditions
Relapsing Multiple Sclerosis
First Posted Date
2021-06-16
Last Posted Date
2021-06-16
Lead Sponsor
Cinnagen
Target Recruit Count
368
Registration Number
NCT04928313

A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS

Phase 3
Completed
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
Other: Placebo
First Posted Date
2019-10-09
Last Posted Date
2023-12-01
Lead Sponsor
Mapi Pharma Ltd.
Target Recruit Count
1016
Registration Number
NCT04121221
Locations
🇺🇦

Mapi Pharma Research site 14, Poltava, Ukraine

🇺🇦

Mapi Pharma Research site 17, Luts'k, Ukraine

🇺🇦

Mapi Pharma Research site 28, Kyiv, Ukraine

and more 30 locations

Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)

Phase 2
Withdrawn
Conditions
Relapsing Multiple Sclerosis
Interventions
Drug: Placebo
Biological: Interferon-beta1
First Posted Date
2019-09-06
Last Posted Date
2023-06-01
Lead Sponsor
Biogen
Registration Number
NCT04079088

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT

Phase 3
Active, not recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2017-12-11
Last Posted Date
2023-09-21
Lead Sponsor
Genzyme, a Sanofi Company
Target Recruit Count
16
Registration Number
NCT03368664
Locations
🇹🇷

Investigational Site Number :7920002, Ankara, Turkey

🇹🇷

Investigational Site Number :7920001, Ankara, Turkey

🇫🇷

Investigational Site Number :2500002, Strasbourg, France

and more 18 locations

Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients

Phase 2
Completed
Conditions
Secondary Progressive Multiple Sclerosis
Interventions
First Posted Date
2017-10-20
Last Posted Date
2019-05-23
Lead Sponsor
Isfahan University of Medical Sciences
Target Recruit Count
84
Registration Number
NCT03315923
Locations
🇮🇷

Kashani Hospital, Isfahan, Iran, Islamic Republic of

Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"

Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2017-07-06
Last Posted Date
2024-06-13
Lead Sponsor
Teva Takeda Pharma Ltd.
Target Recruit Count
1332
Registration Number
NCT03209479
Locations
🇯🇵

Takeda selected site, Tokyo, Japan

Pharmacological Treatment of Rett Syndrome With Glatiramer Acetate (Copaxone)

Phase 2
Completed
Conditions
Rett Syndrome
Interventions
First Posted Date
2014-06-03
Last Posted Date
2018-11-05
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
10
Registration Number
NCT02153723
Locations
🇺🇸

Montefiore Medical center, Bronx, New York, United States

An Open Label, Exploratory Study to Investigate the Treatment Effect of Glatiramer Acetate on Girls Woth Rett Syndrome

Phase 1
Conditions
Rett Syndrome
Interventions
First Posted Date
2013-12-30
Last Posted Date
2014-02-04
Lead Sponsor
Sheba Medical Center
Target Recruit Count
10
Registration Number
NCT02023424
Locations
🇮🇱

Sheba Medical Center, Ramat Gan, Israel

MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

Phase 3
Terminated
Conditions
Relapsing-remitting Multiple Sclerosis (RRMS)
Interventions
First Posted Date
2012-07-04
Last Posted Date
2019-05-28
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1064
Registration Number
NCT01633112
Locations
🇵🇷

Novartis Investigative Site, Guaynabo, Puerto Rico

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