Overview
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.
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 Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/01/18 | N/A | Recruiting | |||
2021/06/16 | N/A | Completed | |||
2019/10/09 | Phase 3 | Completed | |||
2019/09/06 | Phase 2 | Withdrawn | |||
2017/12/11 | Phase 3 | Active, not recruiting | Genzyme, a Sanofi Company | ||
2017/10/20 | Phase 2 | Completed | |||
2017/07/06 | N/A | Completed | |||
2014/06/03 | Phase 2 | Completed | |||
2013/12/30 | Phase 1 | UNKNOWN | |||
2012/07/04 | Phase 3 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Neuroscience, Inc. | 68546-317 | SUBCUTANEOUS | 20 mg in 1 mL | 11/20/2023 | |
| Bryant Ranch Prepack | 63629-8816 | SUBCUTANEOUS | 40 mg in 1 mL | 9/14/2021 | |
| Bryant Ranch Prepack | 63629-8815 | SUBCUTANEOUS | 20 mg in 1 mL | 9/14/2021 | |
| Sandoz Inc | 0781-3250 | SUBCUTANEOUS | 40 mg in 1 mL | 10/31/2018 | |
| Mylan Pharmaceuticals Inc. | 0378-6961 | SUBCUTANEOUS | 40 mg in 1 mL | 3/23/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-6960 | SUBCUTANEOUS | 20 mg in 1 mL | 3/23/2023 | |
| Teva Neuroscience, Inc. | 68546-325 | SUBCUTANEOUS | 40 mg in 1 mL | 11/20/2023 | |
| Sandoz Inc | 0781-3234 | SUBCUTANEOUS | 20 mg in 1 mL | 10/31/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||