Glatiramer acetate
Copaxone (glatiramer acetate) is a small molecule pharmaceutical. Glatiramer acetate was first approved as Copaxone on 1996-12-20. It is used to treat relapsing-remitting multiple sclerosis in the USA.
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Commercial
Trade Name
FDA
EMA
Copaxone (generic drugs available since 2015-04-16)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Glatiramer acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| COPAXONE | Teva | N-020622 RX | 2002-02-12 | 2 products, RLD, RS |
Show 1 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| relapsing-remitting multiple sclerosis | EFO_0003929 | D020529 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1595 | Injection, glatiramer acetate, 20 mg |
Clinical
Clinical Trials
63 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 10 | 10 | 5 | 3 | 28 | |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 3 | 5 | 7 | 8 | 23 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | 1 | 1 | — | — | 2 |
| Chronic progressive multiple sclerosis | D020528 | — | 1 | 1 | — | — | 1 | ||
| Angle-closure glaucoma | D015812 | — | — | 1 | — | — | 1 | ||
| Optic neuritis | D009902 | EFO_0007405 | H46 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rett syndrome | D015518 | F84.2 | 1 | 1 | — | — | — | 2 | |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 1 | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic bone diseases | D001851 | HP_0000938 | — | — | — | — | 1 | 1 | |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | GLATIRAMER ACETATE |
| INN | — |
| Description | Glatiramer acetate (also known as Copolymer 1, Cop-1), sold under the brand name Copaxone among others, is an immunomodulator medication used to treat multiple sclerosis. Glatiramer acetate is approved in the United States to reduce the frequency of relapses, but not for reducing the progression of disability. Observational studies, but not randomized controlled trials, suggest that it may reduce progression of disability. While a conclusive diagnosis of multiple sclerosis requires a history of two or more episodes of symptoms and signs, glatiramer acetate is approved to treat a first episode anticipating a diagnosis. It is also used to treat relapsing-remitting multiple sclerosis. It is administered by subcutaneous injection.
|
| Classification | Small molecule |
| Drug class | polymers |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)O.C[C@H](N)C(=O)O.NCCCC[C@H](N)C(=O)O.N[C@@H](CCC(=O)O)C(=O)O.N[C@@H](Cc1ccc(O)cc1)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 147245-92-9 |
| RxCUI | 84375 |
| ChEMBL ID | CHEMBL1201507 |
| ChEBI ID | — |
| PubChem CID | 3081884 |
| DrugBank | DB05259 |
| UNII ID | — |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
Copaxone - Teva
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,505 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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122,605 adverse events reported
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