Glatiramer acetate
Copaxone, Glatiramer, Glatopa (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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Copaxone, Glatiramer, Glatopa (discontinued: Copaxone)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| copaxone | New Drug Application | 2025-01-31 |
| glatiramer acetate | ANDA | 2025-02-07 |
| glatopa | ANDA | 2025-03-27 |
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
125 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 23 | 23 | 24 | 43 | 112 |
| Sclerosis | D012598 | — | — | 2 | 20 | 23 | 23 | 40 | 105 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 2 | 14 | 18 | 13 | 13 | 58 |
| Retinal diseases | D012164 | — | H35.9 | — | — | — | 1 | — | 1 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | — | 1 | — | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | 2 | 1 | — | 1 | 3 |
| Neuritis | D009443 | — | — | — | 1 | 1 | — | — | 2 |
| Optic neuritis | D009902 | EFO_0007405 | H46 | — | 1 | 1 | — | — | 2 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | 1 | 1 | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 1 | — | — | 1 |
| Angle-closure glaucoma | D015812 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rett syndrome | D015518 | Orphanet_778 | F84.2 | 1 | 1 | — | — | — | 2 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | — | 2 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 1 | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 1 | — | — | — | 1 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | 1 | — | — | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | — | — | — | 1 |
| Cytokine release syndrome | D000080424 | — | D89.83 | — | 1 | — | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Basal cell carcinoma | D002280 | — | — | 1 | — | — | — | — | 1 |
| Squamous cell carcinoma | D002294 | — | — | 1 | — | — | — | — | 1 |
| Squamous cell neoplasms | D018307 | — | — | 1 | — | — | — | — | 1 |
| Basal cell neoplasms | D018295 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukoencephalopathies | D056784 | — | R90.82 | — | — | — | — | 1 | 1 |
| Progressive multifocal leukoencephalopathy | D007968 | EFO_0007455 | A81.2 | — | — | — | — | 1 | 1 |
| Atrophy | D001284 | — | — | — | — | — | — | 1 | 1 |
| Metabolic bone diseases | D001851 | — | — | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Fatigue | D005221 | — | R53.83 | — | — | — | — | 1 | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | — | 1 | 1 |
| Muscle spasticity | D009128 | — | — | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 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) | — |
Identifiers
| PDB | — |
| CAS-ID | 147245-92-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201507 |
| ChEBI ID | — |
| PubChem CID | 3081884 |
| DrugBank | DB05259 |
| UNII ID | — |
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Financial
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Copaxone – Teva
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,604 documents
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Safety
Black-box Warning
Black-box warning for: Copaxone, Glatiramer acetate
Adverse Events
Top Adverse Reactions
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55,263 adverse events reported
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