Identification
- Summary
Glatiramer is an immunomodulator used to reduce the frequency of relapses in Multiple Sclerosis (MS).
- Brand Names
- Copaxone, Glatect, Glatopa
- Generic Name
- Glatiramer
- DrugBank Accession Number
- DB05259
- Background
Glatiramer acetate consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000-9,000 daltons. It is an immunomodulator, licensed in much of the world for reduced frequency of relapses in relapsing-remitting multiple sclerosis.
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Peptides - Protein Chemical Formula
- C254H422N70O72
- Protein Average Weight
- 7000.0 Da (range 5000-9000)
- Sequences
>Example Glatiramer peptide EAYKAAEKAYAAKEAAKEAAKAKAEKKAAYAKAKAAKYEKKAKKAAAEYKKK
Download FASTA Format- Synonyms
- (T,G)-A-L
- COP 1
- COP-1
- Copolymer I (synthetic peptide)
- Copolymer-1
Pharmacology
- Indication
For reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis.
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- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- Pharmacodynamics
Glatiramer acetate was originally designed to mimic a protein in myelin, called myelin basic protein, with the intention of inducing EAE (an animal model of MS). Quite to the contrary, it was found to suppress the disease and as a result came to be trialed in human MS. There is some evidence that Glatiramer acetate converts the body's immune response from a Th1 type to a Th2 one, promotes suppressor T cells or acts as an altered peptide ligand. Studies in animals and in vitro systems suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery. Some fraction of the injected material, either intact or partially hydrolyzed, is presumed to enter the lymphatic circulation, enabling it to reach regional lymph nodes, and some may enter the systemic circulation intact.
- Mechanism of action
Glatiramer acetate (GA) exhibits strong and promiscuous binding to MHC molecules (HLA DRB1* variants) and consequent competition with various myelin antigens for their presentation to T cells. A further aspect of its action is potent induction of specific suppressor cells of the T helper 2 (Th2) type that migrate to the brain and lead to in situ bystander suppression. Furthermore, the GA-specific cells in the brain express the anti-inflammatory cytokines IL-10 and transforming growth factor beta, in addition to brain-derived neurotrophic factor, whereas they do not express the inflammatory cytokine IFN-gamma. Recent evidence also suggests that Glatiramer acetate directly inhibits dendritic cells and monocytes - both of which are circulating antigen presenting cells.
Target Actions Organism UHLA class II histocompatibility antigen, DRB1-1 beta chain binderHumans - Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
Hydrolyzed by proteases
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
Adverse reactions include injection site reactions, vasodilatation, chest pain, asthenia, infection, pain, nausea, arthralgia, anxiety, and hypertonia.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbatacept The risk or severity of adverse effects can be increased when Abatacept is combined with Glatiramer. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Glatiramer. Adenovirus type 7 vaccine live The risk or severity of infection can be increased when Adenovirus type 7 vaccine live is combined with Glatiramer. Aldesleukin The risk or severity of adverse effects can be increased when Aldesleukin is combined with Glatiramer. Alefacept The risk or severity of adverse effects can be increased when Alefacept is combined with Glatiramer. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Glatiramer. Allogeneic processed thymus tissue The therapeutic efficacy of Allogeneic processed thymus tissue can be decreased when used in combination with Glatiramer. Altretamine The risk or severity of adverse effects can be increased when Altretamine is combined with Glatiramer. Amsacrine The risk or severity of adverse effects can be increased when Amsacrine is combined with Glatiramer. Anakinra The risk or severity of adverse effects can be increased when Anakinra is combined with Glatiramer. 
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- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Product Ingredients
Ingredient UNII CAS InChI Key Glatiramer acetate 5M691HL4BO 147245-92-9 Not applicable - Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Copaxone Injection, solution 40 mg/1mL Subcutaneous Teva Neuroscience, Inc. 2014-01-29 Not applicable US 
Copaxone Injection, solution 20 mg/1mL Subcutaneous Teva Neuroscience, Inc. 2008-04-28 Not applicable US Copaxone Solution 40 mg / mL Subcutaneous TEVA Canada Limited 2016-08-26 Not applicable Canada 
Copaxone Powder, for solution 20 mg / vial Subcutaneous Teva Pharmaceutical Industries 1997-10-14 2011-04-28 Canada Copaxone Solution 40 mg / mL Subcutaneous TEVA Canada Limited Not applicable Not applicable Canada Copaxone Injection 20 mg/1mL Subcutaneous Sanofi Aventis 2002-04-22 2010-01-31 US Copaxone Solution 20 mg / mL Subcutaneous TEVA Canada Limited 2002-05-01 Not applicable Canada Glatect Solution 20 mg / mL Subcutaneous Pharmascience Inc 2017-08-21 Not applicable Canada - Generic Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Glatiramer Acetate Injection, solution 40 mg/1mL Subcutaneous Mylan Pharmaceuticals Inc. 2017-10-04 Not applicable US Glatiramer Acetate Injection, solution 20 mg/1mL Subcutaneous Mylan Pharmaceuticals Inc. 2017-10-04 Not applicable US Glatopa Injection, solution 40 mg/1mL Subcutaneous Sandoz Inc 2018-02-12 Not applicable US Glatopa Injection, solution 20 mg/1mL Subcutaneous bryant ranch prepack 2015-06-18 Not applicable US Glatopa Injection, solution 20 mg/1mL Subcutaneous Sandoz Inc 2015-06-18 Not applicable US Glatopa Injection, solution 40 mg/1mL Subcutaneous bryant ranch prepack 2018-02-12 Not applicable US Teva-glatiramer Acetate Solution 20 mg / mL Subcutaneous TEVA Canada Limited Not applicable Not applicable Canada Teva-glatiramer Acetate Solution 40 mg / mL Subcutaneous TEVA Canada Limited Not applicable Not applicable Canada
Categories
- ATC Codes
- L03AX13 — Glatiramer acetate
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- U782C039QP
- CAS number
- 28704-27-0
References
- Synthesis Reference
Tsung-Yu Hsiao, Meng-Fen Ho, "Synthesis of Glatiramer Acetate." U.S. Patent US20100036092, issued February 11, 2010.
US20100036092- General References
- Weber MS, Hohlfeld R, Zamvil SS: Mechanism of action of glatiramer acetate in treatment of multiple sclerosis. Neurotherapeutics. 2007 Oct;4(4):647-53. [Article]
- Arnon R, Aharoni R: Mechanism of action of glatiramer acetate in multiple sclerosis and its potential for the development of new applications. Proc Natl Acad Sci U S A. 2004 Oct 5;101 Suppl 2:14593-8. Epub 2004 Sep 15. [Article]
- Francis DA: Glatiramer acetate (Copaxone). Int J Clin Pract. 2001 Jul-Aug;55(6):394-8. [Article]
- Li Q, Milo R, Panitch H, Swoveland P, Bever CT Jr: Glatiramer acetate blocks the activation of THP-1 cells by interferon-gamma. Eur J Pharmacol. 1998 Jan 26;342(2-3):303-10. [Article]
- External Links
- PubChem Substance
- 46505299
- 214582
- ChEMBL
- CHEMBL1201507
- Therapeutic Targets Database
- DAP001315
- PharmGKB
- PA449760
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Glatiramer_acetate
- FDA label
- Download (558 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Prevention Multiple Sclerosis 1 4 Completed Treatment Multiple Sclerosis 4 4 Completed Treatment Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis 1 4 Completed Treatment Relapsing Remitting Multiple Sclerosis (RRMS) 4 4 Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) / Relapsing Multiple Sclerosis (RMS) 1 4 Recruiting Treatment Relapsing Remitting Multiple Sclerosis (RRMS) 1 4 Terminated Prevention Relapsing Remitting Multiple Sclerosis (RRMS) 1 4 Terminated Treatment Relapsing Remitting Multiple Sclerosis (RRMS) 1 4 Unknown Status Treatment Diabetic Retinopathy (DR) 1 4 Unknown Status Treatment Multiple Sclerosis 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Baxter International Inc.
- Ben Venue Laboratories Inc.
- Sanofi-Aventis Inc.
- Teva Pharmaceutical Industries Ltd.
- Dosage Forms
Form Route Strength Injection, solution Parenteral Injection Subcutaneous 20 mg/1mL Injection, powder, for solution Subcutaneous 20 mg/ml Injection, solution Subcutaneous 20 mg/1mL Injection, solution Subcutaneous 40 mg/1mL Injection, solution Subcutaneous 40 MG/ML Powder, for solution Subcutaneous 20 mg / vial Solution Subcutaneous 20 mg / mL Solution Subcutaneous 40 mg / mL Injection, solution Subcutaneous Solution Subcutaneous 36 mg Injection, solution Subcutaneous 20 MG/ML Solution Subcutaneous 40 mg Injection, solution Solution Subcutaneous 20 mg Injection, solution 20 mg/ml Injection, solution 40 mg/ml - Prices
Unit description Cost Unit Copaxone 20 mg/ml Kit 20 mg Solution, 1 Box = 30 Pre-Filled Syringes 3775.25USD box Copaxone 20 mg injection kit 2264.26USD kit DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US5981589 No 1999-11-09 2014-05-24 US CA2191088 No 2004-09-28 2015-05-23 Canada US8232250 No 2012-07-31 2030-08-19 US US8399413 No 2013-03-19 2030-08-19 US US8969302 No 2015-03-03 2030-08-19 US US9155776 No 2015-10-13 2030-08-19 US US9402874 No 2016-08-02 2030-08-19 US
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Targets
References
- Arnon R, Aharoni R: Mechanism of action of glatiramer acetate in multiple sclerosis and its potential for the development of new applications. Proc Natl Acad Sci U S A. 2004 Oct 5;101 Suppl 2:14593-8. Epub 2004 Sep 15. [Article]
- Chen X, Ji ZL, Chen YZ: TTD: Therapeutic Target Database. Nucleic Acids Res. 2002 Jan 1;30(1):412-5. [Article]
Drug created at November 18, 2007 18:22 / Updated at January 25, 2022 05:27