PeptideTrace
ApprovedImmunomodulator (Random Copolymer)Immune & Anti-inflammatory

Glatiramer Acetate (Copaxone, Glatopa)

A

Evidence Grade A — Regulatory approved. 2160 published studies. 119 registered clinical trials.

119 trials2,160 studiesUSEUCA

Medically reviewed by a licensed medical professional

Licensed Indications

  • Relapsing Multiple Sclerosis

User Experience Reports

Loading...

Overview

Glatiramer acetate (sold as Copaxone and the generic Glatopa) is an injectable treatment for relapsing forms of multiple sclerosis (MS). Rather than being a single molecule, it is a mixture of protein fragments designed to resemble a component of the nerve insulation (myelin) that the immune system mistakenly attacks in MS. It has been a mainstay of MS treatment since 1996, though newer therapies have increasingly taken its place.

Also Known As

Glatiramer Acetate is also known by these brand and alternate names:

Research Activity

2,160studies
Human 1622
Animal 152
In-vitro 110
Reviews 590

2,160 published studies: 1622 human, 152 animal, 110 in-vitro, 590 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
Not authorised by EMA(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUNot applicable (not authorised)
CAPrescription drug

Summary

Glatiramer acetate is marketed as Copaxone (approved December 1996) and the generic Glatopa (approved 2015). Available as 20 mg daily or 40 mg three-times-weekly subcutaneous injections. It is indicated for relapsing forms of MS including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.

Clinical trials showed glatiramer acetate reduces relapse rates by approximately 29–34%. Long-term follow-up data extending to 15 years suggest sustained lower disability scores. Its safety profile is well-established — injection-site reactions are the main side effect, with an occasional transient post-injection systemic reaction. However, glatiramer acetate has been increasingly displaced by higher-efficacy therapies (including oral agents and monoclonal antibodies) that have become available for MS.

Mechanism of Action

In MS, the immune system mistakenly attacks myelin — the insulating coating around nerve fibres. Glatiramer acetate resembles myelin basic protein closely enough that it redirects the immune response. It competes with myelin fragments for binding on immune cells, and crucially, it shifts the T-cells that recognise it from aggressive (Th1) to protective (Th2/regulatory) types. These re-educated immune cells then travel to the brain and spinal cord, where they encounter similar myelin proteins and release anti-inflammatory signals instead of attacking.

Research Summary

Clinical trials showed glatiramer acetate reduces MS relapse rates by approximately 29-34%, with long-term follow-up data extending to 15 years suggesting sustained benefits for disability. Its safety profile is well-established over more than 25 years — injection-site reactions are the main side effect, with no cases of the serious brain infection (PML) that is associated with some more potent MS treatments. However, glatiramer acetate has been increasingly displaced by higher-efficacy therapies including oral drugs (like fingolimod and dimethyl fumarate) and monoclonal antibodies (like ocrelizumab and natalizumab) that offer stronger disease control. It is now primarily positioned as a first-line treatment for milder forms of MS, where its well-known safety profile is valued over maximum disease suppression.

Clinical Trials

PeptideTrace tracks 119 registered clinical trials for Glatiramer Acetate sourced from ClinicalTrials.gov.

NCT07189325Phase IIINot Yet Recruiting

A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis

University Hospital, MontpellierEndpoint: RelapseCompletion: 2030-09-01
NCT06715605Phase IIWithdrawn

A Clinical Trial Evaluating the Safety and Efficacy of Myelin-peptide Loaded tolDC as Treatment for MS

University Hospital, AntwerpEndpoint: Efficacy (Number of new and/or enlarging T2 lesions on MRI)Completion: 2027-10-29
NCT06663189Phase IIINot Yet Recruiting

Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting Multiple Sclerosis Patients Aged 55 and Over (TWINS : Therapies Withdrawal IN Relapsing Multiple Sclerosis)

University Hospital, Strasbourg, FranceEndpoint: Time to first clinical and/or radiological disease activity during a period of 2 years.Completion: 2029-06-01
NCT05767736N/AActive, Not Recruiting

A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)

BiogenEndpoint: Number of Participants With Confirmed Serious Adverse Events (SAEs) in the Vumerity, Tecfidera, Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer Acetate), or Vumerity/Tecfidera Switch CohortsCompletion: 2032-12-01
NCT05718947N/ACompleted

Ultra-high-field Brain MRI in Multiple Sclerosis

Zuyderland Medisch CentrumEndpoint: Detected white- and grey-matter lesionsCompletion: 2024-06-17
View all 119 trials on ClinicalTrials.gov →

Regulatory Timeline

1996
Regulatory

FDA ORIG 1

1997
Regulatory

FDA SUPPL 1

1998
Regulatory

FDA SUPPL 3

1998
Regulatory

FDA SUPPL 2

1999
Regulatory

FDA SUPPL 5

1999
Regulatory

FDA SUPPL 6

1999
Regulatory

FDA SUPPL 8

1999
Regulatory

FDA SUPPL 10

1999
Regulatory

FDA SUPPL 11

1999
Regulatory

FDA SUPPL 12

1999
Regulatory

FDA SUPPL 14

1999
Regulatory

FDA SUPPL 13

1999
Regulatory

FDA SUPPL 16

1999
Regulatory

FDA SUPPL 17

2000
Regulatory

FDA SUPPL 9

2000
Regulatory

FDA SUPPL 4

2000
Regulatory

FDA SUPPL 7

2001
Regulatory

FDA SUPPL 18

2001
Regulatory

FDA SUPPL 19

2001
Regulatory

FDA SUPPL 20

2001
Regulatory

FDA SUPPL 22

2001
Regulatory

FDA SUPPL 15

2002
Regulatory

FDA SUPPL 23

2002
Regulatory

FDA SUPPL 24

2002
Regulatory

FDA SUPPL 25

2002
Regulatory

FDA SUPPL 26

2009
Regulatory

FDA SUPPL 57

2013
Regulatory

FDA SUPPL 79

2013
Regulatory

FDA SUPPL 87

2013
Regulatory

FDA SUPPL 85

2013
Regulatory

FDA SUPPL 83

2013
Regulatory

FDA SUPPL 91

2014
Regulatory

FDA SUPPL 89

2015
Regulatory

FDA SUPPL 92

2015
Regulatory

FDA ORIG 1

2015
Regulatory

FDA SUPPL 94

2015
Regulatory

FDA SUPPL 96

2015
Regulatory

FDA SUPPL 95

2016
Regulatory

FDA SUPPL 93

2016
Regulatory

FDA SUPPL 98

2016
Regulatory

FDA SUPPL 99

2017
Regulatory

FDA ORIG 1

2017
Regulatory

FDA ORIG 1

2018
Regulatory

FDA SUPPL 102

2018
Regulatory

FDA ORIG 1

2018
Regulatory

FDA SUPPL 104

2019
Regulatory

FDA SUPPL 106

2019
Regulatory

FDA SUPPL 107

2020
Regulatory

FDA SUPPL 109

2020
Regulatory

FDA SUPPL 110

2020
Regulatory

FDA SUPPL 5

2020
Regulatory

FDA SUPPL 1

2020
Regulatory

FDA SUPPL 20

2020
Regulatory

FDA SUPPL 8

2020
Regulatory

FDA SUPPL 17

2020
Regulatory

FDA SUPPL 21

2020
Regulatory

FDA SUPPL 18

2020
Regulatory

FDA SUPPL 22

2020
Regulatory

FDA SUPPL 20

2020
Regulatory

FDA SUPPL 8

2022
Regulatory

FDA SUPPL 113

2022
Regulatory

FDA SUPPL 114

2022
Regulatory

FDA SUPPL 9

2022
Regulatory

FDA SUPPL 16

2022
Regulatory

FDA SUPPL 7

2022
Regulatory

FDA SUPPL 12

2022
Regulatory

FDA SUPPL 3

2022
Regulatory

FDA SUPPL 17

2022
Regulatory

FDA SUPPL 8

2022
Regulatory

FDA SUPPL 17

2022
Regulatory

FDA SUPPL 8

2022
Regulatory

FDA SUPPL 4

2022
Regulatory

FDA SUPPL 11

2022
Regulatory

FDA SUPPL 9

2022
Regulatory

FDA SUPPL 16

2022
Regulatory

FDA SUPPL 7

2022
Regulatory

FDA SUPPL 24

2022
Regulatory

FDA SUPPL 25

2022
Regulatory

FDA SUPPL 26

2022
Regulatory

FDA SUPPL 25

2023
Regulatory

FDA SUPPL 115

2023
Regulatory

FDA SUPPL 27

2023
Regulatory

FDA SUPPL 28

2023
Regulatory

FDA SUPPL 116

2024
Regulatory

FDA SUPPL 20

2024
Regulatory

FDA SUPPL 19

2024
Regulatory

FDA SUPPL 19

2024
Regulatory

FDA SUPPL 20

2024
Regulatory

FDA SUPPL 28

2024
Regulatory

FDA SUPPL 29

2024
Regulatory

Health Canada Market Authorisation

2024
Regulatory

FDA ORIG 1

2024
Regulatory

FDA ORIG 1

2025
Regulatory

FDA SUPPL 118

2025
Regulatory

FDA SUPPL 119

2025
Regulatory

FDA SUPPL 31

2025
Regulatory

FDA SUPPL 32

2025
Regulatory

FDA ORIG 1

2025
Regulatory

FDA SUPPL 2

2025
Regulatory

FDA SUPPL 2

2025
Regulatory

FDA ORIG 1

2026
Regulatory

FDA SUPPL 32

2026
Regulatory

FDA SUPPL 33

Scientific Detail

Overview (Scientific)

Glatiramer acetate is a synthetic random copolymer of L-glutamic acid (14%), L-alanine (43%), L-tyrosine (9%), L-lysine (34%). Not a single peptide but a mixture averaging MW 5,000-9,000 Da across chains of 15-100+ AA. Designed to mimic myelin basic protein. SC 20 mg daily or 40 mg 3x weekly. One of the most structurally unusual approved peptide therapeutics.

Mechanism of Action (Scientific)

Multiple immunomodulatory mechanisms. Competes with MBP for MHC class II binding on APCs. Promotes Th1-to-Th2 deviation: glatiramer-reactive T cells shift to anti-inflammatory phenotype (IL-4, IL-10, TGF-beta). These Th2/Treg cells cross BBB, recognize cross-reactive CNS antigens (bystander suppression), and secrete neurotrophic factors (BDNF, NT-3). Also modulates monocytes toward M2 phenotype.

Summary (Scientific)

Marketed as Copaxone (approved December 20, 1996) and Glatopa (generic, 2015). Pivotal (N=251): relapse rate reduced 29% vs. placebo (P=0.007). GALA (N=1,404): 40 mg 3x/week reduced relapses 34% (P<0.001). CONFIRM (N=1,430): comparable to dimethyl fumarate. 15-year follow-up: sustained lower disability. Indication: relapsing forms of MS (CIS, RRMS, active SPMS).

Related Compounds

Vancomycin

Approved
Glycopeptide Antibiotic

Vancomycin is marketed as Vancocin and Firvanq (approved 1958, with oral solution Firvanq approved 2018). It is the standard treatment for serious MRSA infections (bloodstream infections, endocarditis, pneumonia, bone infections) and is first-line for severe C. difficile colitis. Vancomycin requires therapeutic drug monitoring — blood levels must be checked regularly to ensure the dose is effective without causing kidney damage or hearing loss. The rise of vancomycin-resistant enterococci (VRE) and occasional vancomycin-intermediate S. aureus (VISA) strains represent ongoing challenges. Despite being nearly 70 years old, vancomycin remains irreplaceable for many serious infections, though newer alternatives like daptomycin and the lipoglycopeptides offer advantages in specific settings.

Zilucoplan

Approved
Complement C5 Inhibitor (Peptide)

Zilucoplan is marketed as Zilbrysq (approved October 2023) for anti-acetylcholine receptor antibody-positive generalised myasthenia gravis in adults. Administered as a daily subcutaneous self-injection. In the RAISE trial, zilucoplan showed statistically significant improvements in both activities of daily living and quantitative muscle strength scores compared to placebo, with improvements evident from week one. Its key differentiator from existing complement inhibitors (eculizumab, ravulizumab) is the self-injectable format — those alternatives require hospital-based intravenous infusions. As with all complement inhibitors, patients require meningococcal vaccination before starting treatment due to increased susceptibility to meningococcal infection.

Daptomycin

Approved
Lipopeptide Antibiotic

Daptomycin is marketed as Cubicin (approved September 2003). It is indicated for complicated skin and soft tissue infections and S. aureus bloodstream infections including right-sided endocarditis. Administered as a once-daily intravenous infusion. A key limitation is that daptomycin cannot be used for pneumonia — lung surfactant inactivates the drug. In the bacteraemia trial, daptomycin was non-inferior to vancomycin with significantly lower rates of kidney problems (11% versus 26%). Creatine kinase (CK) levels must be monitored during treatment, as daptomycin can cause muscle toxicity. Generics became available after patent expiry, significantly reducing cost.

Related Research

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.