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Glatiramer acetate (Copaxone)
Glatiramer acetate is a synthetic polypeptide that modulates immune responses by promoting anti-inflammatory T cell and B cell responses, reducing attacks on myelin in the central nervous system.
Glatiramer acetate is a synthetic polypeptide that modulates immune responses by promoting anti-inflammatory T cell and B cell responses, reducing attacks on myelin in the central nervous system. Used for Relapsing-remitting multiple sclerosis (RRMS), Clinically isolated syndrome (CIS) with MRI features consistent with MS.
At a glance
| Generic name | Glatiramer acetate (Copaxone) |
|---|---|
| Also known as | Copaxone (Glatiramer acetate, COP, Copolymer-1) |
| Sponsor | Federal University of São Paulo |
| Drug class | Immunomodulator; disease-modifying therapy (DMT) |
| Target | T cell receptor (indirect); myelin basic protein mimic |
| Modality | Small molecule |
| Therapeutic area | Immunology; Neurology |
| Phase | FDA-approved |
Mechanism of action
Glatiramer acetate mimics myelin basic protein and acts as a decoy antigen, shifting the immune response from pro-inflammatory Th1 cells toward anti-inflammatory Th2 and regulatory T cells. This reduces the frequency and severity of relapses in multiple sclerosis by decreasing myelin-reactive immune attacks. The drug also promotes the production of anti-inflammatory cytokines like IL-10 and TGF-β.
Approved indications
- Relapsing-remitting multiple sclerosis (RRMS)
- Clinically isolated syndrome (CIS) with MRI features consistent with MS
Common side effects
- Injection site reactions (erythema, induration, pruritus)
- Immediate post-injection reaction (flushing, chest tightness, dyspnea, palpitations)
- Lipoatrophy at injection sites
- Systemic adverse events (headache, nausea, asthenia)
- Hypersensitivity reactions
Key clinical trials
- A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
- Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS (PHASE3)
- Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis (NA)
- Immune Profiles in Multiple Sclerosis (MS) Patients and Healthy Volunteers Through Thoracic Duct Cannulation (NA)
- A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT (PHASE3)
- A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
- A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
- Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (NA)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |