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Glatiramer acetate (GA)
Glatiramer acetate is a synthetic polypeptide that modulates immune responses by promoting the differentiation of T cells toward anti-inflammatory phenotypes and reducing autoreactive T cell responses in multiple sclerosis.
Glatiramer acetate is a synthetic polypeptide that modulates immune responses by promoting the differentiation of T cells toward anti-inflammatory phenotypes and reducing autoreactive T cell responses in multiple sclerosis. Used for Relapsing-remitting multiple sclerosis (RRMS), Clinically isolated syndrome (CIS) with high risk of developing multiple sclerosis.
At a glance
| Generic name | Glatiramer acetate (GA) |
|---|---|
| Also known as | Copaxone, Copaxone® |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Drug class | Immunomodulator; disease-modifying therapy (DMT) |
| 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/Th17 cells toward anti-inflammatory Th2 and regulatory T cells. This reduces the attack on myelin-producing oligodendrocytes in the central nervous system. The exact molecular targets remain incompletely characterized, but the drug is believed to work through T cell receptor engagement and subsequent immune tolerance mechanisms.
Approved indications
- Relapsing-remitting multiple sclerosis (RRMS)
- Clinically isolated syndrome (CIS) with high risk of developing multiple sclerosis
Common side effects
- Injection site reactions (erythema, induration, pain)
- Lipoatrophy at injection sites
- Systemic post-injection reaction (flushing, chest tightness, dyspnea, palpitations)
- Headache
- Nausea
- Asthenia/fatigue
Key clinical trials
- A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
- Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS (PHASE2)
- Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS (PHASE1, PHASE2)
- A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS (PHASE3)
- Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure (PHASE2)
- Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS) (PHASE2)
- A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo (PHASE3)
- Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA) (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Glatiramer acetate (GA) CI brief — competitive landscape report
- Glatiramer acetate (GA) updates RSS · CI watch RSS
- Teva Branded Pharmaceutical Products R&D, Inc. portfolio CI