Glatiramer acetate
How it works: The first medicines: interferon beta and glatiramer acetate →
Copaxone
EU: Approved nationally (not via EMA)US: FDA approved 1996
- Other names
- glatiramer acetate injection
- Molecule type
- Small molecule
- Mechanism (ChEMBL)
- Unknown
Approvals
- USCopaxone · Approved20 December 1996 Source
Safety communications
- EMA safety letter (DHPC) · 14 August 2024
Glatiramer acetate: Adverse event Source
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
61,613 reports in total, 28,648 marked serious.
- Injection site pain5,347
- Multiple sclerosis relapse5,331
- Drug ineffective4,162
- Injection site reaction3,567
- Fatigue3,369
- Multiple sclerosis3,260
- Dyspnoea3,024
- Injection site erythema2,678
- Fall2,594
- Injection site mass2,267
Trials
Key trials
Large trials with a reported result on their main goal.
- A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-act
Completed · Phase 3 · Relapsing MS · Met its main goal
- Clinical trial to evaluate the effectiveness and safety of IFN beta-1a
Completed · Phase 3 · Relapsing MS · Missed its main goal
- Safety and Tolerability of Glatiramer Acetate
Completed · Phase 3 · Relapsing MS · Met its main goal
- Efficacy and Safety of GTR in Comparison to Copaxone®
Completed · Phase 3 · Relapsing MS · Shown as good as the comparator
- Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Re
Completed · Phase 3 · Relapsing MS · Met its main goal
- A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
Completed · Phase 3 · Relapsing MS · Met its main goal
- Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Scl
Completed · Phase 3 · Relapsing MS · Missed its main goal
- Combination Therapy in Patients With Relapsing-Remitting Multiple Scle
Completed · Phase 3 · Relapsing MS · Missed its main goal
- Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to
Completed · Phase 3 · Early (CIS/RIS) · Met its main goal
Running now
- A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Mai
Recruiting · Phase 3 · Relapsing and progressive · Still running
- Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting
Not yet recruiting · Phase 3 · Relapsing MS · Still running
- A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY
Running, not recruiting · Relapsing MS · Still running
- Disease Modifying Therapies Withdrawal in Inactive Secondary Progressi
Running, not recruiting · Phase 3 · Progressive MS · Still running
Other trials (39)
Completed small trials, dose-finding studies and trials in other diseases.
- Czech Pharmaco-epidemiological Study on Disease Modifying Drugs
Completed · MS (type not specified) · No results found
- Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in
Completed · Phase 2 / Phase 3 · Progressive MS · No results found
- A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab
Terminated · Phase 3 · Relapsing MS · Stopped
- Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Invest
Completed · MS (type not specified) · No results found
- Study to Assess Medication Satisfaction in Patients With Relapsing Rem
Completed · Phase 4 · Relapsing MS · Met its main goal
- Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple
Completed · Relapsing and progressive · No results found
- Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Rela
Completed · Phase 3 · Relapsing MS · Paper found, not read
- A pilot, multicenter, open-label, one-group study to explore the effic
Completed · Phase 2 · Relapsing MS · No results found
- Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis
Completed · Phase 3 · Relapsing MS · No results found
- An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA)
Terminated · Phase 3 · Relapsing MS · Stopped
Trials where it is given as background therapy
- Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or G
Withdrawn · Phase 2 · Relapsing and progressive · Stopped: not working
- Comparison of Rituximab Induction Therapy Followed by Glatiramer Aceta
Completed · Phase 2 · Relapsing MS · Met its main goal
- Long Term Safety of Teriflunomide When Added to Interferon-Beta or Gla
Completed · Phase 2 · MS (type not specified) · Main goal was not benefit
- Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Ac
Completed · Phase 2 · MS (type not specified) · Main goal was not benefit
- Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Sub
Terminated · Phase 4 · Relapsing MS · Stopped: safety
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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