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, glatiramer acetate injection
- Molecule type
- Small molecule
- Mechanism (ChEMBL)
- Unknown
Approvals
- USCopaxone · Approved1996-12-20 Source
Safety communications
- EMA safety letter (DHPC) · 2024-08-14
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.
64,300 reports in total, 29,692 marked serious.
- Injection site pain5,588
- Multiple sclerosis relapse5,407
- Drug ineffective4,292
- Injection site reaction3,743
- Fatigue3,510
- Multiple sclerosis3,307
- Dyspnoea3,128
- Injection site erythema2,832
- Fall2,693
- Injection site mass2,348
Trials
Key trials
Large trials with a reported result on their main goal.
- Glatiramer acetate, phase 3
Completed · Phase 3 · Relapsing MS · Main goal met
- Glatiramer acetate, phase 3
Completed · Phase 3 · Relapsing MS · Main goal not met
- GLACIER
Completed · Phase 3 · Relapsing MS · Main goal met
- GATE
Completed · Phase 3 · Relapsing MS · Equivalent
- ENCORE
Completed · Phase 3 · Relapsing MS · Main goal met
- GALA
Completed · Phase 3 · Relapsing MS · Main goal met
- Glatiramer acetate, phase 3
Completed · Phase 3 · Relapsing MS · Main goal not met
- Glatiramer acetate, phase 3
Completed · Phase 3 · Relapsing MS · Main goal not met
- PreCISe
Completed · Phase 3 · Early (CIS/RIS) · Main goal met
Running now
- DESIRE MS
Recruiting · Phase 3 · Relapsing and progressive · ongoing
- TWINS
Not yet recruiting · Phase 3 · Relapsing MS · ongoing
- Alemtuzumab
Running, not recruiting · Relapsing MS · ongoing
- STOP-I-SEP
Running, not recruiting · Phase 3 · Progressive MS · ongoing
- Glatiramer acetate, phase 4
Ongoing · Phase 4 · Relapsing MS · ongoing
- OCT
Ongoing · Phase 4 · Relapsing MS · ongoing
Other trials (42)
Completed small trials, dose-finding studies and trials in other diseases.
- Biib061, phase 2
Withdrawn · Phase 2 · Relapsing and progressive · Stopped: no effect
- CPE
Completed · MS (type not specified) · no_result_found
- Glatiramer acetate, phase 2 / phase 3
Completed · Phase 2 / Phase 3 · Progressive MS · no_result_found
- LemKids
Terminated · Phase 3 · Relapsing MS · stopped_other
- Glatiramer acetate
Completed · MS (type not specified) · no_result_found
- CONFIDENCE
Completed · Phase 4 · Relapsing MS · Main goal met
- Glatiramer acetate
Completed · Relapsing and progressive · no_result_found
- Glatiramer acetate, phase 3
Completed · Phase 3 · Relapsing MS · result_in_paper_unread
- Glatiramer acetate, phase 2
Completed · Phase 2 · Relapsing MS · no_result_found
- OCTIMS
Completed · Phase 3 · Relapsing MS · no_result_found
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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