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Drug

Glatiramer Acetate

Approved · FDA
Emerging researchLate-stage developmentRising momentum

Also known as Copaxone, Glatopa.

RxNorm84375ChEMBLCHEMBL1201507ATCL03AX13UNII5M691HL4BO
3
Research papers
53
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: GLATIRAMER ACETATE (NDA020622)

Regulatory2026-06-22FDA

A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)

Clinical trial2025-09-08Terminated · ClinicalTrials.gov

Label change: GLATIRAMER ACETATE (NDA020622)

Regulatory2025-01-22FDA

Label change: GLATIRAMER ACETATE (NDA020622)

Regulatory2025-01-22FDA

A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis

Clinical trial2024-09-18Withdrawn · ClinicalTrials.gov

Label change: GLATIRAMER ACETATE (NDA020622)

Regulatory2023-11-16FDA

N-acetylglucosamine inhibits inflammation and neurodegeneration markers in multiple sclerosis: a mechanistic trial.

Research2023-09-13Journal of neuroinflammation

Label change: GLATIRAMER ACETATE (NDA020622)

Regulatory2023-01-04FDA

A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of 40 mg Glatiramer Acetate Injection in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Clinical trial2022-08-03Results posted · ClinicalTrials.gov

A Multinational, Multicenter, Randomized, Parallel-group Study Performed 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 in a Double-blind Design

Clinical trial2021-12-09Results posted · ClinicalTrials.gov

Pharmacologic Treatment of Rett Syndrome With Glatiramer Acetate.

Research2016-05-27Pediatric neurology

Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines [RETIRED].

Research2002-01-01Neurology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Glatiramer Acetate
Aliases & brands
CopaxoneGlatopa
RxNorm CUI
84375
ChEMBL ID
CHEMBL1201507
ATC codes
L03AX13
UNII
5M691HL4BO
Regulatory jurisdictions
fda

Regulatory timeline

53 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1996-12-20
Latest approval
2016-11-18
Authorities
FDA
Total events
53
fdaU.S. Food and Drug Administration· 53 events
2026-06-22Label change
Label change: GLATIRAMER ACETATE (NDA020622)
Evidence ↗
2025-01-22Label change
Label change: GLATIRAMER ACETATE (NDA020622)
Evidence ↗
2025-01-22Label change
Label change: GLATIRAMER ACETATE (NDA020622)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

34 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
34
registered trials across all phases
LATEST COMPLETION 2019
23
Late-stage (III+)
22
Completed
12
Discontinued
PHASE DISTRIBUTIONn = 34
Phase 11Phase 210Phase 2 / 31Phase 312Phase 48Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone

CompletedPH IVTeva Branded Pharmaceutical Products R&D, Inc.n=2082018

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT)

CompletedPH IVNovartis Pharmaceuticalsn=2982013

A Multicenter Longitudinal Cross-sectional Pilot Study, to Compare RNFL Thickness Measured by OCT After Treatment With Glatiramer or After no Treatment in Patients With CIS With or Without Optic Neuritis or With Early RRMS

Unknown statusPH IVAmphia Hospitaln=602012

A Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA)

TerminatedPH IVTeva Branded Pharmaceutical Products R&D, Inc.n=4142009

Effects of Glatiramer Acetate (Copaxone) in the Nerve Fiber Layer Thickness and Retinal Function in Diabetic Patients After Pan- Retinal Photocoagulation (PRP), a Double- Masked Randomized Clinical Trial.

Unknown statusPH IVFederal University of São Paulon=302008

Recent completions

Trials that read out recently, adding to the completed evidence base.

Comparison of Expanded Disability Status Scale, Gad-enhanced Brain Lesions, Annualized Relapse Rate, and Side Effects Between Active Secondary Progressive Multiple Sclerosis Patients on Rituximab and Glatiramer Acetate

CompletedPH II/IIIIsfahan University of Medical Sciencesn=842019

Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone

CompletedPH IVTeva Branded Pharmaceutical Products R&D, Inc.n=2082018

A Multinational, Multicenter, Randomized, Parallel-group Study Performed 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 in a Double-blind Design

CompletedPH IIIKey trialTeva Branded Pharmaceutical Products R&D, Inc.n=1,4042017

Pharmacological Treatment of Rett Syndrome With Glatiramer Acetate (Copaxone)

CompletedPH IIMontefiore Medical Centern=102016

A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis

CompletedPH IIUniversity of Colorado, Denvern=532015

Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, 9 Month, Equivalence Trial Comparing the Efficacy and Safety and Tolerability of GTR (Synthon BV) to Copaxone® (Teva) in Subjects With Relapsing Remitting Multiple Sclerosis Followed by an Open-label 15 Month GTR Treatment Part Evaluating the Long-term GTR Treatment Effects

CompletedPH IIISynthon BVn=7942015

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20022023
Major research themes2
Encephalitis1Multiple Sclerosis1
Journals, researchers & institutions
Top journals
  • Journal of neuroinflammation1
  • Neurology1
  • Pediatric neurology1
Leading researchers
  • Brandt AU1
  • Cordon A1
  • Demetriou M1
  • Dennis JW1
  • Djukic A1
  • Feldman JF1
  • Frohman EM1
  • Galanopoulou AS1
Leading institutions
free-text, unnormalised
  • Albert Einstein College of Medicine1
  • Children's Hospital of Pittsburgh of UPMC1
  • Donald Bren School of Information and Computer Sciences1
  • Montefiore Medical Center1
  • Multiple Sclerosis Centre and Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB)1
  • Queensborough Community College1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas
Multiple Sclerosis2

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acetylglucosamine

Studied across 3 of the same disease areas as Glatiramer Acetate in the shared literature.

3 shared diseases1 shared paper
Mitoxantrone

Studied across the same disease area as Glatiramer Acetate in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.