glatiramer acetate

Trade name: copaxone

PeptideapprovedOrphan Drug FDA

Approved

Dec 20, 1996

Glatiramer acetate, sold under the brand name Copaxone among others, is an immunomodulator medication used to treat multiple sclerosis. Glatiramer acetate is approved in the United States to reduce the frequency of relapses, but not for reducing the progression of disability. Observational studies, but not randomized controlled trials, suggest that it may reduce progression of disability. While a conclusive diagnosis of multiple sclerosis requires a history of two or more episodes of symptoms and signs, glatiramer acetate is approved to treat a first episode anticipating a diagnosis. It is also used to treat relapsing-remitting multiple sclerosis. It is administered by subcutaneous injection. — Wikipedia

Clinical trial activity

64 trials · 59 clinical orgs · 8 marketing orgs

Phase 1
4
Phase 2
38
Phase 3
23
Phase 4
17

Earliest trial started Oct 1, 1991 (NCT00004814)

Timeline

1980s

  1. Nov 9, 1987

    Orphan Drug Designation

1990s

  1. Jan 1, 1991

    Earliest Phase 3 Sponsor(trial)

  2. Dec 20, 1996

    Teva — Earliest FDA Approval

  3. Dec 20, 1996

    Teva — NDA Organization

2000s

  1. Jan 1, 2003

    Teva — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Apr 16, 2015

    Sandoz — Marketing Organization

  2. Apr 16, 2015

    Novartis — Marketing Organization

  3. Oct 3, 2017

    Mylan — Marketing Organization

2020s

  1. Sep 25, 2024

    Byondis — Marketing Organization

  2. May 7, 2025

    Chemi SpA — Marketing Organization

  3. Dec 31, 2025

    ScinoPharm Taiwan — Marketing Organization

  4. Feb 11, 2026

    Hybio — Marketing Organization

Indications

Approved for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

    Contains components of myelin basic protein and may act as a decoy for the immune response

  • UnclearUnclear

    Unclear unclear

Approval history

  • approvedDec 20, 1996

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
Yes
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • cop-1
  • cop-1
  • cop-1
  • copaxone
  • copaxone
  • copaxone
  • copaxone
  • copaxone
  • copolymer 1
  • copolymer 1
  • copolymer-1
  • copolymer-1
  • copolymer-1
  • copoylmer 1
  • glatiramer
  • glatiramer
  • glatiramer
  • glatiramer acetate
  • glatiramer acetate
  • glatiramer acetate
  • glatiramer acetate
  • glatiramer acetate
  • glatiramer acetate
  • glatiramer acetate
  • glatiramer acetate
  • glatiramer acetate
  • protiramer

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07189325Phase 3Sep 30, 2025University of Montpellier
NCT04878211Phase 4Jun 10, 2021Novartis
NCT06003972Phase 2Jan 4, 2021Hebrew University, Weizmann Institute of Science
NCT04121221Phase 3Sep 19, 2019Icahn School of Medicine at Mount Sinai, Mapi Pharma Ltd.
NCT03982212Phase 1Jul 31, 2019University of Kansas
NCT03362294Phase 2Dec 11, 2017Mapi Pharma Ltd.
NCT03315923Phase 2/Phase 3 (Phase 3)Dec 1, 2017Isfahan University
NCT03368664Phase 3Oct 24, 2017Genzyme, Sanofi
NCT02499900Phase 4Aug 1, 2015Teva
NCT02212886Phase 1/Phase 2 (Phase 2)Oct 1, 2014Mapi Pharma Ltd.
NCT02023424Phase 1Jan 1, 2014Tel Aviv University
NCT03133403Phase 2/Phase 3 (Phase 3)Nov 1, 2013Sheffield Hallam University
NCT01963611Phase 2Oct 1, 2013Merck Serono
NCT02753088Phase 3Oct 1, 2013Biocad
NCT02153723Phase 2Aug 1, 2013Rett Syndrome Research Trust, Yeshiva University
NCT01874145Phase 3Jun 1, 2013Teva
NCT01633112Phase 4Aug 9, 2012Novartis
NCT01623596Phase 4Jun 1, 2012Novartis
NCT01404117Phase 2Mar 1, 2012Teva
NCT01578785Phase 3Mar 1, 2012Russian State Medical University, Teva
Showing 20 of 64 trials
Page 1 / 4

Organizations

Research & Development (59)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
TevaFor profit232041994
NovartisFor profit6612010
SanofiFor profit5332003
BiogenFor profit3322007
Icahn School of Medicine at Mount SinaiAcademic/Hospital3122005
Johns Hopkins UniversityAcademic/Hospital3122007
Mapi Pharma Ltd.For profit3322014
Tel Aviv UniversityAcademic/Hospital3332006
Elan PharmaceuticalsFor profit2022010
Hebrew UniversityAcademic/Hospital2222006
Merck SeronoFor profit2222004
National Institute of Neurological Disorders and Stroke (NINDS)Government2022005
Sheffield Hallam UniversityAcademic/Hospital2112006
University of KansasAcademic/Hospital2122007
University of Medicine and Dentistry of New JerseyAcademic/Hospital2122003
University of New MexicoAcademic/Hospital2021994
University of Sao PauloAcademic/Hospital2122006
Amphia Hospital Breda, the NetherlandsAcademic/Hospital1112009
BayerFor profit1112003
BiocadFor profit1112013
59 organizations
Page 1 / 3

Marketing (11)

OrganizationOrg typeRelationshipDate
ByondisFor profitMKTGSep 25, 2024
Chemi SpAFor profitMKTGMay 7, 2025
HybioFor profitMKTGFeb 11, 2026
MylanFor profitMKTGOct 3, 2017
MylanFor profitSYNOct 3, 2017
NovartisFor profitMKTGApr 16, 2015
SandozFor profitMKTGApr 16, 2015
SandozFor profitSYNApr 16, 2015
ScinoPharm TaiwanFor profitMKTGDec 31, 2025
TevaFor profitNDADec 20, 1996
TevaFor profitSYNDec 20, 1996