glatiramer acetate
Trade name: copaxone
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
Earliest trial started Oct 1, 1991 (NCT00004814)
Timeline
1980s
- Nov 9, 1987
Orphan Drug Designation
1990s
2010s
2020s
- Sep 25, 2024
Byondis — Marketing Organization
- May 7, 2025
Chemi SpA — Marketing Organization
- Dec 31, 2025
ScinoPharm Taiwan — Marketing Organization
- Feb 11, 2026
Hybio — Marketing Organization
Indications
Approved for
Studied for
- Amyotrophic Lateral Sclerosis · Phase 2
- Basal Cell Carcinoma · Phase 1
- Carcinoma, Squamous Cell · Phase 1
- Crohn Disease · Phase 2
- Cytokine Release Syndrome · Phase 2
- Diabetic Retinopathy · Phase 4
- Glaucoma · Phase 3
- Heart Failure · Phase 2
- Inflammation · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Macular Degeneration · Phase 2/Phase 3
- Multiple Sclerosis, Chronic Progressive · Phase 2/Phase 3
- Multiple Sclerosis, Relapsing-Remitting · Phase 4
- Optic Neuritis · Phase 3
- Rett Syndrome · Phase 2
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
Sources
- WikipediaGlatiramer acetate ↗
- NCATSU782C039QP ↗
- ChEMBLCHEMBL1201507 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07189325 | Phase 3 | Sep 30, 2025 | University of Montpellier |
| NCT04878211 | Phase 4 | Jun 10, 2021 | Novartis |
| NCT06003972 | Phase 2 | Jan 4, 2021 | Hebrew University, Weizmann Institute of Science |
| NCT04121221 | Phase 3 | Sep 19, 2019 | Icahn School of Medicine at Mount Sinai, Mapi Pharma Ltd. |
| NCT03982212 | Phase 1 | Jul 31, 2019 | University of Kansas |
| NCT03362294 | Phase 2 | Dec 11, 2017 | Mapi Pharma Ltd. |
| NCT03315923 | Phase 2/Phase 3 (Phase 3) | Dec 1, 2017 | Isfahan University |
| NCT03368664 | Phase 3 | Oct 24, 2017 | Genzyme, Sanofi |
| NCT02499900 | Phase 4 | Aug 1, 2015 | Teva |
| NCT02212886 | Phase 1/Phase 2 (Phase 2) | Oct 1, 2014 | Mapi Pharma Ltd. |
| NCT02023424 | Phase 1 | Jan 1, 2014 | Tel Aviv University |
| NCT03133403 | Phase 2/Phase 3 (Phase 3) | Nov 1, 2013 | Sheffield Hallam University |
| NCT01963611 | Phase 2 | Oct 1, 2013 | Merck Serono |
| NCT02753088 | Phase 3 | Oct 1, 2013 | Biocad |
| NCT02153723 | Phase 2 | Aug 1, 2013 | Rett Syndrome Research Trust, Yeshiva University |
| NCT01874145 | Phase 3 | Jun 1, 2013 | Teva |
| NCT01633112 | Phase 4 | Aug 9, 2012 | Novartis |
| NCT01623596 | Phase 4 | Jun 1, 2012 | Novartis |
| NCT01404117 | Phase 2 | Mar 1, 2012 | Teva |
| NCT01578785 | Phase 3 | Mar 1, 2012 | Russian State Medical University, Teva |
Organizations
Research & Development (59)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Teva | For profit | 23 | 20 | 4 | 1994 |
| Novartis | For profit | 6 | 6 | 1 | 2010 |
| Sanofi | For profit | 5 | 3 | 3 | 2003 |
| Biogen | For profit | 3 | 3 | 2 | 2007 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 3 | 1 | 2 | 2005 |
| Johns Hopkins University | Academic/Hospital | 3 | 1 | 2 | 2007 |
| Mapi Pharma Ltd. | For profit | 3 | 3 | 2 | 2014 |
| Tel Aviv University | Academic/Hospital | 3 | 3 | 3 | 2006 |
| Elan Pharmaceuticals | For profit | 2 | 0 | 2 | 2010 |
| Hebrew University | Academic/Hospital | 2 | 2 | 2 | 2006 |
| Merck Serono | For profit | 2 | 2 | 2 | 2004 |
| National Institute of Neurological Disorders and Stroke (NINDS) | Government | 2 | 0 | 2 | 2005 |
| Sheffield Hallam University | Academic/Hospital | 2 | 1 | 1 | 2006 |
| University of Kansas | Academic/Hospital | 2 | 1 | 2 | 2007 |
| University of Medicine and Dentistry of New Jersey | Academic/Hospital | 2 | 1 | 2 | 2003 |
| University of New Mexico | Academic/Hospital | 2 | 0 | 2 | 1994 |
| University of Sao Paulo | Academic/Hospital | 2 | 1 | 2 | 2006 |
| Amphia Hospital Breda, the Netherlands | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Bayer | For profit | 1 | 1 | 1 | 2003 |
| Biocad | For profit | 1 | 1 | 1 | 2013 |
Marketing (11)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Byondis | For profit | MKTG | Sep 25, 2024 |
| Chemi SpA | For profit | MKTG | May 7, 2025 |
| Hybio | For profit | MKTG | Feb 11, 2026 |
| Mylan | For profit | MKTG | Oct 3, 2017 |
| Mylan | For profit | SYN | Oct 3, 2017 |
| Novartis | For profit | MKTG | Apr 16, 2015 |
| Sandoz | For profit | MKTG | Apr 16, 2015 |
| Sandoz | For profit | SYN | Apr 16, 2015 |
| ScinoPharm Taiwan | For profit | MKTG | Dec 31, 2025 |
| Teva | For profit | NDA | Dec 20, 1996 |
| Teva | For profit | SYN | Dec 20, 1996 |