Drugs / Glatiramer Acetate
Glatiramer Acetate
also known as
Copaxone · BCD-063 · COP-1 · Copaxone (glatiramer acetate) · Copaxone (Glatiramer acetate, COP, Copolymer-1) · copolymer 1 · GA Depot · Glatopa · +2 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | COPAXONE | — | 2009-02-27 – 2014-01-28 | fda.gov ↗ |
| Approved | US (FDA) | COPAXONE | — | 1996-12-20 | fda.gov ↗ |
Trials 32 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 38 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00541333 Comparator | Dec 2007 → Dec 2012 | dry age related macular degeneration | The New York Eye & Ear Infirmary | Suspended | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT06715605 Comparator | Apr 2025 | multiple sclerosis | University Hospital, Antwerp | Withdrawn | No outcome recorded |
| Phase 2 | NCT04079088 Background | Jun 2021 → Sep 2024 | multiple sclerosis | Biogen | Withdrawn | No outcome recorded |
| Phase 2 | NCT01963611 Comparator | Oct 2013 → Mar 2015 | relapsing-remitting multiple sclerosis | EMD Serono | Terminated | No outcome recorded |
| Phase 2 | NCT01569451 Background | Feb 2012 → May 2015 | multiple sclerosis | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT01071083 Comparator | Mar 2010 → Nov 2011 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00811395 Background | Oct 2007 → Apr 2010 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT00475865 Background | Apr 2007 → Oct 2009 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT00451204 Comparator | Mar 2007 → Jul 2014 | relapsing-remitting multiple sclerosis | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2 | NCT00273364 Comparator | Nov 2005 → Jan 2017 | multiple sclerosis | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT00203099 Comparator | Dec 2004 → Aug 2006 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00203112 Background | Jun 2004 → Jun 2006 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00202982 Comparator | Aug 2003 → Sep 2005 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00203073 Comparator | Jun 2003 → Jan 2005 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00097760 Background | Jun 2003 → Mar 2004 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT06663189 Comparator | Jan 2025 → Jan 2027 expected | relapsing-remitting multiple sclerosis | University Hospital, Strasbourg, France | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04788615 Comparator | Jul 2021 → Nov 2025 | multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03368664 Background | Oct 2017 → May 2021 | multiple sclerosis | Genzyme, a Sanofi Company | Terminated | No outcome recorded |
| Phase 3 | NCT01874145 Comparator | Jun 2013 → Apr 2014 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01633112 Comparator | Aug 2012 → Apr 2018 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT01936129 Comparator | Sep 2010 → Oct 2013 | acute closed-angle glaucoma | Singapore Eye Research Institute | Unknown | No outcome recorded |
| Phase 3 | NCT01167426 Comparator | Jul → Nov 2010 | multiple sclerosis | Teva Neuroscience, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01058005 Comparator | Mar 2010 → Apr 2012 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT00451451 Comparator | Jun 2007 → Aug 2011 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00337779 Comparator | Aug 2006 → Oct 2008 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00211887 Comparator | Jan 2005 → Apr 2012 | relapsing-remitting multiple sclerosis | Fred Lublin | Completed | No outcome recorded |
| Phase 3 | NCT00099502 Comparator | Nov 2003 → Aug 2007 | relapsing-remitting multiple sclerosis | Bayer | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT04792567 Comparator | Apr → Sep 2021 | secondary progressive multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01623596 Comparator | Jun 2012 → Jul 2015 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01534182 Comparator | Jan 2012 → Jun 2013 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01317004 Comparator | May 2011 → Jun 2014 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00677664 Comparator | Jul 2006 → Jul 2008 | diabetic retinopathy | Federal University of São Paulo | Unknown | No outcome recorded |
| Phase 4 | NCT00239993 Background | Aug → Dec 2005 | multiple sclerosis | Teva Neuroscience, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00203047 Background | Jan 2005 → May 2009 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00240032 Comparator | Oct 2004 → Jun 2006 | multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00078338 Comparator | Feb 2004 → Nov 2006 | relapsing-remitting multiple sclerosis | EMD Serono | Completed | No outcome recorded |
| Phase 4 | NCT00176592 Comparator | Jan 2003 → Jan 2007 | multiple sclerosis | University of Medicine and Dentistry of New Jersey | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00039988 Background | Nov 2001 → Mar 2006 | multiple sclerosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
Press releases naming this drug 114 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-08-07 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis viatris.com ↗ |
| 2022-02-10 | Teva Branded Pharmaceutical Products R&D, Inc. | COPAXONE® Label Now Indicates Its Use in Breastfeeding Mothers with Relapsing Multiple Sclerosis tevapharm.com ↗ |
| 2021-10-13 | Teva Branded Pharmaceutical Products R&D, Inc. | New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis tevapharm.com ↗ |
| 2021-06-22 | Teva Branded Pharmaceutical Products R&D, Inc. | New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis: COBRA study presented at the 7th Congress of the European Academy of Neurology (EAN) tevapharm.com ↗ |
| 2020-05-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva to Present New AJOVY® (fremanezumab) Analyses and Latest COPAXONE® Data (glatiramer acetate injection) at European Academy of Neurology Congress tevapharm.com ↗ |
| 2019-05-10 | Novartis Pharmaceuticals | Novartis data at AAN show Gilenya® is the first and only disease-modifying therapy with proven superiority versus glatiramer acetate in relapsing remitting MS novartis.com ↗ |
| 2019-04-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva’s COPAXONE® 40mg – Favorable Response from European Patent Office tevapharm.com ↗ |
| 2018-10-10 | Novartis Pharmaceuticals | Novartis announces new data from the first direct head-to-head trial to demonstrate superior efficacy of Gilenya® over Copaxone® in patients with relapsing remitting multiple sclerosis novartis.com ↗ |
| 2018-04-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Presents New Long-Term Data Demonstrating Efficacy and Safety of COPAXONE® (glatiramer acetate injection) 40 mg/mL tevapharm.com ↗ |
| 2018-02-13 | Novartis Pharmaceuticals | Sandoz announces US FDA approval and launch of Glatopa® 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis novartis.com ↗ |
| 2017-10-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Comments on Anticipated At-Risk U.S. Launch of Generic Glatiramer Acetate 40mg/mL and Launch of Generic Glatiramer Acetate 20mg/mL tevapharm.com ↗ |
| 2017-05-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Publication of COPAXONE® (glatiramer acetate injection) Pregnancy Data in the International Journal of MS Care tevapharm.com ↗ |
| Show all 114 releases opens the full record — a long page | ||
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Glatiramer acetate | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗58“Glatiramer acetate (GA) 20 mg/mL subcutaneous (SC) injection, the commercial product, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to...” NCT01874145 ↗ “Standard-of-care on first-line treatment such as interferon-beta, glatiramer acetate, teriflunomide, dimethylfumarate, ponesimod and ozanimod.” NCT06715605 ↗ “Discontinuation of patients' own disease modifying therapy (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide)” NCT04260711 ↗ “Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.” NCT00097760 ↗ “selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.” NCT01216072 ↗ “DMTs: Dimethylfumarate, glatirameracetate, interferon, teriflunomode according to respective SmPC” NCT04792567 ↗ “Interferon-β (IFN-β), glatiramer acetate, dimethyl fumarate, teriflunomide or diroximel fumarate” NCT06663189 ↗ “Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot)” NCT02212886 ↗ “Glatiramer acetate minimum dose 20mg or maximum dose 40mg twice a day or three times a week” NCT04788615 ↗ “Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)” NCT03362294 ↗ “Long acting intramuscular injection of glatiramer acetate, once every 4 weeks” NCT04121221 ↗ “Interferon beta 1a or interferon beta 1b or Glatiramer Acetate” NCT01317004 ↗ “Copaxone 20 mg injected SQ every day (glatiramer acetate)” NCT00176592 ↗ “treatment with Copaxone (Glatiramer Acetate) 20 mg” NCT00099502 ↗ “Copaxone (Glatiramer acetate)” NCT00466076 ↗ “glatiramer acetate (Copaxone)” NCT01623596 ↗ “Copaxone (glatiramer acetate)” NCT03535298 ↗ |
| Known as | BCD-063 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02753088 ↗ |
| Known as | COP-1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201507 ↗ |
| Known as | Copaxone | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗19“The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis.” NCT00326625 ↗ “Copaxone is known for its high safety profile and for acting as an effective immunomodulatory agent for the treatment of MS.” NCT00731172 ↗ “Investigational Product:Glatiramer Acetate (Copaxone® , Teva Pharmaceutical Industries Ltd.)” NCT02023424 ↗ “Treatment of Multiple Sclerosis With Copaxone (Glatiramer Acetate)” NCT00039988 ↗ “glatiramer acetate (GA, i.e., Copaxone®) injection” NCT02212886 ↗ “Glatiramer Acetate (Copaxone®)” NCT01489254 ↗ “glatiramer acetate (Copaxone)” NCT01623596 ↗ |
| Known as | Copaxone (glatiramer acetate) | “Copaxone (glatiramer acetate)” NCT03535298 ↗ |
| Known as | Copaxone (Glatiramer acetate, COP, Copolymer-1) | “Copaxone (Glatiramer acetate, COP, Copolymer-1)” NCT00677664 ↗ |
| Known as | copolymer 1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00004814 ↗ |
| Known as | GA Depot | “Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)” NCT03362294 ↗ |
| Known as | Glatopa | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201507 ↗ |
| Known as | Glatopa (glatiramer acetate) | “Glatopa (glatiramer acetate)” NCT03535298 ↗ |
| Known as | GTR | “Glatiramer Acetate (GTR)” NCT01489254 ↗ |
| Modality | Peptide | “copolymer 1, a mixture of synthetic polypeptides” NCT00004814 ↗ |
| Modality | Small molecule | — CHEMBL1201507 ↗ |
| Route | Subcutaneous | “subcutaneously each day” NCT00004814 ↗ |