COPAXONE (glatiramer acetate)
COPAXONE is indicated for the treatment of Multiple Sclerosis.
How COPAXONE Works
While the exact mechanism of glatiramer acetate is not fully understood, it is thought to work by modifying the immune processes responsible for the pathogenesis of multiple sclerosis. Studies suggest that the drug induces and activates specific suppressor T-cells in the peripheral immune system. By modifying these immune functions, the medication may help regulate the autoimmune responses that drive the condition.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-12-20
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE, FOR SOLUTION
COPAXONE Approval History
What COPAXONE Treats
1 indicationsCOPAXONE is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
COPAXONE Boxed Warning
ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with COPAXONE. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction; instruct them to seek immediate medical care should these symptoms occur. Prompt identification of anaphylaxis is importan...
WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with COPAXONE. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction; instruct them to seek immediate medical care should these symptoms occur. Prompt identification of anaphylaxis is important to avoid a delay in treatment [see Warnings and Precautions ( 5.1 )] . COPAXONE is contraindicated in patients with a history of hypersensitivity reactions to COPAXONE, including anaphylaxis. If an anaphylactic reaction occurs, treatment with COPAXONE must be immediately discontinued. Unless a clear alternative etiology is identified, COPAXONE must be permanently discontinued [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . WARNING: ANAPHYLACTIC REACTIONS See full prescribing information for complete boxed warning. Life-threatening and fatal anaphylaxis, which can occur at any time following initiation of therapy (from as early as after the first dose, up to years after initiation of treatment), has been reported in patients receiving COPAXONE. Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction. Prompt identification of anaphylaxis is important to avoid a delay in treatment ( 5.1 ). COPAXONE is contraindicated in patients with a history of hypersensitivity reactions to COPAXONE, including anaphylaxis ( 4 ).
COPAXONE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in COPAXONE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications COPAXONE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to COPAXONE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03368664 LemKids results posted | EFC13429 U1111-1180-6352, 2016-003100-30 | Ph 3 | terminated | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT |
| NCT06003972 Copaxone | 093418-HMO-CTIL | Ph 2 | completed | Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure |
| NCT04079088 | 231MS201 2019-001847-28 | Ph 2 | withdrawn | Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS) |
| NCT01633112 ASSESS results posted | CFTY720D2312 | Ph 3 | terminated | MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone |
| NCT03315923 | 396514 | Ph 2, Ph 3 | completed | Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients |
| NCT02153723 results posted | 13-05-117 | Ph 2 | completed | Pharmacological Treatment of Rett Syndrome With Glatiramer Acetate (Copaxone) |
| NCT01569451 GATEWAYII results posted | 10-1143 | Ph 2 | completed | Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate |
| NCT00856635 results posted | PM030 | Ph 3 | completed | A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon) |
| NCT00947752 Song results posted | PM033 | Ph 3 | completed | Safety of New Formulation of Glatiramer Acetate |
| NCT01058005 SURPASS results posted | 101MS325 | Ph 3 | terminated | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis |
| NCT01578785 GLOW results posted | GA-MS-302 2011-005550-57 | Ph 3 | terminated | An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) |
| NCT01071083 RESTORE results posted | 101MS205 | Ph 2 | completed | Treatment Interruption of Natalizumab |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
COPAXONE FDA Label Details
Indications & Usage
FDA Label (PDF)COPAXONE is indicated for the treatment of Multiple Sclerosis.
WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with COPAXONE. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. Make patients aware of the symptoms...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment