GLATIRAMER ACETATE · SYNTHON BV
Glatiramer acetate is an injectable medication indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. The therapy is used to manage specific disease presentations, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It serves as a therapeutic option for patients experiencing the relapsing stages of this neurological condition by modifying immune processes.
How GLATIRAMER ACETATE Works
Although the exact mechanism is not fully understood, glatiramer acetate is thought to work by modifying immune processes responsible for the pathogenesis of multiple sclerosis. Evidence suggests that administration of the drug induces and activates specific suppressor T-cells in the peripheral immune system. These activated cells are believed to influence the immune functions that drive the progression of the disease.
Details
- Status
- Prescription
- First Approved
- 1996-12-20
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
GLATIRAMER ACETATE Approval History
What GLATIRAMER ACETATE Treats
4 indicationsGLATIRAMER ACETATE is approved for 4 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
- Clinically Isolated Syndrome
- Relapsing-Remitting Disease
- Secondary Progressive Disease
GLATIRAMER ACETATE Boxed Warning
BOXED WARNING WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with Glatiramer acetate injection. 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. Pro...
BOXED WARNING WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with Glatiramer acetate injection. 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 )] . ● Glatiramer acetate injection is contraindicated in patients with a history of hypersensitivity reactions to Glatiramer acetate injection, including anaphylaxis. If an anaphylactic reaction occurs, treatment with Glatiramer acetate injection must be immediately discontinued. Unless a clear alternative etiology is identified, Glatiramer acetate injection 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 Glatiramer acetate injection. ● 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 ). ● Glatiramer acetate injection is contraindicated in patients with a history of hypersensitivity reactions to Glatiramer acetate injection, including anaphylaxis ( 4 ).
GLATIRAMER ACETATE 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 GLATIRAMER ACETATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications GLATIRAMER ACETATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to GLATIRAMER ACETATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 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 |
| 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.
GLATIRAMER ACETATE FDA Label Details
Indications & Usage
Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults .
BOXED WARNING WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with Glatiramer acetate injection. 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. ●...
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Full clinical data, patents, trials, and competitive landscape for glatiramer acetate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.