GLATOPA (glatiramer acetate)
GLATOPA is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting disease; Active secondary progressive disease.
How GLATOPA Works
While the exact mechanism of glatiramer acetate is not fully understood, it is thought to act by modifying immune processes associated with the development of multiple sclerosis. Research suggests that the drug induces and activates specific suppressor T-cells within the peripheral immune system. These activated cells are believed to influence the immune responses that contribute to the damage of the central nervous system.
Details
- Status
- Prescription
- First Approved
- 2015-04-16
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
GLATOPA Approval History
What GLATOPA Treats
3 indicationsGLATOPA is approved for 3 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting disease
- Active secondary progressive disease
GLATOPA 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.
Drugs Similar to GLATOPA
3 of 13FDA-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| NCT04079088 | 231MS201 2019-001847-28 | Ph 2 | withdrawn | Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS) |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.
GLATOPA FDA Label Details
Indications & Usage
FDA Label (PDF)GLATOPA is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting disease; Active secondary progressive disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.