AMPYRA (dalfampridine)
AMPYRA is indicated for the treatment of Multiple Sclerosis.
How AMPYRA Works
Dalfampridine functions as a broad-spectrum potassium channel blocker, though its exact therapeutic mechanism has not been fully elucidated. In animal studies, the drug has been shown to inhibit potassium channels, which increases the conduction of action potentials. This process occurs in demyelinated axons to facilitate the transmission of nerve signals.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-01-22
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
AMPYRA Approval History
What AMPYRA Treats
1 indicationsAMPYRA is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
AMPYRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 AMPYRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AMPYRA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AMPYRA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02868567 | 2016-247 | Ph 1 | active not recruiting | Use of Dalfampridine in Primary Lateral Sclerosis |
| NCT06853015 | STU00221545 | Ph 1, Ph 2 | recruiting | Double Dose 4-AP on Functional Recovery After Spinal Cord Injury |
| NCT02006160 results posted | NEU3270511E | Ph 2, Ph 3 | completed | Effects of Dalfampridine on Cognition in Multiple Sclerosis |
| NCT02391961 results posted | F1180-W 1IK2RX001180-01A2 | Ph 2 | completed | Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis |
| NCT02166346 results posted | NA_00090799 | Ph 2 | completed | Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch) |
| NCT01621113 | D-732-12 H133N110020 | Ph 2 | completed | Combination Therapy With Dalfampridine and Locomotor Training for Chronic, Motor Incomplete Spinal Cord Injury |
| NCT02656160 APIGLOSS results posted | BWH-2014P001033C | Ph 2 | completed | Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults |
| NCT01975324 Ampyra | Dalfampridine 13-265 | Ph 4 | completed | A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) |
| NCT01444300 results posted | GNEUR0637A | Ph 2 | completed | Dalfampridine for Imbalance in Multiple Sclerosis |
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.
AMPYRA FDA Label Details
Indications & Usage
FDA Label (PDF)AMPYRA is indicated for the treatment of Multiple Sclerosis.
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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