DALFAMPRIDINE
Dalfampridine is an extended-release medication indicated for adult patients with multiple sclerosis. The drug is used as a treatment to improve walking in this patient population. Its therapeutic role is demonstrated by its ability to increase walking speed.
How DALFAMPRIDINE Works
Dalfampridine is a broad spectrum potassium channel blocker. While the exact mechanism of its therapeutic effect is not fully elucidated, the drug inhibits potassium channels. In animal studies, this inhibition has been shown to increase the conduction of action potentials in demyelinated axons.
Details
- Status
- Prescription
- First Approved
- 2017-01-23
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
DALFAMPRIDINE Approval History
What DALFAMPRIDINE Treats
1 indicationsDALFAMPRIDINE is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
DALFAMPRIDINE 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 DALFAMPRIDINE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DALFAMPRIDINE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DALFAMPRIDINE
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.
DALFAMPRIDINE FDA Label Details
Indications & Usage
DALFAMPRIDINE is indicated for the treatment of Multiple Sclerosis.
Looking for the branded version?
AMPYRA
Full clinical data, patents, trials, and competitive landscape for dalfampridine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.