FIRDAPSE (amifampridine phosphate)
Firdapse is a medication used for patients with Lambert-Eaton myasthenic syndrome (LEMS). It helps both adults and children six years of age and older manage this condition. This therapy is prescribed to address the symptoms associated with this specific syndrome.
How FIRDAPSE Works
This medication works by acting as a broad-spectrum potassium channel blocker. Although the exact way it produces its therapeutic effect is not yet fully understood, it exerts its action through this channel-blocking mechanism.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-11-28
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- TABLET
FIRDAPSE Approval History
What FIRDAPSE Treats
1 indicationsFIRDAPSE is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Lambert-Eaton Myasthenic Syndrome
FIRDAPSE 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.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03579966 results posted | MSK-003 | Ph 3 | terminated | Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis) |
| NCT03304054 results posted | MSK-002 | Ph 3 | completed | Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG |
| NCT03781479 results posted | SMA-001 | Ph 2 | completed | Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients |
| NCT02562066 results posted | CMS-001 | Ph 3 | completed | Amifampridine Phosphate for the Treatment of Congenital Myasthenic Syndromes |
| NCT02970162 results posted | LMS-003 | Ph 3 | completed | Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS) |
| NCT01377922 results posted | LMS-002 | Ph 3 | completed | A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS) |
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.
FIRDAPSE FDA Label Details
Indications & Usage
FDA Label (PDF)FIRDAPSE is indicated for the treatment of Lambert-Eaton Myasthenic Syndrome.
FIRDAPSE Patents & Exclusivity
Patents (6 active)
Pro Intelligence Preview
Deep insights for FIRDAPSE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 6 active patents
Trial Analysis
- • 6 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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