RUZURGI
Pre-Launchamifampridine
NDAORALTABLETPriority Review
Lifecycle
Pre-Launch
Clinical Trials
9
Data completeness
1/8 — Limited
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RUZURGI (amifampridine) is an oral small-molecule tablet approved as a new drug application for a rare neurological indication. The drug works through a potassium channel blocking mechanism to enhance neuromuscular transmission. Patient population is limited to those with specific neuromuscular disorders.
Pre-Launch
Pre-launch stage suggests small, focused commercial team with emphasis on launch preparation, market access, and rare disease expertise.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Pyridostigmine and Amifampridine for Myasthenia Gravis
Started Mar 2023
24 enrolled
Myasthenia Gravis
Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3
Started Mar 2019
13 enrolled
Spinal Muscular Atrophy Type 3
Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients
Started Jan 2019
13 enrolled
Muscular Atrophy, Spinal
Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)
Started Jun 2018
63 enrolled
Myasthenia Gravis, MuSKAChR Myasthenia Gravis
Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG
Started Apr 2018
93 enrolled
Myasthenia Gravis, Generalized
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.