RUZURGI
Pre-Launchamifampridine
NDAORALTABLETPriority Review
Lifecycle
Pre-Launch
Clinical Trials
9
Data completeness
1/8 — Limited
Priority Review
Drug data last refreshed 15h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RUZURGI (amifampridine) is an oral small-molecule tablet indicated for Lambert-Eaton myasthenic syndrome (LEMS), a rare neuromuscular disorder. The drug enhances acetylcholine release at the neuromuscular junction by inhibiting potassium channels. It addresses a significant unmet medical need in this rare disease population.
Pre-Launch
Pre-launch stage indicates active commercial infrastructure buildout; expect demand for launch specialists, market access, and field team expansion as approval approaches.
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.