NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Aug 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VILTEPSO (viltolarsen) is an intravenous antisense oligonucleotide approved for rare neuromuscular disease. It represents a precision genetic therapy delivered systemically to modulate disease-causing RNA. The drug targets a specific patient population with defined genetic mutations.
Peak7.5 years to LOE
Mid-cycle rare disease product in peak commercial phase with concentrated patient base; team size likely stable.
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 (3)
Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With DMD (Galactic53)
Started Jul 2021
20 enrolled
Duchenne Muscular Dystrophy
Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With DMD (RACER53-X)
Started Apr 2021
74 enrolled
Duchenne Muscular Dystrophy
Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)
Started Apr 2020
77 enrolled
Duchenne Muscular Dystrophy
Career Relevance
VILTEPSO is a stable, specialized rare disease asset with predictable career trajectory through 2031–2034 LOE. Roles concentrate in specialty/rare disease commercial infrastructure, medical affairs, and patient outcomes management rather than broad-market promotion.
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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.