Viltolarsen

💊Medication

Generic name

Viltolarsen

Brand names

Viltepso

Route

Intravenous

Type

Human Prescription Drug

Manufacturer

NS Pharma, Inc.

Indications: 1 INDICATIONS AND USAGE VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production… (per FDA label)

• PHASE3COMPLETED
  Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)NS Pharma, Inc. · NCT04060199
• PHASE2COMPLETED
  Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With DMD (Galactic53)NS Pharma, Inc. · NCT04956289
• APPROVED_FOR_MARKETING
  The Expanded Access Use of Viltolarsen in Duchenne Muscular Dystrophy With Confirmed Exon 53 Amenable MutationNS Pharma, Inc. · NCT04337112
• PHASE3UNKNOWN
  Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With DMD (RACER53-X)NS Pharma, Inc. · NCT04768062
• PHASE4ACTIVE_NOT_RECRUITING
  Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502)NS Pharma, Inc. · NCT04687020

via ClinicalTrials.gov