NanoViricides Files FDA Orphan Drug Application for NV-387 MPox Therapy
NanoViricides has submitted an FDA Orphan Drug Designation application for NV-387 as a treatment for MPox, seeking tax credits, user fee exemptions and seven-year market exclusivity. NV-387 completed a Phase I safety trial with no adverse events and demonstrated strong efficacy in orthopoxvirus mouse models.
1. Orphan Drug Application Filed
NanoViricides filed an Orphan Drug Designation application with the FDA Office of Orphan Products Development for NV-387 as a treatment for MPox to access incentives under the Orphan Drug Act.
2. Clinical Safety and Preclinical Efficacy
NV-387 completed a Phase I human trial showing safety and tolerability in healthy adults with no reported adverse events and has exhibited strong antiviral efficacy in mouse models of orthopoxvirus infections.
3. Incentives and Development Outlook
Designation would grant tax credits, user fee exemptions and seven years of market exclusivity; NanoViricides plans to advance NV-387 into MPox efficacy trials leveraging this regulatory pathway.