NNVC News & Events

NanoViricides announced that it has filed an application for "Rare Pediatric Disease Drug" Designation, RPDD, for NV-387 as a Treatment for Measles with the US FDA Office of Orphan Products Development, OPDD. This RPDD application is expected to be joined together with the Orphan Drug Designation application for NV-387 as a Treatment for Measles that the Company has filed in February, 2026.

NanoViricides announced that a Phase II Clinical Trial of Monkeypox Treatment by NV-387 is expected to begin soon in the Democratic Republic of Congo. Clinical Trial Site preparations are being performed by our CRO in India, Om Sai Clinical Research Pvt. Ltd., and associates in DRC. The CRO personnel are expected to visit the Site for final preparations and for staff training in the first week of April, 2026. Enrollment and dosing of patients is expected to begin after the staff training is completed. The Company previously reported that it has received approval to start said Phase II Clinical Trial of NV-387 for the Treatment of MPox by the Regulatory Agency ACOREP of the Democratic Republic of Congo. The Phase II clinical trial will evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease caused by hMPXV infection. MPox Clade I is endemic in DRC and all cases in the clinical trial are expected to be of the Clade I virus. The other prominent MPox virus, MPox Clade II is substantially less severe an infection than MPox Clade I.