NanoViricides, Inc. (NYSE American: NNVC) has received regulatory approval from the local regulatory agency ACOREP in the Democratic Republic of Congo (DRC) to initiate a Phase II clinical trial of NV-387 Oral Gummies for the treatment of the current Bundibugyo ebolavirus outbreak and other Ebola viruses. The company has engaged Om Sai Clinical Research Private Limited as the contract research organization for the study, with initial trial preparations already underway to accelerate first patient dosing. NanoViricides stated that sufficient quantities of NV-387 Oral Gummies to begin the trial are already in the DRC.
NV-387 is an investigational broad-spectrum antiviral designed to mimic host-side features required by viruses for infection. The oral formulation could offer significant advantages in resource-limited outbreak settings compared with treatments requiring intravenous infusion. The company cited World Health Organization data showing 4,141 confirmed cases and 1,889 confirmed deaths from the current Bundibugyo ebolavirus outbreak in the DRC as of Aug. 6, 2026.
This regulatory approval marks a critical step forward in addressing the ongoing Ebola outbreak in the DRC. The oral gummy formulation of NV-387 could potentially simplify administration, reduce the burden on healthcare workers, and improve patient compliance, especially in areas with limited medical infrastructure. If successful, this trial could lead to a more accessible treatment option for Ebola, which has historically been managed with intravenous therapies that are often difficult to deploy in remote regions.
NanoViricides is a clinical-stage company focused on developing nanomedicines for antiviral therapy. The company’s lead drug candidate, NV-387, is being developed as a broad-spectrum antiviral for multiple indications, including respiratory infections, MPOX, and Ebola. The company’s technology is based on proprietary nanoviricide platforms licensed from TheraCour Pharma, Inc.
The approval to conduct the Phase II trial in the DRC is particularly significant given the urgent need for effective treatments during outbreaks. The oral gummies could be distributed more easily and administered without specialized medical personnel, making them a practical option for outbreak response. Moreover, the trial’s initiation in the DRC, where the outbreak is ongoing, underscores the company’s commitment to addressing global health emergencies.
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