NanoViricides, Inc. (NYSE American: NNVC) has received regulatory approval from ACOREP, the local regulatory agency in the Democratic Republic of Congo (DRC), to initiate a Phase II clinical trial of its investigational drug NV-387 Oral Gummies as a treatment for the ongoing Bundibugyo ebolavirus outbreak and other Ebola viruses. The company has engaged Om Sai Clinical Research Private Limited as the contract research organization, and initial trial preparations are already underway to accelerate the first patient dosing. Sufficient quantities of the oral gummies are already in the DRC to begin the trial.
NV-387 is a broad-spectrum antiviral designed to mimic host-side features that viruses require for infection. The oral formulation could offer significant advantages in resource-limited outbreak settings compared to treatments that require 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 approval marks a critical step in addressing a deadly outbreak, as current Ebola treatments often require cold chain logistics and trained medical personnel for infusion. An oral gummy formulation could be distributed more easily and administered by patients themselves, potentially improving treatment coverage and adherence in remote areas. The trial's success could position NV-387 as a frontline therapy for Ebola, and its broad-spectrum nature might also prove useful against other viral threats, including RSV, COVID-19, and influenza.
NanoViricides is a clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is being developed for multiple indications, including respiratory viruses and poxviruses. The company's nanoviricide technology is based on intellectual property licensed from TheraCour Pharma, Inc. The company has a worldwide exclusive perpetual license for several drugs targeting specific viruses, including Ebola and Marburg viruses.
The initiation of a Phase II trial for Ebola is a significant milestone for the company, which has faced a lengthy and capital-intensive drug development process. While there is no assurance that NV-387 will demonstrate sufficient efficacy and safety in human trials, the regulatory approval in the DRC provides an opportunity to evaluate the drug in a real-world outbreak setting. The oral formulation, if proven effective, could become a valuable tool in global health preparedness against Ebola and other emerging viral diseases.
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