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 for the treatment of the current Bundibugyo ebolavirus outbreak and other Ebola viruses. The announcement marks a significant step in the development of a potentially more accessible therapeutic for Ebola, which has historically required intravenous administration.
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 expedite the first patient dosing. NanoViricides stated that sufficient quantities of NV-387 Oral Gummies to commence the trial are already in the DRC.
NV-387 is a broad-spectrum antiviral designed to mimic host-side features that viruses exploit for infection. The oral formulation could offer distinct advantages in resource-limited outbreak settings, where infrastructure for infusion-based treatments may be lacking. This is particularly relevant given the scale of the current outbreak, with the World Health Organization reporting 4,141 confirmed cases and 1,889 confirmed deaths as of Aug. 6, 2026.
The approval underscores the urgent need for effective and practical Ebola treatments. Existing therapies, such as monoclonal antibodies, require cold chain logistics and intravenous administration, which can be challenging in remote areas. An oral drug like NV-387 could simplify distribution, reduce the burden on healthcare workers, and improve patient compliance.
NanoViricides is a clinical-stage company focused on developing nanomedicines for antiviral therapy. Its lead candidate, NV-387, is also being explored for other viral infections, including RSV, COVID-19, influenza, and MPOX. The company's proprietary nanoviricide technology is based on intellectual property licensed from TheraCour Pharma, Inc.
The Phase II trial in the DRC represents a pivotal opportunity to evaluate the efficacy and safety of NV-387 in a real-world outbreak setting. If successful, it could provide a much-needed oral treatment option for Ebola, potentially transforming outbreak response strategies.
While the approval is a positive development, the company cautions that drug development is lengthy and capital-intensive, and there is no guarantee of success. However, the initiation of this trial brings hope for a more accessible intervention in one of the deadliest viral diseases known to humanity.
For more information on the full press release, visit https://ibn.fm/2Pqu0.
