NanoViricides, Inc. (NYSE American: NNVC) has received regulatory approval from the local agency ACOREP 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 company announced that it has engaged Om Sai Clinical Research Private Limited as the contract research organization, with initial trial preparations already underway to accelerate the first patient dosing. Sufficient quantities of NV-387 Oral Gummies to begin the trial are already in the DRC.
NV-387 is a broad-spectrum antiviral designed to mimic host-side features that viruses require for infection. According to the company, the oral formulation could offer significant advantages in resource-limited outbreak settings compared with 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 severe public health emergency. The ongoing outbreak has already caused thousands of deaths, and the need for effective, easily administered treatments is urgent. Oral gummies could be particularly beneficial in remote areas where medical infrastructure is limited and trained personnel for IV administration are scarce. If successful, this trial could lead to a more accessible treatment option for Ebola, potentially reducing mortality and easing the burden on healthcare systems during outbreaks.
NanoViricides is a clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. The company’s lead drug candidate, NV-387, is being developed for a range of viral infections, including RSV, COVID-19, Long COVID, Influenza, MPOX/Smallpox, and Measles. The company also has other candidates in development, including NV-HHV-1 for shingles. The company’s platform technology is based on the TheraCour nanomedicine technology, licensed from TheraCour Pharma, Inc.
The Ebola trial is particularly significant because it represents a potential breakthrough in antiviral treatment for hemorrhagic fevers. Current treatments for Ebola, such as monoclonal antibodies, typically require intravenous administration and cold chain storage, making them difficult to deploy in outbreak zones. An oral formulation could be distributed more easily and administered by community health workers, potentially improving patient outcomes and helping to contain outbreaks more effectively.
Moreover, this development could have broader implications for pandemic preparedness. The COVID-19 pandemic highlighted the need for versatile antiviral drugs that can be rapidly adapted to new viral threats. NV-387’s broad-spectrum mechanism could make it a valuable tool against future emerging viruses, not just Ebola. If the trial is successful, it could pave the way for further studies against other viral diseases, including those with pandemic potential.
However, as with any drug development, there are inherent risks. The company noted that the path to typical drug development is extremely lengthy and requires substantial capital. There can be no assurance that NV-387 will show sufficient effectiveness and safety in human clinical trials. Nevertheless, the initiation of this Phase II trial is a positive step forward in the fight against Ebola and other viral threats.
For more information, the full press release can be viewed at https://ibn.fm/2Pqu0. NanoViricides’ newsroom is available at https://ibn.fm/NNVC.
