NanoViricides Gets Approval for Phase II Ebola Trial of Oral NV-387 Gummies in DRC

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 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, with initial trial preparations already underway to expedite first patient dosing. NanoViricides stated that sufficient quantities of NV-387 Oral Gummies are already in the DRC to begin the trial.

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. The approval marks a critical step in addressing a public health emergency where existing treatments may be logistically challenging.

The significance of this development lies in the potential for an oral antiviral to simplify Ebola treatment and distribution. Current standard therapies, such as monoclonal antibodies, require cold chain storage and trained medical personnel for administration, which are often scarce in remote outbreak zones. An oral gummy formulation could be administered more easily, improving patient compliance and enabling broader access to treatment. This could be particularly impactful in the DRC, where the outbreak has persisted and strained healthcare resources.

NanoViricides’ platform technology leverages nanomedicine to create targeted antiviral agents. The company holds a worldwide exclusive perpetual license to this technology for several viruses, including Ebola/Marburg viruses. The approval for this Phase II trial is a key milestone in the company’s clinical development program, which is also exploring NV-387 for other indications such as RSV, COVID-19, and influenza. The company’s broader pipeline includes candidates for herpes, HIV, hepatitis, and other viral diseases.

The initiation of this trial is subject to standard regulatory and ethical oversight. While the approval is encouraging, the company cautions that drug development is lengthy and requires substantial capital. There is no assurance that NV-387 will demonstrate sufficient efficacy and safety in human trials. However, the progression to Phase II in a real-world outbreak setting provides valuable data that could accelerate development and potentially lead to a new treatment option for Ebola.

For more information, visit the full press release at https://ibn.fm/2Pqu0. For the latest news and updates on NanoViricides, see the company’s newsroom at https://ibn.fm/NNVC.