NanoViricides, Inc. (NYSE American: NNVC) has announced that it 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 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 are already in the DRC to commence the trial.
NV-387 is an investigational 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. This is particularly relevant given the scale of the current outbreak; according to World Health Organization data cited by the company, there have been 4,141 confirmed cases and 1,889 confirmed deaths from the Bundibugyo ebolavirus outbreak in the DRC as of Aug. 6, 2026.
The approval marks a critical step in the development of NV-387, which is also being investigated for other viral infections including RSV, COVID-19, influenza, and MPOX. The company's lead drug candidate, NV-387, is a broad-spectrum antiviral that has shown promise in preclinical studies. The oral gummy formulation could simplify administration in outbreak zones where healthcare infrastructure is often strained, potentially improving patient compliance and enabling wider distribution.
NanoViricides is a clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. Its nanoviricide technology is based on intellectual property and proprietary know-how licensed from TheraCour Pharma, Inc. The company holds broad, exclusive, sub-licensable field licenses for several viral diseases, including Ebola and Marburg viruses. The ongoing Phase II trial in the DRC will evaluate the safety and efficacy of NV-387 Oral Gummies in treating Ebola, with the potential to provide a much-needed oral treatment option for this deadly disease.
The initiation of this trial is a significant milestone for NanoViricides, as it advances the company's mission to develop effective antiviral treatments that can be deployed in challenging environments. The oral formulation of NV-387 may also offer advantages in terms of manufacturing, storage, and distribution compared to injectable therapies. As the outbreak continues to pose a public health threat, the approval of this trial represents a beacon of hope for the development of a practical treatment solution.
For more information on NanoViricides and its pipeline, visit NanoViricides.com. To view the full press release, see https://ibn.fm/2Pqu0.
