NanoViricides, Inc. (NYSE American: NNVC) has received regulatory approval from the Democratic Republic of Congo's local regulatory agency, ACOREP, to initiate a Phase II clinical trial of NV-387 Oral Gummies for the treatment of the ongoing Bundibugyo ebolavirus outbreak and other Ebola viruses. The company has engaged Om Sai Clinical Research Private Limited as the contract research organization, with preparations underway to accelerate first patient dosing. Sufficient quantities of the investigational drug are already in the DRC.
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 outbreak settings where intravenous treatments are impractical. According to the World Health Organization, the current outbreak has resulted in 4,141 confirmed cases and 1,889 confirmed deaths as of Aug. 6, 2026.
This approval marks a critical step in addressing Ebola outbreaks, which have historically been challenging to manage due to limited treatment options and logistical hurdles. The availability of an oral treatment could improve patient outcomes and reduce transmission by enabling earlier intervention and easier administration in remote areas.
NanoViricides' lead drug candidate, NV-387, is also being developed for other viral infections, including RSV, COVID-19, influenza, and MPOX. The company's nanoviricide technology, based on TheraCour Pharma's proprietary platform, aims to create nanomaterials that specifically target viruses.
The trial's success could have broader implications for pandemic preparedness, offering a scalable and cost-effective antiviral strategy. However, as with all drug development, there is no certainty that NV-387 will demonstrate sufficient efficacy and safety in human trials.
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