NanoViricides, Inc. (NYSE American: NNVC) announced that it has received regulatory approval from the local regulatory agency ACOREP in the Democratic Republic of Congo (DRC) to commence a Phase II clinical trial of NV-387 Oral Gummies as a treatment for 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 the first patient dosing. NanoViricides stated that sufficient quantities of NV-387 Oral Gummies to initiate the trial are already in the DRC.
NV-387 is an investigational broad-spectrum antiviral designed to mimic host-side features that viruses require for infection. The oral formulation may offer significant advantages in resource-limited outbreak settings compared with treatments that require intravenous infusion. The company cited World Health Organization data indicating 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 pivotal step for NanoViricides as it advances NV-387 into human clinical trials. The company's lead drug candidate, NV-387, is being developed as a treatment for multiple viral infections, including RSV, COVID-19, Long COVID, influenza, and other respiratory viral infections, as well as MPOX/smallpox and measles. The company is also developing NV-HHV-1 for shingles.
NanoViricides' platform technology is based on the TheraCour® nanomedicine technology, licensed from TheraCour Pharma, Inc. The company holds a worldwide exclusive perpetual license for several drugs targeting specific mechanisms for the treatment of various human viral diseases, including HIV/AIDS, hepatitis B and C, rabies, herpes simplex virus (HSV-1 and HSV-2), varicella-zoster virus (VZV), influenza and Asian bird flu virus, dengue viruses, Japanese encephalitis virus, West Nile virus, Ebola/Marburg viruses, and certain coronaviruses. The company intends to obtain licenses for RSV, poxviruses, and/or enteroviruses if initial research proves successful.
The approval for the Phase II trial in the DRC is particularly significant given the ongoing outbreak. According to the WHO, the Bundibugyo ebolavirus has caused substantial morbidity and mortality, and the availability of an oral treatment could greatly improve patient outcomes and containment efforts. Unlike infused therapies, oral gummies can be administered more easily in remote areas and require less medical infrastructure, which is critical in outbreak zones.
NanoViricides noted that the trial preparations are already underway, and the presence of the drug in the DRC indicates the company's readiness to proceed. The selection of Om Sai Clinical Research as the CRO underscores the company's commitment to conducting rigorous clinical trials in affected regions.
As with any drug development, there are inherent risks and uncertainties. The company acknowledged that the path to regulatory approval is lengthy and requires substantial capital. There can be no assurance that NV-387 will demonstrate sufficient effectiveness and safety in human trials, nor that successful results in the lab will translate to clinical success. However, the approval for this Phase II trial represents a significant milestone in the fight against Ebola and other viral diseases.
The news is based on a press release from BioMedWire, which can be viewed at https://ibn.fm/2Pqu0. For more information about NanoViricides, visit https://www.nanoviricides.com.
