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 its investigational drug 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 for the study, with initial trial preparations already underway to expedite first patient dosing. Sufficient quantities of NV-387 Oral Gummies to begin the trial are already in the DRC, according to the company.
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 to treatments requiring infusion, as it is easier to administer and does not require specialized medical personnel or equipment. 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, underscoring the urgent need for effective and accessible treatments.
The approval marks a significant milestone for NanoViricides as it advances NV-387 into Phase II human clinical trials. The company's lead drug candidate, NV-387, is a broad-spectrum antiviral being developed for multiple indications, including RSV, COVID-19, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and Measles. The company also has other drug candidates in development, such as NV-HHV-1 for shingles, and is exploring treatments for various viral diseases including Ebola, HIV, Hepatitis C, and Dengue fever.
NanoViricides' platform technology is based on the TheraCour nanomedicine technology, licensed from TheraCour Pharma, Inc. The company holds a worldwide exclusive perpetual license to this technology for several drugs targeting human viral diseases. The company's business model relies on licensing technology from TheraCour for specific application verticals of specific viruses, as established in 2005.
The initiation of the Phase II trial in the DRC is a critical step in evaluating the safety and efficacy of NV-387 in a real-world outbreak setting. If successful, this oral antiviral could become a valuable tool in combating Ebola and other viral outbreaks, particularly in regions where healthcare infrastructure is limited. The company remains focused on advancing its clinical programs, though it acknowledges the inherent risks and lengthy timelines associated with drug development.
For more information on NanoViricides, visit www.nanoviricides.com. To view the full press release, visit https://ibn.fm/2Pqu0. Latest news and updates on the company are available at https://ibn.fm/NNVC.
