NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage antiviral drug developer, announced that its Phase IIA clinical trial of NV-387 Oral Gummies for Ebola Bundibugyo virus disease in the Democratic Republic of Congo is progressing, with advancement to Phase IIB anticipated after the initial phase concludes. Enrollment began on Sept. 23, 2026, and approximately 20 patients are expected to participate in Phase IIA, which is designed to evaluate dosing regimens based on disease severity, according to the company.
The trial’s primary endpoint is 28-day survival, and the initial phase will conclude once the final enrolled patient completes the observation period. The company highlighted the potential importance of an oral antiviral treatment amid the ongoing Ebola Bundibugyo outbreak, citing more than 10,000 confirmed cases and approximately 4,900 deaths in the DRC. NanoViricides stated that no treatments or vaccines are currently approved specifically for Ebola Bundibugyo and that NV-387 Oral Gummies is, to its knowledge, the only oral drug candidate undergoing clinical evaluation for the disease.
This development matters because the outbreak’s scale—over 10,000 confirmed cases and roughly 4,900 deaths—underscores the urgent need for accessible therapeutic options in the DRC. An oral treatment could be particularly valuable in resource-limited settings where injectable therapies or vaccines are difficult to deploy. The company’s assertion that no approved treatments or vaccines exist for Ebola Bundibugyo means that if NV-387 Oral Gummies succeeds in clinical testing, it could become a first-in-class option for a disease with a high fatality rate. For investors, the trial’s progression to Phase IIB would mark a significant milestone for NanoViricides, which is also evaluating NV-387 Oral Gummies in a separate Phase II clinical trial for mpox in the DRC. The full press release is available at https://ibn.fm/JJ69W.
NanoViricides describes itself as a clinical-stage company creating special-purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is a broad-spectrum antiviral that the company plans to develop as a treatment for RSV, COVID, Long COVID, influenza, and other respiratory viral infections, as well as MPOX/smallpox infections and measles. The company’s other advanced candidate is NV-HHV-1 for shingles. Its business model is based on licensing technology from TheraCour Pharma, Inc., and it holds a worldwide exclusive perpetual license for several drugs targeting specific human viral diseases, including Ebola/Marburg viruses. More information about the company is available at www.nanoviricides.com.
The trial’s progress comes as drug developers face lengthy and capital-intensive paths to approval, and NanoViricides notes that there can be no assurance at this time that any of its pharmaceutical candidates will show sufficient effectiveness and safety for human clinical development. Still, the start of patient enrollment and the anticipated move to Phase IIB provide concrete steps in testing a novel oral option against a virus with no approved specific therapies. For industry observers, the outcome of this trial could inform future strategies for developing oral antivirals against hemorrhagic fever viruses. The latest news and updates relating to NNVC are available in the company’s newsroom at https://ibn.fm/NNVC.
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