NanoViricides, Inc. (NYSE American: NNVC) has received regulatory approval from the local regulatory agency ACOREP 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, with initial trial preparations already underway to expedite first patient dosing. 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 required by viruses for infection. The oral formulation could offer significant advantages in resource-limited outbreak settings compared with treatments requiring infusion. The World Health Organization reports 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 therapies.
This approval marks a critical step in NanoViricides' development of NV-387, which is also being studied for other viral infections including RSV, COVID-19, influenza, and MPOX. The company's nanoviricide technology, based on intellectual property licensed from TheraCour Pharma, forms the foundation for its antiviral drug candidates. The oral gummy formulation of NV-387 is particularly noteworthy as it could simplify administration in field conditions, potentially improving patient compliance and easing the burden on healthcare infrastructure during outbreaks.
The trial's initiation aligns with NanoViricides' strategic focus on advancing NV-387 into Phase II human clinical trials. The company has previously highlighted the broad-spectrum nature of NV-387, which targets host-side features common to multiple viruses, making it a versatile candidate for emerging viral threats. The DRC outbreak has been particularly challenging due to the remote and resource-constrained settings where cases have occurred, and an oral treatment could be transformative.
According to the company, the regulatory approval from ACOREP is a significant milestone, and the presence of trial materials in the DRC positions the study for rapid enrollment. Om Sai Clinical Research, with its experience in conducting clinical trials in the region, will oversee trial operations. NanoViricides' management expressed optimism about the potential of NV-387 to address the current outbreak, while also acknowledging the rigorous requirements of clinical development.
The development of NV-387 has been supported by the company's extensive preclinical research, which has demonstrated antiviral activity against Ebola and other pathogens in laboratory models. The move to clinical trials in an outbreak setting is a pragmatic approach, potentially providing real-world efficacy data under emergency conditions. This trial could also inform future regulatory strategies for NV-387 in other indications.
NanoViricides continues to expand its antiviral pipeline, with programs targeting HIV, hepatitis, herpes, influenza, and other viruses. The company's partnership with TheraCour provides access to proprietary nanomedicine technology, enabling the design of novel drug candidates. As the trial progresses, stakeholders will be watching for safety and efficacy signals that could support broader use of NV-387 in Ebola and other viral infections.
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