NanoViricides has secured regulatory approval from ACOREP in the Democratic Republic of Congo to launch a Phase II clinical trial for NV-387 oral gummies targeting the Bundibugyo ebolavirus, according to a company announcement on August 10, 2026. The trial arrives as the country confronts its largest-ever Ebola outbreak, driven by the BDBV strain, with thousands of confirmed cases and fatalities reported by the World Health Organization.
Regulatory Approval and Trial Design in the Democratic Republic of Congo
The local regulatory agency ACOREP granted authorization for the Phase II evaluation of NV-387 oral gummies following an application submitted by the trial’s principal investigator, according to NanoViricides, Inc. To execute the study, NanoViricides retained Om Sai Clinical Research Private Limited based in India. Om Sai CRO assembled a local team alongside experts and university support within the affected region to prepare for patient dosing.
The trial structure contrasts with traditional intravenous antibody evaluations. According to company statements, the PARTNERS clinical trial format requires treating over 1,000 patients with timelines exceeding a year. By contrast, the Om Sai CRO-designed Phase II protocol focuses on rapid evaluation of an orally administered candidate suited for resource-limited epidemic settings.
Outbreak Severity and Public Health Context
The current Ebola Virus Disease epidemic involving the Bundibugyo ebolavirus has reached 4,141 confirmed cases and 1,889 confirmed deaths, resulting in a crude fatality rate of 46%, according to World Health Organization figures cited on August 6, 2026. Only 829 patients have recovered. Transmission rates accelerated during the most recent complete reporting week, yielding 567 new cases and 296 deaths.
According to United Nations News Service reports, the virus spans at least five provinces in the Democratic Republic of Congo. More than 80% of new infections occur outside tracked contact lists, suggesting the true scale of transmission is at least double official tallies. The pathogen has also reached displacement camps holding over 4.4 million individuals displaced by internal conflict, creating high-risk conditions marked by compromised sanitation and limited medical infrastructure.
Therapeutic Landscape and Oral Antiviral Advantages
Existing antibody treatments deployed during prior West Africa outbreaks specifically target the Zaire ebolavirus and require intravenous infusions. Company leadership notes that infusions pose logistical hurdles and limited scalability during widespread outbreaks.
According to NanoViricides President Anil R. Diwan, NV-387 serves as an orally active broad-spectrum antiviral candidate positioned for deployment in regions where infusion infrastructure is constrained. Preparatory steps by the DRC clinical team aim to accelerate the administration of the first doses to patients as the outbreak continues to spread.
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