An adaptive Phase II clinical trial assessing NanoViricides’ NV-387 oral gummies for treating Bundibugyo ebolavirus and other orthoebolaviruses in the Democratic Republic of Congo has been registered in the Pan African Clinical Trials Registry under identification number PACTR202608748555077. The trial evaluates the broad-spectrum antiviral drug combined with optimized supportive care for adult patients.
Clinical Trial Design and Regulatory Approval
The study operates under a descriptive title: “An adaptive, multi-centre Phase IIA/IIB clinical trial of NV-387 oral gummies plus optimised supportive care in adults with Ebola virus disease (Bundibugyo or other orthoebolaviruses): a single-arm safety and dose run-in (Phase IIA) followed by a randomised, controlled, open-label efficacy evaluation with independent blinded-endpoint adjudication (Phase IIB).” Professor Patrick de Marie Chimusa Katoto serves as the principal investigator leading the evaluation. NanoViricides secured regulatory clearance for the study from the local regulatory agency ACOREP in the Democratic Republic of Congo. Drug shipments arrived at the clinical trial site located in Ituru province, setting the stage for patient dosing.
Outbreak Scope and Fatality Statistics
The current outbreak of Ebola Virus Disease caused by the Bundibugyo ebolavirus represents the largest and fastest-growing ebola outbreak recorded in the Democratic Republic of Congo, according to data from the Centers for Disease Control and Prevention. Confirmed cases reached 6,604 with 3,175 deaths in the country as of September 5, 2026, pushing the crude fatality rate to 48%. These figures show an increase from mid-August totals of 4,945 confirmed cases and 2,325 deaths, when the crude fatality rate stood at 46%. The current trajectory places the outbreak on a path to exceed the 2014–2016 West Africa Ebola Zaire outbreak, which recorded 28,616 cases and 11,310 deaths across Guinea, Liberia, and Sierra Leone according to World Health Organization figures.
Treatment Outlook and Timelines
First patient dosing with the NV-387 oral gummies is anticipated within one to two weeks, subject to operational conditions at the trial site in Ituru province, according to NanoViricides President Anil R. Diwan. Diwan noted that the broad-spectrum antiviral aims to combat the Bundibugyo virus strain, which currently lacks any known treatment or vaccine. Public health measures in affected regions continue alongside the trial preparations, with schools remaining open under hygiene protocols despite pediatric case fatality rates reaching 60%, surpassing the sub-50% rate observed in adults.
