A clinical trial for an oral drug targeting the Bundibugyo Ebolavirus has been successfully registered in the Pan African Clinical Trials Registry as the outbreak in the Democratic Republic of Congo accelerates. According to NanoViricides, Inc., the Phase II trial will test NV-387 Oral Gummies combined with supportive care in adult patients, marking a crucial step forward as health authorities track record case numbers and rising fatality rates.
Clinical Trial Registration and Regulatory Approval
The Phase II trial holds the unique identification number PACTR202608748555077, according to the Pan African Clinical Trials Registry database. NanoViricides, Inc., the drug sponsor, received regulatory approval from the local agency ACOREP in the Democratic Republic of Congo to launch the study. Professor Patrick de Marie Chimusa Katoto serves as the principal investigator leading the multi-center evaluation.
The trial uses an adaptive design consisting of a single-arm safety and dose run-in designated as Phase IIA. This phase precedes a randomized, controlled, open-label efficacy evaluation featuring independent blinded-endpoint adjudication, known as Phase IIB. The drug product arrived at the clinical trial site in Ituru province, positioning investigators to administer the first doses within one to two weeks, barring operational hurdles driven by the outbreak itself.
“We now eagerly await the first dosing of Ebola patients with our NV-387 Oral Gummies drug product that is already available in the clinical trial site,” said Anil R. Diwan, PhD, President of NanoViricides, Inc., noting that the company hopes the broad-spectrum antiviral can combat a virus that currently lacks approved treatments or vaccines.
Outbreak Scale and Epidemiological Tracking
The current Ebola Virus Disease outbreak driven by the Bundibugyo ebolavirus represents the largest and fastest-growing occurrence of the disease in the Democratic Republic of Congo. Data from the Centers for Disease Control and Prevention cited by NanoViricides indicate that confirmed cases reached 6,604 with 3,175 deaths as of September 5, 2026. These figures show a sharp escalation from August 14, 2026, when authorities logged 4,945 confirmed cases and 2,325 deaths.
Calculated mortality has shifted alongside the case growth. The crude fatality rate rose to 48%, up from 46% recorded in mid-August. The current outbreak is on track to exceed the worst ever ebola zaire outbreak in West Africa of 2014 through 2016, which recorded 28,616 cases and 11,310 deaths across Guinea, Liberia, and Sierra Leone according to World Health Organization figures.
Vulnerable Populations and Public Health Measures
Schools in affected regions across the Democratic Republic of Congo have reopened despite ongoing transmission risks, as remote learning remains difficult to deploy in resource-limited settings. Public health strategies rely on frequent hand washing and hand sanitizers to maintain in-class attendance. These precautions carry heightened urgency because the case fatality rate among children reaches 60%.