NanoViricides, Inc. began a Phase II clinical trial on September 23, 2026, for NV-387, an oral gummy treatment targeting the Bundibugyo Ebolavirus and other strains in the Democratic Republic of Congo (DRC). The trial, registered in the Pan African Clinical Trials Registry (PACTR202608748555077), seeks to establish a safe dosing protocol and evaluate efficacy in a region facing high mortality rates from the rapidly spreading Bundibugyo variant.
NV-387 Trial Design and Dosing Protocol in Ituri Province
The clinical trial launched at an Ebola Treatment Center in the DRC’s Ituri province under the leadership of principal investigator Prof. Patrick de Marie Chimusa Katoto. The study uses an adaptive, two-tier framework to determine how the drug performs in patients.
The first stage, Phase IIA, is a single-arm safety and dose run-in. This phase focuses on identifying the maximum feasible dose that patients can tolerate while maintaining the highest possible impact on the virus. Once this dosing protocol is established, the trial moves into Phase IIB, which consists of a randomized, controlled, open-label efficacy evaluation. This second stage uses independent blinded-endpoint adjudication to determine if the treatment improves patient survival compared to standard care.
Anil R. Diwan, PhD, President of NanoViricides, stated that the goal of the trial is to maximize patient survival and develop a scalable defense against current and future viral threats.
Oral Administration vs. Intravenous Infusion Logistics
NV-387 differs from existing Ebola therapies primarily through its delivery method. While current standard treatments rely on intravenous (IV) infusions, NV-387 is administered as an oral gummy. This shift in delivery addresses several operational hurdles in the DRC:
- Scalability: Oral gummies can be distributed more easily in remote or resource-limited environments where IV infrastructure is unavailable.
- Healthcare Worker Safety: By removing the need for needles and continuous fluid infusions, the treatment reduces the risk of accidental needlestick injuries and exposure to infectious blood for frontline staff.
- Patient Comfort: The gummy format simplifies administration compared to the invasive nature of IV lines.
Comparison of Ebola Treatment Candidates in the DRC
The NV-387 trial runs alongside other therapeutic evaluations in the region, such as the “PARTNERS” trial launched on July 2, 2026. The PARTNERS trial evaluates approximately 300 patients across four cohorts using monoclonal antibody cocktail MBP134, the antiviral Remdesivir, a combination of both, or local standard care.
| Treatment Candidate | Delivery Method | Primary Trial Focus | Operational Constraints |
|---|---|---|---|
| NV-387 | Oral (Gummy) | Safety, Tolerability, and Efficacy | Scalable distribution; minimal sharps risk |
| Remdesivir & MBP134 | Intravenous Infusion | Efficacy & Combination Therapy | Requires IV infrastructure and sharps management |
Progression of Bundibugyo Ebolavirus Pathophysiology
The urgency of the NV-387 trial is driven by the clinical progression of the Bundibugyo strain, which typically moves through three distinct stages:
- Dry Stage: Initial symptoms include fever, fatigue, and general aches, which often mimic other common infections.
- Wet Stage: The disease progresses to severe diarrhea and explosive vomiting.
- Critical Stage: Patients may experience unexplained bleeding and require intensive care, often resulting in a high fatality rate.
NV-387 Availability and Regulatory Status
NV-387 is currently an investigational drug under Phase II clinical evaluation. It is not available for general public distribution or self-administration. The trial is being conducted to determine if the drug is a viable, scalable alternative to resource-intensive intravenous interventions during large-scale outbreaks.
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