NanoViricides, Inc. (NNVC) has announced that it will begin a Phase II clinical trial of its antiviral candidate NV‑387 for monkeypox in the Democratic Republic of Congo. The trial will evaluate safety and effectiveness in patients infected with the more severe Clade I strain of the virus, which is endemic in the region.
Site preparations are underway under the direction of contract research organization Om Sai Clinical Research and local partners. CRO personnel are scheduled to visit the trial site in the first week of April for final preparations and staff training, after which patient enrollment and dosing are expected to begin.
The milestone positions NV‑387 as a candidate for pandemic preparedness and could open avenues for regulatory approval and funding from agencies such as BARDA. Anil R. Diwan, President and Executive Chairman, said, “This is an important milestone in regulatory development of NV‑387.” He added, “We are now fully engaged in completing the detailed CTA for the Phase II human clinical trial of NV‑387 for the treatment of MPOX disease (hMPXV infection) for submission to the DRC Regulatory Agency, namely MSP.”
NanoViricides remains a clinical‑stage company with no revenue in fiscal years 2024 and 2025 and a net loss of $9.5 million in fiscal year 2025. Cash reserves of $1.6 million and zero long‑term debt give the company less than a year of runway, underscoring the need for additional capital to support the trial and future development.
The trial comes amid a significant monkeypox outbreak in the DRC, where the Clade I strain has caused thousands of cases and hundreds of deaths. NV‑387 is a broad‑spectrum antiviral that has shown pre‑clinical activity against a range of viruses, including orthopoxviruses. With no FDA‑approved antiviral specifically for monkeypox, the trial could address a critical unmet medical need and position NanoViricides for potential orphan drug designation and BARDA support.
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