NanoViricides Advances Broad-Spectrum Antiviral NV-387 Toward Phase II Mpox Trial

NanoViricides is preparing to advance NV-387 into a Phase II clinical trial for Monkeypox (MPox) in the Democratic Republic of Congo. The company has completed the full clinical trial application required to initiate the study and secured import permissions for the drug into the DRC.

The trial has received regulatory approval from ACOREP, subject to completion of certain requirements, most of which have been met. NanoViricides is now finalizing clinical site readiness and related documentation. The next stage involves evaluating and approving clinical sites, training them, and then starting dosing.

The Phase 2 study is fully funded. The company raised approximately $5.5 million in a registered direct offering and private placement in November 2025, along with a $0.68 million ATM offering in October-November 2025. The company maintains a quarterly spend of about $1.8 million and also has access to a $3 million line of credit from its founder.

Although the WHO's global Public Health Emergency declaration has been lifted, Mpox continues to spread in parts of Africa. Cases continue to increase and disperse despite vaccine deployment, supporting the rationale for continued development. The emergency declaration in the African region persists because monkeypox is not going away.

NV-387 is described as an extremely broad spectrum antiviral drug. Preclinical studies cited by the company indicate that NV-387 has activity against a range of viruses, including RSV, Influenza A (H3N2), MPox, Smallpox, and Measles. In animal models, NV-387 demonstrated efficacy that was superior to existing treatments for certain viral infections and may reduce the risk of viral resistance by targeting conserved viral attachment receptors.

The company has filed for Orphan Drug Designation with the US Food and Drug Administration for NV-387 in Measles, MPox, and Smallpox. These designation applications are typically handled in three to four months. If designated, there are significant benefits: R&D tax credits, fee reductions or waivers, and seven-year marketing exclusivity. Clinical trials are usually smaller and shorter for orphan indications, and there is a possibility of accelerated approval after Phase 2, with confirmatory work continuing afterward.

Measles cases are rising in the US, with more than 25 states affected. When a measles case occurs, large groups must quarantine. If an approved drug were available, prophylactic doses could potentially reduce spread.

As of December 31, 2025, NanoViricides reported cash and cash equivalents of approximately $5.29 million and total assets of $12.27 million, with current liabilities of $1.20 million. During the six months ended December 31, 2025, the company used roughly $4 million in cash, including R&D expenditures in preparation for Phase II trials. NanoViricides stated that current funding is sufficient to complete the planned Phase II MPox trial, while additional financing would be needed for broader development programs.