NanoViricides, Inc. (NYSE American: NNVC) announced in its quarterly report filed for the period ended March 31, 2026, that it is advancing its broad-spectrum antiviral candidate NV-387 toward Phase II clinical development for MPox in the Democratic Republic of Congo, where regulatory approval for the trial has already been obtained. The company also detailed progress in its orphan-first regulatory strategy, including FDA orphan drug designation for measles granted after the quarter, with additional applications targeting MPox and smallpox pending.
The development marks a significant step for NanoViricides as it seeks to address multiple viral diseases with a single platform. NV-387 is designed as a broad-spectrum antiviral drug candidate, with potential applications against respiratory infections such as RSV, COVID-19, influenza, as well as orthopoxviruses including MPox and smallpox, and even measles. The company’s strategy focuses on obtaining orphan drug designations to expedite development and market exclusivity for rare diseases.
According to the filing, the company is now concentrating resources on moving NV-387 into Phase II human clinical trials. The MPox trial in the DRC is a key component of this effort, given the ongoing outbreaks in the region. The company has not provided a specific timeline for filing an Investigational New Drug (IND) application, citing dependence on external collaborators and consultants.
Beyond MPox, NanoViricides is pursuing a pipeline of drug candidates based on its nanoviricide technology. Its other advanced candidate, NV-HHV-1, targets shingles. The company also has two COVID-19 candidates: NV-CoV-2 (API NV-387) and NV-CoV-2-R, which encapsulates remdesivir. The company believes that NV-CoV-2-R could be an approvable drug given remdesivir’s existing FDA approval, pending comparable safety results.
The platform technology underlying these candidates is licensed from TheraCour Pharma, Inc., under a memorandum of understanding that covers antiviral infections but excludes cancer. NanoViricides holds exclusive, sub-licensable field licenses for several viral diseases, including HIV, hepatitis B and C, rabies, herpes simplex, influenza, dengue, and coronaviruses. The company intends to expand its license to cover RSV, poxviruses, and enteroviruses if initial research proves successful.
As with all drug development, NanoViricides cautioned that the path to commercialization is lengthy and capital-intensive. The company noted that there is no assurance that any of its candidates will demonstrate sufficient safety and efficacy in clinical trials or ultimately become approved products.
For more information on NanoViricides and its latest updates, visit the company’s newsroom at https://ibn.fm/NNVC. The full press release is available at https://ibn.fm/osO0q.
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