NanoViricides, Inc. (NYSE American: NNVC) has announced that a Phase II clinical trial of its antiviral candidate NV-387 for the treatment of MPox is expected to commence soon in the Democratic Republic of Congo. Site preparation and staff training are scheduled for early April 2026, following approval from the DRC regulatory agency. The study will evaluate the safety and effectiveness of NV-387 against Clade I MPox, as the company advances regulatory development and seeks Orphan Drug Designation from the U.S. FDA.
This trial marks a critical step for NanoViricides as it addresses the urgent need for effective treatments against MPox, particularly the more severe Clade I strain prevalent in Central Africa. The World Health Organization has declared MPox a public health emergency of international concern, and current treatment options are limited. NV-387, a broad-spectrum antiviral drug, has shown promise in preclinical studies and is also being developed for respiratory viral infections such as RSV, COVID-19, and influenza.
The Phase II trial will be a pivotal moment for the company, which has faced a lengthy and capital-intensive drug development path. “The start of this trial is a significant milestone for NanoViricides,” the company stated in the press release. “We are committed to advancing NV-387 as a potential treatment for MPox, a disease that continues to pose a global health threat.”
NanoViricides’ platform technology, based on TheraCour nanomedicine, involves creating special purpose nanomaterials designed to attack viruses. The company holds exclusive licenses for several antiviral applications, including HIV, hepatitis, and influenza. NV-387 is the lead candidate in its pipeline, and the company is also developing NV-CoV-2 and NV-CoV-2-R for COVID-19.
The DRC trial will focus on Clade I MPox, which is associated with higher morbidity and mortality compared to the Clade II strain that caused the 2022 global outbreak. If successful, NV-387 could fill a critical gap in the antiviral arsenal against poxviruses. The company is also seeking Orphan Drug Designation from the FDA, which would provide incentives for development and potential market exclusivity.
Investors can follow the latest updates on NanoViricides in the company’s newsroom at https://ibn.fm/NNVC. The full press release detailing the trial announcement is available at https://ibn.fm/4Ckhk.
