NanoViricides Has Received Approval to Start Phase II Clinical Trial of NV-387 for the Treatment of MPox by the Regulatory Agency ACOREP of the Democratic Republic of Congo
December 9, 2025
The Democratic Republic of the Congo’s approval for NanoViricides to begin its Phase II clinical trial of NV-387 marks a key step in advancing a potential antiviral for mpox. With no proven effective treatments and recent failures of tecovirimat and brincidofovir, NV-387 offers a novel host-mimetic approach that targets viral binding to human cell receptors rather than viral proteins, reducing the likelihood of resistance. The drug’s broad-spectrum design, proven animal efficacy, and oral formulation make it promising for outbreak-prone regions like Central Africa. If successful, NV-387 could redefine antiviral therapy and strengthen pandemic preparedness against orthopoxvirus threats.
The Democratic Republic of the Congo’s regulatory agency, ACOREP, has authorized NanoViricides to proceed with a Phase II clinical trial of NV-387 for mpox, signaling important progress toward an antiviral option for a disease with no effective treatments. The milestone follows prior ethics clearance from DRC’s CNES committee and paves the way for patient recruitment once documentation in English and French is finalized.
NV-387 represents an innovative host-mimetic nanomedicine platform that differs from conventional antivirals. Rather than targeting viral enzymes or proteins that can mutate, NV-387 mimics human cell receptors known as heparan sulfate proteoglycans, which most pathogenic viruses use to attach and infect cells. This approach could prevent viral escape and make NV-387 effective against a wide range of pathogens, including orthopoxviruses, coronaviruses, RSV, influenza, and measles.
Preclinical studies have shown NV-387 significantly improved survival rates in animal models of influenza, measles, and RSV, achieving results comparable or superior to current standard treatments such as tecovirimat and remdesivir. The drug’s oral gummy formulation is also advantageous for mpox patients with painful oral lesions that make swallowing difficult.
Tecovirimat and brincidofovir, both approved under the FDA’s Animal Rule for smallpox, have failed to show clinical efficacy against mpox in human studies. NV-387’s entry into Phase II trials therefore comes at a pivotal time, as the WHO and Africa CDC continue to classify mpox as a public health emergency across Central and East Africa.
If NV-387 proves effective in human trials, it could become the first antiviral therapy for mpox and potentially reshape antiviral preparedness for multiple viral families. The DRC trial could also serve as a model for regional drug development, supporting Africa’s capacity to respond to future epidemics with innovative, broadly protective therapeutics.