NanoViricides Has Signed a Master Services Agreement with OnlyOrphansCote Regarding Orphan Drug Strategy of NV-387 for Treatment of MPox, Smallpox, and Measles
December 1, 2025
NanoViricides’ new partnership with regulatory expert Dr. Timothy Cote and Only Orphans Cote marks a pivotal step in advancing NV-387, its broad-spectrum antiviral, toward orphan drug designation. By targeting rare and high-consequence diseases such as smallpox, mpox, and measles, the company is aligning scientific innovation with a strategic regulatory pathway that could secure market exclusivity and tax benefits. NV-387’s unique mechanism, which mimics host cell receptors to block viral entry, could make it a cornerstone of future pandemic preparedness. If efficacy is confirmed in human trials, NV-387 may redefine how the world approaches broad-spectrum antiviral defense.
NanoViricides’ announcement of a partnership with Dr. Timothy Cote, former director of the FDA Office of Orphan Products Development, underscores a strategic push to advance NV-387, its lead broad-spectrum antiviral candidate, through orphan drug pathways. The agreement with Only Orphans Cote, LLC, is aimed at positioning NV-387 for multiple orphan drug designations, including mpox, smallpox, and measles. Each of these diseases qualifies as an orphan indication in the United States and carries regulatory incentives such as tax credits, fee exemptions, and seven years of market exclusivity.
NV-387 has demonstrated antiviral activity in lethal animal models of orthopoxvirus infection, supporting its potential for smallpox and mpox treatment. Remarkably, the compound has also shown in vivo efficacy against measles in humanized animal models, suggesting it could serve as a much-needed therapeutic for resurgent outbreaks. As measles cases climb across North America, with nearly 1,800 U.S. cases reported in 2025, the urgency for effective antivirals is growing.
Beyond its immediate clinical promise, NV-387’s mechanism sets it apart. The drug is designed to mimic heparan sulfate proteoglycans (HSPG), the host cell molecules that many viruses use to gain entry. By acting as a decoy, NV-387 prevents infection while maintaining broad-spectrum efficacy across multiple viral families, including RSV, influenza, COVID-19, and orthopoxviruses. This host-mimetic approach could overcome one of modern medicine’s greatest challenges: viral mutation and resistance.
Dr. Cote’s involvement adds regulatory credibility and a roadmap for accelerating FDA submissions. If successful, NV-387 could emerge as a cornerstone of next-generation pandemic preparedness—an affordable, adaptable antiviral platform with applications far beyond a single pathogen. In an era where viral evolution is outpacing traditional countermeasures, NanoViricides’ host-targeted innovation offers a compelling vision for the future of global biosecurity.