NanoViricides, Inc. secures U.S. Food and Drug Administration orphan drug designation for NV-387 in Measles, supporting development of a potential antiviral where no approved treatment exists.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
NanoViricides, Inc. has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration for its investigational antiviral NV-387 for the treatment of Measles, marking a regulatory milestone for the clinical-stage candidate.
Granted by the FDA’s Office of Orphan Products Development, the designation provides incentives including tax credits for qualified clinical trials, exemption from certain regulatory fees, and potential seven years of market exclusivity upon approval.
NV-387 is a broad-spectrum antiviral based on host-mimetic nanomedicine designed to bind and neutralize viruses. The candidate has demonstrated strong in vivo activity against lethal measles infection in a humanized animal model. Currently, no approved antiviral treatments are available for measles.
According to Anil R. Diwan, Executive Chairman and President of NanoViricides, the designation is expected to support regulatory advancement of NV-387 and could help address the growing burden of measles if the drug is successfully developed.
Recent outbreaks highlight the ongoing public health challenge of measles. Data from the Centers for Disease Control and Prevention show 1,803 confirmed cases in the United States as of April 30, 2026, following 2,251 cases and three deaths in 2025. Reported cases have increased significantly compared with 285 in 2024 and 59 in 2023, with most infections occurring in unvaccinated individuals or those with unknown vaccination status.
Despite rising incidence, measles remains a rare disease under U.S. regulatory criteria, supporting eligibility for orphan designation.
Vaccination remains highly effective for prevention; however, declining coverage and vaccine hesitancy have contributed to renewed outbreaks. Severe cases can lead to complications such as encephalitis, neurological impairment, immune suppression, and death. Current control strategies rely on vaccination and quarantine of exposed individuals, often for at least 14 days.
NanoViricides has also applied for Rare Pediatric Disease Designation (RPDD) for NV-387. If granted, the designation could make the program eligible for a Priority Review Voucher. Regulatory support for the application was provided by Only Orphans Cote, LLC, led by Timothy Cote.
Beyond measles, NV-387 has shown antiviral activity in preclinical models against multiple viruses, including RSV, influenza, COVID-19, mpox, and smallpox.
Reference