NanoViricides antiviral drug NV-387 wins FDA Orphan Drug Designation for measles treatment
Published: 09:00 04 May 2026 EDT
NanoViricides (NYSE-A:NNVC) said on Monday its broad-spectrum antiviral drug NV-387 has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration, a regulatory milestone the company said could help accelerate the drug's path to approval as a measles treatment.
The designation, granted by the FDA's Office of Orphan Products Development, makes NanoViricides eligible for tax credits on qualified clinical trials, exemption from certain user fees, and up to seven years of market exclusivity following approval.
"The Orphan Drug Designation is an important milestone that will help us speed up the regulatory development of NV-387 for the treatment of measles," said Anil Diwan, president of NanoViricides. "NV-387, as an effective drug would be an important tool to fight measles resurgence in the USA and worldwide, when approved."
NV-387 is the only drug candidate, to the company's knowledge, to have demonstrated strong in vivo activity against lethal measles infection in a humanized animal model study.
The company has also applied to the FDA for a Rare Pediatric Disease Drug designation for NV-387. If granted, it would make NanoViricides eligible for a Priority Review Voucher, which can significantly shorten FDA review time for a new drug application. Such vouchers are tradable and have historically fetched between $150 million and $200 million.
NanoViricides engaged regulatory consultant Only Orphans Cote, led by former director of the FDA's Office of Orphan Products Development, Dr Timothy Cote, to prepare both applications.
Beyond measles, NV-387 has shown effectiveness in animal models of RSV, COVID-19, influenza, mpox, and smallpox.
