NanoViricides Files Orphan Drug Designation for Measles Treatment

Potential incentives include tax credits, user fee exemptions, and market exclusivity if approved

Published on Feb. 10, 2026

NanoViricides, Inc., a clinical-stage biotech company, has filed an application for Orphan Drug Designation (ODD) with the US FDA for its drug candidate NV-387 as a treatment for measles. If approved, ODD would provide the company with various incentives to support the regulatory development and approval of NV-387 as a much-needed treatment option for the growing measles outbreaks worldwide.

Why it matters

Measles cases have been rising globally, including in the US, with over 2,200 confirmed cases and 3 deaths in 2025. Vaccination rates have declined due to hesitancy, making an effective treatment crucial to combat the spread of this highly contagious disease and avoid severe complications like encephalitis and fatalities. NV-387 is the only known drug candidate that has demonstrated strong efficacy against lethal measles infection in animal studies, making it a potentially important tool to address the measles resurgence.

The details

NanoViricides filed the ODD application with the help of regulatory consultant Dr. Timothy Cote, former director of the FDA's Office of Orphan Products Development. If approved, ODD would provide the company with incentives like tax credits, user fee exemptions, and potential 7 years of market exclusivity after approval. NV-387 has shown promise as a broad-spectrum antiviral effective against various viruses including RSV, COVID, influenza, and monkeypox in addition to measles.

  • Measles cases in the US reached 2,251 confirmed with 3 deaths in 2025, up from 285 in 2024 and 59 in 2023.
  • As of February 5, 2026, 727 confirmed measles cases have already been reported in the US this year.

The players

NanoViricides, Inc.

A publicly traded, clinical-stage biotech company developing broad-spectrum antiviral drugs based on its proprietary nanomedicine technology.

Dr. Anil R. Diwan

President and Executive Chairman of NanoViricides, who stated that NV-387 would be an important tool to fight the measles resurgence if approved.

Dr. Timothy Cote

A regulatory consultant who previously served as the Director of the FDA's Office of Orphan Products Development and assisted NanoViricides in developing the ODD application.

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What they’re saying

“NV-387, as an effective drug would be an important tool to fight Measles resurgence in the USA and worldwide, when approved.”

— Anil R. Diwan, PhD, President and Executive Chairman, NanoViricides

What’s next

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