NanoViricides Files for Orphan Drug Designation for MPox Treatment

NV-387 drug candidate shows promise as potential treatment for Monkeypox

Published on Feb. 12, 2026

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NanoViricides, Inc., a clinical-stage biotech company, has filed an application for Orphan Drug Designation with the FDA for its drug candidate NV-387 as a treatment for Monkeypox (MPox). If approved, this designation would provide incentives and potential market exclusivity for the development of NV-387 as an MPox therapy. NV-387 has demonstrated strong effectiveness against multiple viruses, including Orthopoxviruses like Monkeypox, in animal models, making it a viable candidate to address the ongoing MPox outbreaks.

Why it matters

The Monkeypox virus has continued to mutate and spread globally, with the more contagious Clade Ia/Ib strain posing a potential pandemic threat. Currently, there are no approved drugs specifically for treating MPox, and existing antivirals like tecovirimat and brincidofovir have shown limited efficacy and the potential for drug resistance. NV-387's broad-spectrum antiviral activity and unique mechanism of action make it a promising option to fill this critical therapeutic gap.

The details

NanoViricides has filed for Orphan Drug Designation with the FDA for its drug candidate NV-387 as a treatment for Monkeypox. If approved, this would provide the company with incentives like tax credits, user fee exemptions, and potential 7 years of market exclusivity. NV-387 has shown strong effectiveness against Orthopoxviruses like Monkeypox in animal models, and has successfully completed a Phase I clinical trial demonstrating safety and tolerability in healthy adults. The company believes NV-387 is a viable candidate to address the ongoing MPox outbreaks, as existing antivirals have struggled with efficacy and resistance issues.

  • In 2022, the WHO declared a 'Public Health Emergency of International Concern' for Monkeypox due to the spread of the MPXV Clade II strain.
  • In August 2024, the WHO declared a new PHEIC for Monkeypox due to the spread of the more contagious MPXV Clade Ia/Ib strain in Africa, ending it in September 2025.
  • The Africa CDC has continued to declare the Monkeypox pandemic in the African region as a Public Health Emergency of Continental Security due to the continued spread of the virus.

The players

NanoViricides, Inc.

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

Anil R. Diwan, PhD

The president and chairman of NanoViricides, who stated that NV-387 would be an important tool to fight Monkeypox if approved.

Only Orphans Cote, LLC

A regulatory consulting firm founded by Dr. Timothy Cote, the former director of the FDA's Office of Orphan Products Development, which assisted NanoViricides in developing the Orphan Drug Designation application for NV-387.

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What they’re saying

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

— Anil R. Diwan, PhD, President and Chairman, NanoViricides, Inc. (Press Release)

What’s next

If the Orphan Drug Designation is approved, NanoViricides plans to advance NV-387 into Phase II human clinical trials as a potential treatment for Monkeypox.

The takeaway

The ongoing Monkeypox outbreaks highlight the urgent need for effective antiviral treatments, as existing options have shown limited efficacy. NanoViricides' NV-387 drug candidate, with its broad-spectrum activity and unique mechanism of action, represents a promising new therapeutic approach to address this public health challenge.