NanoViricides, Inc. (NYSE American: NNVC) has announced continued advancement of its broad-spectrum antiviral candidate NV-387 toward Phase II clinical development for MPox in the Democratic Republic of Congo, where regulatory approval for the trial has already been obtained. The update came as part of the company's quarterly report for the period ended March 31, 2026, as detailed in a press release.
The company also outlined progress in its orphan-first regulatory strategy, including FDA orphan drug designation for measles granted subsequent to the quarter and additional applications targeting MPox and smallpox. This approach positions NV-387 as a potential treatment across multiple viral diseases, including RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPox, smallpox, and measles.
NV-387 is the lead drug candidate in NanoViricides' pipeline. The company is also developing NV-CoV-2 (API NV-387) for COVID-19, which does not encapsulate remdesivir, and NV-CoV-2-R, which encapsulates remdesivir within its polymeric micelles. The company believes that since remdesivir is already FDA approved, the NV-CoV-2-R candidate is likely to be approvable if safety is comparable. Remdesivir is developed by Gilead.
Beyond these candidates, NanoViricides is developing drugs against a number of viral diseases, including oral and genital Herpes, viral diseases of the eye such as EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus. The company's platform technology is based on the TheraCour nanomedicine technology, licensed from TheraCour Pharma, Inc.
The implications of this news are significant for the pharmaceutical industry and global public health. A successful broad-spectrum antiviral like NV-387 could address unmet medical needs in regions like the Democratic Republic of Congo, where MPox outbreaks have occurred. The orphan drug designations provide incentives for development, potentially accelerating availability of treatments for rare diseases. The company's progress also underscores the potential of nanomedicine approaches in antiviral therapy.
NanoViricides holds a worldwide exclusive perpetual license to the TheraCour technology for several drugs with specific targeting mechanisms for human viral diseases, including HIV/AIDS, Hepatitis B and C, Rabies, Herpes Simplex Virus, Varicella-Zoster Virus, Influenza, Dengue viruses, Japanese Encephalitis, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The company intends to obtain licenses for RSV, Poxviruses, and/or Enteroviruses if initial research is successful.
As with any drug development, the path to typical pharmaceutical product development is extremely lengthy and requires substantial capital. There can be no assurance that any of the company's pharmaceutical candidates will show sufficient effectiveness and safety for human clinical development or lead to a successful product.
For more information, visit the company's newsroom at https://ibn.fm/NNVC. The full press release is available at https://ibn.fm/osO0q.
