NanoViricides to Begin Phase II MPox Clinical Trial in Democratic Republic of Congo

NanoViricides, Inc. announced that a Phase II clinical trial of its antiviral candidate NV-387 for the treatment of MPox is expected to begin soon in the Democratic Republic of Congo. Site preparation and staff training are scheduled for early April 2026 for the study, which has already received approval from the DRC regulatory agency. The trial will evaluate the safety and effectiveness of NV-387 against Clade I MPox as the company advances regulatory development and seeks Orphan Drug Designation from the U.S. Food and Drug Administration.

The company’s novel nanoviricide technology is based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc., with which NanoViricides has a Memorandum of Understanding for the development of drugs based on these technologies for all antiviral infections. The company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms for the treatment of numerous viral diseases, and the company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if initial research is successful.

NV-387 represents the company’s lead drug candidate, a broad-spectrum antiviral drug that NanoViricides plans to develop as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. The company’s other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The company is currently focused on advancing NV-387 into Phase II human clinical trials. Additional information about the company’s technology and approach is available through their corporate website at https://www.nanoviricides.com.

The company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently, with NV-CoV-2 being their nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir, and NV-CoV-2-R being their other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The company believes that since remdesivir is already US FDA approved, their drug candidate encapsulating remdesivir is likely to be an approvable drug if safety is comparable.

NanoViricides is also developing drugs against a number of other viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. The company’s platform technology and programs are based on the TheraCour nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. As with any drug development efforts by any company, there can be no assurance at this time that any of the company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development, and the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital.

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