SHELTON, CONNECTICUT — November 10, 2025 — Leads & Copy — NanoViricides, Inc. (NYSE American:NNVC) announced it has received approval from the Regulatory Agency ACOREP of the Democratic Republic of Congo (DRC) to begin Phase II clinical trials of its drug NV-387 for the treatment of MPox.
The proposed Phase II clinical trial aims to evaluate the safety and effectiveness of NV-387 in treating patients with MPox disease caused by the hMPXV infection. The trial is now cleared to proceed, pending the filing of specific documents.
Dr. Anil R. Diwan, President and Executive Chairman of NanoViricides, Inc., stated that the approval is an important milestone in the regulatory development of NV-387.
Currently, there is no approved drug available for the treatment of hMPXV infection, which causes MPox. A clinical trial of tecovirimat (TPOXX®, SIGA) reportedly failed to demonstrate any effectiveness over placebo, according to a NIH press release on August 15, 2024. Another drug, brincidofovir (TEMBEXA ®, EBS) entered a clinical trial called “MOSA” in January 2025, with early results expected by the end of the quarter, but the status of this clinical trial is currently unknown.
MPox Clade II has become endemic in the USA, primarily affecting a limited population of men-having-sex-with-men (MSM) due to transmission during sexual activity. According to the CDC, recent reports indicate three new cases of MPox Clade I have been found in California in unconnected persons, suggesting that community spread of the MPXV Clade I is likely already occurring. (https://www.aha.org/news/headline/2025-10-29-cdc-says-3-cases-severe-mpox-california-may-be-linked-august-case)
According to Dr. Diwan, NV-387 is a broad-spectrum antiviral drug that is designed to mimic human cells to trap and destroy the virus, targeting over 90-95% of human pathogenic viruses. He stated that the drug’s biomimicry is reminiscent of the antibiotic penicillin, which targets a large number of human pathogenic bacteria.
In May 2025, NanoViricides previously announced it had received approval from the Ethics Committee CNES of the national regulatory agency in DRC, indicating that NV-387 could be considered for a Phase II clinical trial for MPox treatment. That approval was based on a summary of information regarding NV-387 regulatory development. The Ethics Committee approval cleared the path for the company to engage with regulatory agency ACOREP and prepare documentation for their evaluation and approval.
NanoViricides has completed submission of required documentation in draft form and is now compiling the documentation into the final Clinical Trial Application, along with certifications and disclosures. These documents will be translated into French, as required by the DRC, and both the French and English sets of documents, certified as accurately translated, will be submitted to the ACOREP regulatory agency. Patient recruitment will then begin.
MPox disease, caused by the human MPox virus (hMPXV), has been causing a regional pandemic in several countries in the WHO African Region, including the Democratic Republic of Congo (DRC) and Uganda. The WHO declared a Public Health Emergency of International Concern (PHEIC) on August 14, 2024, which was closed in September 2025. The Africa CDC has maintained the status of the MPox pandemic as a Public Health Emergency of Continental Security (PHECS).
In animal model testing, NV-387 has been found to be effective in increasing survival in lethal models of influenza and coronavirus infection, surpassing existing drugs Tamiflu®, Rapivab®, Xofluza®, and remdesivir by a large margin. NV-387 also led to a complete cure of lethal RSV lung infection in an animal model study. Additionally, NV-387 possesses antiviral activity against an orthopoxvirus in an animal model, matching the effectiveness of tecovirimat in models of direct skin and lung infection.
NanoViricides notes that viruses can escape from tecovirimat, vaccines, and antibodies through small changes, but escape from NV-387 is highly unlikely because NV-387 mimics the sulfated proteoglycan signature that the viruses require for cell infection.
NanoViricides, Inc. is a clinical stage company creating special purpose nanomaterials for antiviral therapy. The company’s nanoviricide™ technology is based on intellectual property of TheraCour Pharma, Inc., with NanoViricides holding broad, exclusive, sub-licensable, field licenses to drugs developed from this technology. NanoViricides’ lead drug candidate is NV-387, which the company plans to develop as a treatment for RSV, COVID, Long COVID, Influenza, and MPOX/Smallpox infections. The other advanced drug candidate is NV-HHV-1 for the treatment of Shingles.
The company is also developing drugs against other viral diseases, including oral and genital Herpes, viral diseases of the eye, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of human viral diseases.
NanoViricides’ drug candidates for COVID-19 include NV-CoV-2 (API NV-387) and NV-CoV-2-R, which encapsulates remdesivir within its polymeric micelles. The company believes that because remdesivir is already US FDA approved, its drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable.
NanoViricides cannot project an exact date for filing an IND for any of its drugs due to dependence on external collaborators and consultants. The company is focused on advancing NV-387 into Phase II human clinical trials.
NanoViricides, Inc. Contact: info@nanoviricides.com
Public Relations Contact: ir@nanoviricides.com
Source: NanoViricides, Inc.
