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Phase II Clinical Trial of Monkeypox Treatment by NV-387 to Commence Soon, Announces NanoViricides

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  • NanoViricides, Inc. announced that a Phase II clinical trial for its MPox treatment candidate NV-387 is expected to begin soon in the Democratic Republic of Congo (DRC).
  • The regulatory approval for this trial was granted by ACOREP, the regulatory agency of the DRC.
  • Clinical research organization Om Sai Clinical Research Pvt. Ltd. in India is preparing the trial site, with personnel scheduled to visit for final preparations & staff training in the first week of April 2026.
  • Patient enrollment & dosing are expected to commence after the completion of staff training.
  • The Phase II trial will evaluate the safety & effectiveness of NV-387 specifically against MPox Clade I, which is endemic in the DRC.
  • NanoViricides has applied to the US FDA for Orphan Drug Designation (ODD) for NV-387, which could provide benefits including fee waivers, R&D credits, & marketing exclusivity if granted.
  • No approved drugs currently exist for treating hMPXV infection, & existing US Strategic National Stockpile drugs TPOXX & TEMBEXA are considered unsuitable for pandemic response against Clade I due to efficacy issues or severe toxicity.
  • As of March 23, 2026, the CDC reported 15 MPox Clade I cases in the USA, including 3 cases in California with no travel history to Africa.
  • The Jynneos vaccine shows limited effectiveness (36% for one dose, 66% for two doses) against Clade II & is likely less effective against the more severe Clade I.
  • NV-387 is a host-mimetic drug designed to bind to viral attachment receptors (sulfated proteoglycans), making viral escape via mutation highly unlikely compared to other antivirals.
  • Preclinical animal models demonstrated that NV-387 effectiveness matched that of tecovirimat (TPOXX) against orthopoxviruses.
  • The company plans to develop NV-387 for multiple viral indications including RSV, COVID-19, Influenza, & other respiratory infections.
  • NV-387 is a broad-spectrum antiviral based on TheraCour Pharma technology, with the company holding exclusive worldwide licenses for various viral disease targets.