NanoViricides, Inc. finished manufacturing its lead clinical‑stage candidate, NV‑387 Oral Gummies, in its own cGMP‑compliant facility in Shelton, Connecticut, and announced the completion on March 11 2026. The manufacturing milestone removes a major operational bottleneck and positions the company to begin dosing patients in the upcoming Phase II mpox trial that has received regulatory clearance from the Democratic Republic of Congo’s ACOREP agency, which was granted on November 10 2025.
NV‑387 is designed to trap viruses by mimicking host cell surface receptors, a mechanism that is expected to be resistant to viral escape. The oral formulation is intended for use against mpox and, in preclinical studies, has shown activity against smallpox and measles. Successful Phase II data could open pathways for government stockpiling contracts and broaden the drug’s regulatory reach to other viral indications.
Financially, NanoViricides reported a net loss of $4.0 million for the six months ended December 31 2025, compared with a $5.2 million loss in the prior year, and a cash balance of $5.2 million as of that date. The company has raised approximately $6 million in a direct offering in November 2025 to fund ongoing clinical development, underscoring the need for continued capital to support the Phase II trial and future studies.
The Phase II mpox trial will be conducted in the Democratic Republic of Congo, with patient enrollment and dosing expected to commence as soon as trial sites are prepared. The manufacturing completion therefore accelerates the timeline for generating efficacy data that could unlock government stockpiling contracts and support the company’s broader antiviral platform.
Dr. Anil R. Diwan, President and Executive Chairman, said, “NV‑387, as an effective drug would be an important tool to fight MPox in the USA and worldwide, when approved after clinical trials.” The statement highlights the company’s confidence in the clinical potential of NV‑387 and its strategic focus on expanding the drug’s indications beyond mpox.
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