NanoViricides, Inc. develops clinical-stage antiviral therapeutics based on its nanoviricide technology and host-mimetic nanomedicine approach. Company news centers on NV-387, its lead broad-spectrum antiviral candidate, including clinical development for MPox, respiratory viral infections, measles and other viral diseases, as well as manufacturing updates for clinical product forms such as NV-387 Oral Gummies.
Recurring updates also cover FDA orphan-drug designation activity, rare-disease regulatory strategy, investor-conference participation and the company’s relationship with TheraCour Pharma for antiviral drug development technology. The news flow is focused on antiviral pipeline progress, regulatory designations and disease-area positioning rather than commercial product sales.
NanoViricides (NNVC) is enrolling patients in its Phase IIA trial of NV-387 Oral Gummies for Ebola Bundibugyo infection in the DRC. The exploratory study includes up to 20 subjects and examines dosing, safety and tolerability across disease severity levels. Treatment starts at six days and can extend in three-day increments to a maximum of 12 days.
The company expects mostly severely ill patients with vomiting and diarrhea; some may be unable to take the gummies and withdrawn as unevaluable. The study excludes a parallel group receiving no NV-387, and statistically significant efficacy evaluation is not expected. NanoViricides says a possible efficacy signal would depend on distinguishing treated patients from local infection-to-fatality observations of 67%–75%. Advancement to a randomized, controlled Phase IIB study depends on sufficient safety and tolerability and identification of an appropriate dosing regimen.
NanoViricides (NNVC) will present at NIBA's 153rd Investment Conference on October 7, 2026, in Fort Lauderdale, Florida.
NanoViricides (NNVC) provided details on its ongoing two-part Phase II trial of NV-387 Oral Gummies for Ebola in the Democratic Republic of Congo.
Phase IIA enrollment began on or about September 23, 2026. The trial is proceeding as designed, with patients enrolled slowly because NV-387 is a new chemical entity. This small-patient phase aims to identify a tolerated dosing regimen in patients with Ebola virus disease, including dose amount, frequency and treatment duration. It is not designed to evaluate efficacy statistically.
Identifying a dosing regimen provides the decision gate for an expanded, randomized, controlled Phase IIB trial evaluating effectiveness. NanoViricides expects the optimal regimen to show signs of reduced viral load and potentially patient recovery; these are expectations, not reported trial results.
NanoViricides (NNVC) filed its fiscal 2026 annual report, highlighting Phase II enrollment for NV-387 in mpox and Ebola.
Regulators in the Democratic Republic of Congo approved the mpox trial in September 2025 and the Ebola trial in August 2026. Both began enrollment at the end of September 2026. The U.S. FDA granted NV-387 orphan drug designation for measles in May 2026 and rare pediatric disease designation in June 2026.
Cash and equivalents were approximately $2.79 million at June 30, 2026, while fiscal-year operating cash use was approximately $7.70 million. Equity and warrant sales raised approximately $9.01 million during the fiscal year; a July offering generated approximately $3.8 million in gross proceeds. NanoViricides said it lacks funding for planned operations through September 30, 2027, creating substantial doubt about its ability to continue as a going concern.
NanoViricides (NNVC) began enrolling and dosing patients in a Phase II trial of oral NV-387 for Ebola around September 23, 2026.
The trial is taking place at an Ebola treatment center in the Democratic Republic of Congo’s Ituri province. Adults with Bundibugyo or other Ebola virus disease receive NV-387 oral gummies alongside supportive care. The initial, single-arm Phase IIA stage aims to establish a tolerable dosing protocol, adjusted for disease severity. The planned Phase IIB stage will use that protocol in a randomized, controlled, open-label evaluation of safety and effectiveness, with independent blinded assessment of endpoints. No patient outcomes have been reported.
Om Sai Clinical Research is the trial’s contract research organization. Travel restrictions and shortages of protective equipment and diagnostic kits have delayed trial work; NanoViricides expects further delays.
NanoViricides (NNVC) has begun a Phase II clinical trial of its broad-spectrum antiviral NV-387 as an oral gummy treatment for mpox, with first patient enrollment in Lodja, Sankuru province, Democratic Republic of Congo.
The adaptive, international, multi-center, randomized, open-label, parallel-group Phase IIa/IIb study compares NV-387 to standard of care in patients with clinical signs of mpox and laboratory confirmed or presumptive hMPXV infection. The trial is registered in the Pan African Clinical Trials Registry as PACTR202609506749917, led by Principal Investigator Prof. Vivi Maketa of the University of Kinshasa. All cases are expected to involve mpox Clade I, which is endemic in DRC. NanoViricides has applied to the US FDA for Orphan Drug Designation for NV-387 in mpox, which the company says could yield economic benefits in the tens of millions of dollars if granted.
NanoViricides (NNVC) plans to begin a Phase II clinical trial of its oral NV-387 gummy drug for Ebola virus disease in the Democratic Republic of Congo next week at an Ebola Treatment Center in Ituri province.
The adaptive, multi‑centre Phase IIA/IIB trial will first run a single‑arm safety and dose “run‑in” (Phase IIA), followed by a randomised, controlled, open‑label efficacy evaluation with independent blinded-endpoint adjudication (Phase IIB). NV-387 is described as the only orally administered Ebola drug currently in clinical trials and is formulated as gummies that dissolve in the mouth, aiming to simplify use in resource‑poor outbreak settings.
The study targets Bundibugyo ebolavirus and other Ebola viruses, is led by principal investigator Prof. Patrick de Marie Chimusa Katoto, and is managed by Om Sai Clinical Research as CRO. It is registered in the Pan African Clinical Trials Registry under ID PACTR202608748555077. First patient dosing is anticipated next week, subject to outbreak-related operational constraints.
The company cites animal data in a lethal coronavirus model in which oral NV-387 extended survival more than intravenously administered remdesivir, and argues NV-387’s host‑targeting, broad‑spectrum antiviral mechanism may reduce the likelihood of viral escape. The trial launches amid a rapidly expanding Bundibugyo Ebola outbreak in DRC, with 7,022 confirmed cases and 3,398 confirmed deaths as of 10 September 2026 and a crude fatality rate of about 48%.
NanoViricides (NNVC) has registered its Phase II trial of NV-387 oral gummies for Ebola treatment in the Pan African Clinical Trials Registry.
The trial, led by principal investigator Prof. Patrick de Marie Chimusa Katoto in the Democratic Republic of Congo, carries ID PACTR202608748555077 and has received regulatory approval from ACOREP to begin. Drug product has been shipped and received at the Ituri province trial site, and first Ebola patient dosing is expected within one to two weeks, subject to outbreak-related constraints. The adaptive, multi-centre Phase IIA/IIB design starts with a single-arm safety and dose run-in, followed by a randomised, controlled, open-label efficacy evaluation. NV-387 is an orally delivered, broad‑spectrum antiviral being evaluated amid a rapidly expanding Bundibugyo ebolavirus outbreak.
NanoViricides (NYSE American: NNVC) reported progress in its measles treatment program, highlighting broad-spectrum antiviral candidate NV-387. NV-387 has shown strong in vivo activity against lethal measles infection in a humanized animal model and is being advanced toward a Phase II clinical trial under an IND process with the US FDA.
According to NanoViricides, NV-387 has received both Orphan Drug Designation (ODD) and Rare Pediatric Disease Drug (RPDD) designation from the FDA for measles, making the company eligible for incentives such as tax credits, user-fee exemptions, potential seven-year market exclusivity, and a potential Priority Review Voucher (PRV), which the company notes have recently sold for about $195 million.
NanoViricides (NYSE American: NNVC) reported that local regulator ACOREP in the Democratic Republic of Congo has approved a Phase II clinical trial of NV-387 oral gummies as a treatment for the current Bundibugyo ebolavirus outbreak and other Ebola viruses. Professor Patrick Katoto of the Catholic University of Bukavu will serve as principal investigator, with Om Sai Clinical Research as CRO.
According to the company, trial drug product is already in DRC, originally shipped for an impending Phase II Mpox trial, enabling rapid start of Ebola patient dosing, anticipated within weeks, subject to outbreak-related constraints. The outbreak has reached 4,945 confirmed cases and 2,325 deaths in DRC as of August 14, 2026, with a crude fatality rate of 46%.