Phase II Clinical Trial of Monkeypox Treatment by NV-387 to Commence Soon, Announces NanoViricides
Rhea-AI Summary
NanoViricides (NYSE American:NNVC) announced a Phase II clinical trial of NV-387 for MPox will begin soon in the Democratic Republic of Congo following ACOREP approval. CRO site prep and staff training are scheduled in early April 2026, with enrollment and dosing to commence after training. The company has applied for US FDA Orphan Drug Designation and cites potential economic benefits and Strategic National Stockpile opportunities.
Positive
- ACOREP approval secured to start Phase II in DRC
- CRO site preparation and staff training scheduled first week of April 2026
- Orphan Drug Designation application filed with FDA (potential commercial benefits)
- Animal-model data showed NV-387 matched tecovirimat in two infection models
- Potential SNS market opportunity comparable to hundreds of millions of dollars
Negative
- No assurance NV-387 will show sufficient safety or effectiveness in humans
- Path to approval is lengthy and requires substantial capital
- Company cannot project exact IND filing dates due to external dependencies
News Market Reaction – NNVC
On the day this news was published, NNVC gained 4.66%, reflecting a moderate positive market reaction. Argus tracked a peak move of +2.2% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $877K to the company's valuation, bringing the market cap to $19.70M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
NNVC is up 4.84% while one tracked peer (SABS) is modestly higher and another (FBLG) is down sharply. With only 1 peer moving in the same direction and no peer news, today’s move appears stock‑specific rather than a sector rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 11 | Phase II product ready | Positive | +18.3% | Completion of NV-387 Phase II oral gummies and conference presentation plan. |
| Feb 12 | MPox ODD filing | Positive | -7.9% | Filed Orphan Drug Designation for NV-387 as MPox treatment with FDA OOPD. |
| Feb 10 | Measles ODD filing | Positive | +8.0% | Filed Orphan Drug Designation for NV-387 as treatment for measles. |
| Nov 10 | DRC Phase II approval | Positive | -8.7% | ACOREP approval to start Phase II NV-387 MPox trial in DRC. |
| Oct 15 | Dual-track strategy | Positive | +6.7% | Outlined dual-track Phase II plans for MPox and respiratory infections. |
Clinical and regulatory NV-387 updates often move the stock, with a mix of strong rallies and occasional selloffs on similar 'clinical trial' headlines.
Over the past several months, NanoViricides has repeatedly highlighted NV-387’s clinical and regulatory progress. Prior clinical trial-tagged releases covered Phase I completion, ACOREP approval in the DRC, and multiple Orphan Drug Designation filings for MPox and measles. Reactions ranged from gains of 18.32% and 8.02% to declines of 7.92% and 8.7%. Today’s announcement that a Phase II MPox trial of NV-387 will start in the DRC fits this ongoing clinical advancement narrative.
Historical Comparison
NNVC’s prior clinical trial headlines produced an average move of 3.28%, with both sharp rallies and selloffs. Today’s Phase II-start update continues that pattern of clinically focused catalysts driving meaningful but variable reactions.
Clinical news shows a progression from Phase I completion and ethics/regulatory approvals through Orphan Drug Designation filings to concrete Phase II execution steps for NV-387 in MPox and broader respiratory indications.
Regulatory & Risk Context
An effective Form S-3 shelf registered 7,142,858 warrant shares for resale tied to a November 10, 2025 private placement. Full cash exercise of the Series A and B warrants at $1.75 and $2.00 could provide up to $13.4 million in gross proceeds, while existing filings note substantial doubt about the company’s ability to continue as a going concern.
Market Pulse Summary
This announcement advances NV-387 from regulatory clearance toward an actual Phase II MPox trial in the DRC, building on prior Phase I safety data and Orphan Drug Designation filings. It highlights unmet need, limited vaccine effectiveness of 36%–66%, and weaknesses in existing stockpiled antivirals. Recent filings underline ongoing losses and going‑concern language alongside access to warrant-based capital. Investors may watch trial initiation, enrollment progress, and future funding steps closely.
Key Terms
phase ii clinical trial medical
orphan drug designation regulatory
strategic national stockpile regulatory
black-box warning regulatory
orthopoxvirus medical
polymeric micelle medical
sulfated proteoglycans medical
host-mimetic medical
AI-generated analysis. Not financial advice.
SHELTON, CT / ACCESS Newswire / April 1, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today announced that a Phase II Clinical Trial of Monkeypox Treatment by NV-387 is expected to begin soon in the Democratic Republic of Congo (DRC).
Clinical Trial Site preparations are being performed by our CRO in India, Om Sai Clinical Research Pvt. Ltd., and associates in DRC. The CRO personnel are expected to visit the Site for final preparations and for staff training in the first week of April, 2026. Enrollment and dosing of patients is expected to begin after the staff training is completed.
The Company previously reported that it has received approval to start said Phase II Clinical Trial of NV-387 for the Treatment of MPox by the Regulatory Agency ACOREP of the Democratic Republic of Congo (DRC).
The Phase II clinical trial will evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease caused by hMPXV infection.
MPox Clade I is endemic in DRC and all cases in the clinical trial are expected to be of the Clade I virus. The other prominent MPox virus, MPox Clade II is substantially less severe an infection than MPox Clade I.
"This is an important milestone in regulatory development of NV-387," said Anil R. Diwan, PhD, President and Executive Chairman of the Company.
MPox is an "Orphan Disease" in the USA. NanoViricides has applied to the US FDA for Orphan Drug Designation (ODD) of NV-387 for the treatment of MPox. This ODD, assuming it is granted, would enable several benefits including frequent meetings with FDA, waiver of certain FDA fees, certain R&D credits, as well as extension in exclusivity in marketing once approved.
These ODD benefits can have a positive economic impact for NanoViricides estimated in the range of tens of millions of dollars.
There is no drug available for the treatment of hMPXV infection that causes the MPox disease.
NV-387 would be the "go to" pandemic response candidate if it is successful in the Phase II MPox clinical trial. US Government SNS stockpiling contracts for existing smallpox drugs TPOXX and TEMBEXA have been in several hundreds of millions of dollars, representing an equivalent potential opportunity for NV-387.
MPox Clade II has become endemic in the USA, circulating at low levels. It primarily affects a limited population of Men-having-Sex-with-Men (MSM), because of transmission during sexual activity.
MPox Clade I cases in the USA have been slowly increasing. As of March 23, 2026, there have been 15 cases of MPox Clade I in the USA since November, '25, with 4 of them in March, '26, according to CDC[1].
Community spread of the MPXV Clade I is likely already occurring, with 3 cases of MPox Clade I with no travel to Africa, in California in unconnected persons, according to the CDC[2].
Thus MPox is becoming important in the USA from the perspective of pandemic preparedness and response. Although there is a vaccine originally developed for smallpox, namely, Jynneos, that is in use to prevent MPox (primarily in clade II contacts), its immune protection was found to wane rapidly in a clinical study[3]. The effectiveness of this vaccine is limited, at
The vaccine effectiveness is likely to be much less against the more severe MPox Clade I.
Vaccines do not protect in the first few weeks, limiting their usefulness during pandemic.
A clinical trial of tecovirimat (TPOXX®, SIGA) failed to demonstrate any effectiveness over placebo, as per a NIH press release on August 15, 2024. Another drug, brincidofovir (TEMBEXA®, EBS) entered into a clinical trial called "MOSA" with fanfare in January, 2025, with early topline results expected by the end of that quarter. The status of this clinical trial is not publicly known as of now. Previously, three MPox cases treated with TEMBEXA developed liver dysfunction. TEMBEXA carries a black-box warning, due to severe liver toxicity, entero-gastric toxicity, and requires clinical monitoring, making it unsuitable as a drug for pandemic response.
Thus both of the Smallpox drugs in the USA Strategic National Stockpile (SNS), TPOXX and TEMBEXA, would be unsuitable for pandemic response if MPox Clade I spreads, representing an opportunity for NV-387.
"NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil R. Diwan, Ph.D., adding "NV-387 is designed to mimic human cells to trap and destroy the virus. This single drug can target over 90
NV-387 was found to possess strong antiviral activity against an orthopoxvirus in an animal model that is considered an important model to establish potential effectiveness against MPox and Smallpox viruses, as all of these viruses belong to the same family of orthopoxviruses.
In fact, NV-387 effectiveness matched the effectiveness of the small chemical drug tecovirimat in two different models of infection, one was direct skin infection, and the other was a direct lung infection, by the virus.
Escape of virus from tecovirimat can occur by a single point mutation in a viral protein called VP-37. Vaccines, antibodies, and small chemical drugs such as tecovirimat for MPox/Smallpox, or oseltamivir (Tamiflu ® ), baloxavir (Xofluza ® ) for Influenza are readily escaped by viruses simply by introduction of small changes that viruses undergo when they are faced with these challenges in the field.
In contrast, escape of virus from NV-387 is highly unlikely because no matter how much the virus changes in the field, it continues to use sulfated proteoglycans such as HSPG as "attachment receptor" in order to cause cell infection. NV-387 mimics the sulfated proteoglycan signature feature that the viruses require.
NV-387 is a host-mimetic drug that "looks like a cell" to the virus, displaying numerous ligands that mimic the sulfated proteoglycan, enticing the virus to bind to and become engulfed by the NV-387 dynamic shape-shifting polymeric micelle.
Therefore development of NV-387, a broad-spectrum host-mimetic, direct-acting antiviral drug that the viruses cannot escape even as they change constantly, will be revolutionary once the drug undergoes regulatory development for approval for use in humans.
New viruses and existing viruses acquiring greater pathology and infectivity are bound to keep appearing in time. To combat such threats, we need to develop broad-spectrum drug arsenal that the viruses cannot escape. Vaccines and antibodies simply will not do, and their limitations have become clearly evident during the COVID-19 pandemic.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide ™ class of drug candidates and the nanoviricide ™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.
The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. 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.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.
NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our 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, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company is also developing drugs against a number of 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. 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 the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. 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. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.
Where stated with an ®, the name is a registered trademark, which belongs to the owner of the trademark name.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
[1] https://www.cdc.gov/monkeypox/situation-summary/index.html
[4] From the Mpox Emergency Response Team, CDC (2023-05) "Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States," N Engl J Med 2023;388:2434-43.
SOURCE: NanoViricides, Inc.
View the original press release on ACCESS Newswire
FAQ
When will NanoViricides (NNVC) begin Phase II dosing of NV-387 for MPox?
Has NanoViricides (NNVC) received regulatory approval to start the Phase II MPox trial in DRC?
What benefits could FDA Orphan Drug Designation bring for NV-387 (NNVC)?
How did NV-387 perform in preclinical models compared to tecovirimat, according to NNVC?
What timeline did NanoViricides (NNVC) give for CRO activities and site readiness?
What key risks did NanoViricides (NNVC) highlight about NV-387 development?
