NanoViricides Dual Track Clinical Strategy Explained by a Research Report - Broad-spectrum Antiviral NV-387 At Phase II Clinical Trial Stage for MPox and also for Acute Respiratory Infections of All Viruses
NanoViricides (NYSE:NNVC) outlined a dual-track clinical strategy for its broad‑spectrum polymeric micelle antiviral NV-387, targeting MPox and acute respiratory viruses (influenza, coronaviruses, RSV).
Key disclosed facts: NV-387 completed a Phase 1 safety/tolerability study in 2023; an MPox Phase 2 trial has ethics approval in Congo and could begin by late CY2025–early CY2026; an adaptive respiratory “basket” Phase 2 trial in India is targeted for winter 2026 with possible US follow-ups in 2027. Management cited independent market estimates of $2.6bn for RSV and $4.6bn for influenza.
NanoViricides (NYSE:NNVC) ha delineato una strategia clinica a doppio binario per il suo antivirale a micelle polimeriche ad ampio spettro NV-387, mirato a MPox e ai virus respiratori acuti (influenza, coronavirus, RSV).
Fatti chiave resonposti: NV-387 ha completato uno studio di sicurezza/tollerabilità di fase 1 nel 2023; uno studio di fase 2 su MPox ha l'approvazione etica in Congo e potrebbe iniziare entro la fine del 2025–inizio 2026; un trial adattivo di fase 2 di tipo basket per le malattie respiratorie in India è previsto per inverno 2026, con possibili follow-up negli Stati Uniti nel 2027. Il management ha citato stime indipendenti di mercato di 2,6 miliardi di dollari per RSV e 4,6 miliardi di dollari per l'influenza.
NanoViricides (NYSE:NNVC) delineó una estrategia clínica de doble vía para su antiviral de micelas poliméricas de amplio espectro NV-387, orientada a MPox y a virus respiratorios agudos (influenza, coronavirus, RSV).
Datos clave divulgados: NV-387 completó un estudio de seguridad/tolerabilidad de Fase 1 en 2023; un ensayo de Fase 2 para MPox tiene aprobación ética en Congo y podría comenzar hacia finales de CY2025–principios de CY2026; un ensayo de Fase 2 adaptativo de 'basket' para enfermedades respiratorias en India está previsto para invierno 2026 con posibles seguimientos en EE. UU. en 2027. La dirección citó estimaciones de mercado independientes de $2.6bn para RSV y $4.6bn para la influenza.
나노바이러사이드스(NYSE:NNVC)은 광범위 스펙트럼의 고분자 나노입자 항바이러스제 NV-387에 대해 이중 트랙의 임상 전략을 개략 설명했으며, MPox 및 급성 호흡기 바이러스(독감, 코로나바이러스, RSV)를 겨냥합니다.
공개된 주요 사실: NV-387은 2023년에 1상 안전성/내약성 연구를 완료했고; MPox의 2상 시험은 콩고에서 윤리 심의를 받았으며 2025년 말–2026년 초에 시작될 수 있습니다; 인도에서의 2상 호흡기 ‘바스켓’ 적응적 시험은 2026년 겨울에 목표하며 미국에서의 후속 연구는 2027년에 있을 수 있습니다. 경영진은 RSV에 대해 $2.6bn, 독감에 대해 $4.6bn의 독립 시장 추정치를 인용했습니다.
NanoViricides (NYSE:NNVC) a tracé une stratégie clinique à double voie pour son antiviral à micelles polymères à large spectre NV-387, ciblant MPox et les virus respiratoires aigus (grippe, coronavirus, RSV).
Faits clés divulgués: NV-387 a mené une étude de sécurité/tolérabilité de Phase 1 en 2023; un essai de Phase 2 MPox a obtenu l'approbation éthique au Congo et pourrait commencer vers la fin 2025 – début 2026; un essai Phase 2 adaptatif pour les maladies respiratoires, en Inde, est prévu pour l'hiver 2026 avec d'éventuels suivis aux États-Unis en 2027. La direction a cité des estimations indépendantes du marché de 2,6 milliards de dollars pour RSV et 4,6 milliards de dollars pour la grippe.
NanoViricides (NYSE:NNVC) skizzierte eine duale Verfolgung der klinischen Strategie für sein breit wirkendes polymeres Mikellenantiviral NV-387, das auf MPox und akute respiratorische Viren (Influenzaviren, Coronaviren, RSV) abzielt.
Wichtige offengelegte Fakten: NV-387 hat eine Sicherheit/Tolerabilitäts-Studie der Phase 1 im 2023 abgeschlossen; eine MPox-Phase-2-Studie hat in Kongo ethische Genehmigung erhalten und könnte bis spätes Jahr 2025–Anfang 2026 beginnen; eine adaptive respiratorische Basket-Phase-2-Studie in Indien ist für Winter 2026 vorgesehen, mit möglichen Follow-ups in den USA im Jahr 2027. Das Management hat unabhängige Marktschätzungen von $2.6bn für RSV und $4.6bn für Influenzaviren zitiert.
NanoViricides (NYSE:NNVC) حدّدت استراتيجية سريرية مزدوجة المسار لشبكتها من الميكيلات البوليميرية واسعة النطاق المضاد الفيروسي NV-387، مستهدفة MPox وفيروسات الجهاز التنفسي الحادة (الإنفلونزا، فيروسات كورونا، RSV).
الحقائق الأساسية المعلنة: أكمل NV-387 دراسة السلامة والتحمل من المرحلة 1 في 2023؛ تمت الموافقة الأخلاقية على تجربة المرحلة 2 لـ MPox في الكونغو ويمكن أن تبدأ بحلول أواخر 2025–بداية 2026؛ تجربة المرحلة 2 التكيفية لسلالات الأمراض التنفُّسية في الهند محددة لـ شتاء 2026 مع متابعة محتملة في الولايات المتحدة في 2027. أشارت الإدارة إلى تقديرات سوقية مستقلة قدرها 2.6 مليار دولار لـ RSV و4.6 مليار دولار للإنفلونزا.
NanoViricides (NYSE:NNVC) 概述了一项针对其广谱聚合物胶束抗病毒剂 NV-387 的双轨临床策略，目标包括 MPox 以及急性呼吸道病毒（流感、冠状病毒、 RSV）。
披露的关键信息：NV-387 已在 2023 年完成了 1 期 安全性/耐受性研究；一项 MPox 的 2 期 试验在 刚果 获得伦理批准，可能在 2025 年末–2026 年初 开始；在 印度 的一个 2 期 自适应呼吸道“篮子”试验定于 2026 年冬，并可能在 2027 年在美国跟进。管理层引用了 RSV 为 $2.6bn、流感为 $4.6bn 的独立市场估计。
- Phase 1 complete in 2023 showing safety and tolerability
- Ethics approval secured for an NV-387 Phase 2 MPox trial in Congo
- MPox Phase 2 could start late CY2025–early CY2026
- Planned adaptive respiratory Phase 2 (India) targeted for winter 2026
- Company cites $2.6bn RSV and $4.6bn influenza market estimates
- No firm IND or regulatory filing date; IND timing dependent on external collaborators
- Company states no assurance NV-387 efficacy or successful clinical outcome
- Respiratory trial timing is tentative: winter 2026 start not guaranteed
Insights
NanoViricides outlines a dual-track Phase II program for NV-387 targeting MPox now and respiratory viruses thereafter.
The company advances a broadly acting antiviral, NV-387, into human Phase II testing after a reported Phase I showing of safety and tolerability in
Dependencies and risks include successful completion of formal CTAs, trial execution in Congo and India, and securing development funding if needed; these items are explicitly stated and determine near-term feasibility. Watch for a formal Phase II CTA filing and trial start timing (possible
SHELTON, CONNECTICUT / ACCESS Newswire / October 15, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), reports that an analyst research report was published on the Company that explains its dual-track, rapid clinical development strategy for NV-387, going after MPox and also after all respiratory viral infections, that include Influenzas, Coronaviruses, RSV among others. The analyst research report was published by proactive investors news (https://www.proactiveinvestors.com/companies/news/1080303/nanoviricides-dual-track-clinical-development-during-2026-1080303.html/long).
The analyst research report summarizes:
"Nanoviricides (NNVC), a US company, targets the unmet medical need for an effective, broad- spectrum acute oral antiviral therapy with NV-387. NNVC's nano-polymer, micelle technology directly binds and destroys virus particles in the blood preventing them entering and infecting cells; in effect a highly selective, ruthless (but safe) nanomachine.
NNVC is now pursuing a dual track strategy for clinical development. The first trial will be against MPox virus, a relative of smallpox. The second is in respiratory viral diseases. NV's lead molecule NV-387 has already completed a Phase 1 study in 2023 showing safety and tolerability.
The immediate study, which could start by late CY25 or early in CY26, is for MPox. MPox is an endemic virus related to smallpox so has biodefense applications. Ethics approval for an NV- 387 Phase 2 trial in Congo has already been gained; the next stage is a formal Phase 2 Clinical Trial Application (CTA). A successful African trial could lead to possible development funding from the US biodefense agency (BARDA).
The second planned study uses mostly the same CTA as the MPox study but will target respiratory viral diseases. An adaptive "basket-type" trial in India will gather data on NV-387 efficacy against flu, RSV and coronaviruses. This might start in winter 2026 but a later start is possible. This could lead to focused US trials, perhaps from 2027. Management notes independent estimates of a US
Additional details can be found in the analyst research report.
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.
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
SOURCE: NanoViricides, Inc.
View the original press release on ACCESS Newswire
FAQ
What clinical stage is NanoViricides' NV-387 (NNVC) as of October 15, 2025?
When could NV-387's Phase 2 MPox trial for NNVC begin?
Where has ethics approval been obtained for NNVC's NV-387 MPox Phase 2 trial?
What is the planned timeline for NV-387 respiratory (flu/RSV/coronavirus) trials for NNVC?
Could a successful MPox trial lead to U.S. biodefense funding for NNVC?
What market opportunity figures did management cite for NNVC's NV-387?
