Permanent program record

NV-HHV-1

Preclinical skin cream whose lead indication is shingles, not herpes simplex, with no human study identified through 2026-09-09 and a stronger HSV claim in the developer's latest quarterly report than its annual reports support.

Developer / organization
NanoViricides · TheraCour Pharma
Intervention type
Other approach
Current stage
Preclinical
Preclinical

Sources last checked

Summary

Bottom line

NV-HHV-1 is an experimental skin cream from NanoViricides, Inc. Its lead target is shingles, and the company also names cold sores and genital herpes among its intended uses.

No herpes simplex trial exists. Through September 9, 2026 no application, authorization or registered study for any HSV indication was identified in the checked routes, and none has ever been reported by the company.

The company's annual reports say activity against HSV-1 was seen in other compounds built with the same or related ligands. They describe HSV-2 effectiveness as a belief inferred from shared receptor use.

Its most recent quarterly report compresses both into one sentence: "Previously, NV-HHV-1 was found to have antiviral activity against HSV-1 as well as HSV-2 in animal models." No new study is cited for the stronger version.

This page exists mainly to keep those two versions apart, because the stronger one is the one a reader is most likely to find. As of September 9, 2026 NV-HHV-1 is not approved anywhere and is not available as a treatment.

Plain-language overview

What is this?

A nanoviricide is the company's own term for a self-assembling polymer to which small chemical ligands are attached. The ligand is designed to copy features of HVEM, one of the proteins HSV-1 and HSV-2 use to enter human cells. That is the developer's design rationale rather than a demonstrated result, and the company's own annual report notes it was not known whether the shingles virus uses HVEM at all.

NV-HHV-1 is the drug candidate, NV-360 is its active ingredient, and NV-HHV-101 is the name it carried in earlier filings. It is a topical skin cream; a separately described oral drug on the same active ingredient is a different product at an earlier stage.

NanoViricides develops it under exclusive worldwide licences from TheraCour Pharma, a related party substantially owned by the company's founder, president and executive chairman. That is disclosed in the filings and is a fact about the arrangement, not a criticism of it.

Research goal

What were researchers trying to accomplish?

The intent is therapeutic: a cream applied to a rash or lesion to treat an outbreak.

The lead indication is shingles, caused by varicella-zoster virus, which is a herpesvirus but not herpes simplex. Chickenpox, cold sores and genital ulcers follow it in the company's stated plans. That order matters, because every concrete milestone the company reports belongs to shingles rather than to herpes simplex.

Study and program

What happened?

The company reports holding a pre-application meeting with the FDA in 2019 and receiving the agency's response that May. That meeting was for shingles.

It reports completing the non-clinical work the agency recommended, an animal safety and toxicology package, and manufacture of roughly one kilogram of active ingredient and ten kilograms of formulated product. All of that belongs to the shingles indication.

Seven years later, no application to begin human testing has been reported as filed, for shingles or for anything else.

One human study is associated with the company's platform. It is an early-phase study of a coronavirus formulation, run by a different sponsor in India, and it involves neither this candidate nor herpes.

Reported findings

What did the study find?

There are no human findings, because there has been no human study. The non-clinical picture has to be read carefully, because the company describes it in two materially different ways.

The annual reports for the 2024 and 2025 financial years attribute the HSV-1 activity to other compounds. They say that nanoviricides made with the same or related ligands as the one used in NV-HHV-1 showed antiviral activity against HSV-1, in cell culture and in animal studies.

Those same reports treat HSV-2 as an inference rather than a result. Because HSV-2 also uses HVEM to enter cells, the company writes, it believes NV-HHV-1 should be effective against HSV-2 as well.

The quarterly report for the period ending March 2026 compresses that into a single sentence saying NV-HHV-1 was found active against HSV-1 as well as HSV-2 in animal models. It cites no new study.

Three qualifiers disappear in that compression. The compound tested becomes NV-HHV-1 rather than related compounds, the HSV-2 belief becomes a finding, and cell-culture work is folded into animal work.

HSVHQ does not treat the newer, more categorical wording as superseding the detailed disclosures behind it. Nothing in the checked record supplies a study that would justify the stronger version.

None of this has been published in a peer-reviewed journal. No publication describing this candidate or its herpes simplex data was identified in PubMed through September 9, 2026, so no reported result has been independently checked.

HSVHQ interpretation

What does that mean?

The evidence maturity is preclinical. No person has received NV-HHV-1 for any indication, so there is no early human evidence to describe.

What the record establishes is modest: a licensed platform, a topical candidate built on it, manufacturing and animal safety work for shingles, and herpes simplex listed among the company's intentions.

It does not establish that NV-HHV-1 has any activity against HSV-2, that its HSV-1 activity was shown with NV-HHV-1 rather than related compounds, or that a herpes trial is close. A readiness claim is not a regulatory status, animal activity is not clinical benefit, and an intention is not a program in progress.

In its quarterly report filed May 15, 2026, the company said its available resources would not fund its planned operations for the next twelve months. Substantial doubt therefore exists about its ability to continue as a going concern, and its auditor has included the same warning in the audited accounts for two consecutive years.

That is an accounting disclosure about whether funding is sufficient over a twelve-month horizon. It is not a prediction that the company will close, and companies operate under such disclosures for years, this one having raised further capital in July 2026. It is recorded here only because the company itself makes the herpes program conditional on funding.

Evidence gaps

What don't we know?

Program status

Why did or didn't development continue?

HSVHQ records the herpes work as preclinical and nominally active. There is no human evidence and no regulatory authorization. No press release dedicated to the herpes program has been issued since September 2020, in the filed announcements and published release list checked through September 9, 2026.

The company separately said in its 2025 annual report that it was developing three HerpeCide indications in parallel. Neither an assertion that the program is halted nor one that it is actively progressing is available from this record.

Development is conditional by the company's own account: the program will be re-engaged when resources allow. That is a statement that it is not being advanced at the pace its clinical-sounding descriptions suggest.

As of September 9, 2026 the candidate is not approved anywhere and is not available. The company states it has no products approved for commercial sale. Nothing in the checked record indicates the program has been abandoned either, and absence of recent announcements is not a discontinuation decision.

Confirmed next steps

What happens next?

The annual report for the financial year ending June 30, 2026, expected shortly after this page's evidence cutoff, is the first document capable of changing this record. It will show whether the compressed animal-activity claim persists or the qualified wording returns.

A filed application to begin human testing, or a registered trial for any herpes simplex indication, would be the first real evidence that this program has moved.

A peer-reviewed publication describing NV-360 would allow its non-clinical results to be checked by someone other than the company.

Program record

Organizations
NanoViricides (Developer (current), Licensee (current))TheraCour Pharma (Originator (current))
Goal
Treat HSV
Approach
Topical polymeric micelle carrying a ligand designed to copy features of the HVEM cell-entry receptor
Intended HSV scope
HSV-1 + HSV-2
Human evidence scope
No human evidence
Studied indication / setting
Recurrent orolabial herpes · Recurrent genital herpes
Current stage
Preclinical
Evidence maturity

Preclinical evidence

This describes the strongest research evidence in the sources HSVHQ reviewed. Development stage, regulatory review, and availability are shown separately.

Development history

Timeline

  1. Prospectus makes the program conditional on resources

    A prospectus dated September 2, 2026 says the herpes program will be re-engaged when sufficient resources become available, and incorporates the auditor's going-concern explanatory paragraph.

    Why it matters: This is the developer's own most recent statement of the program's condition, and it is materially weaker than its clinical-sounding descriptions elsewhere.

  2. Quarterly report states a stronger HSV claim than the annual reports support

    The Form 10-Q for the quarter ended March 31, 2026 states that NV-HHV-1 was found to have antiviral activity against HSV-1 as well as HSV-2 in animal models, citing no new study.

    Why it matters: The developer's own annual reports attribute the HSV-1 activity to other compounds built with related ligands and describe HSV-2 effectiveness as a belief. HSVHQ does not treat the compressed wording as superseding the detailed disclosures behind it.

  3. Last press release specific to the herpes program

    The developer's most recent public statement dedicated to the HerpeCide program was issued in September 2020, in the filed announcements and published release list checked through 2026-09-09.

    Why it matters: Silence in press releases is not a discontinuation decision, and none has been announced. The developer separately stated in its 2025 annual report that it was developing three HerpeCide indications in parallel.

  4. FDA pre-application response received, for shingles

    The developer reports holding a pre-application meeting with the FDA and receiving the agency's response in May 2019.

    Why it matters: This is the program's furthest regulatory step, and it belongs to the shingles indication rather than to herpes simplex. No application to begin human testing has been reported filed in the seven years since.

Technical record

Study details

The filings describe the candidate with terms that sound clinical and are not. "Clinical drug candidate", "IND-ready", "at the application stage" and "awaiting to go into the clinic" are all statements about readiness. None of them means an application to begin human testing has been filed.

"Advanced pre-clinical studies" has been the company's description of the HSV candidates across three consecutive annual reporting cycles. The phrase has no regulatory definition and has not changed.

The condition that must be met before the herpes program advances has been stated differently in each of four consecutive annual reports, and four ways within one quarterly report. The most recent prospectus says the program will be re-engaged when sufficient resources become available.

The company reports that its first mid-stage trial is of NV-387, a different candidate, for Ebola virus disease in the Democratic Republic of the Congo. That indication appears in none of the stated conditions gating the herpes program. Those trial details are company statements and were not independently checked here.

No published human trials are linked.

Primary sources first

Evidence and sources

Trial registries document study plans and status. Journal articles and conference abstracts report scientific findings. Company reports are listed separately because they come from organizations with a stake in the program.

  1. 1. Regulatory source
    openFDA Drugs@FDA search audit: no approved product. The FDA orphan-designation route errored, so nothing here may be read as an orphan finding in either direction

    U.S. Food and Drug Administration

  2. 2. Company filing
    Form 8-K exhibit, November 4, 2019: completion of the varicella-zoster field licence

    NanoViricides, Inc. · U.S. Securities and Exchange Commission

  3. 3. Company filing
    NanoViricides Form 10-K for the fiscal year ended June 30, 2025

    NanoViricides, Inc. · U.S. Securities and Exchange Commission

  4. 4. Company filing
    NanoViricides Form 10-K for the fiscal year ended June 30, 2023

    NanoViricides, Inc. · U.S. Securities and Exchange Commission

  5. 5. Company filing
    Form 8-K exhibit, November 14, 2025: most recent filed material mentioning NV-HHV-1

    NanoViricides, Inc. · U.S. Securities and Exchange Commission

  6. 6. Company filing
    NanoViricides Form 424B3 prospectus dated September 2, 2026

    NanoViricides, Inc. · U.S. Securities and Exchange Commission

  7. 7. Company filing
    NanoViricides Form 10-K for the fiscal year ended June 30, 2022

    NanoViricides, Inc. · U.S. Securities and Exchange Commission

  8. 8. Clinical trial registry
    CTRI/2023/04/051726, a coronavirus study of a different formulation by a different sponsor, recorded here only to keep it separate from this program

    WHO ICTRP · Clinical Trials Registry India

    CTRI/2023/04/051726

  9. 9. Company filing
    NanoViricides Form 10-K for the fiscal year ended June 30, 2024

    NanoViricides, Inc. · U.S. Securities and Exchange Commission

  10. 10. Company filing
    NanoViricides Form 10-Q for the quarter ended March 31, 2026

    NanoViricides, Inc. · U.S. Securities and Exchange Commission

  11. 11. Other source
    PubMed literature audit: no peer-reviewed characterization of NV-360, NV-HHV-1 or the HerpeCide program

    PubMed

  12. 12. Other source
    Trial-registry search audit: no NV-HHV-1, NV-360 or HerpeCide study in any checked registry

    ClinicalTrials.gov, WHO ICTRP and EU CTIS

  13. 13. Other source
    NanoViricides company website and press-release list

    NanoViricides, Inc. · NanoViricides, Inc.

  14. 14. Other source
    SEC EDGAR filing index for NanoViricides, CIK 0001379006

    U.S. Securities and Exchange Commission · SEC EDGAR