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New topical drug could tackle stubborn toenail fungus

NCT ID NCT07065773

Disease control Sponsor: Vanda Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a topical solution called Trichostatin A for mild-to-severe toenail fungus (onychomycosis). About 50 adults with a confirmed fungal infection will apply the drug daily for 4 weeks. Researchers will check safety and whether the fungus clears up using lab tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trichostatin A (topical solution)
What this could lead to
If successful, this could provide a new topical treatment option for stubborn toenail fungus infections.
What could go wrong
This is an early Phase 2 study with only 50 participants, so results may not apply broadly. The treatment may not clear the infection or could cause side effects.
Why investors are watching

Vanda Pharmaceuticals is running a Phase 2 trial of VTR-297, a topical solution for nail fungus, testing safety and effectiveness in 50 patients over four weeks. For a small company, this readout matters because it could validate a new product candidate beyond its existing portfolio, making the trial result a key driver of investor attention.

If it works: If the trial shows the treatment clears the fungus and is well tolerated, Vanda could advance VTR-297 toward later-stage development, potentially adding a new revenue source. A positive result may also signal the company can expand its pipeline successfully.

If it fails: Trials often fail to meet their goals, and this one is small and early, so a negative or unclear result could stall the program and raise doubts about Vanda's ability to grow beyond its current drugs. Delays in enrollment or data readouts could also weigh on investor sentiment.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Willingness to provide signed and dated written voluntary informed consent. * Adults with diagnosis of mild-to-severe DLSO/DSO affecting at least one great toenail. * Positive microscopic examination with KOH for dermatophyte hyphae. * Positive dermatophyte culture or mixed dermatophyte/Candida culture. Exclusion Criteria: * Presence of other toenail infection. * Any disease or condition that may interfere with the evaluation including other conditions that affect the toenails or significant active tinea pedis. * History of other significant chronic fungal disease, psoriasis, lichen planus or use of drug medications for those indications 6 months prior to screening and during the study. * Participation in a previous clinical trial 3 months prior to screening or participation in a research study concurrent with this study. * Current or planned pregnancy during the trial period.

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Conditions

The condition(s) this trial relates to.

tinea unguium

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Onychomycosis of toenail

Contacts and locations

Locations

  • Vanda Investigational Site

    Fremont, California, 94538, United States

  • Vanda Investigational Site

    Denver, Colorado, 80210, United States

  • Vanda Investigational Site

    New Brighton, Minnesota, 55112, United States

  • Vanda Investigational Site

    Pflugerville, Texas, 78660, United States

  • Vanda Investigational Site

    Forest, Virginia, 24551, United States

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