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Could a single pill stop lyme disease before it starts?

NCT ID NCT07562087

Prevention Sponsor: Tarsus Pharmaceuticals, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 2 times

Summary

This study tests a new pill called TP-05 (lotilaner) to see if it can prevent Lyme disease in healthy adults who are often around ticks. The pill is already used in pets to kill ticks. Researchers will give either a low dose, high dose, or placebo to 700 volunteers and watch for side effects and how well it works. The goal is to find a safe, easy way to stop Lyme disease before it takes hold.

What this could mean

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

Active substance
TP-05 (lotilaner) pills
What this could lead to
If it works, this could lead to a pill that prevents Lyme disease after a tick bite, reducing the need for antibiotics and worry.
What could go wrong
This is an early phase 2b trial, so it may not prove effective. The drug is already used in animals, but safety and dosing in humans are still being tested.

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

722 people

The number who actually took part.

Started

Mar 2026

Expected to finish

Dec 2027

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 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Overtly healthy adult participants aged 18 to 70 years * Able to provide written informed consent * Willing and able to comply with study procedures * At high risk of exposure to ticks * Contraceptive use by men and women consistent with local regulations Exclusion Criteria: * Prior exposure to TP05 or any isooxazoline in the last 12 months * Known hypersensitivity to TP05 or related compounds * Clinically significant medical conditions that may interfere with study participation * Use of investigational products within 30 days prior to screening. * Received previous vaccination against Lyme borreliosis, including investigational vaccines intended to prevent Lyme borreliosis * Receiving long-term antibiotic therapy * Received active or passive immunization within 4 weeks prior to Day * Pregnant or breastfeeding individuals

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Conditions

The condition(s) this trial relates to.

Bacterial Infections and Mycoses bacterial infectious disease Borrelia infectious disease gram-negative bacterial infections Infections spirochaetales infections tick-borne infectious disease vector-borne disease Lyme disease prevention target

As listed by the trial registrant

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

Lyme disease

Contacts and locations

Locations

  • Study Site

    Pikesville, Maryland, 21208, United States

  • Study Site

    Brookline, Massachusetts, 02445, United States

  • Study Site

    Fall River, Massachusetts, 02723, United States

  • Study Site

    Minneapolis, Minnesota, 55402, United States

  • Study Site

    Marlboro, New Jersey, 07746, United States

  • Study Site

    Albany, New York, 12205, United States

  • Study Site

    Binghamton, New York, 13905, United States

  • Study Site

    Buffalo, New York, 14217, United States

  • Study Site

    East Syracuse, New York, 13057, United States

  • Study Site

    Middletown, New York, 10941, United States

  • Study Site

    New York, New York, 10036, United States

  • Study Site

    Rochester, New York, 14609, United States

  • Study Site

    Erie, Pennsylvania, 16508, United States

  • Study Site

    Hatboro, Pennsylvania, 19040, United States

  • Study Site

    Philadelphia, Pennsylvania, 19107, United States

  • Study Site

    Pittsburgh, Pennsylvania, 15236, United States

  • Study Site

    Pottstown, Pennsylvania, 19464, United States

  • Study Site

    West Chester, Pennsylvania, 19380, United States

  • Study Site

    Warwick, Rhode Island, 02886, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.