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TP-05 to prevent Lyme disease after tick exposure

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TP-05 in Healthy Participants at High Risk of Tick Exposure

Phase 2 Interventional Tarsus Pharmaceuticals, Inc. · NCT07562087

This study tries to see if taking TP-05 by mouth is safe and could prevent Lyme disease in healthy adults who are likely to be exposed to ticks.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorTarsus Pharmaceuticals, Inc. Industry-sponsored
Locations19 sites (Pikesville, Maryland and 18 other locations)
Trial IDNCT07562087 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial in healthy adults conducted before anticipated tick exposure. Participants are randomized to one of two dosing regimens of oral TP-05 (lotilaner) or placebo and receive study treatment according to a predefined schedule for up to 24 weeks. Safety, tolerability, and pharmacokinetics are monitored through adverse event reporting, clinical labs, vital signs, and physical exams. Participants are followed for approximately 15 months to document tick bites and any symptoms of Lyme borreliosis.

Who should consider this trial

Good fit: Healthy adults aged 18 to 70 who are at high risk of tick exposure, can provide consent, comply with study procedures, and attend study visits at the listed sites are the intended candidates.

Not a fit: People who are pregnant or breastfeeding, already have active Lyme infection, are on long-term antibiotic therapy, recently received isooxazoline drugs, or have significant medical conditions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, TP-05 could offer a safe oral option to prevent Lyme disease after tick exposure.

How similar studies have performed: Isoxazoline compounds like lotilaner are effective for tick control in animals, but using TP-05 as a human prophylactic for Lyme is novel and not yet established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Pikesville, Maryland and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lyme DiseaseLyme BorreliosisLymeBorreliaPreventative TherapeuticProphylaxisHealthy VolunteersRandomized Controlled Trial
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.