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TP-05 Low Dose

Phase 2

Lyme Disease | Small molecule | Infectious Disease |Tarsus Pharmaceuticals, Inc.|Last Updated: Jul 9, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment722
FDA Designations
No designations recorded
Clinical trial landscape

TP-05 Low Dose · 1 trial · 1 indication

Phase 2 1
NCT07562087A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick ExposureLyme Disease
ACTIVE NOT_RECRUITING722 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
Lyme Disease
NCT07562087722
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Study Endpoints
Primary Endpoints
The Incidence of Treatment Emergent Adverse Events From Baseline
From day 1 through the end of study follow-up, an average of 15 months.

Safety and tolerability will be evaluated by incidence rate of treatment emergent adverse events from baseline.

Clinically Significant Changes From Baseline Chemistry Laboratory Tests
From day 1 through the end of study follow up, an average of 15 months.

Number of participants with clinically significant changes in clinical laboratory tests

Clinically Significant Changes From Baseline Hematology Laboratory Tests
From day 1 through the end of study follow up, an average of 15 months.

Number of participants with clinically significant changes in clinical laboratory tests.

Clinically Significant Changes From Baseline Vital Signs
From day 1 through the end of study follow up, an average of 15 months.

Number of participants with clinically significant changes in vital signs.

Clinically Significant Changes From Baseline Electrocardiograms (ECGs)
From day 1 through the end of study follow up, an average of 15 months.

Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in mean ventricular rate \[beats/min\].

Clinically Significant Changes From Baseline Electrocardiograms (ECGs) Measures
From day 1 through the end of study follow up, an average of 15 months.

Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in pulse rate \[msec\].

Clinically Significant Changes From Baseline QTC Interval
From day 1 through the end of study follow up, an average of 15 months.

Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QTC interval

Clinically Significant Changes From Baseline QRS Interval
From day 1 through the end of study follow up, an average of 15 months.

Safety will be assessed by evaluating clinically significant changes from Baseline ECGs change in QRS interval.

Secondary Endpoints
Concentration of Lotilaner in Whole Blood
From dose through study completion, an average of 15 months.
Terminal Elimination Half Life (t½) of Lotilaner
At protocol specified timepoints through end study treatment phase, an average of 28 weeks.
Area Under the Concentration Time Curve (AUC) of Lotilaner
At protocol specified timepoints through end of pharmacokinetic sampling, an average of 15 months.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TP-05 (lotilaner) High DoseACTIVE_COMPARATOROral Tablet
PlaceboPLACEBO_COMPARATOROral Tablet
TP-05 (lotilaner) Low DoseACTIVE_COMPARATOROral Tablet
Interventions
NameTypeDescription
TP-05 (lotilaner) Low DoseDRUGTP05 administered orally at the protocol-defined preventative dose.
TP-05 (lotilaner) High DoseDRUGTP05 administered orally at the protocol-defined preventative dose.
PlaceboDRUGMatching placebo administered orally according to the same dosing schedule as TP05.
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Eligibility Criteria
Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites19

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: ...

Countries:United States
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Competitive Landscape -Alzheimer's Disease 66 trials (matched to "Lyme Disease")

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Recent Changes (Last 90 Days)
MEDIUMJul 9, 2026NCT07562087Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 9, 2026NCT07562087Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT07562087primaryCompletionDate: changed
LOWMay 24, 2026NCT07562087studyFirstPostDate: changed
LOWMay 21, 2026NCT07562087NEW_TRIAL: changed
LOWMay 21, 2026NCT07562087NEW_TRIAL: changed