4 completed, 1 active not recruiting, 1 enrolling by invitation, 1 recruiting. 3 Phase 1, 3 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Completed 2, Recruiting 1 |
| Phase 2 | 3 | Active not recruiting 1, Completed 1, Enrolling by invitation 1 |
| Phase 3 | 1 | Completed 1 |
Follow lotilaner: new trials by email Literature Review of lotilaner trials Research Report on lotilaner
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety, Tolerability, Pharmacokinetics, and Mosquitocidal Activity of Lotilaner in Healthy Participants in Mali. Cohort 1 low dose lotilaner with a high-fat meal, Cohort 1 low dose placebo with a high-fat meal, Cohort 2 high dose lotilaner in fasted state - Malaria | Phase 1 | Recruiting | Medicines for Malaria Venture | 75 | 2026-09-14 | 2026-09-24 |
| A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure TP-05 (lotilaner) Low Dose, TP-05 (lotilaner) High Dose, Placebo - Lyme Disease | Phase 2 | Active not recruiting | Tarsus Pharmaceuticals, Inc. | 722 | 2026-03-09 | 2026-07-09 |
| Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE) lotilaner, Vehicle - Ocular Rosacea | Phase 2 | Enrolling by invitation | Tarsus Pharmaceuticals, Inc. | 155 | 2025-12-05 | 2026-03-02 |
| Study to Evaluate the Food Effect of TP-05 in Healthy Participants TP-05 (lotilaner oral), fasted group, TP-05 (lotilaner oral), high-fat group, TP-05 (lotilaner oral), low-fat group - Healthy | Phase 1 | Completed | Tarsus Pharmaceuticals, Inc. | 42 | 2023-01-19 | 2023-06-28 |
| A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05 Low Dose TP-05, High Dose TP-05, Placebo Comparator - Healthy Volunteer | Phase 2 | Completed | Tarsus Pharmaceuticals, Inc. | 30 | 2022-12-12 | 2024-09-19 |
| Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study Lotilaner, Vehicle Control - Blepharitis | Phase 3 | Completed | LianBio LLC | 163 | 2022-10-23 | 2024-05-21 |
| A Pharmacokinetic Study of TP-05 in Healthy Subjects TP-05 (lotilaner oral capsules), Placebo - Healthy | Phase 1 | Completed | Tarsus Pharmaceuticals, Inc. | 67 | 2021-05-06 | 2022-08-03 |
Lyme Disease (2) · Bacterial Infections (1) · Bacterial Infections and Mycoses (1) · Blepharitis (1) · Borrelia Infections (1) · Gram-Negative Bacterial Infections (1) · Infections (1) · Malaria (1) · Rosacea (1) · Spirochaetales Infections (1) · Tick-Borne Diseases (1) · Vector Borne Diseases (1)
Tarsus Pharmaceuticals, Inc. (5) · LianBio LLC (1) · Medicines for Malaria Venture (1)
United States (5) · China (1) · Mali (1)
Jeremy Lim (1) · Jose Trevejo, MD, PhD (1) · Kavita Dhamdhere, MD, PhD (1) · Linden Hu, MD (1) · Prof. Alassane Dicko, MD, PhD (1) · Yoav Golan (1) · Zuguo Liu, M.D (1)