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Also known as lotilaner
Lotilaner, 2.0% · 1 trial · 1 indication
Incidence of local and systemic TEAEs while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel from baseline
Changes from baseline in vital signs change in height in cm while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in weight in kg while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in systolic/diastolic blood pressure in mmHg while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in pulse in beats per minute while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in respiratory rate in breaths per minute while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in temperature in Celsius while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in ECGs change in QRS interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in ECGs change in mean ventricular rate (beats/min) while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in ECGs change in QTC interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline clinical chemistry laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline hematology laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Evaluate local tolerability assessment ((0=none, 3=severe): dryness, scaling, erythema, burning/stinging; itching) of Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
| Arm | Type | Description |
|---|---|---|
| Lotilaner Gel, 2.0% (TP-04) | EXPERIMENTAL | Participants will be randomized to a 2:1 ratio at baseline to apply Lotilaner Gel, 2.0% (TP-04) on the face BID for 12 weeks. |
| Vehicle-Controlled | PLACEBO_COMPARATOR | Participants will be randomized to a 2:1 ratio at baseline to apply vehicle control gel on the face BID for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Lotilaner Gel, 2.0% | DRUG | Lotilaner Gel, 2.0% (TP-04) is an aqueous gel formulation of lotilaner, a member of the isoxazoline family of compounds and parasiticide that selectively inhibits parasite-specific gamma-aminobutyric acid (GABA)-gated chloride channels (GABA-Cls). |
| Vehicle control gel | OTHER | Aqueous gel |
Inclusion criteria: 1. Participant is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures. 2. Male or female participant aged 18 to 59 years, inclusive, at the time of consent. 3. Participant has at least a 6-month h...
Lotilaner, 2.0% is an investigational small molecule being studied for the treatment of ocular rosacea and papulopustular rosacea. It is developed by Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS). The drug is currently in Phase 2 clinical development for these dermatological conditions.
Lotilaner, 2.0% is a small molecule that targets and inhibits parasite-specific GABA-gated chloride channels, leading to paralysis and death of parasites. This mechanism is being evaluated for its potential to treat rosacea by addressing underlying parasitic factors. The drug is administered topically as an ophthalmic gel or other formulation.
Lotilaner, 2.0% is being developed by Tarsus Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol TARS. Tarsus is conducting clinical trials to evaluate the drug's safety and efficacy for treating ocular rosacea and papulopustular rosacea.
Lotilaner, 2.0% is in Phase 2 clinical development. It is not FDA approved and remains investigational. Two Phase 2 trials have been conducted or are ongoing: one completed study in papulopustular rosacea and another enrolling study in ocular rosacea.
Lotilaner, 2.0% is being studied in two Phase 2 trials. NCT05838170, a completed study in papulopustular rosacea with 37 participants in Canada, and NCT07443202, an enrolling study in ocular rosacea with 155 participants in the United States. Both are randomized, double-blind, placebo-controlled trials.
Yes, Lotilaner, 2.0% is the same drug as lotilaner. The 2.0% refers to the concentration of the active ingredient in the formulation being studied. Lotilaner is the generic name for this small molecule compound developed by Tarsus Pharmaceuticals.