Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lotilaner Gel, 2.0%, lotilaner
Lotilaner, 2.0% · 2 trials · 2 indications
Number of patients with treatment related emergent adverse events (TEAEs)
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 |
|---|---|---|
| Treatment arm | EXPERIMENTAL | lotilaner - high dose and low dose |
| Control arm | OTHER | Vehicle of lotilaner - high dose and low dose |
| 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 | DRUG | lotilaner |
| Vehicle | DRUG | Vehicle of lotilaner |
| 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: * 18 years of age or older at the time of consent. * Has moderate to severe ocular rosacea * Use of acceptable methods of contraception * Are willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol Exclusion Crite...
Lotilaner, 2.0% is an investigational small molecule being developed by Tarsus Pharmaceuticals, Inc. (TARS) for rosacea. It is formulated as a gel and is in Phase 2 clinical development for ocular rosacea and papulopustular rosacea. It is not yet approved for any indication.
Lotilaner, 2.0% is being studied for the treatment of ocular rosacea and papulopustular rosacea. These are inflammatory skin conditions affecting the eyes and face. The drug is investigational and has not been approved for any use.
Lotilaner, 2.0% targets GABA-Cl channels. By acting on these chloride channels, it is designed to interfere with the nervous system of mites that are associated with rosacea. This mechanism is being evaluated in clinical trials for ocular and papulopustular rosacea.
Lotilaner, 2.0% is being developed by Tarsus Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker TARS. The company is conducting Phase 2 clinical trials for ocular rosacea and papulopustular rosacea.
Lotilaner, 2.0% is in Phase 2 clinical development. It is being evaluated in a Phase 2 trial for ocular rosacea and a completed Phase 2 trial for papulopustular rosacea. It is investigational and has not been approved by the FDA.
Lotilaner, 2.0% is being studied in two Phase 2 trials. The KORE trial (NCT07443202) is evaluating lotilaner ophthalmic gel in patients with ocular rosacea and is currently enrolling by invitation. A completed Phase 2 trial (NCT05838170) studied TP-04 in participants with papulopustular rosacea.
Yes, lotilaner, 2.0% is also known as lotilaner gel, 2.0%, or simply lotilaner. These names refer to the same investigational small molecule developed by Tarsus Pharmaceuticals for rosacea. The 2.0% indicates the concentration of the gel formulation.