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lotilaner

Phase 2

Ocular Rosacea | Small molecule | Dermatology |Tarsus Pharmaceuticals, Inc.|Last Updated: Mar 2, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment155

FDA Designations

No designations recorded

Clinical trial landscape

lotilaner · 1 trial · 1 indication

Phase 2 1
NCT07443202Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)Ocular Rosacea
ENROLLING BY_INVITATION155 Analytics
PHASE2ENROLLING BY_INVITATION
Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)
Ocular RosaceaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment Emergent Adverse Events
Week 16

Number of patients with treatment related emergent adverse events (TEAEs)

Secondary Endpoints

Intraocular pressure
Week 16
Visual acuity
Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment armEXPERIMENTALlotilaner - high dose and low dose
Control armOTHERVehicle of lotilaner - high dose and low dose

Interventions

NameTypeDescription
lotilanerDRUGlotilaner
VehicleDRUGVehicle of lotilaner
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

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...

Countries:United States
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Frequently asked questions about lotilaner

What is Lotilaner, 2.0% used for?

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.

How does Lotilaner, 2.0% work?

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.

Who makes Lotilaner, 2.0%?

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.

What phase is Lotilaner, 2.0% in?

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.

What clinical trials is Lotilaner, 2.0% in?

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.

Is Lotilaner, 2.0% the same as lotilaner?

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.