Wednesday, July 8, 2026

Drug profile · INN

lotilaner

lotilaner (XDEMVY) is a ectoparasiticide. Associated with Tarsus Pharmaceuticals. Route of administration: ophthalmic. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 8
Pipeline programs 7
News articles 0
Drug details — lotilaner
US status
approved
Class
Route
OPHTHALMIC
Patents
8
Programs
7
Data quality
0.89

Quick answer

lotilaner (XDEMVY) is a ectoparasiticide. Associated with Tarsus Pharmaceuticals. Route of administration: ophthalmic. Current US regulatory status: approved.

Key facts

INN lotilaner
Brand XDEMVY
Mechanism Ectoparasiticide
Route OPHTHALMIC
Formulation SOLUTION/DROPS

Mechanism of action

Ectoparasiticide

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Lotilaner Gel, 2.0% Phase 2 · Tarsus Pharmaceuticals · Papulopustular Rosacea
  2. TP-05 (lotilaner) Low Dose Phase 2 · Tarsus Pharmaceuticals · Lyme Disease
  3. lotilaner Phase 2 · Tarsus Pharmaceuticals · Ocular Rosacea
  4. TP-03 (Lotilaner Ophthalmic Solution), 0.25% Phase 1 · Tarsus Pharmaceuticals · Healthy
  5. TP-05 (lotilaner oral capsules) Phase 1 · Tarsus Pharmaceuticals · Healthy
  6. TP-05 (lotilaner oral), fasted group Phase 1 · Tarsus Pharmaceuticals · Healthy
  7. Lotilaner ophthalmic solution, 0.25% Approved · Tarsus Pharmaceuticals · Demodex Blepharitis
  1. US 12364685

    Isoxazoline parasiticide formulations

    Expires Mon Jul 17 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12213964

    Isoxazoline parasiticide formulations

    Expires Mon Jan 30 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12171750

    Isoxazoline parasiticide formulations and methods for treating blepharitis

    Expires Mon Dec 19 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11752137

    Ophthalmic compositions for treating ocular Demodex using lotilaner formulations

    Expires Mon Sep 07 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11690826

    Methods for treating demodex blepharitis using lotilaner formulations

    Expires Mon Jun 29 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11690827

    Methods for treating ocular Demodex using lotilaner formulations

    Expires Mon Jun 29 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11197847

    Isoxazoline parasiticide formulations and methods for treating blepharitis

    Expires Mon Dec 09 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 10835517

    Methods for treating ocular demodex using isoxazoline parasiticide formulations

    Expires Mon Nov 12 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is lotilaner?

lotilaner (XDEMVY) is a ectoparasiticide. Associated with Tarsus Pharmaceuticals. Route of administration: ophthalmic. Current US regulatory status: approved.

What is the brand name for lotilaner?

XDEMVY is a marketed brand name for lotilaner. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of lotilaner?

lotilaner has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.