Treats Demodex blepharitis. Sold as Xdemvy. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Lotilaner (sold as Xdemvy), first approved Jul 24, 2023, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Xdemvy | Part D | $341M | +199% | 160,278 |
| Safety, Tolerability, Pharmacokinetics, and Mosquitocidal Activity of Lotilaner in Healthy Participants in Mali.Malaria · Medicines for Malaria Venture | Phase 1 | Recruiting | Aug 11, 2026 |
| A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick ExposureLyme Disease · Tarsus Pharmaceuticals, Inc. | Phase 2 | Active, not recruiting | May 1, 2026 |
| Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)Ocular Rosacea · Tarsus Pharmaceuticals, Inc. | Phase 2 | Enrolling by invitation | Mar 2, 2026 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
