Last reviewed · How we verify
Xdemvy (LOTILANER)
Xdemvy works by targeting and killing Demodex mites that cause blepharitis.
At a glance
| Generic name | LOTILANER |
|---|---|
| Sponsor | Tarsus |
| Drug class | Ectoparasiticide [EPC] |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Lotilaner is gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor selective for mites. Inhibition of these GABA chloride channels causes paralytic action in the target organism leading to its death. Lotilaner is not an inhibitor of mammalian GABA mediated chloride channels when tested at up to 30 uM (18 ug/mL) in vitro (approximately 1100 times the RHOD).
Approved indications
- Demodex blepharitis
Common side effects
- instillation site stinging and burning
- chalazion/hordeolum
- punctate keratitis
Key clinical trials
- Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE) (PHASE2)
- Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD (PHASE2)
- Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers (PHASE4)
- A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05 (PHASE2)
- Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study (PHASE3)
- A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects (PHASE1)
- Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex (PHASE2)
- Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (PHASE2,PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xdemvy CI brief — competitive landscape report
- Xdemvy updates RSS · CI watch RSS
- Tarsus portfolio CI