Uses
XDEMVY is indicated for the treatment of Demodex blepharitis. XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis.
Source: US FDA prescribing information
Molecule
Lotilaner
Ectoparasiticide
Available on request
- Presentations
- 1
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Lotilaner is an ectoparasiticide indicated for the treatment of Demodex blepharitis. It is available as eye drops for ophthalmic use. MedsAcross supplies Lotilaner for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Ectoparasiticide
- US FDA first approval
- 24 July 2023
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Ophthalmic
- Dosage forms
- Eye drops
- Identifiers
- UNII HEH4938D7KCAS 1369852-71-0DrugBank DB17992Q27279888
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Lotilaner is a gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor selective for mites. Inhibition of these GABA chloride channels causes a 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 µM (18 µg/mL) in vitro (approximately 1100 times the RHOD).
Source: US FDA prescribing information
Dosing overview
Instill one drop of XDEMVY in each eye twice daily (approximately 12 hours apart) for 6 weeks. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. If one dose is missed, treatment should continue with the next scheduled dose.
Source: US FDA prescribing information
Contraindications
None. None.
Source: US FDA prescribing information
Warnings and precautions
Risk of Contamination Do not allow the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Source: US FDA prescribing information
Side effects
The most common adverse reaction was instillation site stinging and burning (10%).
Source: US FDA prescribing information
Storage
Store at 15°C to 25°C (59°F to 77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
1 presentations of Lotilaner, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Xdemvy 2.5 mg/mL eye dropsOphthalmic | Tarsus Pharmaceuticals | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 24 July 2023 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Questions and answers
Is Lotilaner available for export from India?
Yes, on request. MedsAcross lists 1 presentations of Lotilaner and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Lotilaner have?
The catalogue lists 1 brand names for Lotilaner, including Xdemvy.
Is Lotilaner approved by the US FDA?
Yes. The US FDA first approved Lotilaner on 24 July 2023, according to Drugs@FDA.
Does Lotilaner need cold chain shipping?
No listed presentation of Lotilaner is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
References
- XDEMVY prescribing information (Tarsus Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 10 August 2024
Request Lotilaner for export supply
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