Lotilaner information

Lotilaner
Clinical data
Trade names	Credelio, Xdemvy
Other names	TP-03
AHFS/Drugs.com	Monograph
License data	US DailyMed: Lotilaner;
Routes of; administration	By mouth, eye drops
Drug class	Antiparasitic
ATC code	QP53BE04 (WHO);
Legal status
Legal status	US: ℞-only; EU: Rx-only;
Identifiers
	IUPAC name 3-Methyl-N-[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl]-5-[(5S)-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-4H-1,2-oxazol-3-yl]thiophene-2-carboxamide;
CAS Number	1369852-71-0;
PubChem CID	76959255;
DrugBank	DB17992;
ChemSpider	32699771;
UNII	HEH4938D7K;
KEGG	D11212;
ChEBI	CHEBI:229657;
ChEMBL	ChEMBL3707310;
Chemical and physical data
Formula	C20H14Cl3F6N3O3S
Molar mass	596.75 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES Cc1cc(C2=NO[C@@](c3cc(Cl)c(Cl)c(Cl)c3)(C(F)(F)F)C2)sc1C(=O)NCC(=O)NCC(F)(F)F;
	InChI InChI=1S/C20H14Cl3F6N3O3S/c1-8-2-13(36-16(8)17(34)30-6-14(33)31-7-19(24,25)26)12-5-18(35-32-12,20(27,28)29)9-3-10(21)15(23)11(22)4-9/h2-4H,5-7H2,1H3,(H,30,34)(H,31,33)/t18-/m0/s1; Key:HDKWFBCPLKNOCK-SFHVURJKSA-N;

Lotilaner, sold under the brand name Xdemvy, is an ectoparasiticide (anti-parasitic) medication used for the treatment of blepharitis (inflammation of the eyelid) caused by infestation by Demodex (tiny mites).^[1]^[5] It is used as an eye drop.^[1]

It was approved for medical use in the United States in July 2023.^[1]^[5]^[6]^[7] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.^[8]

^ ^a ^b ^c ^d "Xdemvy- lotilaner ophthalmic solution solution/ drops". DailyMed. 26 July 2023. Retrieved 23 August 2023.
^ "Credelio- lotilaner tablet, chewable". DailyMed. Archived from the original on 5 August 2021. Retrieved 4 August 2021.
^ "Credelio- lotilaner tablet, chewable". DailyMed. Archived from the original on 5 August 2021. Retrieved 4 August 2021.
^ "Credelio EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 27 January 2022. Retrieved 4 August 2021.
^ ^a ^b "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 25 July 2023. Archived from the original on 21 January 2023. Retrieved 5 August 2023.
^ "Xdemvy: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 27 July 2023. Retrieved 5 August 2023.
^ "FDA Approves Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis" (Press release). Tarsus Pharmaceuticals. 25 July 2023. Retrieved 5 August 2023 – via GlobeNewswire.
^ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.

[Xdemvy_FDA_label-1] "Xdemvy- lotilaner ophthalmic solution solution/ drops". DailyMed. 26 July 2023. Retrieved 23 August 2023.

[Credelio_dog_label-2] "Credelio- lotilaner tablet, chewable". DailyMed. Archived from the original on 5 August 2021. Retrieved 4 August 2021.

[Credelio_cat_label-3] "Credelio- lotilaner tablet, chewable". DailyMed. Archived from the original on 5 August 2021. Retrieved 4 August 2021.

[Credelio_EPAR-4] "Credelio EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 27 January 2022. Retrieved 4 August 2021.

[Novel_Drug_Approvals_for_2023-5] "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 25 July 2023. Archived from the original on 21 January 2023. Retrieved 5 August 2023.

[6] "Xdemvy: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 27 July 2023. Retrieved 5 August 2023.

[7] "FDA Approves Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis" (Press release). Tarsus Pharmaceuticals. 25 July 2023. Retrieved 5 August 2023 – via GlobeNewswire.

[8] New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.

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