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Chemical compound
Lotilaner
Trade names Credelio, Xdemvy Other names TP-03
AHFS /
Drugs.com
Monograph
License data
Routes of administration
By mouth ,
eye drops
Drug class
Antiparasitic
ATC code
Legal status
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
PubChem
CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
Formula C 20 H 14 Cl 3 F 6 N 3 O 3 S
Molar mass 596.75 g·mol−1 3D model (
JSmol )
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=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]
Medical uses
Lotilaner is
indicated for the treatment of
Demodex blepharitis.
[1]
Society and culture
Legal status
In March 2024, the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the veterinary medicinal product Lotimax, Chewable tablet, intended for use in dogs..
[9] The applicant for this veterinary medicinal product is Elanco GmbH.
[9]
Veterinary uses
Lotilaner, sold under the brand name Credelio among others, is a
veterinary medication used to control fleas and ticks in dogs and cats.
[2]
[3]
[4]
[10] It is indicated for the treatment and prevention of flea infestations (
Ctenocephalides felis ) and for the treatment and control of tick infestations including
lone star tick (Amblyomma americanum ),
American dog tick (Dermacentor variabilis) ,
black-legged tick (Ixodes scapularis ), and
brown dog tick (Rhipicephalus sanguineus ).
[11] It is taken
by mouth .
[2]
[3]
Lotilaner in combination with
milbemycin oxime is sold under the brand name Credelio Plus.
[12] It is used in dogs to treat concurrent infestations with parasites living outside (ticks and/or fleas) and inside (worms) the animal's body.
[12]
Research
Tarsus Pharmaceuticals has conducted
phase II studies of lotilaner as a remedy to prevent
tick bites in humans.
[13]
[14]
References
^
a
b
c
d
e
"Xdemvy- lotilaner ophthalmic solution solution/ drops" . DailyMed . 26 July 2023. Retrieved 23 August 2023 .
^
a
b
c
"Credelio- lotilaner tablet, chewable" . DailyMed .
Archived from the original on 5 August 2021. Retrieved 4 August 2021 .
^
a
b
c
"Credelio- lotilaner tablet, chewable" . DailyMed .
Archived from the original on 5 August 2021. Retrieved 4 August 2021 .
^
a
b
"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 .
^
a
b
"Lotimax EPAR" . European Medicines Agency . 13 March 2024. Retrieved 20 March 2024 . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ Kuntz EA, Kammanadiminti S (November 2017).
"Safety evaluation of lotilaner in dogs after oral administration as flavoured chewable tablets (Credelio)" . Parasites & Vectors . 10 (1): 538.
doi :
10.1186/s13071-017-2468-y .
PMC
5664904 .
PMID
29089043 .
^
"Freedom Of Information Summary, Supplemental New Animal Drug Application, NADA 141-494, Credelio, Lotilaner, Chewable Tablets, Dogs" . 3 September 2019.
Archived from the original on 18 May 2022. Retrieved 1 December 2019 .
^
a
b
"Credelio Plus EPAR" . European Medicines Agency . 19 February 2021.
Archived from the original on 7 December 2022. Retrieved 4 August 2021 . Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^
"Tarsus Announces Positive Topline Results from Carpo, a Phase 2a Proof-of-Concept "Tick-Kill" Trial Evaluating TP-05 (lotilaner) for the Prevention of Lyme Disease (press release)" . Tarsus Pharmaceuticals . 22 February 2024. Retrieved 17 March 2024 .
^
"A Pill That Kills Ticks Is a Promising New Weapon Against Lyme Disease" .
Wired . 15 March 2024. Retrieved 17 March 2024 .