Lotilaner Explained

Tradename:Credelio, Xdemvy
Dailymedid:Lotilaner
Routes Of Administration:By mouth, eye drops
Class:Antiparasitic
Legal Us:Rx-only
Legal Us Comment:[1] [2] [3]
Legal Eu:Rx-only
Legal Eu Comment:[4]
Cas Number:1369852-71-0
Pubchem:76959255
Drugbank:DB17992
Chemspiderid:32699771
Unii:HEH4938D7K
Kegg:D11212
Chebi:229657
Chembl:3707310
Synonyms:TP-03
Iupac Name:3-Methyl-N-[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl]-5-[(5''S'')-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-4''H''-1,2-oxazol-3-yl]thiophene-2-carboxamide
C:20
H:14
Cl:3
F:6
N:3
O:3
S:1
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
Stdinchi: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
Stdinchikey: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).[5] It is used as an eye drop.

It was approved for medical use in the United States in July 2023.[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.

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. The applicant for this veterinary medicinal product is Elanco GmbH.[9] Lotimax was approved for medical use in the European Union in April 2024.[10]

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.[11] 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).[12] It is taken by mouth.

Lotilaner in combination with milbemycin oxime is sold under the brand name Credelio Plus.[13] It is used in dogs to treat concurrent infestations with parasites living outside (ticks and/or fleas) and inside (worms) the animal's body.

Lotilaner (Lotimax) is used for the treatment of flea and tick infestations in dogs—treatment of demodicosis (caused by Demodex canis).

Research

Tarsus Pharmaceuticals has conducted phase II studies of lotilaner as a remedy to prevent tick bites in humans.[14] [15]

Notes and References

  1. Web site: Xdemvy- lotilaner ophthalmic solution solution/ drops . DailyMed . 26 July 2023 . 23 August 2023.
  2. Web site: Credelio- lotilaner tablet, chewable . DailyMed . 4 August 2021 . 5 August 2021 . https://web.archive.org/web/20210805060048/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=427f2ebc-ce24-452b-bbb3-43d4ef8b63b0 . live .
  3. Web site: Credelio- lotilaner tablet, chewable . DailyMed . 4 August 2021 . 5 August 2021 . https://web.archive.org/web/20210805054924/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=365b701f-e9a8-458f-90ff-33ca1fb947ca . live .
  4. Web site: Credelio EPAR . European Medicines Agency (EMA) . 17 September 2018 . 4 August 2021 . 27 January 2022 . https://web.archive.org/web/20220127082517/https://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio . live .
  5. Web site: Novel Drug Approvals for 2023 . U.S. Food and Drug Administration (FDA) . 25 July 2023 . 5 August 2023 . 21 January 2023 . https://web.archive.org/web/20230121035617/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 . live .
  6. Web site: Xdemvy: FDA-Approved Drugs . U.S. Food and Drug Administration (FDA) . 5 August 2023 . 27 July 2023 . https://web.archive.org/web/20230727150956/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217603 . live .
  7. FDA Approves Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis . Tarsus Pharmaceuticals . GlobeNewswire . 25 July 2023 . 5 August 2023.
  8. New Drug Therapy Approvals 2023 . U.S. Food and Drug Administration (FDA) . January 2024 . PDF . 9 January 2024 . https://web.archive.org/web/20240110032419/https://www.fda.gov/media/175253/download . 10 January 2024 . live .
  9. Web site: Lotimax EPAR . European Medicines Agency . 13 March 2024 . 20 March 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  10. Web site: Lotimax PI . Union Register of medicinal products . 29 April 2024 . 17 June 2024.
  11. Kuntz EA, Kammanadiminti S . Safety evaluation of lotilaner in dogs after oral administration as flavoured chewable tablets (Credelio) . Parasites & Vectors . 10 . 1 . 538 . November 2017 . 29089043 . 5664904 . 10.1186/s13071-017-2468-y . free .
  12. Web site: Freedom Of Information Summary, Supplemental New Animal Drug Application, NADA 141-494, Credelio, Lotilaner, Chewable Tablets, Dogs . 3 September 2019 . 1 December 2019 . 18 May 2022 . https://web.archive.org/web/20220518060831/https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/7663 . live .
  13. Web site: Credelio Plus EPAR . European Medicines Agency . 19 February 2021 . 4 August 2021 . 7 December 2022 . https://web.archive.org/web/20221207022222/https://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio-plus . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. Web site: 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 Feb 2024 . 17 March 2024 .
  15. A Pill That Kills Ticks Is a Promising New Weapon Against Lyme Disease . . 15 March 2024 . 17 March 2024 .

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