Lotilaner: Difference between revisions

Lotilaner
Clinical data
Trade names	Credelio, Xdemvy
Other names	TP-03
License data	US DailyMed: Lotilaner;
Routes of; administration	By mouth, eye drops
Drug class	Antiparasitic
ATCvet 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;
ChEMBL	ChEMBL3707310;
CompTox Dashboard (EPA)	DTXSID701027551 ;
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;

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Revision as of 03:03, 6 August 2023

Lotilaner, sold under the brand name Xdemvy, is a medication used for the treatment of Demodex blepharitis.^[1]^[5] It is used as an eye drop.^[1]

Lotilaner is an ectoparasiticide (anti-parasitic).^[1]

It was approved for medical use in the United States in July 2023.^[1]^[5]^[6]^[7]

Medical uses

Lotilaner is indicated for the treatment of Demodex blepharitis.^[1]

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]^[8] 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).^[9]

Lotilaner in combination with milbemycin oxime is sold under the brand name Credelio Plus.^[10] It is used in dogs to treat concurrent infestations with parasites living outside (ticks and/or fleas) and inside (worms) the animal's body.^[10]

References

^ ^a ^b ^c ^d ^e ^f "Xdemvy (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use" (PDF). Archived (PDF) from the original on 27 July 2023. Retrieved 6 August 2023.
^ ^a ^b "Credelio- lotilaner tablet, chewable". DailyMed. Archived from the original on 5 August 2021. Retrieved 4 August 2021.
^ ^a ^b "Credelio- lotilaner tablet, chewable". DailyMed. Archived from the original on 5 August 2021. Retrieved 4 August 2021.
^ ^a ^b "Credelio EPAR". European Medicines Agency. 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.
^ 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.

This antiinfective drug article is a stub. You can help Wikipedia by expanding it.

[Xdemvy_FDA_label-1] ^ ^a ^b ^c ^d ^e ^f "Xdemvy (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use" (PDF). Archived (PDF) from the original on 27 July 2023. Retrieved 6 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. 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] 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.

[9] "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.

[Credelio_Plus_EPAR-10] "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.

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@@ Line 42: / Line 42: @@
 | legal_UK_comment  =
 | legal_US          = Rx-only
-| legal_US_comment  = <ref name="Xdemvy FDA label">{{cite web | url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217603s000lbl.pdf | title=Xdemvy (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use }}</ref><ref name="Credelio dog label">{{cite web | title=Credelio- lotilaner tablet, chewable | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=427f2ebc-ce24-452b-bbb3-43d4ef8b63b0 | access-date=4 August 2021}}</ref><ref name="Credelio cat label">{{cite web | title=Credelio- lotilaner tablet, chewable | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=365b701f-e9a8-458f-90ff-33ca1fb947ca | access-date=4 August 2021}}</ref>
+| legal_US_comment  = <ref name="Xdemvy FDA label">{{cite web | url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217603s000lbl.pdf | title=Xdemvy (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use | access-date=6 August 2023 | archive-date=27 July 2023 | archive-url=https://web.archive.org/web/20230727150956/https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217603s000lbl.pdf | url-status=live }}</ref><ref name="Credelio dog label">{{cite web | title=Credelio- lotilaner tablet, chewable | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=427f2ebc-ce24-452b-bbb3-43d4ef8b63b0 | access-date=4 August 2021 | archive-date=5 August 2021 | archive-url=https://web.archive.org/web/20210805060048/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=427f2ebc-ce24-452b-bbb3-43d4ef8b63b0 | url-status=live }}</ref><ref name="Credelio cat label">{{cite web | title=Credelio- lotilaner tablet, chewable | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=365b701f-e9a8-458f-90ff-33ca1fb947ca | access-date=4 August 2021 | archive-date=5 August 2021 | archive-url=https://web.archive.org/web/20210805054924/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=365b701f-e9a8-458f-90ff-33ca1fb947ca | url-status=live }}</ref>
 | legal_EU          = Rx-only
-| legal_EU_comment  = <ref name="Credelio EPAR">{{cite web | title=Credelio EPAR | website=European Medicines Agency | url=https://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio | access-date=4 August 2021}}</ref>
+| legal_EU_comment  = <ref name="Credelio EPAR">{{cite web | title=Credelio EPAR | website=European Medicines Agency | url=https://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio | access-date=4 August 2021 | archive-date=27 January 2022 | archive-url=https://web.archive.org/web/20220127082517/https://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio | url-status=live }}</ref>
 | legal_UN          = <!-- N I, II, III, IV / P I, II, III, IV -->
 | legal_UN_comment  =
@@ Line 93: / Line 93: @@
 }}
-'''Lotilaner''', sold under the brand name '''Xdemvy''', is a [[medication]] used for the treatment of [[Demodex|''Demodex'']] [[blepharitis]].<ref name="Xdemvy FDA label" /><ref name="Novel Drug Approvals for 2023">{{cite web | title=Novel Drug Approvals for 2023 | website=U.S. [[Food and Drug Administration]] (FDA) | date=25 July 2023 | url=https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 | access-date=5 August 2023}}</ref> It is used as an [[Ophthalmic drug administration|eye drop]].<ref name="Xdemvy FDA label" />
+'''Lotilaner''', sold under the brand name '''Xdemvy''', is a [[medication]] used for the treatment of [[Demodex|''Demodex'']] [[blepharitis]].<ref name="Xdemvy FDA label" /><ref name="Novel Drug Approvals for 2023">{{cite web | title=Novel Drug Approvals for 2023 | website=U.S. [[Food and Drug Administration]] (FDA) | date=25 July 2023 | url=https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 | access-date=5 August 2023 | archive-date=21 January 2023 | archive-url=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 | url-status=live }}</ref> It is used as an [[Ophthalmic drug administration|eye drop]].<ref name="Xdemvy FDA label" />
 Lotilaner is an [[ectoparasiticide]] (anti-parasitic).<ref name="Xdemvy FDA label" />
-It was approved for medical use in the United States in July 2023.<ref name="Xdemvy FDA label" /><ref name="Novel Drug Approvals for 2023" /><ref>{{cite web | title=Xdemvy: FDA-Approved Drugs | publisher=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217603 | access-date=5 August 2023}}</ref><ref>{{cite press release | title=FDA Approves Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis | publisher=Tarsus Pharmaceuticals | via=GlobeNewswire | date=25 July 2023 | url=https://www.globenewswire.com/en/news-release/2023/07/25/2710273/0/en/FDA-Approves-XDEMVY-lotilaner-ophthalmic-solution-0-25-for-the-treatment-of-Demodex-blepharitis.html | access-date=5 August 2023}}</ref>
+It was approved for medical use in the United States in July 2023.<ref name="Xdemvy FDA label" /><ref name="Novel Drug Approvals for 2023" /><ref>{{cite web | title=Xdemvy: FDA-Approved Drugs | publisher=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217603 | access-date=5 August 2023 | archive-date=27 July 2023 | archive-url=https://web.archive.org/web/20230727150956/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217603 | url-status=live }}</ref><ref>{{cite press release | title=FDA Approves Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis | publisher=Tarsus Pharmaceuticals | via=GlobeNewswire | date=25 July 2023 | url=https://www.globenewswire.com/en/news-release/2023/07/25/2710273/0/en/FDA-Approves-XDEMVY-lotilaner-ophthalmic-solution-0-25-for-the-treatment-of-Demodex-blepharitis.html | access-date=5 August 2023}}</ref>
 == Medical uses ==
@@ Line 103: / Line 103: @@
 == 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.<ref name="Credelio dog label" /><ref name="Credelio cat label" /><ref name="Credelio EPAR" /><ref>{{cite journal | vauthors = Kuntz EA, Kammanadiminti S | title = Safety evaluation of lotilaner in dogs after oral administration as flavoured chewable tablets (Credelio) | journal = Parasites & Vectors | volume = 10 | issue = 1 | pages = 538 | date = November 2017 | pmid = 29089043 | pmc = 5664904 | doi = 10.1186/s13071-017-2468-y | doi-access = free }}</ref> 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)'', [[Ixodes scapularis|black-legged tick]] (''Ixodes scapularis''), and [[brown dog tick]] (''Rhipicephalus sanguineus'').<ref>{{Cite web | url = https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/7663 | title = Freedom Of Information Summary, Supplemental New Animal Drug Application, NADA 141-494, Credelio, Lotilaner, Chewable Tablets, Dogs | date = 3 September 2019 }}</ref>
+Lotilaner, sold under the brand name '''Credelio''' among others, is a [[veterinary medication]] used to control fleas and ticks in dogs and cats.<ref name="Credelio dog label" /><ref name="Credelio cat label" /><ref name="Credelio EPAR" /><ref>{{cite journal | vauthors = Kuntz EA, Kammanadiminti S | title = Safety evaluation of lotilaner in dogs after oral administration as flavoured chewable tablets (Credelio) | journal = Parasites & Vectors | volume = 10 | issue = 1 | pages = 538 | date = November 2017 | pmid = 29089043 | pmc = 5664904 | doi = 10.1186/s13071-017-2468-y | doi-access = free }}</ref> 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)'', [[Ixodes scapularis|black-legged tick]] (''Ixodes scapularis''), and [[brown dog tick]] (''Rhipicephalus sanguineus'').<ref>{{Cite web | url = https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/7663 | title = Freedom Of Information Summary, Supplemental New Animal Drug Application, NADA 141-494, Credelio, Lotilaner, Chewable Tablets, Dogs | date = 3 September 2019 | access-date = 1 December 2019 | archive-date = 18 May 2022 | archive-url = https://web.archive.org/web/20220518060831/https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/7663 | url-status = live }}</ref>
-Lotilaner in combination with [[milbemycin oxime]] is sold under the brand name Credelio Plus.<ref name="Credelio Plus EPAR">{{cite web | title=Credelio Plus EPAR | website=European Medicines Agency | date=19 February 2021 | url=https://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio-plus | access-date=4 August 2021}} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> It is used in dogs to treat concurrent infestations with parasites living outside (ticks and/or fleas) and inside (worms) the animal's body.<ref name="Credelio Plus EPAR" />
+Lotilaner in combination with [[milbemycin oxime]] is sold under the brand name Credelio Plus.<ref name="Credelio Plus EPAR">{{cite web | title=Credelio Plus EPAR | website=European Medicines Agency | date=19 February 2021 | url=https://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio-plus | access-date=4 August 2021 | archive-date=7 December 2022 | archive-url=https://web.archive.org/web/20221207022222/https://www.ema.europa.eu/en/medicines/veterinary/EPAR/credelio-plus | url-status=live }} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> It is used in dogs to treat concurrent infestations with parasites living outside (ticks and/or fleas) and inside (worms) the animal's body.<ref name="Credelio Plus EPAR" />
 == References ==

v t e Pest control: Insecticides
Carbamates	Aldicarb Aminocarb Bendiocarb Butocarboxim Carbaryl Carbofuran Carbosulfan m-Cumenyl methylcarbamate Ethienocarb Fenobucarb Isoprocarb Methomyl Metolcarb Oxamyl Promecarb Propoxur
Inorganic compounds	Aluminium phosphide Boric acid Chromated copper arsenate Copper(II) arsenate Copper(I) cyanide Cryolite Diatomaceous earth Lead hydrogen arsenate Paris Green Scheele's Green
Insect growth regulators	Benzoylureas Diflubenzuron Flufenoxuron Hydroprene Lufenuron Methoprene Pyriproxyfen
Neonicotinoids	Acetamiprid Clothianidin Dinotefuran Imidacloprid Imidaclothiz Nitenpyram Nithiazine Paichongding Thiacloprid Thiamethoxam
Organochlorides	Aldrin Beta-HCH Carbon tetrachloride Chlordane Cyclodiene 1,2-DCB 1,4-DCB 1,1-DCE 1,2-DCE DDD DDE DDT DFDT Dicofol Dieldrin Endosulfan Endrin Heptachlor Kepone Lindane Methoxychlor Mirex Tetradifon Toxaphene
Organophosphorus	Acephate Azamethiphos Azinphos-methyl Bensulide Chlorethoxyfos Chlorfenvinphos Chlorpyrifos Chlorpyrifos-methyl Coumaphos Demeton-S-methyl Diazinon Dichlorvos Dicrotophos Diisopropyl fluorophosphate Dimefox Dimethoate Dioxathion Disulfoton Ethion Ethoprop Fenamiphos Fenitrothion Fenthion Fosthiazate Isoxathion Malathion Methamidophos Methidathion Mevinphos Mipafox Monocrotophos Naled Omethoate Oxydemeton-methyl Parathion Parathion-methyl Phenthoate Phorate Phosalone Phosmet Phoxim Pirimiphos-methyl Quinalphos R-16661 Schradan Temefos Tebupirimfos Terbufos Tetrachlorvinphos Tribufos Trichlorfon
Pyrethroids	Acrinathrin Allethrins Bifenthrin Bioallethrin Cyfluthrin Cyhalothrin Cypermethrin Cyphenothrin Deltamethrin Empenthrin Esfenvalerate Etofenprox Fenpropathrin Fenvalerate Flumethrin Fluvalinate Imiprothrin Metofluthrin Permethrin Phenothrin Prallethrin Pyrethrin (I, II; chrysanthemic acid) Pyrethrum Resmethrin Silafluofen Tefluthrin Tetramethrin Tralomethrin Transfluthrin
Ryanoids	Chlorantraniliprole Cyantraniliprole Flubendiamide Ryanodine Ryanodol
Other chemicals	Afoxolaner Amitraz Azadirachtin Bensultap Buprofezin Cartap Chlordimeform Chlorfenapyr Cyromazine Fenazaquin Fenoxycarb Fipronil Fluralaner Hydramethylnon Indoxacarb Limonene Lotilaner (+milbemycin oxime) Pyridaben Pyriprole Sarolaner Adjuvants (Piperonyl butoxide, Sesamex) Spinosad Sulfluramid Tebufenozide Tebufenpyrad Veracevine Xanthone Metaflumizone
Metabolites	Oxon Malaoxon Paraoxon TCPy
Biopesticides	Bacillus thuringiensis Baculovirus Beauveria bassiana Beauveria brongniartii Isaria fumosorosea Metarhizium acridum Metarhizium anisopliae Nomuraea rileyi Lecanicillium lecanii Paenibacillus popilliae Purpureocillium lilacinum Spinosad