{"id":7616,"date":"2021-11-27T08:50:43","date_gmt":"2021-11-27T08:50:43","guid":{"rendered":"https:\/\/xspraypharma.com\/?page_id=7616"},"modified":"2026-04-17T13:29:56","modified_gmt":"2026-04-17T13:29:56","slug":"pipeline","status":"publish","type":"page","link":"https:\/\/xspraypharma.com\/sv\/pipeline\/","title":{"rendered":"Pipeline"},"content":{"rendered":"\n\n
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Produktportf\u00f6lj<\/h2>\n

Xspray Pharmas produktportf\u00f6lj utvecklas kontinuerligt och omfattar hittills fyra kommunicerade produktkandidater baserade p\u00e5 bolagets HyNap plattform; Dasynoc (dasatinib), Nilopki (nilotinib), XS008 axitinib och XS025 cabozantinib. Dessa \u00e4r f\u00f6rb\u00e4ttrade, amorfa versioner av redan etablerade och marknadsf\u00f6rda proteinkinash\u00e4mmare (PKI) med s\u00e4rl\u00e4kemedelsstatus. Originall\u00e4kemedlen har sekund\u00e4ra patent som l\u00f6per ut under perioden 2026\u20132032 och den sammanlagda \u00e5rliga f\u00f6rs\u00e4ljningen f\u00f6r dessa \u00f6versteg USD 5,2 miljarder \u00e5r 2023 p\u00e5 den amerikanska marknaden.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\t\t\t\t\t

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Nya valda projekt inriktas mot samma indikationer som Dasynoc\u00ae<\/strong> och XS003 nilotinib men ocks\u00e5 mot nya cancerindikationer. De utvecklingsprocesser som har skapats med Dasynoc\u00ae<\/strong> och XS003 nilotinib anv\u00e4nds f\u00f6r nya projekt vilket f\u00f6rkortar utvecklingstiderna f\u00f6r dessa.<\/p>\n

Dasynoc\u00ae (dasatinib)
\n<\/strong>Dasynoc\u00ae \u00e4r en f\u00f6rb\u00e4ttrad version av Sprycel\u00ae f\u00f6r behandling av kronisk myeloisk leukemi (KML) och akut lymfoblastisk leukemi (ALL) och har av FDA beviljats s\u00e4rl\u00e4kemedelsstatus i USA f\u00f6r b\u00e5de KML och ALL. Studier bekr\u00e4ftar att:<\/p>\n

\u2022 Dasynoc\u00ae<\/strong> \u00e4r op\u00e5verkad av magens pH-v\u00e4rde och d\u00e4rmed kan anv\u00e4ndas tillsammans med omeprazol och andra antacida utan att absorptionen av l\u00e4kemedlet p\u00e5verkas. Detta m\u00f6jligg\u00f6r samtidig behandling av vanliga sjukdomar i mags\u00e4cken, som mags\u00e5r och gastrit, med till exempel protonpumpsh\u00e4mmare (PPI) och antacida samtidigt som patienten behandlas f\u00f6r sin cancer
\n\u2022 Dasynoc\u00ae<\/strong> ger ett j\u00e4mnare upptag av l\u00e4kemedlet i kroppen j\u00e4mf\u00f6rt med de variationer som setts i tidigare studier av originalprodukten
\n\u2022 Dasynoc\u00ae<\/strong> kan ges med en 30 procent l\u00e4gre dos \u00e4n originalprodukten vilket f\u00f6rv\u00e4ntas ge f\u00e4rre biverkningar<\/p>\n

FDAs granskning av bolagets ans\u00f6kan om marknadsgodk\u00e4nnande f\u00f6r Dasynoc\u00ae \u00e4r p\u00e5g\u00e5ende. Dasynocs bekr\u00e4ftade profilf\u00f6rdelar, som i genomf\u00f6rda marknadsunders\u00f6kningar st\u00f6ds av s\u00e5v\u00e4l patientf\u00f6retr\u00e4dare som betalare, m\u00f6jligg\u00f6r ett gynnsamt l\u00e4ge f\u00f6r lansering p\u00e5 en v\u00e4letablerad, stabil och v\u00e4rdefull marknad. 2024 uppgick den globala marknaden f\u00f6r Sprycel\u00ae, vars sekund\u00e4ra patent g\u00e5r ut under 2026, till cirka USD 1,93 miljarder, varav den amerikanska marknaden stod f\u00f6r cirka USD 1,45 miljarder. Marknadsv\u00e4rdet f\u00f6r Dasynoc \u00e4r h\u00f6gt b\u00e5de under och efter patentf\u00f6nstrets slut.<\/p>\n

Nilopki (nilotinib)<\/strong>
\nXspray Pharmas produktkandidat Nilopki \u00e4r en amorf icke-kristallin nilotinib f\u00f6r behandling av kronisk myeloisk leukemi (KML). Den amerikanska l\u00e4kemedelsmyndigheten FDA har beviljat s\u00e4rl\u00e4kemedelsstatus f\u00f6r Nilopki f\u00f6r behandling av KML, med anledning av att Nilopki adresserar den f\u00f6dointeraktion som inkluderas i varningstext f\u00f6r Tasigna\u00ae i USA. Nilopki utvecklas som en f\u00f6rb\u00e4ttrad version av det kristallina originall\u00e4kemedlet Tasigna\u00ae.<\/p>\n

I studier har Nilopki visat matchande biotillg\u00e4nglighet med Tasigna\u00ae vid mer \u00e4n 50% l\u00e4gre dos. Detta betyder att en l\u00e4gre dos Nilopki j\u00e4mf\u00f6rt med Tasigna\u00ae ger j\u00e4mf\u00f6rbara plasmakoncentrationer av nilotinib. Eftersom Tasigna\u00ae \u00e4r en h\u00f6gvariabel produkt med pH-beroende l\u00f6slighet, har det varit utmanande att optimera den l\u00e4gre dosstyrkan f\u00f6r Nilopki f\u00f6r att uppn\u00e5 j\u00e4mf\u00f6rbar biotillg\u00e4nglighet.<\/p>\n

Xspray Pharma har l\u00e4mnat in en ans\u00f6kan till FDA om marknadsgodk\u00e4nnande f\u00f6r Nilopki i USA enligt det f\u00f6renklade 505(b)(2) NDA f\u00f6rfarandet. PDUFA datum \u00e4r satt till den 18 juni 2026.<\/p>\n

Den globala f\u00f6rs\u00e4ljningen av Tasigna\u00ae uppgick till USD 1,85 miljarder \u00e5r 2023, varav den amerikanska marknaden stod f\u00f6r USD 0,88 miljarder. Tasignas\u00ae substanspatent g\u00e5r ut i januari 2024 och sekund\u00e4rpatenten i oktober 2032.<\/p>\n

XS008 axitinib
\n<\/strong>Xspray Pharmas produktkandidat XS008 \u00e4r en amorf icke-kristallin axitinib som anv\u00e4nds i behandling av njurcancer. Den f\u00f6r n\u00e4rvarande marknadsf\u00f6rda produkten som bygger p\u00e5 axitinib \u00e4r Inlyta\u00ae, vars patentutg\u00e5ngar skapar ett attraktivt lanseringsf\u00f6nster som l\u00f6per mellan april 2025 och december 2030 i USA. PKI-marknaden f\u00f6r njurcancer omsatte cirka 3 miljarder USD i USA under 2023. F\u00f6rs\u00e4ljningen av Inlyta uppgick till 0,64 miljarder USD i USA och 1,04 miljarder USD globalt under 2023.<\/p>\n

XS025 cabozantinib
\n<\/strong>Xspray Pharmas produktkandidat XS025 \u00e4r en amorf icke-kristallin cabozantinib som anv\u00e4nds vid njurcellscancer och andra cancerformer. Den f\u00f6r n\u00e4rvarande marknadsf\u00f6rda produkten som bygger p\u00e5 cabozantinib \u00e4r Cabometyx\u00ae, vars substanspatent g\u00e5r ut i augusti 2026 och sekund\u00e4rpatenten g\u00e5r ut i juli 2033. Cabozantinib uppn\u00e5dde 1,81 miljarder USD i nettof\u00f6rs\u00e4ljningsint\u00e4kter i USA f\u00f6r\u00a0 r\u00e4kenskaps\u00e5ret 2024.<\/p>\n\t\t\t<\/div>\n\t\t\t<\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-7616","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nPipeline - Xspray<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/xspraypharma.com\/sv\/pipeline\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pipeline - Xspray\" \/>\n<meta property=\"og:url\" content=\"https:\/\/xspraypharma.com\/sv\/pipeline\/\" \/>\n<meta property=\"og:site_name\" content=\"Xspray\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-17T13:29:56+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/xspraypharma.com\/sv\/pipeline\/\",\"url\":\"https:\/\/xspraypharma.com\/sv\/pipeline\/\",\"name\":\"Pipeline - 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