{"id":34585,"date":"2025-06-03T16:37:51","date_gmt":"2025-06-03T08:37:51","guid":{"rendered":"https:\/\/flcube.com\/?p=34585"},"modified":"2025-06-03T16:37:51","modified_gmt":"2025-06-03T08:37:51","slug":"gsks-linerixibat-nda-accepted-by-fda-for-cholestatic-pruritus-in-pbc-patients","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=34585","title":{"rendered":"GSK’s Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients"},"content":{"rendered":"\n

UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK<\/a>) announced that the New Drug Application (NDA) for its investigational drug linerixibat has been accepted for review by the US Food and Drug Administration (FDA). The application seeks approval for linerixibat as a treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC).<\/p>\n\n\n\n

Clinical Trial Success<\/strong>
The filing is supported by positive results from the Phase III GLISTEN study, which met both primary and secondary endpoints. In the study, linerixibat demonstrated a rapid, significant, and sustained therapeutic effect compared to placebo. It effectively relieved cholestatic itching and improved itch-related sleep impairment in patients with PBC.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that the New Drug Application (NDA) for…<\/p>\n","protected":false},"author":1,"featured_media":34586,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[278,184,38,914],"class_list":["post-34585","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-glaxosmithkline","tag-gsk","tag-market-approval-filings","tag-nyse-gsk"],"yoast_head":"\nGSK's Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that the New Drug Application (NDA) for its investigational drug linerixibat has been accepted for review by the US Food and Drug Administration (FDA). The application seeks approval for linerixibat as a treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=34585\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GSK's Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients\" \/>\n<meta property=\"og:description\" content=\"UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that the New Drug Application (NDA) for its investigational drug linerixibat has been accepted for review by the US Food and Drug Administration (FDA). The application seeks approval for linerixibat as a treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=34585\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-03T08:37:51+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/0304.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=34585#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=34585\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"GSK’s Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients\",\"datePublished\":\"2025-06-03T08:37:51+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=34585\"},\"wordCount\":120,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=34585#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/0304.webp\",\"keywords\":[\"GlaxoSmithKline\",\"GSK\",\"Market approval filings\",\"NYSE: GSK\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=34585#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=34585\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=34585\",\"name\":\"GSK's Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=34585#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=34585#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/0304.webp\",\"datePublished\":\"2025-06-03T08:37:51+00:00\",\"description\":\"UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that the New Drug Application (NDA) for its investigational drug linerixibat has been accepted for review by the US Food and Drug Administration (FDA). The application seeks approval for linerixibat as a treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=34585#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=34585\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=34585#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/0304.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/0304.webp\",\"width\":1080,\"height\":608,\"caption\":\"GSK's Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=34585#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"GSK’s Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"GSK's Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients - Insight, China's Pharmaceutical Industry","description":"UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that the New Drug Application (NDA) for its investigational drug linerixibat has been accepted for review by the US Food and Drug Administration (FDA). The application seeks approval for linerixibat as a treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC).","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=34585","og_locale":"en_US","og_type":"article","og_title":"GSK's Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients","og_description":"UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that the New Drug Application (NDA) for its investigational drug linerixibat has been accepted for review by the US Food and Drug Administration (FDA). The application seeks approval for linerixibat as a treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC).","og_url":"https:\/\/flcube.com\/?p=34585","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-06-03T08:37:51+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/0304.webp","type":"image\/png"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=34585#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=34585"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"GSK’s Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients","datePublished":"2025-06-03T08:37:51+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=34585"},"wordCount":120,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=34585#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/0304.webp","keywords":["GlaxoSmithKline","GSK","Market approval filings","NYSE: GSK"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=34585#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=34585","url":"https:\/\/flcube.com\/?p=34585","name":"GSK's Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=34585#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=34585#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/0304.webp","datePublished":"2025-06-03T08:37:51+00:00","description":"UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that the New Drug Application (NDA) for its investigational drug linerixibat has been accepted for review by the US Food and Drug Administration (FDA). The application seeks approval for linerixibat as a treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=34585#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=34585"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=34585#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/0304.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/0304.webp","width":1080,"height":608,"caption":"GSK's Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=34585#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"GSK’s Linerixibat NDA Accepted by FDA for Cholestatic Pruritus in PBC Patients"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/0304.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/34585","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=34585"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/34585\/revisions"}],"predecessor-version":[{"id":34587,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/34585\/revisions\/34587"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/34586"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=34585"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=34585"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=34585"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}