{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T18:48:04Z","timestamp":1792003684534,"version":"4.4.0"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T00:00:00Z","timestamp":1781568000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T00:00:00Z","timestamp":1781568000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2026,9]]},"DOI":"10.1007\/s40265-026-02349-3","type":"journal-article","created":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T06:52:21Z","timestamp":1781592741000},"page":"1545-1551","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Linerixibat: First Approval"],"prefix":"10.1007","volume":"86","author":[{"given":"Sheridan M.","family":"Hoy","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,6,16]]},"reference":[{"issue":"2","key":"2349_CR1","doi-asserted-by":"publisher","first-page":"86","DOI":"10.1007\/s11901-020-00517-x","volume":"19","author":"MM D\u00fcll","year":"2020","unstructured":"D\u00fcll MM, Kremer AE. Newer approaches to the management of pruritus in cholestatic liver disease. Curr Hepatol Rep. 2020;19(2):86\u201395.","journal-title":"Curr Hepatol Rep"},{"key":"2349_CR2","doi-asserted-by":"publisher","first-page":"123","DOI":"10.1007\/s11901-024-00638-7","volume":"23","author":"V Kode","year":"2024","unstructured":"Kode V, Yimam KK. Cholestatic pruritus: pathophysiology, current management approach, and emerging therapies. Curr Hepatol Rep. 2024;23:123\u201336.","journal-title":"Curr Hepatol Rep"},{"issue":"1","key":"2349_CR3","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1016\/S2468-1253(25)00192-X","volume":"11","author":"GM Hirschfield","year":"2026","unstructured":"Hirschfield GM, Bowlus CL, Jones DEJ, et al. Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026;11(1):22\u201333.","journal-title":"Lancet Gastroenterol Hepatol."},{"issue":"7","key":"2349_CR4","doi-asserted-by":"publisher","first-page":"1379","DOI":"10.1016\/j.cgh.2018.12.007","volume":"17","author":"VS Hegade","year":"2019","unstructured":"Hegade VS, Mells GF, Fisher H, et al. Pruritus is common and undertreated in patients with primary biliary cholangitis in the United Kingdom. Clin Gastroenterol Hepatol. 2019;17(7):1379-87 e3.","journal-title":"Clin Gastroenterol Hepatol"},{"issue":"3","key":"2349_CR5","doi-asserted-by":"publisher","first-page":"995","DOI":"10.1007\/s10620-022-07581-x","volume":"68","author":"MJ Mayo","year":"2023","unstructured":"Mayo MJ, Carey E, Smith HT, et al. Impact of pruritus on quality of life and current treatment patterns in patients with primary biliary cholangitis. Dig Dis Sci. 2023;68(3):995\u20131005.","journal-title":"Dig Dis Sci"},{"issue":"1","key":"2349_CR6","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1136\/bmjgast-2023-001287","volume":"11","author":"U Gungabissoon","year":"2024","unstructured":"Gungabissoon U, Smith HT, von Maltzahn R, et al. Pruritus in primary biliary cholangitis is under-recorded in patient medical records. BMJ Open Gastroenterol. 2024;11(1):1\u20139.","journal-title":"BMJ Open Gastroenterol"},{"issue":"5","key":"2349_CR7","doi-asserted-by":"publisher","first-page":"401","DOI":"10.1111\/hepr.13880","volume":"53","author":"RC de Veer","year":"2023","unstructured":"de Veer RC, van Hooff MC, da Silva G, et al. Quality of life in Dutch patients with primary biliary cholangitis: discrepancies between patients\u2019 perspectives and objective disease parameters. Hepatol Res. 2023;53(5):401\u20138.","journal-title":"Hepatol Res"},{"key":"2349_CR8","unstructured":"GSK. LYNAVOY (linerixibat) tablets, for oral use: US prescribing information. 2026. https:\/\/www.fda.gov\/. Accessed 4 May 2026."},{"key":"2349_CR9","unstructured":"GSK. Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC) [media release]. 19 Mar 2026. http:\/\/www.gsk.com."},{"key":"2349_CR10","unstructured":"US Food & Drug Administration. NDA approval for Lynavoy (linerixibat) tablets. 2026. https:\/\/www.fda.gov\/. Accessed 4 May 2026."},{"key":"2349_CR11","unstructured":"GlaxoSmithKline UK Limited. Lynavoy 40 mg film-coated tablets: UK summary of product characteristics. 2026. https:\/\/products.mhra.gov.uk\/. Accessed 11 May 2026."},{"key":"2349_CR12","unstructured":"UK Medicines and Healthcare products Regulatory Agency. MHRA approves Linerixibat (Lynavoy) for the treatment of itch due to biliary tract disease [media release]. 1 May 2026. https:\/\/www.gov.uk\/government\/news\/mhra-approves-linerixibat-lynavoy-for-the-treatment-of-itch-due-to-biliary-tract-disease."},{"key":"2349_CR13","unstructured":"Ministry of Health, Labour and Welfare of Japan. Regarding the revocation and designation of orphan drugs (27 June 2025). 2025. https:\/\/www.mhlw.go.jp\/web\/t_doc?dataId=00tc9215&dataType=1&pageNo=1. Accessed 8 May 2026."},{"key":"2349_CR14","unstructured":"US Food & Drug Administration. Orphan drug designations and approvals. 2019. https:\/\/www.fda.gov\/. Accessed 4 May 2026."},{"key":"2349_CR15","unstructured":"European Medicines Agency. EU\/3\/21\/2515: orphan designation for treatment of primary biliary cholangitis. 2021. https:\/\/www.ema.europa.eu\/en\/medicines\/human\/orphan-designations\/eu-3-21-2515. Accessed 4 May 2026."},{"key":"2349_CR16","unstructured":"Alfasigma S.p.A. Alfasigma completes agreement with GSK for linerixibat [media release]. 27 April 2026. https:\/\/www.alfasigma.com\/."},{"issue":"1","key":"2349_CR17","doi-asserted-by":"publisher","first-page":"70","DOI":"10.1002\/cpdd.576","volume":"8","author":"H Ino","year":"2019","unstructured":"Ino H, Endo A, Wakamatsu A, et al. Safety, tolerability, pharmacokinetic and pharmacodynamic evaluations following single oral doses of GSK2330672 in healthy Japanese volunteers. Clin Pharmacol Drug Dev. 2019;8(1):70\u20137.","journal-title":"Clin Pharmacol Drug Dev."},{"issue":"10074","key":"2349_CR18","doi-asserted-by":"publisher","first-page":"1114","DOI":"10.1016\/S0140-6736(17)30319-7","volume":"389","author":"VS Hegade","year":"2017","unstructured":"Hegade VS, Kendrick SF, Dobbins RL, et al. Effect of ileal bile acid transporter inhibitor GSK2330672 on pruritus in primary biliary cholangitis: a double-blind, randomised, placebo-controlled, crossover, phase 2a study. Lancet. 2017;389(10074):1114\u201323.","journal-title":"Lancet"},{"issue":"7","key":"2349_CR19","doi-asserted-by":"publisher","first-page":"1902","DOI":"10.1016\/j.cgh.2022.10.032","volume":"21","author":"C Levy","year":"2023","unstructured":"Levy C, Kendrick S, Bowlus CL, et al. GLIMMER: a randomized phase 2b dose-ranging trial of linerixibat in primary biliary cholangitis patients with pruritus. Clin Gastroenterol Hepatol. 2023;21(7):1902-12.e13.","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2349_CR20","unstructured":"Impact of linerixibat on pharmacodynamic biomarkers and mediators of cholestatic pruritus in PBC in the phase 3 GLISTEN study. Gastroenterol Hepatol (NY). 2025;21(12 Suppl 10):6\u20137."},{"issue":"2","key":"2349_CR21","doi-asserted-by":"publisher","first-page":"288","DOI":"10.1002\/cpt.3103","volume":"115","author":"F Carre\u00f1o","year":"2024","unstructured":"Carre\u00f1o F, Karatza E, Mehta R, et al. Population dose\u2013response-time analysis of itch reduction and patient-reported tolerability supports phase III dose selection for linerixibat. Clin Pharmacol Ther. 2024;115(2):288\u201398.","journal-title":"Clin Pharmacol Ther"},{"key":"2349_CR22","unstructured":"US National Institutes of Health. ClinicalTrials.gov identifier NCT02966834. 2021. https:\/\/clinicaltrials.gov\/. Accessed 4 May 2026."},{"issue":"7","key":"2349_CR23","doi-asserted-by":"publisher","first-page":"629","DOI":"10.1111\/hepr.13895","volume":"53","author":"A Tanaka","year":"2023","unstructured":"Tanaka A, Atsukawa M, Tsuji K, et al. Japanese subgroup analysis of GLIMMER: a global phase IIb study of linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis. Hepatol Res. 2023;53(7):629\u201340.","journal-title":"Hepatol Res"}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-026-02349-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40265-026-02349-3","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-026-02349-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T18:05:21Z","timestamp":1792001121000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40265-026-02349-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,16]]},"references-count":23,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["2349"],"URL":"https:\/\/doi.org\/10.1007\/s40265-026-02349-3","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,16]]},"assertion":[{"value":"22 April 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 May 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 June 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 October 2026","order":5,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Update","order":6,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This article was originally published under the subscription model but it is now published under an Open Access license.","order":7,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sheridan M. Hoy is a salaried employee of Adis International Ltd\/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.","order":1,"name":"Ethics","label":"Authorship and Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","label":"Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability","group":{"name":"EthicsHeading","label":"Declarations"}}]}}