{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T06:40:45Z","timestamp":1790836845843,"version":"4.1.0"},"reference-count":14,"publisher":"Springer Science and Business Media LLC","issue":"15","license":[{"start":{"date-parts":[[2020,9,14]],"date-time":"2020-09-14T00:00:00Z","timestamp":1600041600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"},{"start":{"date-parts":[[2020,9,14]],"date-time":"2020-09-14T00:00:00Z","timestamp":1600041600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2020,10]]},"DOI":"10.1007\/s40265-020-01400-1","type":"journal-article","created":{"date-parts":[[2020,9,14]],"date-time":"2020-09-14T10:02:53Z","timestamp":1600077773000},"page":"1601-1605","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":124,"title":["Bulevirtide: First Approval"],"prefix":"10.1007","volume":"80","author":[{"given":"Connie","family":"Kang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yahiya Y.","family":"Syed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,9,14]]},"reference":[{"key":"1400_CR1","unstructured":"MYR Pharmaceuticals. MYR Pharmaceuticals receives Conditional Marketing Authorization by the European Commission for HEPCLUDEX\u00ae [media release]. 4 Aug 2020. https:\/\/www.prnewswire.com."},{"key":"1400_CR2","unstructured":"European Medicines Agency. Hepcludex (bulevirtide) powder for solution for injection: EU summary of product characteristics. 2020. https:\/\/ec.europa.eu. Accessed 31 Aug 2020."},{"issue":"3","key":"1400_CR3","doi-asserted-by":"publisher","first-page":"490","DOI":"10.1016\/j.jhep.2016.04.016","volume":"65","author":"P Bogomolov","year":"2016","unstructured":"Bogomolov P, Alexandrov A, Voronkova N, et al. Treatment of chronic hepatitis D with the entry inhibitor Myrcludex B: first results of a phase Ib\/IIa study. J Hepatol. 2016;65(3):490\u20138.","journal-title":"J Hepatol"},{"issue":"3","key":"1400_CR4","doi-asserted-by":"publisher","first-page":"483","DOI":"10.1016\/j.jhep.2016.04.013","volume":"65","author":"A Blank","year":"2016","unstructured":"Blank A, Markert C, Hohmann N, et al. First-in-human application of the novel hepatitis B and hepatitis D virus entry inhibitor Myrcludex B. J Hepatol. 2016;65(3):483\u20139.","journal-title":"J Hepatol"},{"key":"1400_CR5","unstructured":"European Medicines Agency. Hepcludex: EPAR\u2014medicine overview. 2020. https:\/\/www.ema.europa.eu. Accessed 31 Aug 2020."},{"key":"1400_CR6","unstructured":"MYR Pharmaceuticals. MYR Pharmaceuticals\u2014treatment of HBV & HDV infections. 2020. https:\/\/myr-pharma.com. Accessed 31 Aug 2020."},{"key":"1400_CR7","unstructured":"Maxwell Biotech Venture Fund. Maxwell Biotech Venture Fund invests in hepatitis B\/D clinical program [media release]. 15 Mar 2012. https:\/\/www.rvc.ru."},{"issue":"5","key":"1400_CR8","doi-asserted-by":"publisher","first-page":"861","DOI":"10.1016\/j.jhep.2012.12.008","volume":"58","author":"T Volz","year":"2013","unstructured":"Volz T, Allweiss L, Ben MM, et al. The entry inhibitor Myrcludex-B efficiently blocks intrahepatic virus spreading in humanized mice previously infected with hepatitis B virus. J Hepatol. 2013;58(5):861\u20137.","journal-title":"J Hepatol"},{"key":"1400_CR9","unstructured":"European Medicines Agency. Hepcludex: EU assessment report. 2020. https:\/\/www.ema.europa.eu. Accessed 31 Aug 2020."},{"key":"1400_CR10","doi-asserted-by":"crossref","unstructured":"Wedemeyer H, Bogomolov P, Blank A, et al. Final results of a multicenter, open-label phase 2b clinical trial to assess safety and efficacy of Myrcludex B in combination with tenofovir in patients with chronic HBV\/HDV co-infection [abstract no. GS-005]. J Hepatol. 2018;68(Suppl 1):S3.","DOI":"10.1016\/S0168-8278(18)30224-1"},{"key":"1400_CR11","doi-asserted-by":"crossref","unstructured":"Wedemeyer H, Schoneweis K, Bogomolov PO, et al. Final results of a multicenter, open-label phase 2 clinical trial (MYR203) to assess safety and efficacy of Myrcludex B in with PEG-interferon alpha 2a in patients with chronic HBV\/HDV co-infection [abstract no. GS-13]. J Hepatol. 2019;70(1):e81.","DOI":"10.1016\/S0618-8278(19)30141-0"},{"key":"1400_CR12","doi-asserted-by":"crossref","unstructured":"Wedemeyer H, Schoneweis K, Bogomolov P, et al. Safety and efficacy of 10mg (high-dose) bulevirtide (Myrcludex B) in combination with PEG-interferon alpha 2a or tenofovir in patients with chronic HBV\/ HDV co-infection: week 24 interim results of the MYR203 extension study [abstract no. 85]. Hepatology. 2019;70(Suppl 1):58A-9A.","DOI":"10.1016\/S0618-8278(19)30141-0"},{"key":"1400_CR13","doi-asserted-by":"publisher","first-page":"6815","DOI":"10.1007\/s00216-015-8853-5","volume":"407","author":"M Haag","year":"2015","unstructured":"Haag M, Hofmann U, M\u00fcrdter TE, et al. Quantitative bile acid profiling by liquid chromatography quadrupole time-of-flight mass spectrometry: monitoring epatitis B therapy by a novel Na+-taurocholate cotransporting polypeptide inhibitor. Anal Bioanal Chem. 2015;407:6815\u201325.","journal-title":"Anal Bioanal Chem"},{"key":"1400_CR14","unstructured":"Hepatera. Maxwell Biotech portfolio company Hepatera announces proof-of-concept clinical results with Myrcludex B, a novel entry inhibitor for treatment of chronic hepatitis B and Delta [media release]. 21 Oct 2014. https:\/\/www.hepatera.ru."}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-020-01400-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40265-020-01400-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-020-01400-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,9,14]],"date-time":"2021-09-14T00:28:23Z","timestamp":1631579303000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40265-020-01400-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,14]]},"references-count":14,"journal-issue":{"issue":"15","published-print":{"date-parts":[[2020,10]]}},"alternative-id":["1400"],"URL":"https:\/\/doi.org\/10.1007\/s40265-020-01400-1","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,9,14]]},"assertion":[{"value":"14 September 2020","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The preparation of this review was not supported by any external funding.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Connie Kang and Yahiya Y. Syed are salaried employees of Adis International Ltd\/Springer Nature, are responsible for the article content and declare no relevant conflicts of interest.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authorship and Conflict of interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability"}}]}}