{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T14:33:02Z","timestamp":1790346782333,"version":"4.1.0"},"reference-count":25,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2018,8,29]],"date-time":"2018-08-29T00:00:00Z","timestamp":1535500800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Sato Pharmaceutical Co., Ltd, Japan"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Fosravuconazole L\u2010lysine ethanolate (F\u2010RVCZ) is a prodrug of ravuconazole, a novel triazole antifungal agent, exerting broad and potent antifungal activity. The efficacy and safety of F\u2010\n                    <jats:styled-content style=\"fixed-case\">RVCZ<\/jats:styled-content>\n                    , compared with a placebo, were investigated in a multicenter, double\u2010blind, randomized study of Japanese onychomycosis patients with 25% or more clinical involvement of the target toenail. Subjects (\n                    <jats:italic>n<\/jats:italic>\n                    = 153) were randomly assigned to receive F\u2010\n                    <jats:styled-content style=\"fixed-case\">RVCZ<\/jats:styled-content>\n                    (100 mg\n                    <jats:styled-content style=\"fixed-case\">RVCZ<\/jats:styled-content>\n                    ,\n                    <jats:italic>n<\/jats:italic>\n                    = 101) or placebo (\n                    <jats:italic>n<\/jats:italic>\n                    = 52) p.o. once daily for 12 weeks. The primary end\u2010point was the rate of complete cure (clinical cure [0% clinical involvement of the target toenail] plus mycological cure [negative potassium hydroxide examination]) at week 48 (36\u2010week post\u2010treatment visit). Secondary end\u2010points were changes over time in the efficacy and mycological effect of F\u2010\n                    <jats:styled-content style=\"fixed-case\">RVCZ<\/jats:styled-content>\n                    . Safety was also evaluated. The complete cure rate at week 48 was significantly higher with F\u2010\n                    <jats:styled-content style=\"fixed-case\">RVCZ<\/jats:styled-content>\n                    (59.4%, 60\/101) than the placebo (5.8%, 3\/52) in the full analysis set (\n                    <jats:italic>P<\/jats:italic>\n                    &lt; 0.001). The mycological cure rate at week 48 was also significantly higher with F\u2010\n                    <jats:styled-content style=\"fixed-case\">RVCZ<\/jats:styled-content>\n                    (82.0%, 73\/89) than the placebo (20.0%, 10\/50,\n                    <jats:italic>P<\/jats:italic>\n                    &lt; 0.001). Regarding safety, adverse events were observed in 83.2% (84\/101) and 80.8% (42\/52), and adverse drug reactions (\n                    <jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content>\n                    ) in 23.8% (24\/101) and 3.8% (2\/52) of F\u2010\n                    <jats:styled-content style=\"fixed-case\">RVCZ<\/jats:styled-content>\n                    and placebo subjects, respectively.\n                    <jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content>\n                    were mild to moderate in severity, with none being serious. F\u2010\n                    <jats:styled-content style=\"fixed-case\">RVCZ<\/jats:styled-content>\n                    (equivalent to 100 mg ravuconazole) administrated once daily for 12 weeks was more effective than placebo and tolerable in patients with onychomycosis, suggesting it to be a promising drug for onychomycosis treatment.\n                  <\/jats:p>","DOI":"10.1111\/1346-8138.14607","type":"journal-article","created":{"date-parts":[[2018,8,30]],"date-time":"2018-08-30T04:08:36Z","timestamp":1535602116000},"page":"1151-1159","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":74,"title":["Efficacy and safety of fosravuconazole L\u2010lysine ethanolate, a novel oral triazole antifungal agent, for the treatment of onychomycosis: A multicenter, double\u2010blind, randomized phase\n                    <scp>III<\/scp>\n                    study"],"prefix":"10.1111","volume":"45","author":[{"given":"Shinichi","family":"Watanabe","sequence":"first","affiliation":[{"name":"Institute of Medical Mycology Teikyo University Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ichiro","family":"Tsubouchi","sequence":"additional","affiliation":[{"name":"Sato Pharmaceutical Co., Ltd Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7832-5639","authenticated-orcid":false,"given":"Akihiro","family":"Okubo","sequence":"additional","affiliation":[{"name":"Sato Pharmaceutical Co., Ltd Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,8,29]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.3314\/mmj.56.J129"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.3314\/mmj.16-00006"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2005.01212.x"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.3314\/mmj.55.J157"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.46.6.1723-1727.2002"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.44.10.2883-2886.2000"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/13693780410001731583"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.49.12.5136-5138.2005"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.40.10.2237"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.42.2.313"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.39.9.3254-3259.2001"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.8.3107-3111.2004"},{"key":"e_1_2_7_14_1","unstructured":"MummaneniV GeraldesM HadjilambrisOW OuyangZ UdermanH MarinoMR.Effect of ravuconazole on the pharmacokinetics of simvastatin in healthy subjects. In Abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy Toronto Ontario Canada 2000."},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12557"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2133.1999.00008.x"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2012.10.013"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.13816"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.2165\/00128071-200405030-00002"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2009.03487.x"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1665-2681(19)32159-3"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8278(94)80146-0"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2005.00943.x"},{"key":"e_1_2_7_24_1","first-page":"170","article-title":"Hepatotoxicity of antifungal agents","volume":"6","author":"Song JC","year":"2005","journal-title":"Curr Opin Investig Drugs"},{"key":"e_1_2_7_25_1","unstructured":"ITRIZOLE\u00ae(itraconazole) [package insert]. Tokyo Japan: Janssen Pharmaceutical K.K. 2017. (in Japanese)."},{"key":"e_1_2_7_26_1","unstructured":"LAMISIL\u00ae(terbinafine) [package insert]. Tokyo Japan: Sun Pharma Japan Limited 2017. (in Japanese)."}],"container-title":["The Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2F1346-8138.14607","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1346-8138.14607","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,16]],"date-time":"2023-09-16T18:30:09Z","timestamp":1694889009000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1346-8138.14607"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,8,29]]},"references-count":25,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2018,10]]}},"alternative-id":["10.1111\/1346-8138.14607"],"URL":"https:\/\/doi.org\/10.1111\/1346-8138.14607","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.3410\/f.733886324.793561580","asserted-by":"object"}]},"ISSN":["0385-2407","1346-8138"],"issn-type":[{"value":"0385-2407","type":"print"},{"value":"1346-8138","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,8,29]]},"assertion":[{"value":"2018-04-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-07-18","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-08-29","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}