{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T03:29:45Z","timestamp":1789010985468,"version":"build-2803163510"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2021,9,23]],"date-time":"2021-09-23T00:00:00Z","timestamp":1632355200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"SCYNEXIS, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,7,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Vulvovaginal candidiasis affects approximately 75% of women in their lifetime. Approved treatment options are limited to oral or topical azoles. Ibrexafungerp, a novel, first-in-class oral triterpenoid glucan synthase inhibitor, has demonstrated broad fungicidal Candida activity and a favorable tolerability profile. The primary objective of this dose-finding study was to identify the optimal dose of oral ibrexafungerp in patients with acute vulvovaginal candidiasis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients with vulvovaginal signs and symptoms score \u22657 were randomized equally to 6 treatments groups: 5 treatment doses of oral ibrexafungerp or oral fluconazole 150 mg. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms) at the test-of-cure visit (day 10).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 186 patients were randomized into the 6 treatment groups. Results, using the modified intent-to-treat population (baseline positive culture), are reported for ibrexafungerp 300 mg twice daily (BID) for 1 day (n = 27), which was the dose selected for phase 3 studies, and fluconazole 150 mg for 1 day (n = 24). At day 10, the clinical cure rates for ibrexafungerp and fluconazole were 51.9% and 58.3%, respectively; at day 25, patients with no signs or symptoms were 70.4% and 50.0%, respectively. During the study ibrexafungerp patients required less antifungal rescue medications compared with fluconazole (3.7% vs 29.2%, respectively). Ibrexafungerp was well tolerated, with the most common treatment-related adverse events being mild gastrointestinal events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Ibrexafungerp is a well-tolerated novel antifungal with comparable efficacy to fluconazole in the treatment of acute vulvovaginal candidiasis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT03253094<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciab841","type":"journal-article","created":{"date-parts":[[2021,9,22]],"date-time":"2021-09-22T15:19:30Z","timestamp":1632323970000},"page":"2129-2135","source":"Crossref","is-referenced-by-count":36,"title":["Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis"],"prefix":"10.1093","volume":"74","author":[{"given":"Paul","family":"Nyirjesy","sequence":"first","affiliation":[{"name":"Jefferson Vulvovaginal Health Center, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College at Thomas Jefferson University , Philadelphia, Pennsylvania , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane R","family":"Schwebke","sequence":"additional","affiliation":[{"name":"University of Alabama at Birmingham , Birmingham, Alabama , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A","family":"Angulo","sequence":"additional","affiliation":[{"name":"SCYNEXIS, Inc , Jersey City, New Jersey , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Itzel A","family":"Harriott","sequence":"additional","affiliation":[{"name":"SCYNEXIS, Inc , Jersey City, New Jersey , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nkechi E","family":"Azie","sequence":"additional","affiliation":[{"name":"SCYNEXIS, Inc , Jersey City, New Jersey , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jack D","family":"Sobel","sequence":"additional","affiliation":[{"name":"Wayne State University , Detroit, Michigan , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,9,23]]},"reference":[{"key":"2022070618172831400_CIT0001","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1111\/myc.12292","article-title":"Guideline: vulvovaginal candidosis (AWMF 015\/072), S2k (excluding chronic mucocutaneous candidosis)","volume":"58","author":"Mendling","year":"2015","journal-title":"Mycoses"},{"key":"2022070618172831400_CIT0002","first-page":"1","article-title":"Sexually transmitted diseases treatment guidelines, 2015","volume":"64","author":"Workowski","year":"2015","journal-title":"MMWR Recomm Rep"},{"key":"2022070618172831400_CIT0003","doi-asserted-by":"crossref","first-page":"121","DOI":"10.3390\/jof4040121","article-title":"An update on the roles of non-albicans Candida species in vulvovaginitis","volume":"4","author":"Makanjuola","year":"2018","journal-title":"J Fungi"},{"key":"2022070618172831400_CIT0004","volume-title":"Vaginal candidiasis","author":"Jeanmonod","year":"2020"},{"key":"2022070618172831400_CIT0005","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.1097\/AOG.0000000000003604","article-title":"Vaginitis in nonpregnant patients: ACOG practice bulletin, Number 215","volume":"135","author":"Committee on Practice Bulletins\u2014Gynecology.","year":"2020","journal-title":"Obstet Gynecol"},{"key":"2022070618172831400_CIT0006","volume-title":"Diflucan [package insert]","year":"2020"},{"key":"2022070618172831400_CIT0007","doi-asserted-by":"crossref","first-page":"E179","DOI":"10.1503\/cmaj.180963","article-title":"Associations between low- and high-dose oral fluconazole and pregnancy outcomes: 3 nested case-control studies","volume":"191","author":"B\u00e9rard","year":"2019","journal-title":"CMAJ"},{"key":"2022070618172831400_CIT0008","doi-asserted-by":"crossref","first-page":"266","DOI":"10.1016\/S1701-2163(15)30316-9","article-title":"Vulvovaginitis: screening for and management of trichomoniasis, vulvovaginal candidiasis, and bacterial vaginosis","volume":"37","author":"van Schalkwyk","year":"2015","journal-title":"J Obstet Gynaecol Can"},{"key":"2022070618172831400_CIT0009","doi-asserted-by":"crossref","first-page":"830","DOI":"10.1056\/NEJMoa1301066","article-title":"Use of oral fluconazole during pregnancy and the risk of birth defects","volume":"369","author":"M\u00f8lgaard-Nielsen","year":"2013","journal-title":"N Engl J Med"},{"key":"2022070618172831400_CIT0010","doi-asserted-by":"crossref","first-page":"1407","DOI":"10.1097\/AOG.0b013e31827307b2","article-title":"Fluconazole-resistant Candida albicans vulvovaginitis","volume":"120","author":"Marchaim","year":"2012","journal-title":"Obstet Gynecol"},{"key":"2022070618172831400_CIT0011","doi-asserted-by":"crossref","first-page":"238","DOI":"10.4236\/aid.2013.34035","article-title":"Prevalence of non-albicans Candida infections in women with recurrent vulvovaginal symptomatology","volume":"3","author":"Mintz","year":"2013","journal-title":"Adv Infect Dis"},{"key":"2022070618172831400_CIT0012","doi-asserted-by":"crossref","first-page":"869","DOI":"10.4155\/fmc-2018-0465","article-title":"Targeting the fungal cell wall: current therapies and implications for development of alternative antifungal agents","volume":"11","author":"Hasim","year":"2019","journal-title":"Future Med Chem"},{"key":"2022070618172831400_CIT0013","doi-asserted-by":"crossref","first-page":"e00833","DOI":"10.1128\/AAC.00833-17","article-title":"De novo acquisition of resistance to SCY-078 in Candida glabrata involves FKS mutations that both overlap and are distinct from those conferring Echinocandin resistance","volume":"61","author":"Jim\u00e9nez-Ortigosa","year":"2017","journal-title":"Antimicrob Agents Chemother"},{"key":"2022070618172831400_CIT0014","doi-asserted-by":"crossref","first-page":"893","DOI":"10.1080\/13543784.2020.1791820","article-title":"Oral Ibrexafungerp: an investigational agent for the treatment of vulvovaginal candidiasis","volume":"29","author":"Azie","year":"2020","journal-title":"Expert Opin Investig Drugs"},{"key":"2022070618172831400_CIT0015","doi-asserted-by":"crossref","first-page":"28","DOI":"10.3390\/jof6010028","article-title":"Aspiring antifungals: review of current antifungal pipeline developments","volume":"6","author":"Gintjee","year":"2020","journal-title":"J Fungi (Basel)"},{"key":"2022070618172831400_CIT0016","doi-asserted-by":"crossref","first-page":"e02611","DOI":"10.1128\/AAC.02611-18","article-title":"A novel 1,3-beta-D-glucan inhibitor, ibrexafungerp (formerly SCY-078), shows potent activity in the lower pH environment of vulvovaginitis","volume":"63","author":"Larkin","year":"2019","journal-title":"Antimicrob Agents Chemother"},{"key":"2022070618172831400_CIT0017","doi-asserted-by":"crossref","first-page":"e02119","DOI":"10.1128\/AAC.02119-18","article-title":"SCY-078, a novel fungicidal agent, demonstrates distribution to tissues associated with fungal infections during mass balance studies with intravenous and oral [14 C]SCY-078 in albino and pigmented rats","volume":"63","author":"Wring","year":"2019","journal-title":"Antimicrob Agents Chemother"},{"key":"2022070618172831400_CIT0018","article-title":"SCY-078 phase 2 study in moderate and severe vulvovaginal candidiasis (VVC) [","author":"Roman"},{"key":"2022070618172831400_CIT0019","article-title":"Effect of SCY-078 on the pharmacokinetics of tacrolimus: results from a phase 1 clinical drug-drug interaction trial [","author":"Angulo"},{"key":"2022070618172831400_CIT0020","article-title":"Effect of SCY-078 on the pharmacokinetics of CYP2C8 substrate (rosiglitazone): results from a phase 1 clinical trial [","author":"Angulo"},{"key":"2022070618172831400_CIT0021","author":"US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research (CDER).","year":"2019"},{"key":"2022070618172831400_CIT0022","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1159\/000371759","article-title":"Miconazole nitrate vaginal suppository 1,200 mg versus oral fluconazole 150 mg in treating severe vulvovaginal candidiasis","volume":"80","author":"Fan","year":"2015","journal-title":"Gynecol Obstet Invest"},{"key":"2022070618172831400_CIT0023","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1016\/j.jiph.2011.05.006","article-title":"Oral fluconazole 150 mg single dose versus intra-vaginal clotrimazole treatment of acute vulvovaginal candidiasis","volume":"4","author":"Sekhavat","year":"2011","journal-title":"J Infect Public Health"},{"key":"2022070618172831400_CIT0024","doi-asserted-by":"crossref","first-page":"363","DOI":"10.1067\/mob.2001.115116","article-title":"Treatment of complicated Candida vaginitis: comparison of single and sequential doses of fluconazole","volume":"185","author":"Sobel","year":"2001","journal-title":"Am J Obstet Gynecol"},{"key":"2022070618172831400_CIT0025","doi-asserted-by":"crossref","first-page":"419","DOI":"10.1111\/myc.12485","article-title":"The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis","volume":"59","author":"Zhou","year":"2016","journal-title":"Mycoses"}],"container-title":["Clinical Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/cid\/advance-article-pdf\/doi\/10.1093\/cid\/ciab841\/40433544\/ciab841.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/74\/12\/2129\/44479588\/ciab841.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/74\/12\/2129\/44479588\/ciab841.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,7,6]],"date-time":"2022-07-06T14:46:22Z","timestamp":1657118782000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/cid\/article\/74\/12\/2129\/6374584"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9,23]]},"references-count":25,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2021,9,23]]},"published-print":{"date-parts":[[2022,7,6]]}},"URL":"https:\/\/doi.org\/10.1093\/cid\/ciab841","relation":{},"ISSN":["1058-4838","1537-6591"],"issn-type":[{"value":"1058-4838","type":"print"},{"value":"1537-6591","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2022,6,15]]},"published":{"date-parts":[[2021,9,23]]}}}