{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T09:02:02Z","timestamp":1790240522725,"version":"4.1.0"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T00:00:00Z","timestamp":1630454400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,6,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS] = 0) at test-of-cure (day 11 \u00b1 3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS \u2264 1) at test-of-cure, and symptom resolution at follow-up (day 25 \u00b1 4).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95\/188] vs 28.6% [28\/98]; P = .001), mycological eradication (49.5% [93\/188] vs 19.4% [19\/98]; P &amp;lt; .001), and overall success (36.0% [64\/178] vs 12.6% [12\/95]; P &amp;lt; .001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112\/188] vs 44.9% [44\/98]; P = .009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for Black patients (54.8% [40\/73] and 63.4% [47\/73], respectively) and patients with a body mass index &amp;gt;35 (54.5% [24\/44] and 68.2% [30\/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Ibrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciab750","type":"journal-article","created":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T07:21:13Z","timestamp":1630480873000},"page":"1979-1985","source":"Crossref","is-referenced-by-count":77,"title":["Ibrexafungerp Versus Placebo for Vulvovaginal Candidiasis Treatment: A Phase 3, Randomized, Controlled Superiority Trial (VANISH 303)"],"prefix":"10.1093","volume":"74","author":[{"given":"Jane R","family":"Schwebke","sequence":"first","affiliation":[{"name":"University of Alabama at Birmingham , Birmingham, Alabama , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan","family":"Sobel","sequence":"additional","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":"Janet K","family":"Gersten","sequence":"additional","affiliation":[{"name":"New Age Medical Research Corp , Miami, Florida , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven A","family":"Sussman","sequence":"additional","affiliation":[{"name":"Lawrence OB\/GYN Clinical Research , Lawrenceville, New Jersey , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel N","family":"Lederman","sequence":"additional","affiliation":[{"name":"Altus Research Inc, Lake Worth, Florida , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark A","family":"Jacobs","sequence":"additional","affiliation":[{"name":"Life Research , Inc, Houston, Texas , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B Todd","family":"Chappell","sequence":"additional","affiliation":[{"name":"WR-Medical Research Center of Memphis, LLC , Memphis, Tennessee , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David L","family":"Weinstein","sequence":"additional","affiliation":[{"name":"Consultants in Women\u2019s Healthcare, Inc , St. Louis, Missouri , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Alfred H","family":"Moffett","sequence":"additional","affiliation":[{"name":"OB-GYN Associates of Mid-Florida, PA , Leesburg, Florida , 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":"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":"Katyna","family":"Borroto-Esoda","sequence":"additional","affiliation":[{"name":"KBE Consulting , Raleigh, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahmoud A","family":"Ghannoum","sequence":"additional","affiliation":[{"name":"Case Western Reserve University and University Hospitals Cleveland Medical Center , Cleveland, Ohio , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Nyirjesy","sequence":"additional","affiliation":[{"name":"Jefferson Vulvovaginal Health Center, 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