Trial reportBJOG : an international journal of obstetrics and gynaecology2022
Efficacy and safety of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis: a global phase 3, randomised, placebo-controlled superiority study (VANISH 306).
Trial report in BJOG : an international journal of obstetrics and gynaecology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.
- Global characteristics and trends in research onFrontiers in microbiology · 2023Pooled it
- Efficacy and safety of oral ibrexafungerp in Chinese patients with vulvovaginal candidiasis: a phase III, randomized, double-blind study.Infection · 2024Trial
- Safety, tolerability, and pharmacokinetics of ibrexafungerp in healthy Chinese subjects: a randomized, double-blind, placebo-controlled phase 1 trial.Antimicrobial agents and chemotherapy · 2023Trial
- Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306.Journal of women's health (2002) · 2023Trial
- Efficacy and safety of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis: a global phase 3, randomised, placebo-controlled superiority study (VANISH 306).BJOG : an international journal of obstetrics and gynaecology · 2022Trial
- Improvement of enfumafungin production by Hormonema carpetanum via mutagenesis and process optimization: mutant generation and preliminary transcriptomic analysis.World journal of microbiology & biotechnology · 2026Article
- Therapeutic Tools for Vulvovaginal Candidiasis: Current and Emerging Antifungal Agents.Journal of fungi (Basel, Switzerland) · 2026Review
- Aloe emodin disrupts Candida albicans mitochondrial iron homeostasis against its hyphal development and oral candidiasis.Applied microbiology and biotechnology · 2026Article
- Real-World Ibrexafungerp Use Patterns Among Patients with Commercial Health Insurance, United States, 2021-2023.Drugs - real world outcomes · 2025Article
- Ibrexafungerp: Mechanism of Action, Clinical, and Translational Science.Clinical and translational science · 2025Review
- Next-generation antifungal drugs: Mechanisms, efficacy, and clinical prospects.Acta pharmaceutica Sinica. B · 2025Review
- Beyond Conventional Antifungals: Combating Resistance Through Novel Therapeutic Pathways.Pharmaceuticals (Basel, Switzerland) · 2025Review
- New antifungal strategies and drug development against WHO critical priority fungal pathogens.Frontiers in cellular and infection microbiology · 2025Review
- Usage of Antifungal Agents in Pediatric Patients Versus Adults: Knowledge and Gaps.Mycopathologia · 2024Review
- Novel antifungals and treatment approaches to tackle resistance and improve outcomes of invasive fungal disease.Clinical microbiology reviews · 2024Review
- Article
- Phytotherapy of Vulvovaginal Candidiasis: A Narrative Review.International journal of molecular sciences · 2024Review
- A review of the fernane-type triterpenoids as anti-fungal drugs.Frontiers in pharmacology · 2024Review
- Ibrexafungerp: A narrative overview.Current research in microbial sciences · 2024Review
- The Role of Novel Antifungals in the Management of Candidiasis: A Clinical Perspective.Mycopathologia · 2023Review
Corrections and comments
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Authors and funding
9 authors at 5 institutions in 1 country.
Funding
Abstract
objectiveTo evaluate the efficacy and safety of ibrexafungerp versus placebo for acute vulvovaginal candidiasis (VVC) treatment.
designGlobal phase 3, randomised, placebo-controlled superiority study.
settingStudy sites in the USA (n = 19) and Bulgaria (n = 18). POPULATION: Female patients aged ≥12 years with acute VVC and a vulvovaginal signs and symptoms (VSS) score ≥4 at baseline.
methodsPatients were randomly assigned 2:1 to ibrexafungerp (300 mg twice for 1 day) or placebo.
main outcome measuresThe primary endpoint was the percentage of patients with a clinical cure (VSS = 0) at the test-of-cure visit (day 11 ± 3). Secondary endpoints included percentages of patients with mycological eradication, clinical cure and mycological eradication (overall success), clinical improvement (VSS ≤1) at test-of-cure visit, and complete resolution of symptoms at follow-up visit (day 25 ± 4).
resultsAt the test-of-cure visit, patients receiving ibrexafungerp had significantly higher rates of clinical cure (63.3% [119/188] versus 44.0% [37/84]; P = 0.007), mycological eradication (58.5% [110/188] versus 29.8% [25/84]; P < 0.001), overall success (46.1% [82/188] versus 28.4% [23/84]; P = 0.022) and clinical improvement (72.3% [136/188] versus 54.8% [46/84]; P = 0.01) versus those receiving placebo. Symptom resolution was sustained and further increased with ibrexafungerp (73.9%) versus placebo (52.4%) at follow-up (P = 0.001). Ibrexafungerp was generally well tolerated. Adverse events were primarily gastrointestinal and were mild to moderate in severity.
conclusionsIbrexafungerp demonstrated statistical superiority over placebo for the primary and secondary endpoints. Ibrexafungerp is a promising novel, well-tolerated and effective oral 1-day treatment for acute VVC. TWEETABLE ABSTRACT: Ibrexafungerp is statistically superior to placebo for the treatment of vulvovaginal candidiasis.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.