Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022
Ibrexafungerp Versus Placebo for Vulvovaginal Candidiasis Treatment: A Phase 3, Randomized, Controlled Superiority Trial (VANISH 303).
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
40 citing papers in PubMed, 76 citations in OpenAlex.
- 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
- Antifungal activity of propolis against Candida spp.New microbes and new infections · 2026Review
- Epidemiology, Diagnostics and Therapy of Vulvovaginal Fungal Infections.Pathogens (Basel, Switzerland) · 2026Review
- Therapeutic Tools for Vulvovaginal Candidiasis: Current and Emerging Antifungal Agents.Journal of fungi (Basel, Switzerland) · 2026Review
- Non-Frontiers in microbiology · 2026Review
- 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
- Antifungal resistance: Emerging mechanisms and implications (Review).Molecular medicine reports · 2025Review
- Vaginal mycobiome characteristics and therapeutic strategies in vulvovaginal candidiasis (VVC): differentiating pathogenic species and microecological features for stratified treatment.Clinical microbiology reviews · 2025Review
- Genome-scale metabolic modeling reveals specific vaginalMicrobiology spectrum · 2025Article
- Beyond Conventional Antifungals: Combating Resistance Through Novel Therapeutic Pathways.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Fungal β-1,3-glucan synthase: a review of structure, mechanism, and regulation.FEMS yeast research · 2025Review
- Structure-guided design and synthesis of C22- and C32-modified FK520 analogs with enhanced activity against human pathogenic fungi.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- New antifungal strategies and drug development against WHO critical priority fungal pathogens.Frontiers in cellular and infection microbiology · 2025Review
- New Ground in Antifungal Discovery and Therapy for Invasive Fungal Infections: Innovations, Challenges, and Future Directions.Journal of fungi (Basel, Switzerland) · 2024Review
- Host-microbe interaction paradigms in acute and recurrent vulvovaginal candidiasis.Cell host & microbe · 2024Review
- 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
Corrections and comments
- Commented on by
Authors and funding
16 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCurrent 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.
methodsPatients 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 ± 3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS ≤ 1) at test-of-cure, and symptom resolution at follow-up (day 25 ± 4).
resultsPatients 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 < .001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P < .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 >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.
conclusionsIbrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC.
Indexed as
Identifiers
What OpenQuestion holds
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.