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Antifungal

Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)

Phase 3
Waitlist Available
Research Sponsored by Scynexis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 8-14
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.

Eligible Conditions
  • Yeast Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8-14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8-14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Cure (Complete Resolution of Signs and Symptoms)
Secondary study objectives
Clinical Cure and Mycological Eradication (Responder Outcome)
Complete Clinical Response at Follow-Up
Mycological Eradication (Negative Culture for Growth of Yeast)
+1 more

Side effects data

From 2023 Phase 3 trial • 233 Patients • NCT03059992
70%
Diarrhoea
48%
Nausea
39%
Vomiting
16%
Headache
13%
Pyrexia
11%
Abdominal Pain
9%
Fatigue
9%
Urinary Tract Infection
8%
Abdominal Pain Upper
7%
Dizziness
7%
Acute Kidney Injury
6%
Rash
6%
Decreased Appetite
6%
Cough
6%
COVID-19
5%
Hyperkalaemia
5%
Dyspnoea
3%
Respiratory failure
3%
Acute kidney injury
2%
Pneumonia
2%
Urinary tract infection
2%
Dehydration
2%
Septic shock
2%
Sepsis
1%
Acute respiratory failure
1%
Abdominal infection
1%
Multiple organ dysfunction syndrome
1%
Pleural effusion
1%
Febrile neutropenia
1%
Cardiac failure
1%
Haematuria
1%
Anaemia
1%
Acute myocardial infarction
1%
Cardiac arrest
1%
Osteonecrosis
1%
Pain
1%
Cardiac failure chronic
1%
Cerebral infarction
1%
Atrial fibrillation
1%
Bacteraemia
1%
Bronchopulmonary aspergillosis
1%
Enterococcal bacteraemia
1%
Haemoptysis
1%
Hypoglycaemia
1%
Hyponatraemia
1%
Liver abscess
1%
Transient ischaemic attack
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibrexafungerp (SCY-078)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ibrexafungerp (SCY-078)Experimental Treatment1 Intervention
300 mg orally every 12 hrs for 1 day (2 doses in 1 day)
Group II: PlaceboPlacebo Group1 Intervention
Matching Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrexafungerp
FDA approved

Find a Location

Who is running the clinical trial?

Scynexis, Inc.Lead Sponsor
17 Previous Clinical Trials
2,102 Total Patients Enrolled
David Angulo, MDStudy DirectorScynexis, Inc.
7 Previous Clinical Trials
814 Total Patients Enrolled
~54 spots leftby Dec 2025
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