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Glucan Synthase Inhibitor
Ibrexafungerp for Vaginal Yeast Infection
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
Subject should also have:
A recurrent vulvovaginal candidiasis (RVVC) episode with breakthrough symptoms while receiving maintenance antifungal therapy. OR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days post baseline through 60 days post end of treatment
Awards & highlights
Study Summary
This trial will treat people with a tough form of yeast infection who haven't gotten better from other drugs. Ibrexafungerp will be given for 1, 3, or 7 days.
Who is the study for?
This trial is for post-menarchal women aged 18 or older with a severe yeast infection that didn't improve after fluconazole treatment, or those allergic to azoles. Participants must not be pregnant, breastfeeding, or planning pregnancy and agree to use two forms of birth control. They should have no other vaginal infections and be willing to follow the study procedures.Check my eligibility
What is being tested?
The trial tests Ibrexafungerp's effectiveness in treating complicated vulvovaginal candidiasis (VVC) over 1, 3, or 7 days in women who haven't responded well to standard fluconazole therapy. It aims to see if this new treatment can better manage symptoms of persistent or resistant VVC.See study design
What are the potential side effects?
Potential side effects of Ibrexafungerp may include digestive issues like nausea and diarrhea, headaches, dizziness, menstrual changes, and possible liver enzyme elevations. Allergic reactions are also a concern for those with known hypersensitivity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I apologize, but it seems like you didn't provide any specific criteria in your previous statement. Could you please provide more information or specify the criteria you would like me to summarize?
Select...
You have a recurring yeast infection in the vagina that keeps coming back even with ongoing treatment.
Select...
You have had a bad reaction or cannot tolerate azole medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days post baseline through 60 days post end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days post baseline through 60 days post end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Cure
Secondary outcome measures
Clinical Improvement
Clinical Success
Side effects data
From 2019 Phase 3 trial • 376 Patients • NCT0373499126%
Diarrhoea
16%
Nausea
9%
Headache
7%
Abdominal pain
6%
Abdominal discomfort
5%
Bacterial vaginosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Ibrexafungerp (SCY-078)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group b (7 Day dosing)Experimental Treatment1 Intervention
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Group II: Group B (3 Day dosing)Experimental Treatment1 Intervention
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Group III: Group AExperimental Treatment1 Intervention
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrexafungerp
2019
Completed Phase 3
~1220
Find a Location
Who is running the clinical trial?
Scynexis, Inc.Lead Sponsor
17 Previous Clinical Trials
2,328 Total Patients Enrolled
Lori TierneyStudy DirectorScynexis, Inc.
Lori TiernyStudy DirectorScynexis, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have no other vaginal co-infections based on wet mount microscopic examination (and/or DNA probe).You have at least 2 of the 4 VSS signs or symptoms (moderate or worse) at baseline.You are able to understand and sign a written ICF.I apologize, but it seems like you didn't provide any specific criteria in your previous statement. Could you please provide more information or specify the criteria you would like me to summarize?You have a recurring yeast infection in the vagina that keeps coming back even with ongoing treatment.You have had a bad reaction or cannot tolerate azole medications.You are allergic to any of the ingredients in the medicine.You have been treated with ibrexafungerp in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B (3 Day dosing)
- Group 3: Group b (7 Day dosing)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do you think Ibrexafungerp is a safe medication for patients?
"Ibrexafungerp has undergone Phase 3 clinical trials, meaning that there is both existing data supporting its efficacy and multiple rounds of safety testing. Consequently, our team rates Ibrexafungerp as a 3 in terms of safety."
Answered by AI
Do you think that this research is applicable to a Canadian context?
"Additionally, this clinical trial has 6 other sites besides Seattle Clinical Research Center in Seattle, Washington, Women Under Study in New Orleans, Louisiana and Clinical Research Prime in Idaho Falls."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
TMC Life Research, Inc
What portion of applicants met pre-screening criteria?
Met criteria
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